Schedule 1—Specified permissible ingredients and requirements applying to these ingredients when contained in a medicine
(section 4)
Part 2—Table 1
Column 1 | Column 2 Ingredient Name | Column 3 Purpose of the ingredient in the medicine | Column 4 Specific requirement(s) applying to the ingredient in Column 2 | |
724 | BACKHOUSIA CITRIODORA | A,E,H | The herbal substance must be derived from leaf oil only. Only for use in topical medicines for dermal application. The concentration in the medicine must be no more than 10g/kg or 10g/L or 1%. The medicine requires the following warning statements on the medicine label: - (IRRIT) 'If irritation develops - discontinue use' - (CHILD3) 'Use in children under 12 years is not recommended' - (PREGNT) 'Not recommended for use by pregnant and lactating women' (or words to that effect). | |
725 | BACOPA MONNIERI | A,H |
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726 | BALLOTA NIGRA | A,H |
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727 | BALM OF GILEAD BUD DRY | A,H |
| |
BALM OF GILEAD BUD POWDER | A,H |
| ||
729 | BALSAM COPAIBA | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. | |
730 | BAMBUSA BREVIFLORA | A,E,H |
| |
731 | BAMBUSA TEXTILIS | A,H |
| |
732 | BANANA | E |
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733 | BANANA DISTILLATE | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. | |
734 | BAPHICACANTHUS CUSIA | A,H |
| |
735 | BAPTISIA CONFUSA | A,H |
| |
736 | BAPTISIA TINCTORIA | A,H |
| |
737 | BARBAREA VULGARIS | A,H |
| |
738 | BARIUM CARBONATE | H | Only for use as an active homoeopathic ingredient. | |
739 | BARIUM CHLORIDE | H | Only for use as an active homoeopathic ingredient. | |
BARIUM SULFATE | E | Only for use in topical medicines for dermal application. | ||
741 | BARLEY | E | Gluten is a mandatory component of Barley when the route of administration is other than topical and mucosal. When the route of administration is other than topical or mucosal, the medicine requires the following warning statement on the medicine label: - (GLUTEN) 'Contains [insert name of ingredient]' or words to that effect. | |
742 | BARLEY BRAN | E | Gluten is a mandatory component of Barley bran when the route of administration is other than topical and mucosal. When the route of administration is other than topical or mucosal, the medicine requires the following warning statement on the medicine label: - (GLUTEN) 'Contains [insert name of ingredient]' or words to that effect. | |
743 | BARLEY GERM | E | Gluten is a mandatory component of Barley germ when the route of administration is other than topical and mucosal. When the route of administration is other than topical or mucosal, the medicine requires the following warning statement on the medicine label: - (GLUTEN) 'Contains [insert name of ingredient]' or words to that effect. | |
744 | BARLEY LEAF | E |
| |
745 | BASIC BUTYLATED METHACRYLATE COPOLYMER | E | Only for use in oral medicines. | |
BASIC FUCHSIN | E | Only for use as a colour ingredient in topical medicines for dermal application. | ||
747 | BASIC RED 1 | E | Only for use as a colour in topical medicines for dermal application and not to be included in medicines intended for use in the eye or on damaged skin. The concentration in the medicine must be no more than 0.1%. | |
748 | BASIC VIOLET 11:1 | E | Only for use as a colour in topical medicines for dermal application and not intended for use in the eye or on damaged skin. The concentration in the medicine must be no more than 0.1%. | |
BASIL OIL COMOROS | A,E,H | Methyl chavicol is a mandatory component of Basil oil Comoros. When the concentration of Methyl chavicol in the medicine is more than 5%, the nominal capacity of the container must be no more than 25mL. When the concentration of Methyl chavicol in the medicine is more than 5% and the nominal capacity of the container is 25mL or less, a restricted flow insert must fitted on the container, and the medicine requires the following warning statement on the medicine label: - (CHILD) 'Keep out of reach of children' (or words to that effect). | ||
750 | BASIL OIL EUROPEAN | A,E,H | Methyl chavicol is a mandatory component of Basil oil European. When the concentration of Methyl chavicol in the medicine is more than 5%, the nominal capacity of the container must be no more than 25mL. When the concentration of Methyl chavicol in the medicine is more than 5% and the nominal capacity of the container is 25mL or less, a restricted flow insert must fitted on the container, and the medicine requires the following warning statement on the medicine label: - (CHILD) 'Keep out of reach of children' (or words to that effect). | |
751 | BASSIA SCOPARIA | A,H |
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752 | BATYL ALCOHOL | E | Only for use in topical medicines for dermal application. | |
753 | BAY LEAF | E |
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754 | BAY OIL | A,E,H | When the concentration of Bay oil in the medicine is more than 25%, the nominal capacity of the container must be no more than 25 mL. When the concentration of Bay oil in the medicine is more than 25% and the nominal capacity of the container is no more than 15 mL, there must be a restricted flow insert fitted on the container. When the concentration of Bay oil in the medicine is more than 25% and the nominal capacity of the container is more than 15 mL, a child resistant closure and restricted flow insert must be fitted on the container. The medicine requires the following warning statements on the medicine label: - (CHILD) 'Keep out of reach of children' (or word to that effect) - (NTAKEN) 'Not to be taken' | |
BEESWAX ABSOLUTE | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. | ||
756 | BEET RED | E | Permitted for use as a colour for oral and topical use. | |
757 | BEETROOT | E,H |
| |
758 | BEGONIA FIMBRISTIPULA | A,H |
| |
759 | BEHENETH-10 | E | Only for use in topical medicines for dermal application and not to be included in topical medicines intended for use in the eye. The concentration in the medicine must be no more than 1.5%. Residual levels of ethylene oxide are to be kept below the level of detection. | |
760 | BEHENIC ACID | E | When for oral ingestion, the maximum recommended daily dose must not provide more than 383.5 milligrams of behenic acid. | |
BEHENOXY DIMETHICONE | E | Only for use in topical medicines for dermal application. | ||
762 | BEHENOYL STEARIC ACID | E | Only for use in topical medicines for dermal application and not to be included in topical medicines intended for use in the eye. The concentration in the medicine must be no more than 2.4%. | |
763 | BEHENYL ALCOHOL | E | Only for use in topical medicines for dermal application. | |
764 | BELLADONNA HERB DRY | A,H | Alkaloids calculated as hyoscyamine and atropine are mandatory components of Belladonna herb dry. The concentration of alkaloids calculated as hyoscyamine in the medicine and must be no more than 300 micrograms/Kg or 300 micrograms/L or 0.00003%. The concentration of atropine in the medicine must be no more than 100 micrograms/kg or 100 micrograms/L or 0.00001%. | |
BELLADONNA HERB POWDER | A,H | Alkaloids calculated as hyoscyamine and atropine are mandatory components of Belladonna herb powder. The concentration of alkaloids calculated as hyoscyamine in the medicine must be no more than 300 micrograms/Kg or 300 micrograms/L or 0.00003%. The concentration of atropinei n the medicine must be no more than 100 micrograms/kg or 100 micrograms/L or 0.00001%. | ||
766 | BELLADONNA HERB PREPARED | A,H | Alkaloids calculated as hyoscyamine and atropine are mandatory components of Belladonna herb prepared and must be declared in the application. The concentration of alkaloids calculated as hyoscyamine from all ingredients in the product must be no more than 300 micrograms/Kg or 300 micrograms/L or 0.00003%. The concentration of atropine from all ingredients in the product must be no more than 100 micrograms/kg or 100 micrograms/L or 0.00001%. | |
767 | BELLIS PERENNIS | A,H |
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768 | BEMOTRIZINOL | A | Only for use as an active ingredient in topical sunscreens for dermal application. The concentration in the medicine must be no more than 10%. | |
769 | BENINCASA HISPIDA | A,E,H |
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770 | BENTONITE | E |
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771 | BENZALDEHYDE | E |
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772 | BENZALDEHYDE GLYCERYL ACETAL | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. | |
BENZALKONIUM CHLORIDE | E | Only for use in topical medicines for dermal application and nasal sprays. The concentration in the medicine must be no more than 5%.
| ||
774 | BENZETHONIUM CHLORIDE | E | Only for use as a preservative in topical medicines for dermal application. The medicine requires the warning statement: - (BNZTHC) 'Contains Benzethonium chloride' (or words to that effect). | |
775 | BENZOIC ACID | E,H | Medicines containing benzoates require the following warning statement on the medicine label: - (TBNZO8) ‘Contains benzoates' (or words to this effect)’ if the medicine contains two or more benzoate sources or ‘Contains [insert the approved name of benzoate used] (or words to this effect)’ if product contains one benzoate source. | |
776 | BENZOIN | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. | |
777 | BENZOIN SIAM | A,E,H |
| |
778 | BENZOIN SUMATRA | A,E,H |
| |
BENZOPHENONE | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. | ||
780 | BENZYL ACETATE | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. | |
781 | BENZYL ACETONE | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used as a fragrance the total fragrance concentration in a medicine must be no more than 1%. | |
782 | BENZYL ALCOHOL | E | The medicine requires the warning statement: - (BNZALC) 'Contains benzyl alcohol [quantity]' (or words to that effect). | |
783 | BENZYL BENZOATE | E | Only for use in topical medicines for dermal application. Medicines containing benzoates require the warning statement: - (TBNZO8) 'Contains benzoates' (or words to this effect) if the medicine contains two or more benzoate sources or 'Contains [insert the approved name of benzoate used]' (or words to this effect) if product contains one benzoate source. | |
BENZYL BUTYRATE | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. | ||
785 | BENZYL CINNAMATE | E | Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.15%. | |
786 | BENZYL DIMETHYL CARBINYL-N-BUTYRATE | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. | |
787 | BENZYL FORMATE | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. | |
788 | BENZYL ISOAMYL ETHER | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. | |
BENZYL ISOBUTYRATE | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. | ||
790 | BENZYL ISOVALERATE | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. | |
791 | BENZYL LAURATE | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. | |
792 | BENZYL PHENYLACETATE | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. | |
BENZYL PROPIONATE | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. | ||
794 | BENZYL SALICYLATE | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. | |
795 | BENZYLIDENE ACETONE | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. | |
796 | BENZYLIDENE CAMPHOR SULFONIC ACID | A | Only for use as an active ingredient in sunscreens for dermal application. The concentration in the preparation must be no more than 6% (as acid). | |
797 | BERBERIS AQUIFOLIUM | A,H |
| |
798 | BERBERIS ARISTATA | A | Only for use in oral medicines. The medicine requires the following warning statement on the medicine label: - (PREGNT) 'Not recommended for use by pregnant and lactating women' (or words to that effect). | |
BERBERIS VULGARIS | A,E,H |
| ||
800 | BERGAMOT OIL | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. | |
801 | BERGAMOT OIL BERGAPTEN-FREE | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. | |
BERGAMOT OIL COLDPRESSED | A,E,H | When for internal use oxedrine is a mandatory component of bergamot oil coldpressed. The maximum recommended daily dose must provide no more than 30 milligrams of oxedrine. The warning statement (SENS) 'Application to skin may increase sensitivity to sunlight' (or words to that effect) must be included on the medicine label unless the medicine is: a) for internal use; or b) in preparations containing 0.4 per cent or less of bergamot oil coldpressed; or c) for use in soaps or bath or shower gels that are washed off the skin. | ||
803 | BERGAMOT OIL TERPENELESS | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. | |
804 | BERTHOLLETIA EXCELSA | A,E,H |
| |
805 | BETA-CARYOPHYLLENE | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. | |
806 | BETA-DAMASCENONE | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. | |
BETA-DAMASCONE | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. | ||
808 | BETA-HOMO CYCLOCITRAL | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. | |
809 | BETA-HYDROXY-BETA-METHYLBUTYRIC ACID | A |
| |
810 | BETA-IONONE | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. | |
811 | BETA-ISO-METHYL IONONE | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. | |
BETA-METHYL NAPHTHYL KETONE | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. | ||
813 | BETA-N-METHYL IONONE | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. | |
814 | BETA-NAPHTHOL ETHYLETHER | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. | |
815 | BETA-NAPHTHOL METHYL ETHER | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. | |
BETA-NAPHTHYL ISOBUTYL ETHER | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. | ||
817 | BETA-PINENE | E | Permitted for use only in combination with other permitted ingredients as a flavour or fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. | |
818 | BETA-TOCOPHEROL | E |
| |
819 | BETA RAPA | A,E,H |
| |
820 | BETA VULGARIS | A,E,H |
| |
821 | BETA,4-DIMETHYLCYCLOHEX-3-ENE-1-PROPAN-1-AL | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. | |
822 | BETACAROTENE | A,E |
| |
823 | BETADEX | E |
| |
824 | BETAGLUCAN | E | Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.01%. | |
825 | BETAINE | E | Only for use in topical medicines for dermal application. | |
BETAINE HYDROCHLORIDE | E |
| ||
827 | BETULA LENTA | A,H | Methyl salicylate is a mandatory component of Betula lenta. Only for use in topical medicines for dermal application. The concentration of methyl salicylate in the medicine must be no more than 0.001%. When the concentration of methyl salicylate in a liquid preparation is more than 5%, and the dosage form is other than spray, the medicine requires child resistant packaging. When the concentration of methyl salicylate in a liquid preparation is more than 5%, and the dosage form is spray, the medicine does not require child resistant packaging but the delivery device must be engaged into the container in such a way that prevents it from being readily removed, direct suction through the delivery device results in delivery of no more than one dosage unit, and actuation of the spay device is ergonomically difficult for young children to accomplish. | |
BETULA NIGRA | A,H |
| ||
829 | BETULA PENDULA | A,E,H | Methyl salicylate is a mandatory component of Betula pendula. Only for use in topical medicines for dermal application. The concentration of methyl salicylate in the medicine must be no more than 0.001%. When the concentration of methyl salicylate in a liquid preparation is more than 5%, and the dosage form is other than spray, the medicine requires child resistant packaging. When the concentration of methyl salicylate in a liquid preparation is more than 5%, and the dosage form is spray, the medicine does not require child resistant packaging but the delivery device must be engaged into the container in such a way that prevents it from being readily removed, direct suction through the delivery device results in delivery of no more than one dosage unit, and actuation of the spay device is ergonomically difficult for young children to accomplish. | |
830 | BETULA PUBESCENS | A,E,H |
| |
831 | BICYCLO(2.2.1)HEPT-5-ENE-2-CARBOXYLIC ACID, 3-(1-METHYLETHYL)-, ETHYL ESTER, (1R,2R,3R,4S)-REL- | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. | |
832 | BICYCLO(2.2.2)OCT-5-ENE-2-CARBOXALDEHYDE, 6-METHYL-8-(1-METHYLETHYL)- | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. | |
833 | BIFIDOBACTERIUM ADOLESCENTIS | A |
| |
834 | BIFIDOBACTERIUM ANIMALIS | A |
| |
835 | BIFIDOBACTERIUM ANIMALIS SSP ANIMALIS | A |
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BIFIDOBACTERIUM ANIMALIS SSP LACTIS | A |
| ||
837 | BIFIDOBACTERIUM BIFIDUM | A |
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838 | BIFIDOBACTERIUM BREVE | A |
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839 | BIFIDOBACTERIUM INFANTIS | A |
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840 | BIFIDOBACTERIUM LACTIS | A |
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841 | BIFIDOBACTERIUM LONGUM | A |
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842 | BILBERRY | E |
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843 | BIOSACCHARIDE GUM-1 | E | Only for use in topical medicines for dermal application and not to be included in topical medicines intended for use in the eye. The concentration in the medicine must be no more than 5%. | |
844 | BIOTA ORIENTALIS | A,H |
| |
845 | BIOTIN | A,E | When used as an active ingredient and the route of administration is oral or sublingual, the medicine requires the following warning statement on the medicine label: - (VIT) ‘Vitamins can only be of assistance if the dietary vitamin intake is inadequate.’ or ‘Vitamin supplements should not replace a balanced diet.’ | |
846 | BIRCH LEAF DRY | A,E,H |
| |
847 | BIRCH TAR OIL RECTIFIED | A,E,H |
| |
BIS-DIGLYCERYL POLYACYLADIPATE-2 | E | Only for use in topical medicines for dermal application. | ||
849 | BIS-ETHYLHEXYL HYDROXYDIMETHOXY BENZYLMALONATE | E | Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 4%. | |
850 | BIS-MACROGOL 900 METHYL ETHER DIMETHYL SILANE | E | Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye or on damaged skin. The concentration in the medicine must be no more than 2.5%. | |
851 | BIS-PEG-12 DIMETHICONE BEESWAX | E | Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.2%. | |
852 | BIS-STEARYL ETHYLENEDIAMINE/NEOPENTYL GLYCOL/STEARYL HYDROGENATED DIMER DILINOLEATE COPOLYMER | E | Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 7%. | |
BISABOLENE | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. | ||
854 | BISABOLOL | E | If used as an excipient, the medicine is only for use in topical medicines for dermal application. | |
855 | BITTER ALMOND OIL | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. The absence of amygdalin in the medicine must be declared. | |
856 | BIXA ORELLANA | A,E,H |
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857 | BLACK BONED CHICKEN POWDER | A |
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858 | BLACK COHOSH DRY | A,H | The medicine requires the following warning statement on the medicine label: - (BCOHOSH) 'Warning: In very rare cases - black cohosh has been associated with liver failure. If you are experiencing yellowing of the skin or whites of the eyes - dark urine - nausea - vomiting - unusual tiredness - weakness - stomach or abdominal pain - and/or loss of appetite - you should stop using this product and see your doctor.' | |
859 | BLACK COHOSH POWDER | A,H | The medicine requires the following warning statement on the medicine label: - (BCOHOSH) 'Warning: In very rare cases - black cohosh has been associated with liver failure. If you are experiencing yellowing of the skin or whites of the eyes - dark urine - nausea - vomiting - unusual tiredness - weakness - stomach or abdominal pain - and/or loss of appetite - you should stop using this product and see your doctor.' | |
BLACK CURRANT | E |
| ||
861 | BLACK CURRANT ABSOLUTE | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. | |
862 | BLACK CURRANT FRESH | A,E,H |
| |
863 | BLACK CURRANT SEED OIL | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. | |
864 | BLACK OF CURACAO SPIDER | H | Only for use as an active homoeopathic ingredient. | |
865 | BLACK PEPPER OIL | A,E,H |
| |
866 | BLACK RASPBERRY | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. | |
867 | BLACK SNAKE | H | Only for use as an active homoeopathic ingredient. | |
868 | BLACKBERRY | E |
| |
BLACKBERRY OILS | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. | ||
870 | BLACKBERRY WINE | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. | |
871 | BLACKCURRANT ESTERS | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. | |
872 | BLACKCURRANT JUICE | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. | |
873 | BLACKSTRAP MOLASSES | E | When for oral or sublingual use, Sucrose is a mandatory component of Molasses - blackstrap. When the medicine is for oral ingestion and the total amount of all sugars (monosaccharides and disaccharides such as glucose, honey, invert sugar, lactose, maltose, and sucrose) is more than 100 mg in the maximum daily dose, then the medicine requires the following warning statement on the medicine label: - (SUGARS) ‘Contains [insert name of sugar]’ if medicine contains one sugar OR ‘Contains sugars' (or words to that effect) if medicine contains two or more sugars. If one of the sugars is lactose then the medicine also requires the following warning statement on the medicine label: - (LACT) ‘Contains lactose' (or words to that effect). | |
BLADDERWRACK DRY | A,H | Iodine is a mandatory component of Bladderwrack dry. Only for external use when the concentration of iodine in the medicine (excluding salts derivatives or iodophors) is 2.5% or less. Only for internal use when the medicine contains less than 300 micrograms of iodine per maximum recommended daily dose. The indication 'For mineral (may state the mineral) supplementation' is only permitted when the medicine is for oral or sublingual use. | ||
875 | BLADDERWRACK POWDER | A,H | Iodine is a mandatory component of Bladderwrack powder. Only for external use when the concentration of iodine in the medicine (excluding salts derivatives or iodophors) is 2.5% or less. Only for internal use when the medicine contains less than 300 micrograms of iodine per maximum recommended daily dose. The indication 'For mineral (may state the mineral) supplementation' is only permitted when the medicine is for oral or sublingual use. | |
876 | BLAINVILLEA ACMELLA | A,E,H | When used as an excipient, permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. | |
877 | BLETILLA STRIATA | A,H |
| |
878 | BLUE FLAG RHIZOME DRY | A,H |
| |
879 | BLUE FLAG RHIZOME POWDER | A,H |
| |
880 | BLUEBERRY | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. | |
881 | BLUEBERRY JUICE | E | Permitted for use only in combination with other permitted ingredients as a flavour or fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. | |
882 | BLUMEA LACERA | A,H |
| |
BOEHMERIA NIVEA | A,H |
| ||
884 | BOERHAVIA DIFFUSA | A,H |
| |
885 | BOERHAVIA REPENS | A,H |
| |
886 | BOGBEAN LEAF DRY | A,H |
| |
887 | BOGBEAN LEAF POWDER | A,H |
| |
888 | BOIS DE ROSE OIL | A,E,H |
| |
889 | BOMBAX CEIBA | A,H |
| |
890 | BORAGO OFFICINALIS | A,E,H | Only for use when the preparation is 'fixed oil' and the fixed oil is derived from seeds of Borago officinalis. | |
BORAX | A,E,H | Boron is a mandatory component of Borax. The percentage of Boron from Borax should be calculated based on the molecular weight of Borax. The maximum recommended daily dose must provide no more than 6mg of Boron. In preparations for dermal use, which are not for paediatric or antifungal use, the concentration of boron in the medicine must be no more than 3500 mg/kg or 3500 mg/L or 0.35%. The indication 'For mineral (may state the mineral) supplementation' is only permitted for use when the medicine is for oral or sublingual use. | ||
892 | BORAX PENTAHYDRATE | A,E | Boron is a mandatory component of Borax Pentahydrate. The percentage of Boron from Borax pentahydrate should be calculated based on the molecular weight of Borax Pentahydrate. The maximum recommended daily dose must provide no more than 6mg of Boron from Borax pentahydrate. In preparations for dermal use, which are not for paediatric or antifungal use, the concentration of boron in the medicine must be no more than 3500 mg/kg or 3500 mg/L or 0.35%. The indication 'For mineral (may state the mineral) supplementation' is only permitted for use when the medicine is for oral or sublingual use. | |
BORIC ACID | A,H | Boron is a mandatory component of Boric acid. The percentage of Boron from Boric acid should be calculated based on the molecular weight of Boric acid The maximum recommended daily dose must provide no more than 6mg of Boron. In preparations for dermal use, which are not for paediatric or antifungal use, the concentration of boron in the medicine must be no more than 3500 mg/kg or 3500 mg/L or 0.35% The indication 'For mineral (may state the mineral) supplementation' is only permitted for use when the medicine is for oral or sublingual use. | ||
894 | BORNEOL | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. | |
895 | BORNYL ACETATE | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. | |
896 | BORON NITRIDE | E | Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.5%. | |
BORONIA ABSOLUTE | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. | ||
898 | BORONIA MEGASTIGMA | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. | |
899 | BOSWELLIA CARTERII | A,E,H |
| |
900 | BOSWELLIA SERRATA | A,E,H |
| |
901 | BOSWELLIA THURIFERA | A,H |
| |
902 | BOTRYTIS CINEREA | A,H |
| |
903 | BOVINE CALCIUM CHONDROITIN SULFATE | A |
| |
904 | BOVINE CHONDROITIN SULFATE | A |
| |
905 | BOVINE COLOSTRUM POWDER | A | The medicine requires the warning statement: - (BOVCOL) 'Products containing bovine colostrum powder contain lactose and cow's milk proteins (or words to that effect). This product is not suitable for use in children under the age of 12 months except on professional health advice.' | |
906 | BOVINE LACTOFERRIN | A | The medicine requires the following warning statement on the medicine label: - (COWMK) 'Derived from cow's milk.' | |
907 | BOVINE POTASSIUM CHONDROITIN SULFATE | A |
| |
908 | BOVINE SODIUM CHONDROITIN SULFATE | A |
| |
909 | BOVINE WHEY IG-RICH FRACTION | A | Only for use in oral medicines. The medicine requires the following warning statements on the medicine label: - (COWMK) 'Derived from cows milk' - (BABY3) 'Not suitable for use in children under the age of 12 months - except on the advice of a health professional)'. | |
910 | BRANDY | E |
| |
BRASSICA CHINENSIS | A,H | Allyl isothiocyanate is a mandatory component of Brassica chinensis when the plant part is seed. The maximum recommended daily dose must not provide more than 20 mg of allyl isothiocyanate. | ||
912 | BRASSICA JUNCEA | A,H | Allyl isothiocyanate is a mandatory component of Brassica juncea when the plant part is seed. The maximum recommended daily dose must not provide more than 20 mg of allyl isothiocyanate. | |
913 | BRASSICA NAPUS | A,E,H | Allyl isothiocyanate is a mandatory component of Brassica napus when the plant part is seed. The maximum recommended daily dose must not provide more than 20 mg of allyl isothiocyanate. | |
914 | BRASSICA NIGRA | A,H | Allyl isothiocyanate is a mandatory component of Brassica nigra when the plant part is seed. The maximum recommended daily dose must not provide more than 20 mg of allyl isothiocyanate. | |
915 | BRASSICA OLERACEA VAR. BOTRYTIS | A,E,H | Allyl isothiocyanate is a mandatory component of Brassica oleracea var. botrytis when the plant part is seed. The maximum recommended daily dose must not provide more than 20 mg of allyl isothiocyanate. | |
BRASSICA OLERACEA VAR. CAPITATA | A,E,H | Allyl isothiocyanate is a mandatory component of Brassica oleracea var. capitata when the plant part is seed. The maximum recommended daily dose must not provide more than 20 mg of allyl isothiocyanate. | ||
917 | BRASSICA OLERACEA VAR. GEMMIFERA | A,H | Allyl isothiocyanate is a mandatory component of Brassica oleracea var. gemmifera when the plant part is seed. The maximum recommended daily dose must not provide more than 20 mg of allyl isothiocyanate. | |
918 | BRASSICA OLERACEA VAR. ITALICA | A,H | Allyl isothiocyanate is a mandatory component of Brassica oleracea var. italica when the plant part is seed. The maximum recommended daily dose must not provide more than 20 mg of allyl isothiocyanate. | |
919 | BRASSICA OLERACEA VAR. VIRIDIS | A,H | Allyl isothiocyanate is a mandatory component of Brassica oleracea var. viridis when the plant part is seed. The maximum recommended daily dose must not provide more than 20 mg of allyl isothiocyanate. | |
920 | BRASSICA PEKINENSIS | A,H | Allyl isothiocyanate is a mandatory component of Brassica pekinensis when the plant part is seed. The maximum recommended daily dose must not provide more than 20 mg of allyl isothiocyanate. | |
921 | BRASSICA RAPA | A,E,H | Allyl isothiocyanate is a mandatory component of Brassica rapa when the plant part is seed. The maximum recommended daily dose must not provide more than 20 mg of allyl isothiocyanate. | |
922 | BRAZIL NUT | E |
| |
923 | BRILLIANT BLACK BN | E | Permitted for use as a colour for oral and topical use. | |
924 | BRILLIANT BLUE FCF | E | Permitted for use as a colour for oral and topical use. | |
BRILLIANT BLUE FCF ALUMINIUM LAKE | E | Permitted for use as a colour for oral and topical use. | ||
926 | BRILLIANT BLUE FCF BARIUM LAKE | E | Permitted for use as a colour for oral and topical use. | |
927 | BRILLIANT SCARLET 4R | E | Permitted for use as a colour for oral and topical use. | |
928 | BRILLIANT SCARLET 4R ALUMINIUM LAKE | E | Permitted for use as a colour for oral and topical use. | |
929 | BRIZA MEDIA | A,H |
| |
930 | BROCCOLI | E |
| |
931 | BROMELAINS | A | May be derived from either the stem or fruit of the pineapple (Ananas comosus). If used in a divided preparation, the allowed units are papain units and million papain units. If used in an undivided preparation, the allowed units are million papain units per gram. | |
932 | BROMINE | H | Only for use as an active homoeopathic ingredient. The concentration of bromine in the preparation must be no more than 14mg/Kg or 14mg/L or 0.0014% for oral and sublingual use. | |
933 | BROMOSTYROL | E | Not for use in infants Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. | |
934 | BROMUS CATHARTICUS | A,H |
| |
BROMUS INERMIS | A,H |
| ||
936 | BROMUS RAMOSUS SUBSP. RAMOSUS | A,H |
| |
937 | BRONOPOL | E | Only for use as an excipient in topical medicines for dermal application. The medicine requires the warning statement: - (BRONOP) 'Contains bronopol [quantity]' (or words to that effect). | |
938 | BROUSSONETIA PAPYRIFERA | A,H |
| |
939 | BROWN FK | E | Permitted for use as a colour for topical use. | |
940 | BRUNFELSIA UNIFLORA | A,H | The maximum daily dose must be no more than the equivalent of 1mg of the dry herbal material. | |
941 | BRUSSEL SPROUT | E |
| |
942 | BRYONIA ALBA | A,H |
| |
943 | BRYONIA DIOICA | A,H |
| |
944 | BUCHU LEAF DRY | A,H |
| |
945 | BUCHU LEAF OIL | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. | |
946 | BUCHU LEAF POWDER | A,E,H |
| |
BUCKWHEAT | E,H | Only for use as an active homoeopathic or excipient ingredient. | ||
948 | BUDDLEJA OFFICINALIS | A,H |
| |
949 | BULNESIA SARMIENTI | A,E,H |
| |
950 | BUNIAS ORIENTALIS | A,H |
| |
951 | BUPLEURUM FALCATUM | A,H |
| |
952 | BURDOCK LEAF DRY | A,H |
| |
953 | BURDOCK LEAF POWDER | A,H |
| |
954 | BURDOCK ROOT DRY | A,H |
| |
955 | BURDOCK ROOT POWDER | A,H |
| |
956 | BUSHMASTER SNAKE | H | Only for use as an active homoeopathic ingredient. | |
957 | BUTAN-1-OL | E | The residual solvent limit for Butan-1-ol is 50 mg per maximum recommended daily dose. The concentration in the medicine must be no more than 0.5%. | |
958 | BUTANE | E | Only for use as an excipient propellant ingredient. | |
959 | BUTOXYETHANOL | E | Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.1%. | |
BUTTER | E |
| ||
961 | BUTTER ACIDS | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. | |
962 | BUTTER ESTERS | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. | |
963 | BUTTER STARTER DISTILLATE | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. | |
964 | BUTYL 2-METHYLBUTYRATE | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. | |
BUTYL ACETATE | E | The residual solvent limit for Butyl acetate is 50 mg per maximum recommended daily dose. The concentration in the medicine must be no more than 0.5%. | ||
966 | BUTYL BUTYRATE | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. | |
967 | BUTYL BUTYRYL LACTATE | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. | |
968 | BUTYL CAPROATE | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. | |
969 | BUTYL ESTER OF PVM/MA COPOLYMER | E | Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 15%. The medicine requires the following warning statements on the medicine label: - (EYE) 'Avoid contact with eyes' (or words to that effect) - (EYE2) 'May be irritant to the eyes' (or words to that effect). | |
BUTYL FORMATE | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. | ||
971 | BUTYL HYDROXYBENZOATE | E | Only for use in topical medicines for dermal application. Medicines containing hydroxybenzoates require the following warning statement on the medicine label: - (TOTBNZ) ‘Contains hydroxybenzoates’ (or words to this effect) if the medicine contains more than one hydroxybenzoate source OR ‘Contains [insert the approved name of hydroxybenzoate used]’ (or words to this effect) if product contains one hydroxybenzoate source. | |
972 | BUTYL ISOBUTYRATE | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. | |
973 | BUTYL ISOVALERATE | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. | |
BUTYL LACTATE | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. | ||
975 | BUTYL LEVULINATE | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. | |
976 | BUTYL METHOXYDIBENZOYLMETHANE | A | Only for use as an active ingredient in sunscreens for dermal application and not to be included in medicines intended for use in the eye. The concentration in preparation must be no more than 5%. | |
977 | BUTYL PROPIONATE | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. | |
978 | BUTYL STEARATE | E | Only for use in topical medicines for dermal application. | |
979 | BUTYL UNDECYLENATE | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. | |
980 | BUTYLATED HYDROXYANISOLE | E | The medicine requires the warning statement: - (BHANIS) 'Contains butylated hydroxyanisole' (or words to that effect). | |
BUTYLATED HYDROXYTOLUENE | E |
| ||
982 | BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE | E | Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 10%. | |
983 | BUTYLIDENE PHTHALIDE | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. | |
984 | BUTYLOCTYL SALICYLATE | E | Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 7%. | |
BUTYLPHENYL METHYLPROPIONAL | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. | ||
986 | BUTYRALDEHYDE | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. | |
987 | BUTYRIC ACID | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. | |
988 | C1-8 ALKYL TETRAHYDROXYCYCLOHEXANOATE | E | Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.012%. | |
989 | C10-12 ALKANE/CYCLOALKANE | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. | |
990 | C10-30 CHOLESTEROL/LANOSTEROL ESTERS | E | Only for use in topical medicines for dermal application. | |
C11-14-ISO-ALCOHOL C-13 RICH | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. | ||
992 | C12-13 PARETH-23 | E | Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.125%. Residual levels of 1,4-dioxane and ethylene oxide (and related substances) are to be kept below the level of detection. | |
993 | C12-15 ALKYL LACTATE | E | Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 1.2%. | |
994 | C12-15 ALKYL OCTANOATE | E | Only for use in topical medicines for dermal application. | |
995 | C12-20 ACID PEG-8 ESTER | E | Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.2%. | |
996 | C12-20 ALKYL GLUCOSIDE | E | Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.75%. | |
C13-14 ISOPARAFFIN | E | Only for use in topical medicines for dermal application. | ||
998 | C14-22 ALCOHOLS | E | Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 2.55%. | |
999 | C15-19 ALKANE | E | Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 7%. | |
1000 | C18-36 ACID GLYCOL ESTER | E | Only for use topical medicines for dermal application. | |
1001 | C18-36 ACID TRIGLYCERIDE | E | Only for use in topical medicines for dermal application. | |
1002 | C2-OCTENAL | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. | |
1003 | C20-40 ALCOHOLS | E | Only for use in topical medicines for dermal application. | |
1004 | C20-40 ALKYL STEARATE | E | Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 2%. | |
C20-40 PARETH-24 | E | Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.25%. | ||
1006 | C20-40 PARETH-3 | E | Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 2%. | |
1007 | C30-45 ALKYL CETEARYL DIMETICONE CROSSPOLYMER | E | Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 1%. | |
1008 | C9-11 ISOPARAFFIN | E | Only for use in topical medicines for dermal application. | |
1009 | C9-11 PARETH-3 | E | Only for use in topical medicines for dermal application. | |
1010 | C9-15 ALKYL PHOSPHATE | E | Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.12% | |
1011 | CABBAGE | E |
| |
1012 | CABREUVA OIL | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. | |
CADE OIL | A,E,H |
| ||
CAESALPINIA SAPPAN | A,H |
| ||
CAFFEINE | A,E | When used as an excipient, only for use in topical medicines for dermal application. Only for use as an active ingredient for oral use in adults when the medicine consists principally of one or more designated active ingredients prescribed in Schedule 14 to the Regulations (other than caffeine); and contains no more than 100 mg of caffeine per maximum daily dose. Medicines for oral use containing caffeine as an active ingredient require the following warning statement on the medicine label: - (ADULT) 'Adults only' (or words to that effect). When the route of administration is oral or sublingual and the medicine provides a maximum recommended daily dose of: a) more than 1 mg but no more than 10 mg of caffeine the medicine requires the following warning statement on the medicine label: - (CAFFR) 'The recommended dose of this medicine provides small amounts of caffeine.' b) more than 10 mg of caffeine the medicine requires the following warning statement on the medicine label: - (CAFF) 'Contains caffeine [state quantity per dosage unit or per mL or per gram of product]'. | ||
1016 | CAJUPUT OIL | A,E,H | Cineole is a mandatory component of Cajuput oil. When the concentration in the medicine is more than 25%, the nominal capacity of the container must be no more than 25 mL. When the concentration in the medicine is more than 25% and the nominal capacity of the container is more than 15 mL, a child resistant closure and restricted flow insert must be fitted on the container. When the concentration in the medicine is more than 25% and the nominal capacity of the container is less than 15 mL, a restricted flow insert must be fitted to the container. When the concentration in the medicine is more than 25%, the medicine requires the following warning statements on the medicine label: - (CHILD) 'Keep out of reach of children' (or word to that effect) - (NTAKEN) 'Not to be taken'. When the concentration of cineole in the preparation is more than 25%, the nominal capacity of the container must not be more than 25 mL. When the concentration of cineole in the preparation is more than 25% and the nominal capacity of the container is more than 15 mL but no more than 25mL, the medicine must have a child resistant closure and restricted flow insert fitted on the container and the medicine requires the following warning statements on the medicine label: - (CHILD) 'Keep out of reach of children' (or word to that effect) - (NTAKEN) 'Not to be taken'. When the concentration of cineole in the preparation is more than 25% and the nominal capacity of the container is no more than 15 mL, the medicine must have the restricted flow insert fitted on the container and the medicine requires the following warning statements on the medicine label: - (CHILD) 'Keep out of reach of children' (or word to that effect) - (NTAKEN) 'Not to be taken'. | |
1017 | CALAMINE | A,E | Only for use as an active or excipient ingredient for dermal application. When used as an active ingredient, can only be supplied as an uncompounded medicine substance packed for retail sale and must comply with an uncompounded substance monograph of the British Pharmacopoeia, as in force or existing from time to time. | |
1018 | CALCIFIED LITHOTHAMNION SPECIES | A | Only for use in oral medicines. | |
CALCIFIED LITHOTHAMNION TOPHIFORME | A | Only for oral use. | ||
1020 | CALCIUM ALGINATE | E |
| |
CALCIUM AMINO ACID CHELATE | A,H | May only be used as a source of calcium. Calcium is a mandatory component of calcium amino acid chelate. The concentration of calcium in the calcium amino acid chealte must be no more than 25% w/w. The following indications are only permitted when the medicine is for oral and sublingual use: - (OSPOR1) ‘Source of calcium. May assist in the prevention and/or treatment of osteoporosis’ - (OSPOR2) ‘Source of calcium. Women's calcium requirements are increased after menopause. Calcium supplementation may be of assistance in the prevention and/or treatment of osteoporosis’ - (CALC1) ‘Source of calcium. Women's calcium requirements are increased after menopause’ - (CALC2) ‘Source of calcium. A calcium supplement formulated to strengthen bone and tissue in growing and mature users. (or) Source of calcium. A calcium supplement formulated to strengthen bone and tissue for children and older adults’ - (CALC3) ‘Source of calcium. Adequate dietary calcium in our youth and throughout life is required to maximise bone’ - (CALC4) ‘Source of calcium. A diet deficient in calcium can lead to osteoporosis in later life.’ The indication ‘For mineral (may state the mineral) supplementation’ is only permitted for use when the medicine is for oral or sublingual use. | ||
CALCIUM ASCORBATE | A,E,H | The percentage of calcium from Calcium ascorbate should be calculated based on the molecular weight of calcium ascorbate. The percentage of ascorbic acid from calcium ascorbate should be calculated based on the molecular weight of calcium ascorbate. The following indications are only permitted when the medicine is for oral and sublingual use: - (OSPOR1) ‘Source of calcium. May assist in the prevention and/or treatment of osteoporosis’ - (OSPOR2) ‘Source of calcium. Women's calcium requirements are increased after menopause. Calcium supplementation may be of assistance in the prevention and/or treatment of osteoporosis’ - (CALC1) ‘Source of calcium Women's calcium requirements are increased after menopause’ - (CALC2) ‘Source of calcium. A calcium supplement formulated to strengthen bone and tissue in growing and mature users. (or) Source of calcium. A calcium supplement formulated to strengthen bone and tissue for children and older adults’ - (CALC3) ‘Source of calcium. Adequate dietary calcium in our youth and throughout life is required to maximise bone’ - (CALC4) ‘Source of calcium. A diet deficient in calcium can lead to osteoporosis in later life.’ The indication ‘For mineral (may state the mineral) supplementation’ is only permitted for use when the medicine is for oral or sublingual use. | ||
CALCIUM ASCORBATE DIHYDRATE | A,E,H | The percentage of ascorbic acid from Calcium ascorbate dihydrate should be calculated based on the molecular weight of Calcium ascorbate dihydrate. The percentage of calcium from Calcium ascorbate dihydrate should be calculated based on the molecular weight of Calcium ascorbate dihydrate. The following indications are only permitted when the medicine is for oral and sublingual use: (OSPOR1) ‘Source of calcium. May assist in the prevention and/or treatment of osteoporosis’ - (OSPOR2) ‘Source of calcium. Women's calcium requirements are increased after menopause. Calcium supplementation may be of assistance in the prevention and/or treatment of osteoporosis’ - (CALC1) ‘Source of calcium. Women's calcium requirements are increased after menopause’ - (CALC2) ‘Source of calcium. A calcium supplement formulated to strengthen bone and tissue in growing and mature users. (or) Source of calcium. A calcium supplement formulated to strengthen bone and tissue for children and older adults’ - (CALC3) ‘Source of calcium. Adequate dietary calcium in our youth and throughout life is required to maximise bone’ - (CALC4) ‘Source of calcium. A diet deficient in calcium can lead to osteoporosis in later life.’ The indication ‘For mineral (may state the mineral) supplementation’ is only permitted for use when the medicine is for oral or sublingual use. | ||
CALCIUM ASPARTATE | A | Calcium is a mandatory component of Calcium aspartate and availability is restricted to use as a source of the relevant mineral only. The percentage of calcium from calcium aspartate should be calculated based on the molecular weight of calcium aspartate. The following indications are only permitted when the medicine is for oral and sublingual use: - (OSPOR1) ‘Source of calcium. May assist in the prevention and/or treatment of osteoporosis’ - (OSPOR2) ‘Source of calcium. Women's calcium requirements are increased after menopause. Calcium supplementation may be of assistance in the prevention and/or treatment of osteoporosis’ - (CALC1) ‘Source of calcium. Women's calcium requirements are increased after menopause’ - (CALC2) ‘Source of calcium. A calcium supplement formulated to strengthen bone and tissue in growing and mature users. (or) Source of calcium. A calcium supplement formulated to strengthen bone and tissue for children and older adults’ - (CALC3) ‘Source of calcium. Adequate dietary calcium in our youth and throughout life is required to maximise bone’ - (CALC4) ‘Source of calcium. A diet deficient in calcium can lead to osteoporosis in later life.’ The indication ‘For mineral (may state the mineral) supplementation’ is only permitted for use when the medicine is for oral or sublingual use. | ||
1025 | CALCIUM ASPARTATE HYDROCHLORIDE DIHYDRATE | A | Only for use as an active ingredient in oral medicines. Calcium is a mandatory component of Calcium aspartate hydrochloride dihydrate and availability is restricted to use as a source of the relevant mineral only. The percentage of calcium from calcium aspartate hydrochloride dihydrate should be calculated based on the molecular weight of calcium aspartate hydrochloride dihydrate. The following indications are only permitted when the medicine is for oral and sublingual use: - (OSPOR1) ‘Source of calcium. May assist in the prevention and/or treatment of osteoporosis’ - (OSPOR2) ‘Source of calcium. Women's calcium requirements are increased after menopause. Calcium supplementation may be of assistance in the prevention and/or treatment of osteoporosis’ - (CALC1) ‘Source of calcium. Women's calcium requirements are increased after menopause’ - (CALC2) ‘Source of calcium. A calcium supplement formulated to strengthen bone and tissue in growing and mature users. (or) Source of calcium. A calcium supplement formulated to strengthen bone and tissue for children and older adults’ - (CALC3) ‘Source of calcium. Adequate dietary calcium in our youth and throughout life is required to maximise bone’ - (CALC4) ‘Source of calcium. A diet deficient in calcium can lead to osteoporosis in later life.’ The indication ‘For mineral (may state the mineral) supplementation’ is only permitted for use when the medicine is for oral or sublingual use. | |
CALCIUM BEHENATE | E | Behenic acid is a mandatory component of Calcium behenate. When for oral ingestion, the maximum recommended daily dose must not provide more than 383.5 mg of Behenic acid. | ||
CALCIUM BETA-HYDROXY-BETA-METHYLBUTYRATE | A,H | The declared quantity of Calcium from Calcium beta-hydroxy-beta-methylbutryate must be no less than 13.9% and must be no more than 15.3% of the Calcium beta-hydroxy-beta-methylbutryate in the formulation. These figures incorporate a 5% variance to allow for rounding in calculations. The following indications are only permitted when the medicine is for oral and sublingual use: - (OSPOR1) ‘Source of calcium. May assist in the prevention and/or treatment of osteoporosis’ - (OSPOR2) ‘Source of calcium. Women's calcium requirements are increased after menopause. Calcium supplementation may be of assistance in the prevention and/or treatment of osteoporosis’ - (CALC1) ‘Source of calcium. Women's calcium requirements are increased after menopause’ - (CALC2) ‘Source of calcium. A calcium supplement formulated to strengthen bone and tissue in growing and mature users. (or) Source of calcium. A calcium supplement formulated to strengthen bone and tissue for children and older adults’ - (CALC3) ‘Source of calcium. Adequate dietary calcium in our youth and throughout life is required to maximise bone’ - (CALC4) ‘Source of calcium. A diet deficient in calcium can lead to osteoporosis in later life.’ | ||
CALCIUM BETA-HYDROXY-BETA-METHYLBUTYRATE MONOHYDRATE | A,H | The declared quantity of Calcium from Calcium beta-hydroxy-beta-methylbutryate monohydrate must be no less than 13.07% and must be no more than 14.45% of the Calciumbeta-hydroxy-beta-methylbutryate monohydrate in the formulation. These figures incorporate a 5% variance to allow for rounding in calculations. The following indications are only permitted when the medicine is for oral and sublingual use: - (OSPOR1) ‘Source of calcium. May assist in the prevention and/or treatment of osteoporosis’ - (OSPOR2) ‘Source of calcium. Women's calcium requirements are increased after menopause. Calcium supplementation may be of assistance in the prevention and/or treatment of osteoporosis’ - (CALC1) ‘Source of calcium. Women's calcium requirements are increased after menopause’ - (CALC2) ‘Source of calcium. A calcium supplement formulated to strengthen bone and tissue in growing and mature users. (or) Source of calcium. A calcium supplement formulated to strengthen bone and tissue for children and older adults’ - (CALC3) ‘Source of calcium. Adequate dietary calcium in our youth and throughout life is required to maximise bone’ - (CALC4) ‘Source of calcium. A diet deficient in calcium can lead to osteoporosis in later life.’ | ||
1029 | CALCIUM CARBONATE | A,E,H | When used as an active ingredient and the medicine is intended as a mineral supplementation, calcium is a mandatory component of Calcium carbonate. The percentage of calcium from calcium carbonate should be calculated based on the molecular weight of calcium carbonate. The following indications are only permitted when the medicine is for oral and sublingual use: - (OSPOR1) ‘Source of calcium. May assist in the prevention and/or treatment of osteoporosis’ - (OSPOR2) ‘Source of calcium. Women's calcium requirements are increased after menopause. Calcium supplementation may be of assistance in the prevention and/or treatment of osteoporosis’ - (CALC1) ‘Source of calcium. Women's calcium requirements are increased after menopause’ - (CALC2) ‘Source of calcium. A calcium supplement formulated to strengthen bone and tissue in growing and mature users. (or) Source of calcium. A calcium supplement formulated to strengthen bone and tissue for children and older adults’ - (CALC3) ‘Source of calcium. Adequate dietary calcium in our youth and throughout life is required to maximise bone’ - (CALC4) ‘Source of calcium. A diet deficient in calcium can lead to osteoporosis in later life.’ The indication ‘For mineral (may state the mineral) supplementation’ is only permitted for use when the medicine is for oral or sublingual use. | |
1030 | CALCIUM CASEINATE | E |
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CALCIUM CHLORIDE DIHYDRATE | E |
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CALCIUM CITRATE | A,E,H | When used as an active ingredient and the medicine is intended as a mineral supplementation, calcium is a mandatory component of Calcium citrate. The percentage of calcium from calcium citrate should be calculated based on the molecular weight of calcium citrate. The following indications are only permitted when the medicine is for oral and sublingual use: - (OSPOR1) ‘Source of calcium. May assist in the prevention and/or treatment of osteoporosis’ - (OSPOR2) ‘Source of calcium. Women's calcium requirements are increased after menopause. Calcium supplementation may be of assistance in the prevention and/or treatment of osteoporosis’ - (CALC1) ‘Source of calcium. Women's calcium requirements are increased after menopause’ - (CALC2) ‘Source of calcium. A calcium supplement formulated to strengthen bone and tissue in growing and mature users. (or) Source of calcium. A calcium supplement formulated to strengthen bone and tissue for children and older adults’ - (CALC3) ‘Source of calcium. Adequate dietary calcium in our youth and throughout life is required to maximise bone’ - (CALC4) ‘Source of calcium. A diet deficient in calcium can lead toosteoporosis in later life.’ The indication ‘For mineral (may state the mineral) supplementation’ is only permitted for use when the medicine is for oral or sublingual use. | ||
CALCIUM CITRATE TETRAHYDRATE | A,E,H | If used as an active ingredient and the medicine is intended as a mineral supplementation, calcium is a mandatory component of calcium citrate tetrahydrate. The amount of calcium in the active ingredient should be calculated based on the molecular weight of calcium citrate tetrahydrate. The following indications are only permitted when the medicine is for oral and sublingual use: - (OSPOR1) ‘Source of calcium. May assist in the prevention and/or treatment of osteoporosis’ - (OSPOR2) ‘Source of calcium. Women's calcium requirements are increased after menopause. Calcium supplementation may be of assistance in the prevention and/or treatment of osteoporosis’ - (CALC1) ‘Source of calcium. Women's calcium requirements are increased after menopause’ - (CALC2) ‘Source of calcium. A calcium supplement formulated to strengthen bone and tissue in growing and mature users. (or) Source of calcium. A calcium supplement formulated to strengthen bone and tissue for children and older adults’ - (CALC3) ‘Source of calcium. Adequate dietary calcium in our youth and throughout life is required to maximise bone’ - (CALC4) ‘Source of calcium. A diet deficient in calcium can lead to osteoporosis in later life.’ The indication ‘For mineral (may state the mineral) supplementation’ is only permitted for use when the medicine is for oral or sublingual use. | ||
CALCIUM DIASPARTATE | A | Only for use as active ingredient in oral medicines. Calcium is a mandatory component of Calcium diaspartate and availability is restricted to use as a source of the relevant mineral only. The percentage of calcium from calcium diaspartate should be calculated based on the molecular weight of calcium diaspartate. The following indications are only permitted when the medicine is for oral and sublingual use:- (OSPOR1) ‘Source of calcium. May assist in the prevention and/or treatment of osteoporosis’ - (OSPOR2) ‘Source of calcium. Women's calcium requirements are increased after menopause. Calcium supplementation may be of assistance in the prevention and/or treatment of osteoporosis’ - (CALC1) ‘Source of calcium. Women's calcium requirements are increased after menopause’- (CALC2) ‘Source of calcium. A calcium supplement formulated to strengthen bone and tissue in growing and mature users. (or) Source of calcium. A calcium supplement formulated to strengthen bone and tissue for children and older adults’ - (CALC3) ‘Source of calcium. Adequate dietary calcium in our youth and throughout life is required to maximise bone’ - (CALC4) ‘Source of calcium. A diet deficient in calcium can lead to osteoporosis in later life.’ The indication ‘For mineral (may state the mineral) supplementation’ is only permitted for use when the medicine is for oral or sublingual use. | ||
CALCIUM FLUORIDE | H | The percentage of fluoride from Calcium fluoride should be calculated based on the molecular weight of Calcium fluoride.The concentration of fluoride in the product from all ingredients must be no more than 10mg/kg or 10mg/L or 0.1%.
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CALCIUM FOLINATE | A | Folinic acid is a mandatory component of calcium folinate. The maximum daily dose must provide no more than 500 micrograms of folinic acid. When folic acid, folinic acid, levomefolate salts and/or their derivatives are used in combination, the medicine provides not more than a total of 500 micrograms of folic acid, folinic acid, levomefolate salts and/or their derivatives in total per daily dose. The following indications are only permitted when the medicine is for oral and sublingual use: ‑ (OSPOR1) 'Source of calcium. May assist in the prevention and/or treatment of osteoporosis.' ‑ (OSPOR2) 'Source of calcium. Women's calcium requirements are increased after menopause. Calcium supplementation may be of assistance in the prevention and/or treatment of osteoporosis.' ‑ (CALC1) 'Source of calcium. Women's calcium requirements are increased after menopause.' ‑ (CALC2) 'Source of calcium. A calcium supplement formulated to strengthen bone and tissue in growing and mature users.’ OR ‘Source of calcium. A calcium supplement formulated to strengthen bone and tissue for children and older adults.' ‑ (CALC3) 'Source of calcium. Adequate dietary calcium in our youth and throughout life is required to maximise bone.' ‑ (CALC4) 'Source of calcium. A diet deficient in calcium can lead to osteoporosis in later life.' The indication 'For mineral [may state the mineral] supplementation' is only permitted for use when the medicine is for oral or sublingual use. When used as an active ingredient and the route of administration is oral or sublingual, the medicine requires the following warning statement on the medicine label: ‑ (VIT) 'Vitamins can only be of assistance if the dietary vitamin intake is inadequate.' OR 'Vitamin supplements should not replace a balanced diet.' When used in preparations indicated for reducing the risk of having a child with spina bifida/neural tube defects, the following statement must be included on the label: - (NEUR) 'Warning: Do not exceed the stated dose except on medical advice. If you have had a baby with a neural tube defect/spina bifida - seek specific medical advice (or words to that effect)’ | ||
CALCIUM GLUCONATE MONOHYDRATE | A,E,H | When used as an active ingredient and the medicine is intended as a mineral supplementation, calcium is a mandatory component of calcium gluconate monohydrate. The percentage of calcium from calcium gluconate monohydrate should be calculated based on the molecular weight of calcium gluconate. The following indications are only permitted when the medicine is for oral and sublingual use: - (OSPOR1) ‘Source of calcium. May assist in the prevention and/or treatment of osteoporosis’ - (OSPOR2) ‘Source of calcium. Women's calcium requirements are increased after menopause. Calcium supplementation may be of assistance in the prevention and/or treatment of osteoporosis’ - (CALC1) ‘Source of calcium. Women's calcium requirements are increased after menopause’ - (CALC2) ‘Source of calcium. A calcium supplement formulated to strengthen bone and tissue in growing and mature users. (or) Source of calcium. A calcium supplement formulated to strengthen bone and tissue for children and older adults’ - (CALC3) ‘Source of calcium. Adequate dietary calcium in our youth and throughout life is required to maximise bone’ - (CALC4) ‘Source of calcium. A diet deficient in calcium can lead to osteoporosis in later life.’ The indication ‘For mineral (may state the mineral) supplementation’ is only permitted for use when the medicine is for oral or sublingual use. | ||
CALCIUM GLYCEROPHOSPHATE | A,E,H | When used as an active ingredient and the medicine is intended as a mineral supplementation, calcium is a mandatory component of Calcium glycerophosphate. The percentage of calcium from calcium glycerophosphate should be calculated based on the molecular weight of calcium glycerophosphate. The following indications are only permitted when the medicine is for oral and sublingual use: - (OSPOR1) ‘Source of calcium. May assist in the prevention and/or treatment of osteoporosis’ - (OSPOR2) ‘Source of calcium. Women's calcium requirements are increased after menopause. Calcium supplementation may be of assistance in the prevention and/or treatment of osteoporosis’ - (CALC1) ‘Source of calcium. Women's calcium requirements are increased after menopause’ - (CALC2) ‘Source of calcium. A calcium supplement formulated to strengthen bone and tissue in growing and mature users. (or) Source of calcium. A calcium supplement formulated to strengthen bone and tissue for children and older adults’ - (CALC3) ‘Source of calcium. Adequate dietary calcium in our youth and throughout life is required to maximise bone’ - (CALC4) ‘Source of calcium. A diet deficient in calcium can lead to osteoporosis in later life.’ The indication ‘For mineral (may state the mineral) supplementation’ is only permitted for use when the medicine is for oral or sublingual use. | ||
CALCIUM GLYCINATE | A | Only for use as active ingredient in oral medicines. Calcium is a mandatory component of Calcium glycinate and availability is restricted to use as a source of the relevant mineral only. Based on molecular weights the declared quantity of Calcium from Calcium glycinate must be no less than 20.24% and no more than 22.37% of the Calcium glycinate in the formulation. These figures incorporate a 5% variance to allow for rounding in calculations. The following indications are only permitted when the medicine is for oral and sublingual use: - (OSPOR1) ‘Source of calcium. May assist in the prevention and/or treatment of osteoporosis’ - (OSPOR2) ‘Source of calcium. Women's calcium requirements are increased after menopause. Calcium supplementation may be of assistance in the prevention and/or treatment of osteoporosis’ - (CALC1) ‘Source of calcium. Women's calcium requirements are increased after menopause’ - (CALC2) ‘Source of calcium. A calcium supplement formulated to strengthen bone and tissue in growing and mature users. (or) Source of calcium. A calcium supplement formulated to strengthen bone and tissue for children and older adults’ - (CALC3) ‘Source of calcium. Adequate dietary calcium in our youth and throughout life is required to maximise bone’ - (CALC4) ‘Source of calcium. A diet deficient in calcium can lead to osteoporosis in later life.’ The indication ‘For mineral (may state the mineral) supplementation’ is only permitted for use when the medicine is for oral or sublingual use. | ||
1040 | CALCIUM GLYCINATE DIHYDRATE | A | Calcium is a mandatory component of Calcium glycinate dihydrate and availability is restricted to use as a source of the relevant mineral only. Based on molecular weights the declared quantity of Calcium from Calcium glycinate dihydrate must be no less than 17% and must be no more than 18.8% of the Calcium glycinate dihydrate in the formulation. These figures incorporate a 5% variance to allow for rounding in calculations. The following indications are only permitted when the medicine is for oral and sublingual use: - (OSPOR1) ‘Source of calcium. May assist in the prevention and/or treatment of osteoporosis’ - (OSPOR2) ‘Source of calcium. Women's calcium requirements are increased after menopause. Calcium supplementation may be of assistance in the prevention and/or treatment of osteoporosis’ - (CALC1) ‘Source of calcium. Women's calcium requirements are increased after menopause’ - (CALC2) ‘Source of calcium. A calcium supplement formulated to strengthen bone and tissue in growing and mature users. (or) Source of calcium. A calcium supplement formulated to strengthen bone and tissue for children and older adults’ - (CALC3) ‘Source of calcium. Adequate dietary calcium in our youth and throughout life is required to maximise bone’ - (CALC4) ‘Source of calcium. A diet deficient in calcium can lead to osteoporosis in later life.’ The indication ‘For mineral (may state the mineral) supplementation’ is only permitted for use when the medicine is for oral or sublingual use. | |
CALCIUM HEXAFLUOROSILICATE | H | Only for use as an active homoeopathic ingredient. | ||
CALCIUM HYDROGEN PHOSPHATE | A,E,H | Calcium is a mandatory component of calcium hydrogen phosphate. If used as an active ingredient and the medicine is intended as a mineral supplementation, calcium is a mandatory component of calcium hydrogen phosphate. The percentage of calcium from calcium hydrogen phosphate should be calculated based on the molecular weight of calcium hydrogen phosphate. The following indications are only permitted when the medicine is for oral and sublingual use: - (OSPOR1) ‘Source of calcium. May assist in the prevention and/or treatment of osteoporosis’ - (OSPOR2) ‘Source of calcium. Women's calcium requirements are increased after menopause. Calcium supplementation may be of assistance in the prevention and/or treatment of osteoporosis’ - (CALC1) ‘Source of calcium. Women's calcium requirements are increased after menopause’ - (CALC2) ‘Source of calcium. A calcium supplement formulated to strengthen bone and tissue in growing and mature users. (or) Source of calcium. A calcium supplement formulated to strengthen bone and tissue for children and older adults’ - (CALC3) ‘Source of calcium. Adequate dietary calcium in our youth and throughout life is required to maximise bone’ - (CALC4) ‘Source of calcium. A diet deficient in calcium can lead to osteoporosis in later life.’ The indication ‘For mineral (may state the mineral) supplementation’ is only permitted for use when the medicine is for oral or sublingual use. | ||
CALCIUM HYDROGEN PHOSPHATE DIHYDRATE | A,E,H | When used as an active ingredient and the medicine is intended as a mineral supplementation, calcium is a mandatory component of calcium hydrogen phosphate dihydrate. The percentage of calcium from calcium hydrogen phosphate dihydrate should be calculated based on the molecular weight of calcium hydrogen phosphate dihydrate. The following indications are only permitted when the medicine is for oral and sublingual use: (OSPOR1) ‘Source of calcium. May assist in the prevention and/or treatment of osteoporosis’ - (OSPOR2) ‘Source of calcium. Women's calcium requirements are increased after menopause. Calcium supplementation may be of assistance in the prevention and/or treatment of osteoporosis’ - (CALC1) ‘Source of calcium. Women's calcium requirements are increased after menopause’ - (CALC2) ‘Source of calcium. A calcium supplement formulated to strengthen bone and tissue in growing and mature users. (or) Source of calcium. A calcium supplement formulated to strengthen bone and tissue for children and older adults’ - (CALC3) ‘Source of calcium. Adequate dietary calcium in our youth and throughout life is required to maximise bone’ - (CALC4) ‘Source of calcium. A diet deficient in calcium can lead to osteoporosis in later life.’ The indication ‘For mineral (may state the mineral) supplementation’ is only permitted for use when the medicine is for oral or sublingual use. | ||
CALCIUM HYDROGEN PHOSPHATE MONOHYDRATE | A,E,H | When used as an active ingredient and the medicine is intended as a mineral supplementation, calcium is a mandatory component of Calcium hydrogen phosphate monohydrate. The percentage of calcium from Calcium Hydrogen Phosphate Monohydrate should be calculated based on the molecular weight of Calcium Hydrogen Phosphate Monohydrate. The following indications are only permitted when the medicine is for oral and sublingual use: - (OSPOR1) ‘Source of calcium. May assist in the prevention and/or treatment of osteoporosis’ - (OSPOR2) ‘Source of calcium. Women's calcium requirements are increased after menopause. Calcium supplementation may be of assistance in the prevention and/or treatment of osteoporosis’ - (CALC1) ‘Source of calcium. Women's calcium requirements are increased after menopause’ - (CALC2) ‘Source of calcium. A calcium supplement formulated to strengthen bone and tissue in growing and mature users. (or) Source of calcium. A calcium supplement formulated to strengthen bone and tissue for children and older adults’ - (CALC3) ‘Source of calcium. Adequate dietary calcium in our youth and throughout life is required to maximise bone’ - (CALC4) ‘Source of calcium. A diet deficient in calcium can lead to osteoporosis in later life.’ The indication ‘For mineral (may state the mineral) supplementation’ is only permitted for use when the medicine is for oral or sublingual use. | ||
CALCIUM HYDROXIDE | A,E,H | When used as an active ingredient and the medicine is intended as a mineral supplementation, calcium is a mandatory component of Calcium hydroxide. The percentage of calcium from calcium hydroxide should be calculated based on the molecular weight of calcium hydroxide. When used as a standard active ingredient, can only be supplied as an uncompounded medicine substance packed for retail sale, and must comply with an uncompounded substance monograph of the British Pharmacopoeia, as in force or existing from time to time. The following indications are only permitted when the medicine is for oral and sublingual use: - (OSPOR1) ‘Source of calcium. May assist in the prevention and/or treatment of osteoporosis’ - (OSPOR2) ‘Source of calcium. Women's calcium requirements are increased after menopause. Calcium supplementation may be of assistance in the prevention and/or treatment of osteoporosis’ - (CALC1) ‘Source of calcium. Women's calcium requirements are increased after menopause’ - (CALC2) ‘Source of calcium. A calcium supplement formulated to strengthen bone and tissue in growing and mature users. (or) Source of calcium. A calcium supplement formulated to strengthen bone and tissue for children and older adults’ - (CALC3) ‘Source of calcium. Adequate dietary calcium in our youth and throughout life is required to maximise bone’ - (CALC4) ‘Source of calcium. A diet deficient in calcium can lead to osteoporosis in later life.' The indication ‘For mineral (may state the mineral) supplementation’ is only permitted for use when the medicine is for oral or sublingual use. | ||
1046 | CALCIUM HYDROXYCITRATE | A,H | When used as an active ingredient and the medicine is intended as a mineral supplementation, calcium is a mandatory component of Calcium hydroxycitrate. The percentage of calcium from calcium hydroxycitrate should be calculated based on the molecular weight of Calcium hydroxycitrate. The following indications are only permitted when the medicine is for oral and sublingual use: - (OSPOR1) ‘Source of calcium. May assist in the prevention and/or treatment of osteoporosis’ - (OSPOR2) ‘Source of calcium. Women's calcium requirements are increased after menopause. Calcium supplementation may be of assistance in the prevention and/or treatment of osteoporosis’ - (CALC1) ‘Source of calcium. Women's calcium requirements are increased after menopause’ - (CALC2) ‘Source of calcium. A calcium supplement formulated to strengthen bone and tissue in growing and mature users. (or) Source of calcium. A calcium supplement formulated to strengthen bone and tissue for children and older adults’ - (CALC3) ‘Source of calcium. Adequate dietary calcium in our youth and throughout life is required to maximise bone’ - (CALC4) ‘Source of calcium. A diet deficient in calcium can lead to osteoporosis in later life.’ The indication ‘For mineral (may state the mineral) supplementation’ is only permitted for use when the medicine is for oral or sublingual use. | |
1047 | CALCIUM HYPOPHOSPHITE | H | Only for use as an active homoeopathic ingredient. | |
CALCIUM IODIDE | H | Only for use as an active homoeopathic ingredient. | ||
CALCIUM KETOGLUCONATE | E | Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye or on damaged skin. The concentration must be no more than 1% | ||
CALCIUM L-THREONATE | A | Only for oral use. Calcium is a mandatory component of Calcium L-threonate. The percentage of calcium from calcium L-threonate should be calculated based on the molecular weight of calcium L-threonate. The following indications are only permitted when the medicine is for oral and sublingual use: - (OSPOR1) ‘Source of calcium. May assist in the prevention and/or treatment of osteoporosis’ - (OSPOR2) ‘Source of calcium. Women's calcium requirements are increased after menopause. Calcium supplementation may be of assistance in the prevention and/or treatment of osteoporosis’ - (CALC1) ‘Source of calcium. Women's calcium requirements are increased after menopause’ - (CALC2) ‘Source of calcium. A calcium supplement formulated to strengthen bone and tissue in growing and mature users. (or) Source of calcium. A calcium supplement formulated to strengthen bone and tissue for children and older adults’ - (CALC3) ‘Source of calcium. Adequate dietary calcium in our youth and throughout life is required to maximise bone’ - (CALC4) ‘Source of calcium. A diet deficient in calcium can lead to osteoporosis in later life.’ The indication ‘For mineral (may state the mineral) supplementation’ is only permitted for use when the medicine is for oral or sublingual use. | ||
CALCIUM LACTATE | A,E,H | If used as an active ingredient and the medicine is intended as a mineral supplementation, calcium is a mandatory component of calcium lactate. The percentage of calcium from calcium lactate should be calculated based on the molecular weight of calcium lactate. The following indications are only permitted when the medicine is for oral and sublingual use: - (OSPOR1) ‘Source of calcium. May assist in the prevention and/or treatment of osteoporosis’ - (OSPOR2) ‘Source of calcium. Women's calcium requirements are increased after menopause. Calcium supplementation may be of assistance in the prevention and/or treatment of osteoporosis’ - (CALC1) ‘Source of calcium. Women's calcium requirements are increased after menopause’ - (CALC2) ‘Source of calcium. A calcium supplement formulated to strengthen bone and tissue in growing and mature users. (or) Source of calcium. A calcium supplement formulated to strengthen bone and tissue for children and older adults’ - (CALC3) ‘Source of calcium. Adequate dietary calcium in our youth and throughout life is required to maximise bone’ - (CALC4) ‘Source of calcium. A diet deficient in calcium can lead to osteoporosis in later life.’ The indication ‘For mineral (may state the mineral) supplementation’ is only permitted for use when the medicine is for oral or sublingual use. | ||
CALCIUM LACTATE GLUCONATE | A,E,H | When used as an active ingredient and the medicine is intended as a mineral supplementation, calcium is a mandatory component of Calcium lactate gluconate. The percentage of calcium from Calcium lactate gluconate should be calculated based on the molecular weight of Calcium lactate gluconate. The following indications are only permitted when the medicine is for oral and sublingual use: - (OSPOR1) ‘Source of calcium. May assist in the prevention and/or treatment of osteoporosis’ - (OSPOR2) ‘Source of calcium. Women's calcium requirements are increased after menopause. Calcium supplementation may be of assistance in the prevention and/or treatment of osteoporosis’ - (CALC1) ‘Source of calcium. Women's calcium requirements are increased after menopause’ - (CALC2) ‘Source of calcium. A calcium supplement formulated to strengthen bone and tissue in growing and mature users. (or) Source of calcium. A calcium supplement formulated to strengthen bone and tissue for children and older adults’ - (CALC3) ‘Source of calcium. Adequate dietary calcium in our youth and throughout life is required to maximise bone’ - (CALC4) ‘Source of calcium. A diet deficient in calcium can lead to osteoporosis in later life.’ The indication ‘For mineral (may state the mineral) supplementation’ is only permitted for use when the medicine is for oral or sublingual use. | ||
CALCIUM LACTATE PENTAHYDRATE | A,E,H | When used as an active ingredient and the medicine is intended as a mineral supplementation, calcium is a mandatory component of Calcium lactate pentahydrate. The percentage of calcium from Calcium Lactate Pentahydrate should be calculated based on the molecular weight of Calcium Lactate Pentahydrate. The following indications are only permitted when the medicine is for oral and sublingual use: - (OSPOR1) ‘Source of calcium. May assist in the prevention and/or treatment of osteoporosis’ - (OSPOR2) ‘Source of calcium. Women's calcium requirements are increased after menopause. Calcium supplementation may be of assistance in the prevention and/or treatment of osteoporosis’ - (CALC1) ‘Source of calcium. Women's calcium requirements are increased after menopause’ - (CALC2) ‘Source of calcium. A calcium supplement formulated to strengthen bone and tissue in growing and mature users. (or) Source of calcium. A calcium supplement formulated to strengthen bone and tissue for children and older adults’ - (CALC3) ‘Source of calcium. Adequate dietary calcium in our youth and throughout life is required to maximise bone’ - (CALC4) ‘Source of calcium. A diet deficient in calcium can lead to osteoporosis in later life.’ The indication ‘For mineral (may state the mineral) supplementation’ is only permitted for use when the medicine is for oral or sublingual use. | ||
CALCIUM LACTATE TRIHYDRATE | A,E,H | If used as an active ingredient and the preparation is intended as a mineral supplementation, calcium is a mandatory component of Calcium lactate trihydrate. The percentage of calcium from Calcium Lactate Trihydrate should be calculated based on the molecular weight of Calcium Lactate Trihydrate. The following indications are only permitted when the medicine is for oral and sublingual use: - (OSPOR1) ‘Source of calcium. May assist in the prevention and/or treatment of osteoporosis’ - (OSPOR2) ‘Source of calcium. Women's calcium requirements are increased after menopause. Calcium supplementation may be of assistance in the prevention and/or treatment of osteoporosis’ - (CALC1) ‘Source of calcium. Women's calcium requirements are increased after menopause’ - (CALC2) ‘Source of calcium. A calcium supplement formulated to strengthen bone and tissue in growing and mature users. (or) Source of calcium. A calcium supplement formulated to strengthen bone and tissue for children and older adults’ - (CALC3) ‘Source of calcium. Adequate dietary calcium in our youth and throughout life is required to maximise bone’ - (CALC4) ‘Source of calcium. A diet deficient in calcium can lead to osteoporosis in later life.’ The indication ‘For mineral (may state the mineral) supplementation’ is only permitted for use when the medicine is for oral or sublingual use. | ||
CALCIUM LYSINATE | A | Only for use as active ingredient in oral medicines. Calcium is a mandatory component of Calcium lysinate and availability is restricted to use as a source of the relevant mineral only. The percentage of calcium from Calcium Lysinate should be calculated based on the molecular weight of Calcium Lysinate. The following indications are only permitted when the medicine is for oral and sublingual use: - (OSPOR1) ‘Source of calcium. May assist in the prevention and/or treatment of osteoporosis’ - (OSPOR2) ‘Source of calcium. Women's calcium requirements are increased after menopause. Calcium supplementation may be of assistance in the prevention and/or treatment of osteoporosis’ - (CALC1) ‘Source of calcium. Women's calcium requirements are increased after menopause’ - (CALC2) ‘Source of calcium. A calcium supplement formulated to strengthen bone and tissue in growing and mature users. (or) Source of calcium. A calcium supplement formulated to strengthen bone and tissue for children and older adults’ - (CALC3) ‘Source of calcium. Adequate dietary calcium in our youth and throughout life is required to maximise bone’ - (CALC4) ‘Source of calcium. A diet deficient in calcium can lead to osteoporosis in later life.’ The indication ‘For mineral (may state the mineral) supplementation’ is only permitted for use when the medicine is for oral or sublingual use. | ||
CALCIUM METHIONINATE | A | Only for use as active ingredient in oral medicines. Calcium is a mandatory component of Calcium methioninate and availability is restricted to use as a source of the relevant mineral only. Based on molecular weights the declared quantity of Calcium from Calcium methioninate must be no less than 11.32% and must be no more than 12.51% of the Calcium methioninate in the formulation. These figures incorporate a 5% variance to allow for rounding in calculations. The following indications are only permitted when the medicine is for oral and sublingual use: - (OSPOR1) ‘Source of calcium. May assist in the prevention and/or treatment of osteoporosis’ - (OSPOR2) ‘Source of calcium. Women's calcium requirements are increased after menopause. Calcium supplementation may be of assistance in the prevention and/or treatment of osteoporosis’ - (CALC1) ‘Source of calcium. Women's calcium requirements are increased after menopause’ - (CALC2) ‘Source of calcium. A calcium supplement formulated to strengthen bone and tissue in growing and mature users. (or) Source of calcium. A calcium supplement formulated to strengthen bone and tissue for children and older adults’ - (CALC3) ‘Source of calcium. Adequate dietary calcium in our youth and throughout life is required to maximise bone’ - (CALC4) ‘Source of calcium. A diet deficient in calcium can lead to osteoporosis in later life.’ The indication ‘For mineral (may state the mineral) supplementation.’ is only permitted for use when the medicine is for oral or sublingual use. | ||
1057 | CALCIUM OROTATE | A,E,H | When used as an active ingredient and the medicine is intended as a mineral supplementation, calcium is a mandatory component of Calcium orotate. The percentage of calcium from Calcium Orotate should be calculated based on the molecular weight of Calcium Orotate. The following indications are only permitted when the medicine is for oral and sublingual use: - (OSPOR1) ‘Source of calcium. May assist in the prevention and/or treatment of osteoporosis’ - (OSPOR2) ‘Source of calcium. Women's calcium requirements are increased after menopause. Calcium supplementation may be of assistance in the prevention and/or treatment of osteoporosis’ - (CALC1) ‘Source of calcium. Women's calcium requirements are increased after menopause’ - (CALC2) ‘Source of calcium. A calcium supplement formulated to strengthen bone and tissue in growing and mature users. (or) Source of calcium. A calcium supplement formulated to strengthen bone and tissue for children and older adults’ - (CALC3) ‘Source of calcium. Adequate dietary calcium in our youth and throughout life is required to maximise bone’ - (CALC4) ‘Source of calcium. A diet deficient in calcium can lead to osteoporosis in later life.’ The indication ‘For mineral (may state the mineral) supplementation’ is only permitted for use when the medicine is for oral or sublingual use. | |
CALCIUM OXIDE | E | Only for use in topical medicines for dermal application. | ||
CALCIUM PANTOTHENATE | A,E,H | When used as an active ingredient and the medicine is intended as a mineral supplementation, calcium is a mandatory component of Calcium pantothenate. The percentage of calcium from Calcium Pantothenate should be calculated based on the molecular weight of Calcium Pantothenate. The following indications are only permitted when the medicine is for oral and sublingual use: - (OSPOR1) ‘Source of calcium. May assist in the prevention and/or treatment of osteoporosis’ - (OSPOR2) ‘Source of calcium. Women's calcium requirements are increased after menopause. Calcium supplementation may be of assistance in the prevention and/or treatment of osteoporosis’ - (CALC1) ‘Source of calcium. Women's calcium requirements are increased after menopause’ - (CALC2) ‘Source of calcium. A calcium supplement formulated to strengthen bone and tissue in growing and mature users. (or) Source of calcium. A calcium supplement formulated to strengthen bone and tissue for children and older adults’ - (CALC3) ‘Source of calcium. Adequate dietary calcium in our youth and throughout life is required to maximise bone’ - (CALC4) ‘Source of calcium. A diet deficient in calcium can lead to osteoporosis in later life.’ The indication ‘For mineral (may state the mineral) supplementation’ is only permitted for use when the medicine is for oral or sublingual use. The following indications are only permitted when the medicine is for oral and sublingual use: | ||
CALCIUM PHOSPHATE | A,E,H | When used as an active ingredient and the preparation is intended as a mineral supplementation, calcium is mandatory component of Calcium phosphate. The percentage of calcium from Calcium Phosphate should be calculated based on the molecular weight of Calcium Phosphate. The following indications are only permitted when the medicine is for oral and sublingual use: - (OSPOR1) ‘Source of calcium. May assist in the prevention and/or treatment of osteoporosis’ - (OSPOR2) ‘Source of calcium. Women's calcium requirements are increased after menopause. Calcium supplementation may be of assistance in the prevention and/or treatment of osteoporosis’ - (CALC1) ‘Source of calcium. Women's calcium requirements are increased after menopause’ - (CALC2) ‘Source of calcium. A calcium supplement formulated to strengthen bone and tissue in growing and mature users. (or) Source of calcium. A calcium supplement formulated to strengthen bone and tissue for children and older adults’ - (CALC3) ‘Source of calcium. Adequate dietary calcium in our youth and throughout life is required to maximise bone’ - (CALC4) ‘Source of calcium. A diet deficient in calcium can lead to osteoporosis in later life.’ The indication ‘For mineral (may state the mineral) supplementation’ is only permitted for use when the medicine is for oral or sublingual use. | ||
CALCIUM PYRUVATE | A | When used as an active ingredient and the medicine is intended as a mineral supplementation, calcium is a mandatory component of Calcium pyruvate. The percentage of calcium from calcium pyruvate should be calculated based on the molecular weight of calcium pyruvate. The following indications are only permitted when the medicine is for oral and sublingual use: - (OSPOR1) ‘Source of calcium. May assist in the prevention and/or treatment of osteoporosis’ - (OSPOR2) ‘Source of calcium. Women's calcium requirements are increased after menopause. Calcium supplementation may be of assistance in the prevention and/or treatment of osteoporosis’ - (CALC1) ‘Source of calcium. Women's calcium requirements are increased after menopause’ - (CALC2) ‘Source of calcium. A calcium supplement formulated to strengthen bone and tissue in growing and mature users. (or) Source of calcium. A calcium supplement formulated to strengthen bone and tissue for children and older adults’ - (CALC3) ‘Source of calcium. Adequate dietary calcium in our youth and throughout life is required to maximise bone’ - (CALC4) ‘Source of calcium. A diet deficient in calcium can lead to osteoporosis in later life.’ The indication ‘For mineral (may state the mineral) supplementation’ is only permitted for use when the medicine is for oral or sublingual use. | ||
1062 | CALCIUM SACCHARATE | E |
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1063 | CALCIUM SILICATE | E |
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CALCIUM SODIUM CASEINATE | A,H | The medicine requires the following warning statement on the medicine label: - (COWMK) 'Derived from cow's milk'. | ||
1065 | CALCIUM SODIUM LACTATE | A,E,H | When used as an active ingredient and the medicine is intended as a mineral supplementation, calcium is a mandatory component of calcium sodium lactate. The percentage of calcium from calcium sodium lactate should be calculated based on the molecular weight of calcium sodium lactate. The following indications are only permitted when the medicine is for oral and sublingual use: - (OSPOR1) ‘Source of calcium. May assist in the prevention and/or treatment of osteoporosis’ - (OSPOR2) ‘Source of calcium. Women's calcium requirements are increased after menopause. Calcium supplementation may be of assistance in the prevention and/or treatment of osteoporosis’ - (CALC1) ‘Source of calcium. Women's calcium requirements are increased after menopause’ - (CALC2) ‘Source of calcium. A calcium supplement formulated to strengthen bone and tissue in growing and mature users. (or) Source of calcium. A calcium supplement formulated to strengthen bone and tissue for children and older adults’ - (CALC3) ‘Source of calcium. Adequate dietary calcium in our youth and throughout life is required to maximise bone’ - (CALC4) ‘Source of calcium. A diet deficient in calcium can lead to osteoporosis in later life.’ The indication ‘For mineral (may state the mineral) supplementation’ is only permitted for use when the medicine is for oral or sublingual use. | |
CALCIUM STEARATE | E |
| ||
CALCIUM SUCCINATE | A,E,H | When used as an active ingredient and the medicine is intended as a mineral supplementation, calcium is a mandatory component of calcium succinate. The percentage of calcium from calcium succinate should be calculated based on the molecular weight of calcium succinate. The following indications are only permitted when the medicine is for oral and sublingual use: - (OSPOR1) ‘Source of calcium. May assist in the prevention and/or treatment of osteoporosis’ - (OSPOR2) ‘Source of calcium. Women's calcium requirements are increased after menopause. Calcium supplementation may be of assistance in the prevention and/or treatment of osteoporosis’ - (CALC1) ‘Source of calcium. Women's calcium requirements are increased after menopause’ - (CALC2) ‘Source of calcium. A calcium supplement formulated to strengthen bone and tissue in growing and mature users. (or) Source of calcium. A calcium supplement formulated to strengthen bone and tissue for children and older adults’ - (CALC3) ‘Source of calcium. Adequate dietary calcium in our youth and throughout life is required to maximise bone’ - (CALC4) ‘Source of calcium. A diet deficient in calcium can lead to osteoporosis in later life.’ The indication ‘For mineral (may state the mineral) supplementation’ is only permitted for use when the medicine is for oral or sublingual use. | ||
CALCIUM SULFATE | A,E,H | If used as an active ingredient and the medicine is intended as a mineral supplementation, calcium is a mandatory component of calcium sulfate. The amount of calcium in the active ingredient should be calculated based on the molecular weight of calcium sulfate. The following indications are only permitted when the medicine is for oral and sublingual use: - (OSPOR1) ‘Source of calcium. May assist in the prevention and/or treatment of osteoporosis’ - (OSPOR2) ‘Source of calcium. Women's calcium requirements are increased after menopause. Calcium supplementation may be of assistance in the prevention and/or treatment of osteoporosis’ - (CALC1) ‘Source of calcium. Women's calcium requirements are increased after menopause’ - (CALC2) ‘Source of calcium. A calcium supplement formulated to strengthen bone and tissue in growing and mature users. (or) Source of calcium. A calcium supplement formulated to strengthen bone and tissue for children and older adults’ - (CALC3) ‘Source of calcium. Adequate dietary calcium in our youth and throughout life is required to maximise bone’ - (CALC4) ‘Source of calcium. A diet deficient in calcium can lead to osteoporosis in later life.’ The indication ‘For mineral (may state the mineral) supplementation.’ is only permitted for use when the medicine is for oral or sublingual use. | ||
CALCIUM SULFATE DIHYDRATE | A,E,H | When used as an active ingredient and the medicine is intended as a mineral supplementation, calcium is a mandatory component of calcium sulfate dihydrate. The percentage of calcium from calcium sulfate dihydrate should be calculated based on the molecular weight of calcium sulfate dihydrate. The following indications are only permitted when the medicine is for oral and sublingual use: - (OSPOR1) ‘Source of calcium. May assist in the prevention and/or treatment of osteoporosis’ - (OSPOR2) ‘Source of calcium. Women's calcium requirements are increased after menopause. Calcium supplementation may be of assistance in the prevention and/or treatment of osteoporosis’ - (CALC1) ‘Source of calcium. Women's calcium requirements are increased after menopause’ - (CALC2) ‘Source of calcium. A calcium supplement formulated to strengthen bone and tissue in growing and mature users. (or) Source of calcium. A calcium supplement formulated to strengthen bone and tissue for children and older adults’ - (CALC3) ‘Source of calcium. Adequate dietary calcium in our youth and throughout life is required to maximise bone’ - (CALC4) ‘Source of calcium. A diet deficient in calcium can lead to osteoporosis in later life.’ The indication ‘For mineral (may state the mineral) supplementation’ is only permitted for use when the medicine is for oral or sublingual use. | ||
CALCIUM SULFIDE | H | Only for use as an active homoeopathic ingredient. | ||
1071 | CALCIUM THREONINATE | A | Only for use as an active ingredient. Calcium is a mandatory component of Calcium threoninate and availability is restricted to use as a source of the relevant mineral only. The percentage of calcium from Calcium Threonite should be calculated based on the molecular weight of Calcium Threonite. The following indications are only permitted when the medicine is for oral and sublingual use - (OSPOR1) ‘Source of calcium. May assist in the prevention and/or treatment of osteoporosis’ - (OSPOR2) ‘Source of calcium. Women's calcium requirements are increased after menopause. Calcium supplementation may be of assistance in the prevention and/or treatment of osteoporosis’ - (CALC1) ‘Source of calcium. Women's calcium requirements are increased after menopause’ - (CALC2) ‘Source of calcium. A calcium supplement formulated to strengthen bone and tissue in growing and mature users. (or) Source of calcium. A calcium supplement formulated to strengthen bone and tissue for children and older adults’ - (CALC3) ‘Source of calcium. Adequate dietary calcium in our youth and throughout life is required to maximise bone’ - (CALC4) ‘Source of calcium. A diet deficient in calcium can lead to osteoporosis in later life.’ The indication ‘For mineral (may state the mineral) supplementation’ is only permitted for use when the medicine is for oral or sublingual use. | |
1072 | CALENDULA FLOWER DRY | A,E,H |
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1073 | CALENDULA FLOWER POWDER | A,H |
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1074 | CALENDULA OFFICINALIS | A,E,H |
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1075 | CALLERYA RETICULATA | A,H |
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1076 | CALLICARPA PEDUNCULATA | A,H |
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1077 | CALLISTEMON CITRINUS | A,H |
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1078 | CALLISTEPHUS CHINENSIS | A,H |
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1079 | CALLITRIS INTRATROPICA | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. | |
1080 | CALLITRIS RHOMBOIDEA | A,H |
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1081 | CALLUNA VULGARIS | A,E,H |
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1082 | CALOCHORTUS TOLMIEI | A,H |
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CALTHA PALUSTRIS | A,H |
| ||
1084 | CALUMBA ROOT DRY | A,H |
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1085 | CALUMBA ROOT POWDER | A,H |
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1086 | CALVATIA GIGANTEA | A,E,H |
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1087 | CALYCANTHUS FLORIDUS | A,H |
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1088 | CALYCANTHUS PRAECOX | A,H |
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1089 | CAMELLIA JAPONICA | A,H |
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CAMELLIA OLEIFERA | A,E,H | If Camellia oleifera (seed oil) is used as a solvent, it is restricted to topical or sunscreen preparations for dermal application only. | ||
1091 | CAMELLIA SINENSIS | A,E,H | Caffeine is a mandatory component of Camellia sinensis for oral use. Medicines for oral or sublingual administration that contain caffeine as a component of a herbal substance and that provide a maximum recommended daily dose of: a) more than 1 mg but no more than 10 mg of caffeine require the following warning statement on the medicine label: - (CAFFR) 'The recommended dose of this medicine provides small amounts of caffeine.' b) more than 10 mg of caffeine require the following warning statement on the medicine label: - (CAFF) 'Contains caffeine [state quantity per dosage unit or per mL or per gram of product].' Polyphenols calculated as gallic acid (of Camellia sinensis) is only permitted for use as a component when the plant part is leaf. | |
CAMPHENE | E | Permitted for use only in combination with other permitted ingredients as a coating solution, a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. | ||
1093 | CAMPHOR | E,H | In solid and semi solid preparations, the concentration of camphor must be no more than 12.5%. In liquid preparations other than essential oils, the concentration of camphor must be no more than 2.5%. In essential oil preparations, if the concentration of camphor is more than 2.5% but less than or equal to 10%, and the nominal capacity of the container is less than 25 millilitres, the medicine must have a restricted flow insert fitted on the container and include the following warning statements on the medicine label: ‑ (CHILD) 'Keep out of reach of children' (or words to that effect); and ‑ (NTAKEN) 'Not to be taken'. In essential oil preparations, if the concentration of camphor is more than 10%, and the nominal capacity of the container is less than 15 millilitres, the medicine must have a restricted flow insert fitted on the container and include the following warning statements on the medicine label: ‑ (CHILD) 'Keep out of reach of children' (or words to that effect); and ‑ (NTAKEN) 'Not to be taken'. In essential oil preparations, if the concentration of camphor is more than 10%, and the nominal capacity of the container is more than 15 millilitres but less than or equal to 25 millilitres, the medicine must have a restricted flow insert and child resistant closure fitted on the container and include the following warning statements on the medicine label: ‑ (CHILD) 'Keep out of reach of children' (or words to that effect); and ‑ (NTAKEN) 'Not to be taken'. | |
CAMPHOR BENZALKONIUM METHOSULFATE | A | Only for use as an active ingredient in sunscreens for dermal application. The concentration in the preparation must be no more than 6%. | ||
CAMPHOR OIL BROWN | A,H | Camphor, cineole and safrole are mandatory components of Camphor oil brown. In solid and semi solid preparations, the concentration of camphor must be no more than 12.5%. In liquid preparations other than essential oils, the concentration of camphor must be no more than 2.5%. In essential oil preparations, if the concentration of camphor is more than 2.5% but less than or equal to 10%, and the nominal capacity of the container is less than 25 millilitres, the medicine must have a restricted flow insert fitted on the container and include the following warning statements on the medicine label: ‑ (CHILD) 'Keep out of reach of children' (or words to that effect); and ‑ (NTAKEN) 'Not to be taken'. In essential oil preparations, if the concentration of camphor is more than 10%, and the nominal capacity of the container is less than 15 millilitres, the medicine must have a restricted flow insert fitted on the container and include the following warning statements on the medicine label: ‑ (CHILD) 'Keep out of reach of children' (or words to that effect); and ‑ (NTAKEN) 'Not to be taken'. In essential oil preparations, if the concentration of camphor is more than 10%, and the nominal capacity of the container is more than 15 millilitres but less than or equal to 25 millilitres, the medicine must have a restricted flow insert and child resistant closure fitted on the container and include the following warning statements on the medicine label: ‑ (CHILD) 'Keep out of reach of children' (or words to that effect); and ‑ (NTAKEN) 'Not to be taken'. When the concentration of cineole in the preparation is more than 25%, the nominal capacity of the container must not be more than 25 millilitres. When the concentration of cineole in the preparation is more than 25% and the nominal capacity of the container is more than 15 millilitres but less than or equal to 25 millilitres, the medicine must have a child resistant closure and restricted flow insert fitted on the container and include the following warning statements on the medicine label: ‑ (CHILD) 'Keep out of reach of children' (or words to that effect); and ‑ (NTAKEN) 'Not to be taken'. When the concentration of cineole in the preparation is more than 25% and the nominal capacity of the container is no more than 15 millilitres, the medicine must have the restricted flow insert fitted on the container and include the following warning statements on the medicine label: ‑ (CHILD) 'Keep out of reach of children' (or words to that effect); and ‑ (NTAKEN) 'Not to be taken'. When for internal use then the concentration of safrole in a medicine must be no more than 0.1%. When for topical use then the concentration of safrole in a medicine must be no more than 1.0%. | ||
1096 | CAMPHOR OIL WHITE | A,E,H | Camphor and safrole are mandatory components of camphor oil white. In solid and semi solid preparations, the concentration of camphor must be no more than 12.5%. In liquid preparations other than essential oils, the concentration of camphor must be no more than 2.5%. In essential oil preparations, if the concentration of camphor is more than 2.5% but less than or equal to 10%, and the nominal capacity of the container is less than 25 millilitres, the medicine must have a restricted flow insert fitted on the container and include the following warning statements on the medicine label: ‑ (CHILD) 'Keep out of reach of children' (or words to that effect); and ‑ (NTAKEN) 'Not to be taken'. In essential oil preparations, if the concentration of camphor is more than 10%, and the nominal capacity of the container is less than 15 millilitres, the medicine must have a restricted flow insert fitted on the container and include the following warning statements on the medicine label: ‑ (CHILD) 'Keep out of reach of children' (or words to that effect); and ‑ (NTAKEN) 'Not to be taken'. In essential oil preparations, if the concentration of camphor is more than 10%, and the nominal capacity of the container is more than 15 millilitres but less than or equal to 25 millilitres, the medicine must have a restricted flow insert and child resistant closure fitted on the container and include the following warning statements on the medicine label: ‑ (CHILD) 'Keep out of reach of children' (or words to that effect); and ‑ (NTAKEN) 'Not to be taken'. When for internal use then the concentration of safrole in a medicine must be no more than 0.1%. When for topical use then the concentration of safrole in a medicine must be no more than 1.0%. | |
1097 | CAMPSIS GRANDIFLORA | A,H |
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1098 | CANADA BALSAM | A,H |
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1099 | CANANGA ODORATA | A,E,H |
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1100 | CANANGA OIL | A,E,H |
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1101 | CANARIUM INDICUM | A,H | The plant part must be seed and the plant preparation is oil. The medicine requires the following warning statement on the medicine label: - (DERIVED) 'This product contains material derived from nuts' (or words to that effect). | |
1102 | CANARIUM LUZONICUM | A,H |
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1103 | CANDELILLA WAX | A,E,H |
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1104 | CANDIDA ALBICANS | H | Only for use as an active homoeopathic ingredient. | |
1105 | CANDIDA UTILIS | A,H |
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CANINE MILK | H | Only for use as an active homoeopathic ingredient. | ||
1107 | CANOLA OIL | A,E,H | Allyl isothiocyanate is a mandatory component of Canola oil. The maximum recommended daily dose must not provide more than 20 mg of Allyl isothiocyanate. | |
1108 | CANTHARIDES | H | Only available as an active homoeopathic ingredient. | |
1109 | CANTHAXANTHIN | E | Permitted as an excipient ingredient as a colour for oral and topical use. | |
1110 | CAPRIC ACID | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. | |
1111 | CAPROIC ALDEHYDE | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. | |
CAPRYLIC ALDEHYDE | E | Permitted for use only in combination with other permitted ingredients as a coating solution, a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. | ||
1113 | CAPRYLIC/CAPRIC GLYCERIDES | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. | |
1114 | CAPRYLIC/CAPRIC/ISOSTEARIC/ADIPIC TRIGLYCERIDE | E |
| |
1115 | CAPRYLIC/CAPRIC/MYRISTIC/STEARIC TRIGLYCERIDE | E | Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine is not to exceed 3% | |
1116 | CAPRYLIC/CAPRIC/STEARIC TRIGLYCERIDE | E | Only for use in topical medicines for dermal application. | |
1117 | CAPRYLOYL GLYCINE | E | Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must not be more than 2% | |
CAPRYLOYL SALICYLIC ACID | E | Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye or on damaged skin. The concentration in the medicine must not be more than 0.3%. | ||
1119 | CAPRYLYL GLYCOL | E | Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 2% | |
1120 | CAPRYLYL METHICONE | E | Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 10%. | |
1121 | CAPSELLA BURSA-PASTORIS | A,H |
| |
1122 | CAPSICUM | E,H | Only for use as an active homoeopathic or excipient ingredient. | |
1123 | CAPSICUM ANNUUM | A,E,H |
| |
1124 | CAPSICUM DRY | A,E,H |
| |
1125 | CAPSICUM FRUIT OLEORESIN | A,E |
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1126 | CAPSICUM FRUTESCENS | A,E,H |
| |
1127 | CAPSICUM POWDER | A,E,H |
| |
1128 | CARALLUMA ADSCENDENS VAR. FIMBRIATA | A | The plant part must be herb and the plant preparation must be a hydroethanolic extract. | |
1129 | CARAMEL | E | Permitted as an excipient ingredient as a colour for oral and topical use. | |
CARAPICHEA IPECACUANHA | A,H | Emetine is a mandatory component of Carapichea ipecacuanha. The concentration of emetine in the medicine must be no more than 0.2%. Except when used in a medicine containing only homoeopathic preparations, a child resistant closure must be fitted onto the container. | ||
1131 | CARAWAY DRY | A,H |
| |
1132 | CARAWAY OIL | A,E,H |
| |
1133 | CARAWAY POWDER | A,H |
| |
1134 | CARBOMER 1342 | E | Only for use as an excipient in topical medicines for dermal application. | |
1135 | CARBOMER 2001 | E | Only for use as an excipient ingredient in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration must be no more than 1% in formulations at pH 7 (approximately neutral) and 0.1% in formulations at a different pH. | |
1136 | CARBOMER 934 | E | Only for use in topical medicines for dermal application. | |
1137 | CARBOMER 934P | E | Only for use in topical medicines for dermal application. | |
1138 | CARBOMER 940 | E | Only for use in topical medicines for dermal application. | |
1139 | CARBOMER 941 | E | Only for use as an excipient in topical medicines for dermal application. | |
1140 | CARBOMER 954 | E | Only for use as an excipient in topical medicines for dermal application. | |
1141 | CARBOMER 980 | E | Only for use as an excipient in topical medicines for dermal application. | |
1142 | CARBOMER 981 | E | Only for use as an excipient in topical medicines for dermal application. | |
CARBOMER COPOLYMER (TYPE B) | E | Only for use as an excipient in topical medicines for dermal application. | ||
1144 | CARBOMER HOMOPOLYMER (TYPE B) | E | Only for use as an excipient in topical medicines for dermal application. | |
1145 | CARBOMER U-10 | E | Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 5%. | |
1146 | CARBON | E,H | Only for use as an active homoeopathic or excipient ingredient. | |
1147 | CARBON BLACK | E | Permitted as an excipient ingredient as a colour for oral and topical use. | |
1148 | CARBON DIOXIDE | E |
| |
1149 | CARDAMOM FRUIT DRY | A,H |
| |
1150 | CARDAMOM FRUIT POWDER | A,E,H |
| |
1151 | CARDAMOM OIL | A,E,H |
| |
1152 | CARDIOSPERMUM HALICACABUM | A,H |
| |
1153 | CARICA PAPAYA | A,E,H |
| |
1154 | CARLINA ACAULIS | A,H |
| |
1155 | CARMELLOSE | E |
| |
1156 | CARMELLOSE CALCIUM | E |
| |
1157 | CARMELLOSE SODIUM | E |
| |
CARMINE | E | Permitted for use as a colour for oral and topical use. | ||
1159 | CARMOISINE | E | Permitted as an excipient ingredient as a colour for oral and topical use. | |
1160 | CARMOISINE ALUMINIUM LAKE | E | Permitted as an excipient ingredient as a colour for oral and topical use. | |
1161 | CARNAUBA WAX | A,E,H |
| |
1162 | CARNOSINE | E | Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.2%. | |
1163 | CAROB BEAN EXTRACT | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. | |
1164 | CAROB GUM | E |
| |
1165 | CAROB POD | E |
| |
1166 | CAROTENES | E | Permitted as an excipient ingredient as a colour for oral and topical use. | |
1167 | CARPINUS BETULUS | A,H |
| |
1168 | CARPINUS CORDATA | A,H |
| |
1169 | CARRAGEENAN | E |
| |
1170 | CARROT | E |
| |
CARROT SEED OIL | A,E,H |
| ||
1172 | CARTHAMUS TINCTORIUS | A,E,H | Carthamus tinctorius (sunflower oil) when used as a solvent is restricted to topical or sunscreen preparations for dermal application only. If for oral use, the medicine requires the following warning statement on the medicine label: - (PREGNT2) 'Do not use if pregnant or likely to become pregnant' (or words to that effect). | |
1173 | CARUM CARVI | A,H |
| |
1174 | CARVACROL | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. | |
1175 | CARVACRYL METHYL ETHER | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. | |
1176 | CARVEOL | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. | |
CARVONE | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. | ||
1178 | CARVYL ACETATE | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. | |
1179 | CARYA ILLINOINENSIS | A,H |
| |
1180 | CARYA OVATA | A,H |
| |
CARYOPHYLLENE OXIDE | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. | ||
CASCARA DRY | A,H | Hydroxyanthracene derivatives calculated as cascaroside A is a mandatory component of Cascara dry when the route of administration is oral. When used in oral medicines, if the maximum recommended daily dose contains more than 10 mg of hydroxyanthracene derivatives the medicine requires the following warning statements on the medicine label: - (CHILD3) ‘Use in children under 12 years is not recommended’ - (LAX2) ‘Prolonged use may cause serious bowel problems’ - (LAX3) ‘Do not use when abdominal pain, nausea or vomiting are present, or if you develop diarrhoea. If you are pregnant or breast feeding, seek the advice of a healthcare professional before taking this product' (or words to that effect) - (S) ‘If symptoms persist consult your healthcare practitioner' (or words to that effect). When promoted or marketed as a laxative, the medicine requires the following warning statement on the medicine label: - (LAX1) ‘Drink plenty of water' (or words to that effect) When not promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label: - (LAX5) ‘This product contains [name of the herb(s) or the chemical component(s)]’ - (LAX4) ‘This product may have laxative effect’ When used in oral medicines, if the maximum recommended daily dose contains less than 10 mg of hydroxyanthracene derivatives and is promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label: - (CHILD3) ‘Use in children under 12 years is not recommended’ - (LAX1) ‘Drink plenty of water' (or words to that effect) - (LAX2) ‘Prolonged use may cause serious bowel problems’ - (S) ‘If symptoms persist consult your healthcare practitioner' (or words to that effect). | ||
1183 | CASCARA POWDER | A,H | Hydroxyanthracene derivatives calculated as cascaroside A is a mandatory component of Cascara powder when the route of administration is oral administration. When used in oral medicines, if the maximum recommended daily dose contains more than 10 mg of hydroxyanthracene derivatives the medicine requires the following warning statements on the medicine label: - (CHILD3) ‘Use in children under 12 years is not recommended’ - (LAX2) ‘Prolonged use may cause serious bowel problems’ - (LAX3) ‘Do not use when abdominal pain, nausea or vomiting are present, or if you develop diarrhoea. If you are pregnant or breast feeding, seek the advice of a healthcare professional before taking this product' (or words to that effect) - (S) ‘If symptoms persist consult your healthcare practitioner' (or words to that effect). When promoted or marketed as a laxative, the medicine requires the following warning statement on the medicine label: - (LAX1) ‘Drink plenty of water' (or words to that effect) When not promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label: - (LAX5) ‘This product contains [name of the herb(s) or the chemical component(s)]’ - (LAX4) ‘This product may have laxative effect’ When used in oral medicines, if the maximum recommended daily dose contains less than 10 mg of hydroxyanthracene derivatives and is promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label: - (CHILD3) ‘Use in children under 12 years is not recommended’ - (LAX1) ‘Drink plenty of water' (or words to that effect) - (LAX2) ‘Prolonged use may cause serious bowel problems’ - (S) ‘If symptoms persist consult your healthcare practitioner' (or words to that effect). | |
1184 | CASCARILLA OIL | A,H | The medicine must not contain more than 1mg of the equivalent dry herbal material per the maximum recommended daily dose. | |
1185 | CASEIN | E |
| |
CASHEW NUT | E |
| ||
1187 | CASSIA ALATA LEAF EXTRACT | E | Only for use as an excipient ingredient in sunscreens for dermal application and not to be intended for use in the eye. The extraction ratio of the Cassia alata can only be 1:3 in 62.5% glycerine:water. The concentration in the medicine must be no more than 0.0275%. | |
1188 | CASSIA CINNAMON BARK DRY | A,H | When used as an active ingredient, the maximum daily dose of the medicine must contain no more than 0.001% of coumarin. | |
CASSIA CINNAMON BARK POWDER | A,H | When used as an active ingredient, the maximum daily dose of the medicine must contain no more than 0.001% of coumarin. | ||
CASSIA FISTULA | A,H | Hydroxyanthracene glycosides calculated as sennoside B is a mandatory component of Cassia fistula when the route of administration is oral. When used in oral medicines, if the maximum recommended daily dose contains more than 10 mg of hydroxyanthracene derivatives the medicine requires the following warning statements on the medicine label: - (CHILD3) ‘Use in children under 12 years is not recommended’ - (LAX2) ‘Prolonged use may cause serious bowel problems’ - (LAX3) ‘Do not use when abdominal pain, nausea or vomiting are present, or if you develop diarrhoea. If you are pregnant or breast feeding, seek the advice of a healthcare professional before taking this product' (or words to that effect) - (S) ‘If symptoms persist consult your healthcare practitioner' (or words to that effect). When promoted or marketed as a laxative, the medicine requires the following warning statement on the medicine label: - (LAX1) ‘Drink plenty of water' (or words to that effect) When not promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label: - (LAX5) ‘This product contains [name of the herb(s) or the chemical component(s)]’ - (LAX4) ‘This product may have laxative effect’ When used in oral medicines, if the maximum recommended daily dose contains less than 10 mg of hydroxyanthracene derivatives and is promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label: - (CHILD3) ‘Use in children under 12 years is not recommended’ - (LAX1) ‘Drink plenty of water' (or words to that effect) - (LAX2) ‘Prolonged use may cause serious bowel problems’ - (S) ‘If symptoms persist consult your healthcare practitioner' (or words to that effect). | ||
1191 | CASSIA OCCIDENTALIS | A,H | Hydroxyanthracene glycosides calculated as sennoside B is a mandatory component of Cassia occidentalis when the route of administration is oral administration. When used in oral medicines, if the maximum recommended daily dose contains more than 10 mg of hydroxyanthracene derivatives the medicine requires the following warning statements on the medicine label: - (CHILD3) ‘Use in children under 12 years is not recommended’ - (LAX2) ‘Prolonged use may cause serious bowel problems’ - (LAX3) ‘Do not use when abdominal pain, nausea or vomiting are present, or if you develop diarrhoea. If you are pregnant or breast feeding, seek the advice of a healthcare professional before taking this product [or words to that effect]’ - (S) ‘If symptoms persist consult your healthcare practitioner [or words to that effect]’. When promoted or marketed as a laxative, the medicine requires the following warning statement on the medicine label: - (LAX1) ‘Drink plenty of water [or words to that effect] When not promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label: - (LAX5) ‘This product contains [name of the herb(s) or the chemical component(s)]’ - (LAX4) ‘This product may have laxative effect’ When used in oral medicines, if the maximum recommended daily dose contains less than 10 mg of hydroxyanthracene derivatives and is promoted or marketed as laxative, the medicine the following warning statements on the medicine label: - (CHILD3) ‘Use in children under 12 years is not recommended’ - (LAX1) ‘Drink plenty of water [or words to that effect]’ - (LAX2) ‘Prolonged use may cause serious bowel problems’ - (S) ‘If symptoms persist consult your healthcare practitioner [or words to that effect]’ | |
1192 | CASSIA OIL | A,E,H | The concentration of Cassia oil in the product must be no more than 2% unless the preparation is for dermal use as a rubefacient, in which case the concentration of cassia oil must be no more than 5%. | |
CASSIE ABSOLUTE | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. | ||
1194 | CASTANEA MOLLISSIMA | A,H |
| |
1195 | CASTANEA SATIVA | A,H |
| |
1196 | CASTOR OIL | A,E |
| |
1197 | CASTOREUM | H | Only permitted for use as an active homoeopathic ingredient.
| |
1198 | CASUARINA EQUISITIFOLIA | A,H |
| |
1199 | CATALPA BIGNONIOIDES | A,H |
| |
1200 | CATALPA OVATA | A,H |
| |
1201 | CATECHU | A,H |
| |
CATHARANTHUS ROSEUS | A,H | Vinblastine, vincamine, vincristine, vindesine, vinorelbine and yohimbine are mandatory components of Cantharanthus roseus. The concentration of vinblastine, vincamine, vincristine, vindesine, vinorelbine and yohimbine in the medicine must be no more than 10mg/kg or 10 mg/L or 0.001%. | ||
1203 | CAULIFLOWER | E |
| |
1204 | CAULOPHYLLUM THALICTROIDES | A,E,H |
| |
1205 | CAUSTICUM | H | Only for use as an active homoeopathic ingredient. | |
1206 | CEANOTHUS AMERICANUS | A,H |
| |
1207 | CEDAR LEAF OIL | A,E,H |
| |
1208 | CEDARWOOD OIL | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. | |
1209 | CEDARWOOD OIL ATLAS | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. | |
CEDARWOOD OIL TERPENES | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. | ||
1211 | CEDARWOOD OIL VIRGINIA | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. | |
1212 | CEDRENOL | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. | |
1213 | CEDRENYLACETATE | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. | |
1214 | CEDROL | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. | |
1215 | CEDRUS ATLANTICA | A,E,H |
| |
1216 | CEDRUS DEODARA | A,H |
| |
1217 | CEDRUS LIBANI | H | Only for use as an active homoeopathic ingredient. | |
CEDRYL ACETATE | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. | ||
1219 | CEDRYL METHYL ETHER | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. | |
1220 | CELERY LEAF | E,H |
| |
1221 | CELERY SEED DRY | A,E,H |
| |
1222 | CELERY SEED OIL | A,E,H |
| |
1223 | CELERY SEED POWDER | A,H |
| |
1224 | CELLACEFATE | E |
| |
1225 | CELLULASE | A | Must be derived from Trichoderma longibrachiatum only. If used as an undivided preparation, the allowed unit is Cellulase unit per gram or Thousand cellulase unit per gram. If used as an divided preparation, the allowed unit is Thousand cellulase unit or cellulase unit. | |
1226 | CELLULOSE | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. | |
CELOSIA ARGENTEA | A,H |
| ||
1228 | CELOSIA ARGENTEA L. VAR. CRISTATA | A,H |
| |
1229 | CENTAUREA CYANUS | A,E,H |
| |
1230 | CENTAURIUM ERYTHRAEA | A,H |
| |
1231 | CENTELLA ASIATICA | A,E,H |
| |
1232 | CENTELLA ASIATICA MERISTEM CELL CULTURE | E | Only for use as an excipient ingredient in topical medicines for dermal application and not to be included in medicines intended for use in the eye or on damaged skin. The concentration in the medicine must be no more than 0.05%. | |
1233 | CENTIPEDA CUNNINGHAMII | A,E,H |
| |
1234 | CENTIPEDA MINIMA | A,H |
| |
1235 | CEPHALANOPSIS SEGETUM | A,H |
| |
1236 | CERAMIDE 1 | E | Only for use in topical medicines for dermal application. | |
1237 | CERAMIDE 2 | E | Only for use in topical medicines for dermal application and not to be included in topical medicines intended for use in the eye. The concentration in the medicine must be no more than 0.05%. | |
1238 | CERAMIDE 3 | E | Only for use in topical medicines for dermal application. | |
CERATONIA SILIQUA | A,E,H |
| ||
1240 | CERATOSTIGMA WILLMOTTIANUM | A,H |
| |
1241 | CERESIN | E | Only for use in topical medicines for dermal application. | |
1242 | CESTRUM LATIFOLIUM | E | Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye or on damaged skin. The plant part must be leaf and must be a water extract. The concentration must be no more than 0.5%. | |
1243 | CETEARETH-12 | E | Only for use in topical medicines for dermal application. | |
1244 | CETEARETH-2 | E | Only for use in topical medicines for dermal application. | |
1245 | CETEARETH-20 | E | Only for use in topical medicines for dermal application. | |
1246 | CETEARETH-25 | E | Only for use in topical medicines for dermal application. | |
1247 | CETEARETH-30 | E | Only for use in topical medicines for dermal application. | |
1248 | CETEARETH-33 | E | Only for use as an excipient ingredient for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.2%. Residual levels of 1,4-dioxane oxide (and related substances) are to be kept below the level of detection. | |
CETEARYL GLUCOSIDE | E | Only for use in topical medicines for dermal application. | ||
1250 | CETEARYL ISONONANOATE | E | Only for use in topical medicines for dermal application. | |
1251 | CETEARYL OCTANOATE | E | Only for use in topical medicines for dermal application. | |
1252 | CETETH-10 | E | Only for use in topical medicines for dermal application. | |
1253 | CETETH-2 | E | Only for use in topical medicines for dermal application. | |
1254 | CETETH-24 | E | Only for use in topical medicines for dermal application. | |
1255 | CETETH-5 | E | Only for use in topical medicines for dermal application. | |
1256 | CETOMACROGOL 1000 | E | Only for use in topical medicines for dermal application. | |
1257 | CETOMACROGOL 1000 PHOSPHATE | E | Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye or on damaged skin. The concentration in the medicine must be no more than 2%. | |
1258 | CETOMACROGOL 500 PHOSPHATE | E | Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye or on damaged skin. The concentration in the medicine must be no more than 2%. | |
1259 | CETOSTEARYL ALCOHOL | E |
| |
CETOSTEARYL ALCOHOL/COCO-GLUCOSIDE COMPLEX | E | Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye or on damaged skin. The concentration in the medicine must be no more than 5.0 % | ||
1261 | CETRARIA ISLANDICA | A,H |
| |
1262 | CETRIMONIUM BROMIDE | E | Only for use in topical medicines for dermal application. | |
1263 | CETRIMONIUM CHLORIDE | E | Only for use in topical medicines for dermal application. | |
1264 | CETYL-PG HYDROXYETHYL PALMITAMIDE | E | Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 8%. | |
1265 | CETYL ACETATE | E | Only for use in topical medicines for dermal application. | |
1266 | CETYL ALCOHOL | E | Only for use in topical medicines for dermal application. | |
1267 | CETYL DIMETHICONE COPOLYOL | E | Only for use in topical medicines for dermal application. | |
1268 | CETYL DIMETICONE | E | Only for use in topical medicines for dermal application. | |
1269 | CETYL DIMETICONE/BIS-VINYLDIMETICONE CROSSPOLYMER | E | Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye or on damaged skin. The concentration in the medicine must be no more than 0.1%. | |
CETYL ESTERS WAX | E | Only for use in topical medicines for dermal application. | ||
1271 | CETYL HYDROXYETHYLCELLULOSE | E | Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 1%. | |
1272 | CETYL LACTATE | E | Only for use in topical medicines for dermal application. | |
1273 | CETYL OCTANOATE | E | Only for use in topical medicines for dermal application. | |
1274 | CETYL PALMITATE | E | Only for use in topical medicines for dermal application. | |
1275 | CETYL PHOSPHATE | E | Only for use in topical medicines for dermal application. | |
1276 | CETYLPYRIDINIUM CHLORIDE | E | Only for use in topical medicines for dermal application. Medicines for topical use must include the name of any antimicrobial preservative in the goods. | |
1277 | CHAENOMELES LAGENARIA | A,H |
| |
1278 | CHAENOMELES SPECIOSA | A,H |
| |
1279 | CHAETOMIUM INDICUM | A,H |
| |
1280 | CHALK | A,E | When used as an active ingredient, can only be supplied as an uncompounded medicine substance packed for retail sale and must comply with an uncompounded substance monograph of the British Pharmacopoeia, as in force or existing from time to time. | |
1281 | CHAMAECYPARIS LAWSONIANA | A,H |
| |
1282 | CHAMAELIRIUM LUTEUM | A,H |
| |
CHAMAEMELUM NOBILE | A,E,H |
| ||
1284 | CHAMOMILE FLOWER DRY | A,E,H |
| |
1285 | CHAMOMILE OIL ENGLISH | A,E,H |
| |
1286 | CHAMOMILE OIL GERMAN | A,E,H |
| |
1287 | CHANGIUM SMYRNIOIDES | A,H |
| |
1288 | CHEIRANTHUS CHEIRI | A,H |
| |
1289 | CHELIDONIUM MAJUS | A,E,H | When for oral or sublingual use, the medicine requires the following warning statement on the medicine label: - (CELAND) 'WARNING: Greater Celandine may harm the liver in some people. Use only under the supervision of a healthcare professional'. | |
1290 | CHELONE GLABRA | A,H |
| |
1291 | CHENOPODIUM ALBUM | A,H |
| |
CHENOPODIUM VULVARIA | A,H |
| ||
1293 | CHERRY | E |
| |
1294 | CHERRY DISTILLATE | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. | |
1295 | CHESTNUT SWEET | E,H |
| |
1296 | CHILLI | E,H |
| |
1297 | CHIMAPHILA UMBELLATA | A,H |
| |
1298 | CHIONANTHUS VIRGINICA | A,H |
| |
1299 | CHLORELLA | E | Iodine is a mandatory component of Chlorella. Only for external use when the concentration of iodine in the medicine (excluding salts derivatives or iodophors) is 2.5% or less. Only for internal use when the medicine contains less than 300 micrograms of iodine per maximum recommended daily dose. | |
CHLORELLA PYRENOIDOSA | E |
| ||
1301 | CHLORELLA VULGARIS | A,E | Iodine is a mandatory component of Chlorella vulgaris. Only for external use when the concentration of iodine in the medicine (excluding salts derivatives or iodophors) is 2.5% or less. Only for internal use when the medicine contains less than 300 micrograms of iodine per maximum recommended daily dose. The indication 'For mineral (may state the mineral) supplementation' is only permitted when the medicine is for oral or sublingual use. | |
1302 | CHLORHEXIDINE ACETATE | E | Only for use in topical medicines for dermal application. | |
1303 | CHLORHEXIDINE GLUCONATE | E | Only for use in topical medicines for dermal application. | |
1304 | CHLOROACETAMIDE | E | Only for use in topical medicines for dermal application. | |
CHLOROBUTANOL HEMIHYDRATE | E | Only for use in topical preparations for localised effect. The concentration in the medicine must be no more than 0.5%. The medicine requires the following warning statement on the medicine label: - (CHLORB) 'Contains chlorbutol' (or words to that effect). | ||
1306 | CHLOROCRESOL | E | Only for use in topical medicines for dermal application. The concentration in the medicine must be no more than 3%. The medicine requires the following warning statement on the medicine label: - (CHLCRS) 'Contains chlorocresol [quantity]' (or words to that effect) | |
1307 | CHLOROFORM | E | The residual solvent limit must be no more than 0.6 mg per recommended daily dose and the concentration in the medicine must be no more than 0.006%. | |
1308 | CHLOROPHYLL | A,E | Only for use as a colour in oral and topical medicines. | |
1309 | CHLOROPHYLL-COPPER COMPLEXES | E | Only for use as a colour in oral and topical medicines. | |
1310 | CHLOROPHYLLIN-COPPER COMPLEX | E | Only for use as a colour in oral and topical medicines. | |
1311 | CHLOROPHYLLIN-COPPER COMPLEX ALUMINIUM LAKE | E | Only for as a colour in oral and topical medicines. | |
1312 | CHLOROXYLENOL | E | Only for use in topical medicines for dermal application. | |
1313 | CHLORPHENESIN | E | Only for use in topical medicines for dermal application. | |
1314 | CHOCOLATE BROWN HT | E | Permitted for use as a colour for oral and topical use. | |
1315 | CHOLESTEROL | E,H | Only for use as an active ingredient in homoeopathic medicines or an excipient ingredient in topical preparations. | |
1316 | CHOLESTERYL HYDROXYSTEARATE | E | Only for use in topical medicines for dermal application. | |
CHOLESTERYL MACADAMIATE | E | Only for use in topical medicines for dermal application. | ||
1318 | CHOLESTERYL/BEHENYL/OCTYLDODECYL LAUROYL GLUTAMATE | E | Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.5%. | |
1319 | CHOLETH-24 | E | Only for use in topical medicines for dermal application. | |
1320 | CHOLINE BITARTRATE | A,E |
| |
1321 | CHOLINE DIHYDROGEN CITRATE | A | Only for use in oral medicines. | |
1322 | CHONDRODENDRON TOMENTOSUM | A,H | The concentration of equivalent dry Chondrodendron tomentosum in the product must be no more than 10mg/Kg or 10mg/L or 0.001%. | |
CHONDRUS CRISPUS | A,E,H | Iodine is a mandatory component of Chondrus crispus. Only for external use when the concentration of iodine in the medicine (excluding salts derivatives or iodophors) is 2.5% or less. Only for internal use when the medicine contains less than 300 micrograms of iodine per maximum recommended daily dose. The indication 'For mineral (may state the mineral) supplementation' is only permitted when the medicine is for oral or sublingual use. | ||
1324 | CHONDRUS DRY | A,E,H | Iodine is a mandatory component of Chondrus dry. Only for external use when the concentration of iodine in the medicine (excluding salts derivatives or iodophors) is 2.5% or less. Only for internal use when the medicine contains less than 300 micrograms of iodine per maximum recommended daily dose. The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use. | |
CHONDRUS EXTRACT | A,E,H | Iodine is a mandatory component of Chondrus extract. Only for external use when the concentration of iodine in the medicine (excluding salts derivatives or iodophors) is 2.5% or less. Only for internal use when the medicine contains less than 300 micrograms of iodine per maximum recommended daily dose. The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use. | ||
1326 | CHROMIC CHLORIDE HEXAHYDRATE | A,H | If used as an active ingredient in a preparation for mineral supplementation, chromium is a mandatory component of chromic chloride hexahydrate. The amount of chromium in the active ingredient should be calculated based on the molecular weight of chromic chloride hexahydrate. The maximum recommended daily dose must provide 50 micrograms or less of chromium from organic sources (i.e.: chromium picolinate, chromium nicotinate and yeast - high chromium). The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use. | |
1327 | CHROMIUM NICOTINATE | A | Chromium is a mandatory component of Chromium nicotinate. The maximum recommended daily dose must not provide more than 50 micrograms of chromium from organic sources. Chromium Nicotinate is considered to be an organic form of chromium. The indication 'For mineral (may state mineral) supplementation' is only permitted when the medicine is for oral and sublingual use. | |
CHROMIUM PICOLINATE | A | Chromium is a mandatory component of Chromium picolinate. The maximum recommended daily dose must not provide more than 50 micrograms of chromium from organic sources. Chromium picolinate is considered to be an organic form of chromium. The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use. | ||
1329 | CHRYSANTHEMUM BALSAMITA | A,H |
| |
1330 | CHRYSANTHEMUM INDICUM | A,H |
| |
1331 | CHRYSANTHEMUM LEUCANTHEMUM | A,H |
| |
1332 | CHRYSANTHEMUM MARSHALLII | A,H |
| |
1333 | CHRYSANTHEMUM SINENSE | A,H |
| |
1334 | CHRYSOPOGON ZIZANIOIDES | A,E,H |
| |
1335 | CHRYSOSPORIUM PRUINOSUM | A,H |
| |
1336 | CIBOTIUM BAROMETZ | A,H |
| |
1337 | CICHORIUM INTYBUS | A,E,H |
| |
1338 | CICUTA VIROSA | A,H | The maximum recommended daily dose must be no more than the equivalent of 1mg of the dry herbal material. | |
CINCHONA BARK DRY | A,H | Quinidine and quinine are mandatory components of Cinchona bark dry. The medicine must contain no more than 50 micrograms of quinine and no more than 10 micrograms concentration of quinidine per g or mL. | ||
1340 | CINCHONA BARK POWDER | A,H | Quinidine and quinine are mandatory components of Cinchona bark powder. The medicine must contain no more than 50 micrograms of quinine and no more than 10 micrograms concentration of quinidine per g or mL. | |
1341 | CINCHONA OFFICINALIS | A,H | Quinidine and quinine are mandatory components of Cinchona officinalis. The medicine must contain no more than 50 micrograms of quinine and no more than 10 micrograms concentration of quinidine per g or mL. | |
CINCHONA PUBESCENS | A,H | Quinidine and quinine are mandatory components of Cinchona pubescens. The medicine must contain no more than 50 micrograms of quinine and no more than 10 micrograms concentration of quinidine per g or mL. | ||
1343 | CINEOLE | E | In liquid preparations when the concentration of cineole in the preparation is more than 25%: a) the nominal capacity of the container must be no more than 25 millilitres; b) a restricted flow insert must be fitted on the container; and c) the container must include the following warning statements on the medicine label: - (CHILD) 'Keep out of reach of children' (or words to that effect); and - (NTAKEN) 'Not to be taken'. In liquid preparations, when the concentration of cineole in the preparation is more than 25% and the nominal capacity of the container is more than 15 millilitres but less than or equal to 25 millilitres the medicine must also have a child resistant closure. | |
1344 | CINNAMALDEHYDE | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. | |
CINNAMIC ACID | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. | ||
CINNAMOMUM CAMPHORA | A,E,H | Camphor, cineole and safrole are mandatory components of Cinnamomum camphora. In solid and semi solid preparations, the concentration of camphor must be no more than 12.5%. In liquid preparations other than essential oils or distillates, the concentration of camphor must be no more than 2.5%. In essential oil preparations or distillates, the nominal capacity of the container must be no more than 25 millilitres and the following warning statements must be included on the medicine label: - (CHILD) 'Keep out of reach of children' (or words to that effect); - (NTAKEN) 'Not to be taken'; and - Do not apply to infants under 12 months of age except on the advice of a doctor or pharmacist. In essential oil preparations or distillates, if the concentration of camphor is more than 2.5% but less than or equal to 10%, and the nominal capacity of the container is less than 25 millilitres, the medicine must have a restricted flow insert fitted on the container. In essential oil preparations or distillates, if the concentration of camphor is more than 10%, and the nominal capacity of the container is less than 15 millilitres, the medicine must have a restricted flow insert fitted on the container. In essential oil preparations or distillates, if the concentration of camphor is more than 10%, and the nominal capacity of the container is more than 15 millilitres but less than or equal to 25 millilitres, the medicine must have a restricted flow insert and child resistant closure fitted on the container. In liquid preparations other than essential oils or distillates, when the concentration of cineole in the preparation is more than 25% the nominal capacity of the container must be no more than 25 millilitres and the medicine must include the following warning statements on the medicine label: - (CHILD) 'Keep out of reach of children' (or words to that effect); and - (NTAKEN) 'Not to be taken'. In liquid preparations other than essential oils or distillates, when the concentration of cineole in the preparation is more than 25% and the nominal capacity of the container is more than 15 millilitres but less than or equal to 25 millilitres, the medicine must have a child resistant closure and restricted flow insert fitted on the container. In liquid preparations other than essential oils or distillates, when the concentration of cineole in the preparation is more than 25% and the nominal capacity of the container is no more than 15 millilitres, the medicine must have a restricted flow insert fitted on the container. When for internal use then the concentration of safrole in a medicine must be no more than 0.1%. When for uses other than internal use, the concentration of safrole in a medicine must be no more than 1.0%. When used as an active ingredient, the maximum daily dose of the medicine must contain no more than 0.001% of coumarin. | ||
CINNAMOMUM CASSIA | A,E | Cassia oil is a mandatory component of Cinnamomum cassia if the plant preparation is an essential oil, distillate, fixed oil or infused oil. The concentration of Cassia oil in the medicine must be no more than 2%. When used as an active ingredient, the maximum daily dose of the medicine must contain no more than 0.001% of coumarin. | ||
1348 | CINNAMOMUM VERUM | A,E,H | When used as an active ingredient, coumarin is a mandatory component of Cinnamomum verum. Cinnamon bark oil is a mandatory component of Cinnamomum verum when the plant part is bark and the plant preparation is essential oil, distillate, fixed oil or infused oil. The concentration of cinnamon bark oil in the medicine must be no more than 2%. Cinnamon leaf oil is a mandatory component of Cinnamomum verum when the plant part is leaf. When the concentration of cinnamon leaf oil in the preparation is more than 25%: a) the nominal capacity of the container must be no more than 25 millilitres; b) a restricted flow insert must be fitted on the container; and c) the container must include the following warning statements on the medicine label: - (CHILD) 'Keep out of reach of children' (or words to that effect); and - (NTAKEN) 'Not to be taken'. When the concentration of cinnamon leaf oil in the preparation is more than 25% and the nominal capacity of the container is more than 15 millilitres but no more than 25millilitres, the medicine must have a child resistant closure and restricted flow insert fitted on the container. When the concentration of cinnamon leaf oil in the preparation is more than 25% and the nominal capacity of the container is no more than 15 millilitres, the container must be fitted with a restricted flow insert. When used as an active ingredient: a) coumarin is a mandatory component of Cinnamomum verum; and b) the maximum daily dose of the medicine must contain no more than 0.001% of coumarin. | |
1349 | CINNAMON BARK OIL | A,E,H | The concentration of Cinnamon bark oil in the product must be no more than 2%. When used as an active ingredient, the maximum daily dose of the medicine must contain no more than 0.001% Coumarin. | |
CINNAMON DRY | A,H | Cinnamon bark oil is a mandatory component of Cinnamon dry. The concentration of cinnamon bark oil in the product must be no more than 2%. When used as an active ingredient, the maximum daily dose of the medicine must contain no more than 0.001% of Coumarin. | ||
1351 | CINNAMON LEAF OIL | A,E,H | When the concentration of cinnamon leaf oil in the preparation is more than 25%, the nominal capacity of the container must not be more than 25 mL. When the concentration of cinnamon leaf oil in the preparation is more than 25% and the nominal capacity of the container is more than 15 mL but no more than 25mL, the medicine must have a child resistant closure and restricted flow insert fitted on the container and requires the following warning statement on the medicine label: - (CHILD) ‘Keep out of reach of children’ (or words to that effect) - (NTAKEN) ‘Not to be taken’ When the concentration of cinnamon leaf oil in the preparation is more than 25% and the nominal capacity of the container is no more than 15 mL , the container must be fitted with a restricted flow insert and requires the following warning statement on the medicine label: - (CHILD) ‘Keep out of reach of children’ (or words to that effect) - (NTAKEN) ‘Not to be taken’ When used as an active ingredient, the maximum daily dose of the medicine must contain no more than 0.001% of Coumarin. | |
CINNAMON POWDER | A,E,H | Cinnamon bark oil is a mandatory component of Cinnamon powder. The concentration of cinnamon bark oil in the product must be no more than 2%. When used as an active ingredient, the maximum daily dose of the medicine must contain no more than 0.001% Coumarin. | ||
1353 | CINNAMYL ACETATE | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. | |
1354 | CINNAMYL ALCOHOL | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. | |
1355 | CINNAMYL BUTYRATE | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. | |
CINNAMYL CINNAMATE | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. | ||
1357 | CINNAMYL FORMATE | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. | |
1358 | CINNAMYL ISOBUTYRATE | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. | |
1359 | CINNAMYL ISOVALERATE | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used as a flavour the total flavour concentration in a medicine must be no more than 5%. | |
1360 | CINNAMYL PROPIONATE | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. | |
1361 | CINOXATE | A | Only for use as an active ingredient in sunscreens for dermal application only. The concentration of the ingredient must be no more than 6% and must not be used in topical products intended for use in the eye. | |
CIS-2-METHYL-4-PROPYL-1,3-OXATHIANE | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. | ||
1363 | CIS-3-HEXEN-1-OL | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. | |
1364 | CIS-3-HEXENAL | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. | |
1365 | CIS-3-HEXENYL 2-METHYLBUTYRATE | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. | |
CIS-3-HEXENYL ACETATE | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. | ||
1367 | CIS-3-HEXENYL BENZOATE | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. | |
1368 | CIS-3-HEXENYL BUTYRATE | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. | |
1369 | CIS-3-HEXENYL FORMATE | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. | |
1370 | CIS-3-HEXENYL HEXANOATE | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. | |
CIS-3-HEXENYL ISOBUTYRATE | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. | ||
1372 | CIS-3-HEXENYL ISOVALERATE | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. | |
1373 | CIS-3-HEXENYL LACTATE | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. | |
1374 | CIS-3-HEXENYL METHYL CARBONATE | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. | |
1375 | CIS-3-HEXENYL SALICYLATE | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. | |
1376 | CIS-4-HEPTENAL | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. | |
CIS-6-NONEN-1-AL | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. | ||
1378 | CIS-6-NONENOL | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. | |
1379 | CIS-BETA-OCIMENE | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. | |
1380 | CIS-HEXAHYDROCUMINYL ALCOHOL | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. | |
CIS-JASMONE | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. | ||
1382 | CISTANCHE DESERTICOLA | A,H |
| |
1383 | CISTANCHE SALSA | A,H |
| |
1384 | CISTUS LADANIFERUS | A,E,H |
| |
1385 | CITRAL | E |
| |
1386 | CITRAL DIETHYL ACETAL | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. | |
1387 | CITRAL DIMETHYL ACETAL | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. | |
1388 | CITRIC ACID | A,E | Where intended for topical use, sponsors should consider the impact of excipients on the sensitivity of the skin to sunlight and should ensure the finished product is safe for its intended purpose. | |
CITRIC ACID DIHYDRATE | A,E |
| ||
1390 | CITRIC ACID MONOHYDRATE | A,E | Where intended for topical use, sponsors should consider the impact of excipients on the sensitivity of the skin to sunlight and should ensure the finished product is safe for its intended purpose. | |
1391 | CITRIC AND FATTY ACID ESTERS OF GLYCEROL | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. | |
1392 | CITROL | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. | |
1393 | CITRON | E |
| |
1394 | CITRONELLA OIL | A,E,H | Medicines for topical use containing citronella oil require the following warning statement on the medicine label: - (CITRON) 'Contains citronella oil'. | |
1395 | CITRONELLA TERPENES | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. | |
CITRONELLAL | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. | ||
1397 | CITRONELLIC ACID | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. | |
1398 | CITRONELLOL | E | Only for use in topical medicines for dermal application. | |
1399 | CITRONELLYL ACETATE | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. | |
1400 | CITRONELLYL BUTYRATE | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. | |
CITRONELLYL FORMATE | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. | ||
1402 | CITRONELLYL ISOBUTYRATE | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. | |
1403 | CITRONELLYL NITRILE | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. | |
1404 | CITRONELLYL OXYACETALDEHYDE | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. | |
CITRONELLYL PROPIONATE | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. | ||
1406 | CITRONELLYL TIGLATE | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. | |
1407 | CITRONNOL | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. | |
1408 | CITRULLUS COLOCYNTHIS | H | Only for use as an active homoeopathic ingredient. When for oral use, the concentration of Citrullus colocynthis must be more than 4X (i.e. 1X 2X 3X). | |
1409 | CITRULLUS VULGARIS | A,H |
| |
1410 | CITRUS AURANTIFOLIA | A,E,H | When the plant preparation is oil or distillate, the warning statement (SENS) 'Application to skin may increase sensitivity to sunlight' (or words to that effect) must be included on the medicine label unless the medicine is: a) for internal use; or b) in preparations containing 0.5% or less of citrus aurantifolia oil or distillate; or c) for use in soaps or bath or shower gels that are washed off the skin. | |
1411 | CITRUS AURANTIUM | A,E,H | Oxedrine is a mandatory component of Citrus aurantium when intended for internal use. The quantity of oxedrine in the maximum recommended daily dose must be no more than 30 mg. When the plant preparation is oil or distillate, the warning statement (SENS) 'Application to skin may increase sensitivity to sunlight' (or words to that effect) must be included on the medicine label unless the medicine is: a) for internal use; or b) in preparations containing 1.4% or less of citrus aurantium oil or distillate; or c) for use in soaps or bath or shower gels that are washed off the skin. | |
1412 | CITRUS BIOFLAVONOIDS EXTRACT | A,E,H |
| |
1413 | CITRUS CHACHIENSIS | A,H |
| |
1414 | CITRUS EXTRACT | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. | |
CITRUS FIBRE | E |
| ||
1416 | CITRUS LIMETTA | A,H | When the plant preparation is oil or distillate, the warning statement (SENS) 'Application to skin may increase sensitivity to sunlight' (or words to that effect) must be included on the medicine label unless the medicine is: a) for internal use; or b) in preparations containing 0.5% or less of citrus limetta oil or distillate; or c) for use in soaps or bath or shower gels that are washed off the skin. | |
1417 | CITRUS LIMON | A,E,H | Oxedrine is a mandatory component of Citrus limon when intended for internal use. The quantity of oxedrine in the maximum recommended daily dose must be no more than 30 milligrams. When the plant preparation is oil or distillate, the warning statement (SENS) 'Application to skin may increase sensitivity to sunlight' (or words to that effect) must be included on the medicine label unless the medicine is: a) for internal use; or b) in preparations containing 0.05% or less of citrus limon oil or distillate; or c) for use in soaps or bath or shower gels that are washed off the skin. | |
1418 | CITRUS MAXIMA | A,H |
| |
1419 | CITRUS MEDICA | A,E,H | When the plant preparation is oil or distillate, the warning statement (SENS) 'Application to skin may increase sensitivity to sunlight' (or words to that effect) must be included on the medicine label unless the medicine is: a) for internal use; or b) in preparations containing 0.05% or less of citrus medica oil or distillate; or c) for use in soaps or bath or shower gels that are washed off the skin. | |
1420 | CITRUS OIL DISTILLED | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. | |
1421 | CITRUS RETICULATA | A,E,H | Oxedrine is a mandatory component of Citrus reticulata when intended for internal use. The quantity of Oxedrine in the recommended daily dose must be no more than 30 mg. | |
1422 | CITRUS SINENSIS | A,E,H | Oxedrine is a mandatory component of Citrus sinensis when intended for internal use. The quantity of Oxedrine in the recommended daily dose must be no more than 30 mg. | |
CITRUS SINENSIS PEEL MOLASSES EXTRACT | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. | ||
1424 | CITRUS UNSHIU | A,E,H | Oxedrine is a mandatory component of Citrus unshiu when intended for internal use. The quantity of Oxedrine in the recommended daily dose must be no more than 30 mg. | |
1425 | CITRUS X PARADISI | A,E,H |
| |
1426 | CITRUS X WILSONII | A,H |
| |
1427 | CIVET | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. | |
1428 | CIVET ABSOLUTE | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. | |
1429 | CIVET SYNTHETIC | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. | |
1430 | CIVETONE | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. | |
CLARY OIL | A,E,H |
| ||
1432 | CLAVICEPS PURPUREA | A,H | The concentration of equivalent dry Claviceps purpurea must be no more than 10mg/Kg or 10mg/L or 0.001%. | |
1433 | CLEMATIS ARMANDII | A,H |
| |
1434 | CLEMATIS CHINENSIS | A,E,H |
| |
1435 | CLEMATIS RECTA | A,H |
| |
1436 | CLEMATIS VITALBA | A,H |
| |
1437 | CLERODENDRUM TRICHOTOMUM | A,H |
| |
1438 | CLINOPODION POLYCEPHALUM | A,H |
| |
1439 | CLINOPODIUM NEPETA SUBSP. GLANDULOSUM | A,H |
| |
1440 | CLIVER HERB DRY | A,H |
| |
CLIVER HERB POWDER | A,H |
| ||
1442 | CLOVE BUD OIL | A,E,H | When the concentration of Clove Bud Oil in the preparation is more than 25%, the nominal capacity of the container must be no more than 25 mL. When the concentration of Clove Bud Oil in the preparation is more than 25% and the nominal capacity of the container is more 15 mL but no more than 25mL, a child resistant closure and restricted flow insert must be fitted on the container and requires the following warning statement on the medicine label: - (CHILD) ‘Keep out of reach of children’ (or words to that effect) - (NTAKEN) ‘Not to be taken’ When the concentration of clove bud oil in the preparation is more than 25% and the nominal capacity of the container is more than 15 mL , a restricted flow insert must be fitted on the container and requires the following warning statement on the medicine label: - (CHILD) ‘Keep out of reach of children’ (or words to that effect) - (NTAKEN) ‘Not to be taken’ | |
CLOVE DRY | A,E,H |
| ||
1444 | CLOVE LEAF OIL | A,E,H | When the concentration of Clove Leaf Oil in the preparation is more than 25%, the nominal capacity of the container must be no more than 25 mL. When the concentration of Clove Leaf Oil in the preparation is more than 25% and the nominal capacity of the container is more 15 mL but no more than 25mL, a child resistant closure and restricted flow insert must be fitted on the container and requires the following warning statement on the medicine label: - (CHILD) ‘Keep out of reach of children’ (or words to that effect) - (NTAKEN) ‘Not to be taken’ When the concentration of clove leaf oil in the preparation is more than 25% and the nominal capacity of the container is more than 15 mL, a restricted flow insert must be fitted on the container and requires the following warning statement on the medicine label: - (CHILD) ‘Keep out of reach of children’ (or words to that effect) - (NTAKEN) ‘Not to be taken’ | |
1445 | CLOVE OIL TERPENES | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. | |
CLOVE POWDER | A,E,H |
| ||
1447 | CLOVE STEM OIL | A,E,H | When the concentration of Clove Stem Oil in the preparation is more than 25%, the nominal capacity of the container must be no more than 25 mL. When the concentration of Clove Stem Oil in the preparation is more than 25% and the nominal capacity of the container is more 15 mL but no more than 25mL, a child resistant closure and restricted flow insert must be fitted on the container requires the following warning statements on the medicine label: - (CHILD) ‘Keep out of reach of children’ (or words to that effect) - (NTAKEN) ‘Not to be taken’ When the concentration of Clove Stem oil in the preparation is more than 25% and the nominal capacity of the container is more than 15 mL , a restricted flow insert must be fitted on the container and requires the following warning statements on the medicine label: - (CHILD) ‘Keep out of reach of children’ (or words to that effect) - (NTAKEN) ‘Not to be taken’ | |
1448 | CLUPEA HARENGUS LIPID EXTRACT | A | Only for use in oral medicines. The maximum recommended daily dose must not provide more than 2750 mg EPA, DHA and DPA combined, when used alone or in combination with other sources of omega-3 fatty acids. | |
1449 | CNICUS BENEDICTUS | A,H |
| |
1450 | CNICUS JAPONICUS | A,H |
| |
1451 | CNIDIUM MONNIERI | A,H |
| |
1452 | CNIDIUM OFFICINALE | A,H |
| |
1453 | COBALTOUS NITRATE HEXAHYDRATE | H | Only for use as an active homoeopathic ingredient. | |
1454 | COCAMIDE DEA | E | Only for use in topical medicines for dermal application. | |
1455 | COCAMIDE MEA | E | Only for use in topical medicines for dermal application. | |
COCAMIDOPROPYL BETAINAMIDE MEA CHLORIDE | E | Only for use in topical medicines for dermal application and not to be included in topical products intended for use in the eye. The concentration in the medicine must be no more than 1%. | ||
1457 | COCAMIDOPROPYL BETAINE | E | Only for topical, mucous membrane (buccal mucosa) and dental use and not to be included in topical medicines intended for use in the eye. The concentration in the medicine must be: a) no more than 1% in leave on medicines b) no more than 15% in wash on /wash off medicines c) 1.2% for buccal mucosa and dental medicines. Levels of impurities 3-dimethylaminopropylamine (DMAPA) and amidoamine (dimethylaminopropylcocoamide; AA) must be controlled to below the level of detection. | |
1458 | COCCOLOBIA UVIFERA | A,H |
| |
1459 | COCCULUS SARMENTOSUS | A,H |
| |
1460 | COCHINEAL | E,H | Only for use as an active homoeopathic or excipient ingredient. Permitted for use as a colour ingredient for oral and topical use. | |
1461 | COCHLEARIA OFFICINALIS | A,H |
| |
1462 | COCHLIOBOLUS HETEROSTROPHUS | A,H |
| |
1463 | COCILLANA DRY | A,H |
| |
1464 | COCILLANA POWDER | A,H |
| |
COCO-BETAINE | E | Only for use in topical medicines for dermal application. | ||
1466 | COCO-CAPRYLATE | E | Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration is to be no more than 12.5% in the medicine. | |
1467 | COCO-GLUCOSIDE | E | Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.025% | |
1468 | COCO-OCTANOATE/DECANOATE | E | Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. | |
1469 | COCOA EXTRACT | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. | |
1470 | COCOA POWDER | A,E,H |
| |
1471 | COCOGLYCERIDES | E |
| |
1472 | COCONUT | E |
| |
1473 | COCONUT ACID | E | Only for use in topical medicines for dermal application. | |
1474 | COCONUT OIL | A,E,H |
| |
COCOS NUCIFERA | A,E,H |
| ||
1476 | COD-LIVER OIL | A,E | Vitamin A and colecalciferol are mandatory components of Cod-liver oil. When for use in topical medicines, the concentration of Vitamin A in the medicine must be no more than 1%. When for internal use, the maximum daily dose must be no more than 3000 micrograms of Retinol Equivalents. Divided preparations for internal use must contain more than 33 micrograms of Retinol Equivalents per dosage unit and no more than 3000 micrograms of Retinol Equivalents of Vitamin A in the maximum daily dose. Undivided preparations for internal use must contain more than 33 micrograms Retinol Equivalents per gram of vitamin A and no more than 3000 micrograms of Retinol Equivalents of Vitamin A in the maximum daily dose. When for use in adults the medicine requires the following warning statements on the medicine label: - (VITA2) ‘WARNING: If you are pregnant - or considering becoming pregnant - do not take vitamin A supplements without consulting your doctor or pharmacist [or words to that effect].’ NOTE: Position this warning at the beginning of the directions for use. - (VITA4) ‘WARNING - When taken in excess of 3000 micrograms retinol equivalents - vitamin A can cause birth defects.’ NOTE: Position this warning at the beginning of the directions for use. - (VITA3) ‘The recommended daily amount of vitamin A from all sources is 700 micrograms retinol equivalents for women and 900 micrograms retinol equivalents for men.’ When for internal use, the maximum recommended daily dose must be no more than 25 micrograms of vitaminD. When used as an active ingredient and the route of administration is oral or sublingual, the medicine requires the following warning statement on the medicine label: - (VIT) ‘Vitamins can only be of assistance if the dietary vitamin intake is inadequate.’ or ‘Vitamin supplements should not replace a balanced diet.’ The indication ‘Vitamin D helps calcium absorption (or words of like intent)’ and ‘A diet deficient in calcium can lead to osteoporosis in later life’ are permitted only for oral use. | |
1477 | CODONOPSIS LANCEOLATA | A,H |
| |
1478 | CODONOPSIS PILOSULA | A,H |
| |
CODONOPSIS TANGSHEN | A,H |
| ||
1480 | COFFEA ARABICA | A,E,H | Caffeine is a mandatory component of Coffea arabica. When the route of administration is oral or sublingual and the medicine provides a maximum recommended daily dose of: a) more than 1 mg but no more than 10 mg of caffeine the medicine requires the following warning statement on the medicine label: - (CAFFR) 'The recommended dose of this medicine provides small amounts of caffeine.' b) more than 10 mg of caffeine the medicine requires the following warning statement on the medicine label: - (CAFF) 'Contains caffeine [state quantity per dosage unit or per mL or per gram of product]'. | |
COFFEA CANEPHORA | A,E,H | Caffeine is a mandatory component of Coffea canephora. When the route of administration is oral or sublingual and the medicine provides a maximum recommended daily dose of: a) more than 1 mg but no more than 10 mg of caffeine the medicine requires the following warning statement on the medicine label: - (CAFFR) 'The recommended dose of this medicine provides small amounts of caffeine.' b) more than 10 mg of caffeine the medicine requires the following warning statement on the medicine label: - (CAFF) 'Contains caffeine [state quantity per dosage unit or per mL or per gram of product]'. | ||
1482 | COFFEE | E,H | Caffeine is a mandatory component of coffee. When the route of administration is oral or sublingual and the medicine provides a maximum recommended daily dose of: a) more than 1 mg but no more than 10 mg of caffeine the medicine requires the following warning statement on the medicine label: - (CAFFR) 'The recommended dose of this medicine provides small amounts of caffeine.' b) more than 10 mg of caffeine the medicine requires the following warning statement on the medicine label: - (CAFF) 'Contains caffeine [state quantity per dosage unit or per mL or per gram of product]'. | |
1483 | COFFEE OIL | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. | |
1484 | COFFEE SOLID EXTRACT | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. | |
1485 | COGNAC OIL | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. | |
COGNAC OIL GREEN | A,E,H |
| ||
1487 | COGNAC OIL WHITE | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. | |
1488 | COIX LACHRYMA-JOBI | A,H |
| |
COLA ACUMINATA | A,E,H | Caffeine is a mandatory component of Cola acuminata. When the route of administration is oral or sublingual and the medicine provides a maximum recommended daily dose of: a) more than 1 mg but no more than 10 mg of caffeine the medicine requires the warning statement: - (CAFFR) 'The recommended dose of this medicine provides small amounts of caffeine.' b) more than 10 mg of caffeine the medicine requires the warning statement: - (CAFF) 'Contains caffeine [state quantity per dosage unit or per mL or per gram of product]'. | ||
1490 | COLA COTYLEDON DRY | A,H | Caffeine is a mandatory component of Cola cotyledon dry. When the route of administration is oral or sublingual and the medicine provides a maximum recommended daily dose of: a) more than 1 mg but no more than 10 mg of caffeine the medicine requires the warning statement: - (CAFFR) 'The recommended dose of this medicine provides small amounts of caffeine.' b) more than 10 mg of caffeine the medicine requires the warning statement: - (CAFF) 'Contains caffeine [state quantity per dosage unit or per mL or per gram of product]'. | |
COLA COTYLEDON POWDER | A,H | Caffeine is a mandatory component of Cola cotyledon powder. When the route of administration is oral or sublingual and the medicine provides a maximum recommended daily dose of: a) more than 1 mg but no more than 10 mg of caffeine the medicine requires the warning statement: - (CAFFR) 'The recommended dose of this medicine provides small amounts of caffeine.' b) more than 10 mg of caffeine the medicine requires the warning statement: - (CAFF) 'Contains caffeine [state quantity per dosage unit or per mL or per gram of product]'. | ||
1492 | COLA NITIDA | A,E,H | Caffeine is a mandatory component of Cola nitida. When the route of administration is oral or sublingual and the medicine provides a maximum recommended daily dose of: a) more than 1 mg but no more than 10 mg of caffeine the medicine requires the warning statement: - (CAFFR) 'The recommended dose of this medicine provides small amounts of caffeine.' b) more than 10 mg of caffeine the medicine requires the warning statement: - (CAFF) 'Contains caffeine [state quantity per dosage unit or per mL or per gram of product]'. | |
1493 | COLCHICUM AUTUMNALE | H | Only for use as an active homoeopathic ingredient.
| |
1494 | COLECALCIFEROL | A,E | When for internal use, the maximum recommended daily dose must not be more than 25 micrograms of Vitamin D. When used as an active ingredient and the route of administration is oral or sublingual, the medicine requires the following warning statement on the medicine label: - (VIT) 'vitamins can only be of assistance if the dietary intake is inadequate.' OR 'Vitamin supplements should not replace a balanced diet.' The indication 'Vitamin D helps calcium absorption (or words to that intent) and a diet deficient in calcium can lead to osteoporosis in later life' is permitted only for oral use. | |
1495 | COLEUS FORSKOHLII | A,E,H |
| |
COLLAGEN | E |
| ||
1497 | COLLINSONIA CANADENSIS | A,H |
| |
1498 | COLLOIDAL ANHYDROUS SILICA | A,E,H | Only for use when the route of administration is other than inhalation. | |
1499 | COLOPHONY | A,E,H |
| |
1500 | COMMIPHORA HABESSINICA | A,H |
| |
1501 | COMMIPHORA KATAF | A,H |
| |
1502 | COMMIPHORA MYRRHA | A,E,H |
| |
1503 | COMMON INDIAN COBRA | H | Only for use as an active homoeopathic ingredient. | |
CONCENTRATED FISH OMEGA-3 TRIGLYCERIDES | A | Only for oral use. | ||
1505 | CONCENTRATED SQUID OMEGA-3 TRIGLYCERIDES | A | Only for oral use. 'Concentrated squid omega-3 triglycerides' must be obtained from species of the order Teuthida of the class Cephalopoda AND be in combination with other ingredients in the preparation AND be presented in a therapeutic dosage form for therapeutic use. The medicine requires the following warning statement on the medicine label: - (SFOOD) 'Derived from seafood'. | |
1506 | CONIFER GREEN NEEDLE COMPLEX | A | Only for topical and oral use. Must be made by petroleum ether extraction of needles of the conifer species Pinus sylvestris (Scotch Pine) and Picea abies (Norwegian Spruce). | |
1507 | CONIFER PHYTOSTEROL COMPLEX | A |
| |
1508 | CONIOSELIUM UNIVITTATUM | A,H |
| |
1509 | CONIUM MACULATUM | H | Only for use as an active homoeopathic ingredient. The concentration must be no more than exceed 12X homoeopathic dilution. | |
1510 | CONVALLARIA MAJALIS | A,H | The concentration of equivalent dry Convallaria majalis in the product must be no more than 10mg/Kg or 10mg/L or 0.001%. | |
1511 | CONYZA CANADENSIS | A,H |
| |
1512 | COPAIBA OIL | A,E,H |
| |
1513 | COPAIFERA LANGSDORFFII | A,E,H |
| |
1514 | COPERNICIA CERIFERA | A,E,H |
| |
COPOVIDONE | E |
| ||
1516 | COPPER | H | Only for use as an active homoeopathic ingredient. When for internal use the maximum daily dose must not contain more than 5 mg of copper. When for other than internal use, the concentration of copper compounds must be no more than 5%. | |
1517 | COPPER (II) ASPARTATE | A,H | Copper is a mandatory component of copper (II) aspartate. The percentage of copper from copper (II) aspartate should be calculated based on the molecular weight of Copper (II) aspartate. The concentration of copper compounds in products must be no more than 5%. The maximum daily dose must not contain more than 5mg of copper. The indication 'For mineral (may state the mineral) supplementation' is only permitted for use when the medicine is for oral and sublingual use. | |
COPPER (II) GLYCINATE | A,H | Copper is a mandatory component of copper (II) glycinate. The percentage of copper from copper (II) glycinate should be calculated based on the molecular weight of Copper (II) glycinate. The concentration of copper compounds in products must be no more than 5%. The maximum daily dose must not contain more than 5mg of copper. The indication 'For mineral (may state the mineral) supplementation' is only permitted for use when the medicine is for oral and sublingual use. | ||
1519 | COPPER (II) LYSINATE | A,H | Copper is a mandatory component of copper (II) lysinate. The percentage of copper from copper (II) lysinate should be calculated based on the molecular weight of Copper (II) lysinate. The concentration of copper compounds in products must be no more than 5%. The maximum daily dose must not contain more than 5mg of copper. The indication 'For mineral (may state the mineral) supplementation' is only permitted for use when the medicine is for oral and sublingual use. | |
1520 | COPPER ACETYL TYROSINATE METHYLSILANOL | E | Only for use in topical medicines for dermal application. | |
1521 | COPPER CHLOROPHYLL | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. | |
COPPER CHLOROPHYLLIN | E | Only for use as a colour in oral and topical medicines. | ||
1523 | COPPER GLUCONATE | A,E | Copper is a mandatory component of copper gluconate. The percentage of copper from copper gluconate should be calculated based on the molecular weight of copper gluconate. When for internal use the maximum daily dose must not contain more than 5 mg of copper. When for other than internal use, the concentration of copper compounds must be no more than 5%. The indication 'For mineral (may state the mineral) supplementation' is only permitted for use when the medicine is for oral and sublingual use. | |
1524 | COPPER TRIPEPTIDE-1 | E | Only for use in topical medicines for dermal application. The concentration in the medicine must be no more than 3%. | |
1525 | COPTIS CHINENSIS | A,H |
| |
1526 | COPTIS JAPONICA | A,H |
| |
1527 | CORALLINA OFFICINALIS | E | Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine is to be no more than 1%. | |
1528 | CORDYCEPS SINENSIS | A,E,H | Must not contain material of animal origin such as insect larvae. | |
1529 | CORIANDER DRY | A,H |
| |
1530 | CORIANDER OIL | A,E,H |
| |
1531 | CORIANDER POWDER | A,H |
| |
1532 | CORIANDRUM SATIVUM | A,E,H |
| |
1533 | CORN GLYCERIDES | E |
| |
1534 | CORN SILK DRY | A,H |
| |
CORN SILK POWDER | A,H |
| ||
1536 | CORN SYRUP | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. | |
1537 | CORN SYRUP SOLIDS | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. | |
1538 | CORNUS FLORIDA | A,H |
| |
1539 | CORNUS OFFICINALIS | A,H |
| |
1540 | CORTISONE ACETATE | H | Only available as an active homoeopathic ingredient. | |
1541 | CORYDALIS AMBIGUA | A,E,H |
| |
1542 | CORYDALIS BUNGEANA | A,H |
| |
1543 | CORYDALIS CAVA | A,H |
| |
1544 | CORYDALIS FABACEA | A,H |
| |
1545 | CORYDALIS FORMOSA | A,H |
| |
1546 | CORYDALIS TURTSCHANINOVII | A,H |
| |
1547 | CORYLUS AMERICANA | A,H |
| |
CORYLUS AVELLANA | A,H |
| ||
CORYMBIA CITRIODORA | A,E,H | Cineole is a mandatory component of Corymbia citriodora. In liquid preparations when the concentration of cineole OR the concentration of oil or distillate in the preparation is more than 25%: a) the nominal capacity of the container must be no more than 25 millilitres; b) a restricted flow insert must be fitted on the container; and c) the container must include the following warning statements on the medicine label: - (CHILD) 'Keep out of reach of children' (or words to that effect); and - (NTAKEN) 'Not to be taken'. In liquid preparations, when the concentration of cineole OR the concentration of oil or distillate in the preparation is more than 25% and the nominal capacity of the container is more than 15 millilitres but less than or equal to 25 millilitres the medicine must also have a child resistant closure. | ||
1550 | CORYMBIA FICIFOLIA | A,H | Cineole is a mandatory component of Corymbia ficifolia. In liquid preparations when the concentration of cineole OR the concentration of oil or distillate in the preparation is more than 25%: a) the nominal capacity of the container must be no more than 25 millilitres; b) a restricted flow insert must be fitted on the container; and c) the container must include the following warning statements on the medicine label: - (CHILD) 'Keep out of reach of children' (or words to that effect); and - (NTAKEN) 'Not to be taken'. In liquid preparations, when the concentration of cineole OR the concentration of oil or distillate in the preparation is more than 25% and the nominal capacity of the container is more than 15 millilitres but less than or equal to 25 millilitres the medicine must also have a child resistant closure. | |
1551 | COSMOS BIPINNATUS | A,H |
| |
1552 | COSTUS ROOT OIL | A,H |
| |
1553 | COSTUS SPICATUS | A,H |
| |
1554 | COTTONSEED OIL | A,E,H |
| |
1555 | COUCH GRASS RHIZOME DRY | A,H |
| |
1556 | COUCH GRASS RHIZOME POWDER | A,H |
| |
COUMARIN | H | Only for use as an active homoeopathic ingredient. The concentration in the medicine must be no more than 0.001%. | ||
1558 | CRANBERRY | E |
| |
1559 | CRATAEGUS CUNEATA | A,E,H |
| |
1560 | CRATAEGUS LAEVIGATA | A,E,H |
| |
1561 | CRATAEGUS MONOGYNA | A,E,H |
| |
1562 | CRATAEGUS PINNATIFIDA | A,E,H |
| |
1563 | CRATEVA NURVALA | A,E,H |
| |
1564 | CREATINE | A,E | The medicine requires the following warning statement on the medicine label: - (PROFES) 'Seek professional advice before long term use'. | |
1565 | CREATINE MONOHYDRATE | A,E | The medicine requires the following warning statement on the medicine label: - (PROFES) 'Seek professional advice before long term use'. | |
1566 | CREATINE PHOSPHATE | A,E | The medicine requires the following warning statement on the medicine label: - (PROFES) 'Seek professional advice before long term use'. | |
CREATININE | E | Only for use in topical medicines for dermal application and not for use in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.2%. | ||
1568 | CREOSOL | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. | |
1569 | CREOSOTE | H | Only for use as an active homoeopathic ingredient. | |
1570 | CRESOL | E | Only for use as a preservative in topical medicines. The concentration of phenols (including cresols and xylenols and any other homologue of phenol) boiling below 220 degrees centigrade must be no more than 3%. The medicine requires the following warning statement on the medicine label: - (CRESOL) 'Contains cresol' (or words to that effect) | |
1571 | CRESYL ISOBUTYRATE | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. | |
1572 | CRITHMUM MARITIMUM WHOLE PLANT EXTRACT | E | Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.00341%. | |
CROCUS SATIVUS | A,H |
| ||
1574 | CROSCARMELLOSE SODIUM | E | When for oral or sublingual use and the total amount of sodium from all ingredients in the maximum daily dose is more than 120 mg, the medicine requires the following warning statement on the medicine label: - (SODIUM) ‘The recommended daily dose of this medicine contains [state quantity and units] of sodium (or words to that effect).’ | |
1575 | CROSPOVIDONE | E |
| |
1576 | CROTON CASCARILLA | A,H | The maximum recommended daily dose must be no more than the equivalent of 1mg of the dry herbal material. | |
1577 | CROTON ELUTERIA | A,H | The maximum recommended daily dose must be no more than the equivalent of 1mg of the dry herbal material. | |
1578 | CRYPTOMERIA JAPONICA | A,H |
| |
1579 | CUBEB OIL | A,H |
| |
1580 | CUBEBENE | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. | |
1581 | CUCUMBER | E |
| |
1582 | CUCUMIS MELO | A,H |
| |
1583 | CUCUMIS SATIVUS | A,E,H |
| |
1584 | CUCURBITA MAXIMA | A,E,H |
| |
CUCURBITA MOSCHATA | A,H |
| ||
1586 | CUCURBITA PEPO | A,E,H |
| |
1587 | CULLEN CORYLIFOLIUM | A,H |
| |
1588 | CUMIC ALCOHOL | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. | |
1589 | CUMIN OIL | A,E,H |
| |
1590 | CUMINALDEHYDE | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. | |
1591 | CUMINUM CYMINUM | A,H |
| |
1592 | CUMINYL NITRILE | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. | |
1593 | CUPRESSUS ARIZONICA | A,H |
| |
1594 | CUPRESSUS FUNEBRIS | A,E,H |
| |
CUPRESSUS MACROCARPA | A,H |
| ||
1596 | CUPRESSUS SEMPERVIRENS | A,E,H |
| |
1597 | CUPRIC ACETATE MONOHYDRATE | H | Only for use as an active homoeopathic ingredient. | |
1598 | CUPRIC ARSENITE | H | Only for use as an active homoeopathic ingredient. | |
CUPRIC CITRATE | A,E,H | When for oral or sublingual use, copper is a mandatory component of Cupric citrate. The percentage of copper from cupric citrate should be calculated based on the molecular weight of cupric citrate. The medicine must not contain more than 750 micrograms of copper from Cupric citrate per the recommended daily dose or the medicine must not contain more than 1.86 milligrams of cupric citrate per the recommended daily dose. The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use. | ||
1600 | CUPRIC CITRATE HEMIPENTAHYDRATE | A,E,H | When for oral or sublingual use, copper is a mandatory component of cupric citrate hemipentahydrate. The percentage of copper from cupric citrate hemipenthydrate should be calculated based on the molecular weight of cupric citrate hemipenthydrate. The medicine must not contain more than 750 micrograms of copper from cupric citrate hemipentahydrate per the recommended daily dose OR the medicine must not contain more than 2.13 milligrams of cupric citrate hemipentahydrate per the recommended daily dose. The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use. | |
CUPRIC OXIDE | A,E,H | When for oral or sublingual use, copper is a mandatory component of Cupric oxide. The percentage of copper from cupric oxide should be calculated based on the molecular weight of cupric oxide. When for internal use the maximum daily dose must not contain more than 5 mg of copper. When for other than internal use, the concentration of copper compounds must be no more than 5%. The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use. | ||
1602 | CUPRIC SULFATE | A,E,H | When for oral or sublingual use, copper is a mandatory component of cupric sulfate. The percentage of copper from cupric sulfate should be calculated based on the molecular weight of cupric sulfate. When for internal use the maximum daily dose must not contain more than 5 mg of copper. When for other than internal use, the concentration of copper compounds must be no more than 5%. The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use. | |
CUPRIC SULFATE MONOHYDRATE | A,E,H | When for oral or sublingual use, copper is a mandatory component of cupric sulfate monohydrate. The percentage of copper from cupric sulfate monohydrate should be calculated based on the molecular weight of cupric sulfate monohydrate. When for internal use the maximum daily dose must not contain more than 5 mg of copper. When for other than internal use, the concentration of copper compounds must be no more than 5%. When used topically, cupric sulfate is a mandatory component of cupric sulfate monohydrate. | ||
1604 | CUPRIC SULFATE PENTAHYDRATE | A,E,H | Where for oral or sublingual use, copper is a mandatory component of cupric sulfate pentahydrate. The percentage of copper from cupric sulfate pentahydrate should be calculated based on the molecular weight of cupric sulfate pentahydrate. When for internal use the maximum daily dose must not contain more than 5 mg of copper. When for other than internal use, the concentration of copper compounds must be no more than 5%. When used topically cupric sulfate is a mandatory component of cupric sulfate pentahydrate. The percentage of cupric sulfate from cupric sulfate pentahydrate should be calculated based on the molecular weight of cupric sulfate pentahydrate. The indication'For mineral (may state mineral) supplementation' is only permitted when the medicine is for oral or sublingual use. | |
1605 | CURCULIGO ORCHIOIDES | A,H |
| |
1606 | CURCUMA AROMATICA | A,H |
| |
1607 | CURCUMA LONGA | A,E,H |
| |
1608 | CURCUMA XANTHORRHIZA | A,H |
| |
1609 | CURCUMA ZEDOARIA | A,H |
| |
1610 | CURCUMIN | A,E,H | When for excipient use, only permitted for use as a colour in topical and oral medicines. | |
1611 | CUSCUTA EPITHYMUM | A,H |
| |
1612 | CUSCUTA EUROPAEA | A,H |
| |
1613 | CUSCUTA HYGROPHILAE | A,H |
| |
1614 | CUSCUTA RACEMOSA | A,H |
| |
1615 | CUSPARIA FEBRIFUGA | A,H |
| |
CYAMOPSIS TETRAGONOLOBA | A,E,H |
| ||
1617 | CYANOCOBALAMIN | A,E,H | When used as an active ingredient and the route of administration is oral or sublingual, the medicine requires the following warning statement on the medicine label: - (VIT) ‘Vitamins can only be of assistance if the dietary vitamin intake is inadequate.’ or ‘Vitamin supplements should not replace a balanced diet.’ The following indications are permitted for the medicine: - (VIT3) 'May assist in the management of dietary vitamin B12 deficiency.' - (VB121) 'Source of vitamin B12. Can assist in maintaining normal blood.' - (VB122) 'Source of vitamin B12. Can assist in maintaining normal blood. Blood tonic.' | |
1618 | CYANOMETHYLPHENYL MENTHANE CARBOXAMIDE | E | For dental use only in proprietary ingredients. Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in the medicine must be no more than 5%. | |
1619 | CYATHULA OFFICINALIS | A,H |
| |
1620 | CYCLAMEN ALDEHYDE | E | Only for use as an excipient ingredient in topical medicines. | |
CYCLAMEN PURPURASCENS | A,H |
| ||
1622 | CYCLOHEXADECENONE-8 | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. | |
1623 | CYCLOHEXANE | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. | |
1624 | CYCLOHEXANE, 1-ETHENYL-1-METHYL-2-(1-METHYLETHENYL)-4-(1-METHYLETHYL)-, DIDEHYDRO DERIV. | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. | |
1625 | CYCLOHEXANEETHANOL | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. | |
1626 | CYCLOHEXYL ACETATE | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. | |
CYCLOHEXYL PHENETHYL ETHER | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. | ||
1628 | CYCLOHEXYL SALICYLATE | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. | |
1629 | CYCLOMETHICONE | E | Only for use as an excipient ingredient in topical medicines. | |
1630 | CYCLOPENTADECANONE | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. | |
1631 | CYDONIA OBLONGA | A,H |
| |
1632 | CYMBOPOGON FLEXUOSUS | A,E,H | The concentration or Aldehydes calculated as citral in the medicine must be no more than 5% for topical use. | |
1633 | CYMBOPOGON MARTINI | A,H | The concentration or Aldehydes calculated as citral in the medicine must be no more than 5% for topical use. | |
1634 | CYMBOPOGON NARDUS | A,H | The concentration or Aldehydes calculated as citral in the medicine must be no more than 5% for topical use. | |
1635 | CYMBOPOGON SCHOENANTHUS | A,E,H | The concentration or Aldehydes calculated as citral in the medicine must be no more than 5% for topical use. | |
1636 | CYNANCHUM ATRATUM | A,H |
| |
1637 | CYNANCHUM STAUNTONII | A,E,H |
| |
CYNARA SCOLYMUS | A,E,H |
| ||
1639 | CYNODON DACTYLON | A,E,H |
| |
1640 | CYNOMORIUM SONGARICUM | A,H |
| |
1641 | CYPERUS LONGUS | A,H |
| |
1642 | CYPERUS ROTUNDUS | A,H |
| |
1643 | CYPRESS OIL | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. | |
1644 | CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS | A,H |
| |
1645 | CYSTEINE | A |
| |
1646 | CYSTEINE HYDROCHLORIDE | A |
| |
1647 | CYSTEINE HYDROCHLORIDE MONOHYDRATE | A,E | When used as an excipient, permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. | |
1648 | CYSTINE | A |
| |
CYTISUS SCOPARIUS | A,H | Sparteine is a mandatory component of Cytisus scoparius. The concentration of Sparteine in the medicine must be no more than 0.001%. | ||
1650 | D-ALPHA-TOCOPHEROL | A,E | When used as an active ingredient and the route of administration is oral or sublingual, the medicine requires the following warning statement on the medicine label: - (VIT) ‘Vitamins can only be of assistance if the dietary vitamin intake is inadequate.’ or ‘Vitamin supplements should not replace a balanced diet.’ | |
1651 | D-ALPHA-TOCOPHERYL ACETATE | A,E,H | When used as an active ingredient and the route of administration is oral or sublingual, the medicine requires the following warning statement on the medicine label: - (VIT) ‘Vitamins can only be of assistance if the dietary vitamin intake is inadequate.’ or ‘Vitamin supplements should not replace a balanced diet.’ | |
1652 | D-ALPHA-TOCOPHERYL ACID SUCCINATE | A,E | When used as an active ingredient and the route of administration is oral or sublingual, the medicine requires the following warning statement on the medicine label: - (VIT) ‘Vitamins can only be of assistance if the dietary vitamin intake is inadequate.’ or ‘Vitamin supplements should not replace a balanced diet.’ | |
1653 | D-ALPHA-TOCOPHERYL PHOSPHATES | E | Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye or on damaged skin. The concentration in the medicine must be no more than 3%. | |
D-BORNEOL | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. | ||
1655 | D-CARVONE | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. | |
1656 | D-FENCHONE | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. | |
1657 | D-LIMONENE | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. | |
D-PULEGONE | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. The concentration of d-pulegone in the medicine must be no more than 4%. | ||
1659 | D-RIBOSE-L-CYSTEINE | A | Only for use in oral medicines. Cysteine is a mandatory component of D-Ribose-L-Cysteine. The medicine must provide no more than 450 mg of cysteine per maximum recommended daily dose. | |
1660 | DACTYLIS GLOMERATA | A,H |
| |
1661 | DACTYLORHIZA INCARNATA SUBSP. INCARNATA | A,H |
| |
1662 | DAEMONOROPS DRACO | A,E,H |
| |
1663 | DAHLIA PINNATA | A,H |
| |
1664 | DALBERGIA ODORIFERA | A,H |
| |
1665 | DAMIANA LEAF POWDER | A |
| |
1666 | DANDELION LEAF DRY | A,H |
| |
1667 | DANDELION LEAF POWDER | A,H |
| |
1668 | DANDELION ROOT DRY | A,H |
| |
1669 | DANDELION ROOT POWDER | A,H |
| |
1670 | DAPHNE GENKWA | A,H |
| |
1671 | DAPHNE MEZEREUM | A,H | The maximum recommended daily dose must be no more than the equivalent of 1mg of the dry herbal material. | |
DATE | E |
| ||
1673 | DATURA STRAMONIUM | A,H | Only for use in oral medicines. Alkaloids calculated as hyoscyamine is a mandatory component of Datura stramonium. The concentration of alkaloids calculated as hyoscyamine from all ingredients in the product must be no more than 300 micrograms/Kg or 300 micrograms/L or 0.00003%. | |
1674 | DAUCUS CAROTA | A,E,H |
| |
1675 | DAVANA OIL | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. | |
1676 | DEA-OLETH-3 PHOSPHATE | E | Only for use in topical medicines for dermal application and not be included in topical medicines intended for use in the eye. The concentration in the medicine must be no more than 1%. The medicine requires the following warning statements on the medicine label: - (EYE) 'Avoid contact with eyes' - (EYE2) 'May be irritant to the eyes' (or words to that effect). | |
DECAHYDRO-2,2,6,6,7,8,8-HEPTAMETHYL-2H-INDENO(4,5-B) FURAN | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. | ||
1678 | DECAHYDRO-BETA-NAPHTHYLACETATE | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. | |
1679 | DECAHYDRO-BETA-NAPHTHYLFORMATE | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. | |
1680 | DECAHYDROSPIRO(FURAN-2(3H),5'-(4,7)METHANO(5H)INDENE) | E |
| |
1681 | DECALACTONE | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. | |
DECANAL | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. | ||
1683 | DECANAL DIMETHYL ACETAL | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. | |
1684 | DECARBOXY CARNOISINE DIHYDROCHLORIDE | E | Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.05. | |
1685 | DECENAL | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. | |
1686 | DECYL ACETATE | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. | |
1687 | DECYL ALCOHOL | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. | |
DECYL GLUCOSIDE | E | Only for use in topical medicines for dermal application. | ||
1689 | DECYL OLEATE | E | Only for use in topical medicines for dermal application. | |
1690 | DECYLENE GLYCOL | E | Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye or on damaged skin. The concentration in the medicine must be no more than 0.5%. | |
1691 | DEER ANTLER CARTILAGE | H | Only for use as an active homoeopathic ingredient. | |
DEER VELVET ANTLER POWDER | A | Medicines that contain 'deer velvet antler powder' as the therapeutically active ingredient are subject to the following conditions: a) the medicines are for oral use only; b) the antlers (including the velvet) are sourced only from red deer (Cervus elaphus), elk/wapiti (Cervus canadensis), or a crossbreed of these species; c) the deer are sourced only from farmed stock bred and raised in New Zealand; d) the deer are sourced only from herds farmed for food in accordance with the Animal Products Act 1999 (New Zealand) and the regulations made under that Act, as in force or existing from time to time; e) the antlers are removed from the deer only according to the Animal Welfare Act 1999 (New Zealand) and the regulations made under that Act, as in force or existing from time to time. | ||
1693 | DEER VELVET ANTLER SLICE | A | Medicines that contain 'deer velvet antler slice' as the therapeutically active ingredient are subject to the following conditions: a) the medicines are for oral use only; b) the antlers (including the velvet) are sourced only from red deer (Cervus elaphus), elk/wapiti (Cervus canadensis), or a crossbreed of these species; c) the deer are sourced only from farmed stock bred and raised in New Zealand; d) the deer are sourced only from herds farmed for food in accordance with the Animal Products Act 1999 (New Zealand) and the regulations made under that Act, as in force or existing from time to time; e) the antlers are removed from the deer only according to the Animal Welfare Act 1999 (New Zealand) and the regulations made under that Act, as in force or existing from time to time. | |
1694 | DEERTONGUE ABSOLUTE | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. | |
DEHYDROACETIC ACID | E | Only for use in topical medicines for dermal application. The medicine requires the following warning statement on the medicine label: - (DACACD) 'Contains dehydroacetic acid [quantity]' (or words to that effect). | ||
1696 | DEHYDROMENTHOFUROLACTONE | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. | |
1697 | DEHYDROXANTHAN GUM | E | Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 2%. | |
1698 | DELPHINIUM STAPHISAGRIA | A,H | The concentration of the equivalent dry Delphinium staphisagria in the medicine must be no more than 0.2%. | |
1699 | DELTA-DAMASCONE | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. | |
DELTA-DECALACTONE | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. | ||
1701 | DELTA-DODECALACTONE | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. | |
1702 | DELTA-NONALACTONE | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. | |
1703 | DELTA-OCTALACTONE | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. | |
1704 | DELTA-TETRADECALACTONE | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. | |
DELTA-TOCOPHEROL | E |
| ||
1706 | DELTA-UNDECALACTONE | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. | |
1707 | DEMINERALISED FISH PROTEOGLYCAN EXTRACT | A |
| |
1708 | DENATONIUM BENZOATE | E |
| |
1709 | DENDROBIUM NOBILE | A,H |
| |
1710 | DESCURAINIA SOPHIA | A,H |
| |
1711 | DESMODIUM STYRACIFOLIUM | A,H |
| |
1712 | DESMODIUM TRIQUETUM | A,H |
| |
1713 | DEVIL'S CLAW TUBER DRY | A,H |
| |
1714 | DEVIL'S CLAW TUBER POWDER | A,H |
| |
DEXPANTHENOL | A,E | When used as an active ingredient and the route of administration is oral or sublingual, the medicine requires the following warning statement on the medicine label: - (VIT) ‘Vitamins can only be of assistance if the dietary vitamin intake is inadequate.’ or ‘Vitamin supplements should not replace a balanced diet.’ | ||
1716 | DEXTRAN 20 | E | Only for use in topical medicines for dermal application and not be included in topical medicines intended for use in the eye or on damaged skin. The concentration in the medicine must be no more than 0.3%. | |
1717 | DEXTRAN 40 | A,E |
| |
1718 | DEXTRATES | E |
| |
1719 | DEXTRIN | E |
| |
1720 | DEXTRIN PALMITATE | E | Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 3%. | |
1721 | DHA/EPA RICH SCHIZOCHYTRIUM ALGAL OIL | A |
Only for use in oral medicines when in combination with other active or excipient ingredients. The ratio of docosahexaenoic acid (DHA) to eicosapentaenoic acid (EPA) must be 2:1. | |
1722 | DI-C12-13 ALKYL MALATE | E | Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 5%. | |
1723 | DI-C12-15 ALKYL FUMARATE | E | Only for use in topical medicines forr dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 5%. | |
DI-N-PROPYL ISOCINCHOMERONATE | E | Only for use in topical medicines for dermal application. The concentration in the medicine must be no more than 25%. | ||
1725 | DI-PPG-3 MYRISTYL ETHER ADIPATE | E | Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 15%. | |
1726 | DIACETIN | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. | |
1727 | DIACETYL | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. | |
1728 | DIACETYL TARTARIC ACID ESTERS OF MONO- AND DIGLYCERIDES | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. | |
1729 | DIACETYLATED MONOGLYCERIDES | E | Permitted for use only in combination with other permitted ingredients as a coating solution. | |
1730 | DIAMMONIUM LAURYL SULFOSUCCINATE | E | Only for use as an excipient ingredient in topical medicines. | |
DIANTHUS SUPERBUS | A,H |
| ||
1732 | DIAZOLIDINYL UREA | E | Only for use in topical medicines for dermal application. The medicine requires requires the following warning statement on the medicine label: - (DUREA) 'Contains diazolidinyl urea' (or words to that effect). | |
1733 | DIBASIC POTASSIUM PHOSPHATE | A,E,H | When used as an active ingredient and the medicine is intended as a mineral supplementation, potassium is a mandatory component of dibasic potassium phosphate. The percentage of potassium from dibasic potassium phosphate should be calculated based on the molecular weight of dibasic potassium phosphate. When used in a solid preparation, the pH of a 10 g/L aqueous solution must not be more than 11.5. When used in a liquid or a semi-solid preparation, the pH of the preparation must not exceed 11.5. The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use. | |
DIBASIC SODIUM PHOSPHATE | A,E,H | When used as an active ingredient and the preparation is intended as a mineral supplementation, sodium is a mandatory component of dibasic sodium phosphate. The percentage of Sodium from Dibasic sodium phosphate should be calculated based on the molecular weight of Dibasic sodium phosphate. When used in a solid preparation, the pH of a 10 g/L aqueous solution must not be more than 11.5. When used in a liquid or a semi-solid preparation, the pH of the preparation must not exceed 11.5. When for oral or sublingual use and the total amount of sodium from all ingredients in the maximum daily dose is more than 120 mg, the medicine requires the following warning statement on the medicine label: - (SODIUM) ‘The recommended daily dose of this medicine contains [state quantity and units] of sodium’ (or words to that effect). The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use. | ||
DIBASIC SODIUM PHOSPHATE DIHYDRATE | A,E,H | When used as an active ingredient and the preparation is intended as a mineral supplementation, sodium is a mandatory component of dibasic sodium phosphate dihydrate. The percentage of Sodium from Dibasic sodium phosphate dihydrate should be calculated based on the molecular weight of Dibasic sodium phosphate dihydrate. When used in a solid preparation, the pH of a 10 g/L aqueous solution must not be more than 11.5. When used in a liquid or a semi-solid preparation, the pH of the preparation must not exceed 11.5. When for oral or sublingual use and the total amount of sodium from all ingredients in the maximum daily dose is more than 120 mg, the medicine requires the following warning statement on the medicine label: - (SODIUM) ‘The recommended daily dose of this medicine contains [state quantity and units] of sodium’ (or words to that effect). The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use. | ||
DIBASIC SODIUM PHOSPHATE DODECAHYDRATE | A,E,H | When used as an active ingredient and the preparation is intended as a mineral supplementation, sodium is a mandatory component of dibasic sodium phosphate dodecahydrate. The percentage of sodium from Dibasic sodium phosphate dodecahydrate should be calculated based on the molecular weight of Dibasic sodium phosphate dodecahydrate. When used in a solid preparation, the pH of a 10 g/L aqueous solution must not be more than 11.5. When used in a liquid or a semi-solid preparation, the pH of the preparation must not exceed 11.5. When for oral or sublingual use and the total amount of sodium from all ingredients in the maximum daily dose is more than 120 mg, the medicine requires the following warning statement on the medicine label: - (SODIUM) ‘The recommended daily dose of this medicine contains [state quantity and units] of sodium’ (or words to that effect). The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use. | ||
DIBASIC SODIUM PHOSPHATE HEPTAHYDRATE | A,E,H | When used as an active ingredient and the preparation is intended as a mineral supplementation, sodium is a mandatory component of dibasic sodium phosphate heptahydrate. The amount of sodium in the active ingredient should be calculated based on the molecular weight of dibasic sodium phosphate heptahydrate. When used in a solid preparation, the pH of a 10 g/L aqueous solution must not be more than 11.5. When used in a liquid or a semi-solid preparation, the pH of the preparation must not exceed 11.5. When for oral or sublingual use and the total amount of sodium from all ingredients in the maximum daily dose is more than 120 mg, the medicine requires the following warning statement on the medicine label: - (SODIUM) ‘The recommended daily dose of this medicine contains [state quantity and units] of sodium’ (or words to that effect). The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use. | ||
1738 | DIBASIC SODIUM PHOSPHATE MONOHYDRATE | A,E,H | When used as an active ingredient and the preparation is intended as a mineral supplementation, sodium is a mandatory component of dibasic sodium phosphate monohydrate. The percentage of Sodium from Dibasic sodium phosphate monohydrate should be calculated based on the molecular weight of Dibasic sodium phosphate monohydrate. When used in a solid preparation, the pH of a 10 g/L aqueous solution must not be more than 11.5. When used in a liquid or a semi-solid preparation, the pH of the preparation must not exceed 11.5. When for oral or sublingual use and the total amount of sodium from all ingredients in the maximum daily dose is more than 120 mg, the medicine requires the following warning statement on the medicine label: - (SODIUM) ‘The recommended daily dose of this medicine contains [state quantity and units] of sodium’ (or words to that effect). The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use. | |
1739 | DIBASIC TETRAHYDRATE MAGNESIUM CITRATE | A | Only for use in oral medicines. When used as an active ingredient and the medicine is intended as a mineral supplementation, magnesium is a mandatory component of dibasic tetrahydrate magnesium citrate. The percentage of magnesium from dibasic tetrahydrate magnesium citrate should be calculated based on the molecular weight of dibasic tetrahydrate magnesium citrate. The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use. | |
1740 | DIBASIC TRIHYDRATE MAGNESIUM PHOSPHATE | A,E,H | Magnesium is a mandatory component of Dibasic trihydrate magnesium phosphate. The percentage of magnesium from dibasic trihydrate magnesium phosphate should be calculated based on the molecular weight of dibasic trihydrate magnesium phosphate. | |
1741 | DIBASIC TRIHYDRATE POTASSIUM PHOSPHATE | A,E,H | When used as an active ingredient and the medicine is intended as a mineral supplementation, potassium is a mandatory component of dibasic trihydrate potassium phosphate. The percentage of potassium from dibasic trihydrate potassium phosphate should be calculated based on the molecular weight of dibasic trihydrate potassium phosphate. When used in a solid preparation, the pH of a 10 g/L aqueous solution must not be more than 11.5. When used in a liquid or a semi-solid preparation, the pH of the preparation must not exceed 11.5. The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use. | |
1742 | DIBENZYL KETONE | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. | |
1743 | DIBUTYL ADIPATE | E | Only for use in topical medicines for dermal application. | |
1744 | DIBUTYL PHTHALATE | E | Only for use in topical medicines for dermal application. | |
1745 | DIBUTYL SEBACATE | E |
| |
1746 | DIBUTYLAMINE | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in the medicine must be no more than 5%. | |
1747 | DICAPRYLYL CARBONATE | E | Only for use in topical medicines for dermal application. The concentration in the medicine must be no more than 34%. | |
DICAPRYLYL ETHER | E | Only for use in topical medicines for dermal application. | ||
1749 | DICAPRYLYL MALEATE | E | Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 10%. | |
1750 | DICETYL PHOSPHATE | E | Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye or on damaged skin. The concentration in the medicine must be no more than 2%. | |
1751 | DICHLOROBENZYL ALCOHOL | E |
| |
1752 | DICHLOROMETHANE | E | The concentration in the medicine must be no more than 0.06%. The residual solvent limit for Dichloromethane is 6 mg per recommended daily dose. | |
1753 | DICTAMNUS ALBUS | A,H |
| |
1754 | DICTAMNUS DESYCARPUS | A,H |
| |
1755 | DICYCLOHEXYL DISULFIDE | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. | |
1756 | DIEFFENBACHIA SEGUINE | H | Only for use as an active homoeopathic ingredient. | |
DIETHANOLAMINE | E | Only for use in topical medicines for dermal application. The concentration in the medicine must be no more than 5%. | ||
1758 | DIETHYL CITRACONATE | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. | |
1759 | DIETHYL MALONATE | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. | |
1760 | DIETHYL PHTHALATE | E |
| |
1761 | DIETHYLAMINE | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. | |
1762 | DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE | A | Only for use as an active ingredient in sunscreens for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 10%. | |
1763 | DIETHYLAMINOMETHYLCOUMARIN | E | Only for use in topical medicines for dermal application. The concentration in the medicine must be no more than 0.1%. | |
DIETHYLDIMETHYL-2-CYCLOHEXENONE | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. | ||
1765 | DIETHYLENE GLYCOL | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. | |
1766 | DIETHYLENE GLYCOL MONOETHYL ETHER | E | Only for use in topical medicines for dermal application. | |
1767 | DIETHYLHEXYL-2,6-NAPHTHALATE | E | Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 10%. The medicine requires the following warning statement on the medicine label: - (EYE2) 'May be irritant to the eyes' (or words to that effect). | |
1768 | DIETHYLHEXYL CARBONATE | E | Only for use in topical medicines for dermal application and not be included in medicines intended for use in the eye or on damaged skin. The concentration in the medicine must be no more than 3%. | |
1769 | DIETHYLHEXYL SEBACATE | E | Only for use in topical medicines for dermal application. | |
DIETHYLHEXYL SYRINGYLIDENEMALONATE | E | Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 1%. | ||
1771 | DIETHYLTOLUAMIDE | E | Only for use in topical medicines for dermal application. The concentration in the medicine must be no more than 20%. The medicine requires the following warning statement on the medicine label: - (DEET) 'WARNING: May be dangerous; particularly to children, if you use large amounts on the skin, clothes or bedding or on large areas of the body, especially if you keep using it for a long time.' | |
1772 | DIGITALIS LEAF DRY | A,H | The concentration of Digitalis leaf dry in the product must be no more than 10mg/Kg or 10mg/L or 0.001%. | |
1773 | DIGITALIS LEAF POWDER | A,H | The concentration of Digitalis leaf powder in the product must be no more than 10mg/Kg or 10mg/L or 0.001%. | |
1774 | DIGITALIS PURPUREA | A,H | The concentration of equivalent dry Digitalis purpurea in the medicine must be no more than 10mg/Kg or 10mg/L or 0.001%. | |
1775 | DIGLYCOL/CHDM/ISOPHTHALATES/SIP COPOLYMER | E | Only for use in topical medicines for dermal application. | |
1776 | DIHEXYL FUMARATE | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. | |
DIHYDRO-ALPHA-TERPINEOL | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. | ||
1778 | DIHYDRO-BETA-IONONE | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. | |
1779 | DIHYDRO-ISOJASMONE | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. | |
1780 | DIHYDRO JASMONE | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. | |
1781 | DIHYDRO TERPINYLACETATE | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. | |
DIHYDROACTINIDIOLIDE | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. | ||
1783 | DIHYDROAMBRETTOLIDE | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. | |
1784 | DIHYDROCARVYL ACETATE | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. | |
1785 | DIHYDROCOUMARIN | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. | |
1786 | DIHYDROEUGENOL | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. | |
DIHYDROGENATED TALLOW PHTHALIC ACID AMIDE | E | Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 5%. | ||
1788 | DIHYDROINDENYL-2,4-DIOXANE | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. | |
1789 | DIHYDROLINALOOL | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. | |
1790 | DIHYDROMYRCENOL | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. | |
1791 | DIHYDROMYRCENYL ACETATE | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. | |
1792 | DIHYDROXYACETONE | E | Only for use in topical medicines for dermal application. | |
DIISOPROPYL ADIPATE | E | Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 15%. | ||
1794 | DIISOPROPYL SEBACATE | E | Only for use in topical medicines for dermal application and not be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 10%. | |
1795 | DIISOSTEARYL DIMER DILINOLEATE | E | Only for use in topical medicines for dermal application. | |
1796 | DILAURYL THIODIPROPIONATE | E | Only for use in topical medicines for dermal application. | |
1797 | DILL HERB OIL | A,E,H |
| |
1798 | DILL SEED OIL | A,E,H |
| |
1799 | DILL WEED OIL | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. | |
1800 | DIMER DISTEARYLTRICARBONATE | E | Only for use in topical medicines for dermal application and not to be used in medicines intended for use in the eye. The concentration in the medicine must be no more than 4%. | |
1801 | DIMETHICONE 12500 | E |
| |
1802 | DIMETHICONE 4000 | E | Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 3%. | |
DIMETHICONE CROSSPOLYMER | E | Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye or on damaged skin. The concentration in the medicine must be no more than 15%. | ||
1804 | DIMETHICONE SILYLATE | E | Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 10%. | |
1805 | DIMETHICONE/METHICONE COPOLYMER | E | Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 4%. | |
1806 | DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER | E | Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 1.5%. | |
1807 | DIMETHYL 3-CYCLOHEXENE-1-CARBOXALDEHYDE | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. | |
DIMETHYL ANTHRANILATE | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. | ||
1809 | DIMETHYL BENZYL CARBINOL | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. | |
1810 | DIMETHYL BENZYL CARBINYL ACETATE | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. | |
1811 | DIMETHYL BENZYL CARBINYL BUTYRATE | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. | |
1812 | DIMETHYL BENZYL CARBINYL ISOBUTYRATE | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. | |
DIMETHYL PHENYLETHYL CARBINOL | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. | ||
1814 | DIMETHYL PHTHALATE | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. | |
1815 | DIMETHYL POLYSILOXANE | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. | |
1816 | DIMETHYL SUCCINATE | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. | |
1817 | DIMETHYL SULFATE | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. | |
1818 | DIMETHYL SULFIDE | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. | |
DIMETHYL SULFONE | A | Only for use in oral and topical medicines. | ||
1820 | DIMETHYL SULFOXIDE | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. | |
1821 | DIMETHYLACETAL | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. | |
1822 | DIMETHYLCYCLOHEXYLETHOXY ISOBUTYLPROPANOATE | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. | |
1823 | DIMETHYLGLYCINE HYDROCHLORIDE | A | Only for use in oral medicines. | |
1824 | DIMETHYLOL DIMETHYL HYDANTOIN | E | Only for use in topical medicines for dermal application. | |
1825 | DIMETICONE 1.5 | E | Only for use in topical medicines for dermal application. The concentration in the medicine must be no more than 10%. | |
1826 | DIMETICONE 10 | E |
| |
1827 | DIMETICONE 100 | E | Only for use in topical medicines for dermal application. | |
DIMETICONE 1000 | E |
| ||
1829 | DIMETICONE 1510 | E | Permitted for use only in combination with other permitted ingredients as a printing ink. If used in a printing ink the total printing ink concentration in a medicine must be no more than 0.1% | |
1830 | DIMETICONE 2 | E | Only for use in topical medicines for dermal application. The concentration in the medicine must be no more than 2.5%. | |
1831 | DIMETICONE 20 | E | Only for use in topical medicines for dermal application. | |
1832 | DIMETICONE 200 | E | Only for use in topical medicines for dermal application. | |
1833 | DIMETICONE 30 | E | Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration is the medicine must be no more than 4%. | |
1834 | DIMETICONE 350 | E | Only for use in topical and oral medicines. When used orally, the maximum daily dose must be no more than 7.5mg. | |
1835 | DIMETICONE 360 | E | Only for use in topical medicines for dermal application. | |
1836 | DIMETICONE 450 | E | Only for use in topical medicines for dermal application. | |
1837 | DIMETICONE 5 | E | Only for use in topical medicines for dermal application. The concentration in the medicine must be no more than 10%. | |
1838 | DIMETICONE 50 | E | Only for use in topical medicines for dermal application. | |
DIMETICONE 5000 | E | Only for use in topical medicines for dermal application. | ||
1840 | DIMETICONE 6 | E | Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 10%. | |
1841 | DIMETICONE COPOLYOL | E | Only for use in topical medicines for dermal application. | |
1842 | DIMETICONE COPOLYOL PHOSPHATE | E | Only for use in topical medicines for dermal application. | |
1843 | DIMETICONE CROSSPOLYMER-3 | E | Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye or on damaged skin. The concentration in the medicine must be no more than 15%. | |
1844 | DIMETICONE/PEG-10/15 CROSSPOLYMER | E | Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 1%. | |
1845 | DIMETICONOL | E | Only for use in topical medicines for dermal application. | |
1846 | DIMETICONOL STEARATE | E | Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 2%. | |
DIMOCARPUS LONGAN | A,H |
| ||
1848 | DIOCTYL ADIPATE | E | Only for use in topical medicines for dermal application. | |
1849 | DIOCTYL MALEATE | E | Only for use in topical medicines for dermal application. | |
1850 | DIOCTYL SUCCINATE | E | Only for use in topical medicines for dermal application. | |
1851 | DIOCTYL TEREPHTHALATE | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. | |
1852 | DIOLAMINE C8-18 PERFLUOROALKYLETHYL PHOSPHATE | E | Only for use in topical medicines for dermal application and not be included in topical medicines intended for use in the eye. The concentration in the medicine must be no more than 0.7% | |
1853 | DIOLAMINE CETYL PHOSPHATE | E | Only for use in topical medicines for dermal application and not be included in topical medicines intended for use in the eye. | |
1854 | DIOSCOREA COLLETTII | A,H |
| |
1855 | DIOSCOREA COLLETTII VAR. HYPOGLAUCA | A,H |
| |
1856 | DIOSCOREA JAPONICA | A,H |
| |
DIOSCOREA OPPOSITIFOLIA | A,H |
| ||
1858 | DIOSCOREA POLYSTACHYA | A,H |
| |
1859 | DIOSCOREA SEPTEMLOBA | A,H |
| |
1860 | DIOSCOREA VILLOSA | A,E,H |
| |
1861 | DIOSPYROS KAKI | A,E,H |
| |
1862 | DIOXYBENZONE | A | Only for use as an active ingredient in sunscreens for dermal application. The concentration in a medicine must be no more than 3%. When used in primary sunscreen products, the medicine requires the following warning statements on the label: ‑ (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and ‑ (SUNPRO) 'Wear protective clothing ‑ hats and eyewear when exposed to the sun' (or words to this effect). | |
1863 | DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE | E | Only for use in topical medicines for dermal application and not to be included in medicines intended for use on damaged skin. The concentration in the medicine must be no more than 0.5%. | |
DIPENTAERYTHRITYL TETRAHYDROXYSTEARATE/TETRAISOSTEARATE | E | Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 5%. | ||
1865 | DIPENTAERYTHRITYL TRI-POLYHYDROXYSTEARATE | E | Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 2%. | |
1866 | DIPHENYL DIMETHICONE | E | Only for use in topical medicines for dermal application. | |
1867 | DIPHENYL METHANE | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. | |
1868 | DIPHENYL OXIDE | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. | |
1869 | DIPOTASSIUM GLYCYRRHIZATE | E | Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.1%. | |
1870 | DIPROPIONYL | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. | |
DIPROPYLENE GLYCOL | E | Only for use in topical medicines for dermal application. | ||
1872 | DIPROPYLENE GLYCOL DIBENZOATE | E | Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 4.2%. | |
1873 | DIPROPYLENE GLYCOL SALICYLATE | E | Only for use in topical medicines for dermal application. | |
1874 | DIPSACUS ASPER | A,H |
| |
1875 | DIPSACUS JAPONICUS | A,H |
| |
1876 | DIPTERYX ODORATA | A,E,H |
| |
1877 | DISODIUM ASCORBYL SULFATE | E | Only for use in topical medicines for dermal application. | |
1878 | DISODIUM COCOAMPHODIACETATE | E | Only for use in topical medicines for dermal application. | |
1879 | DISODIUM COCOAMPHODIPROPIONATE | E | Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 2%. | |
DISODIUM DIMETICONE COPOLYOL SULFOSUCCINATE | E | Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 14%. | ||
1881 | DISODIUM EDETATE | E | When for oral or sublingual use and the total amount of sodium from all ingredients in the maximum daily dose is more than 120 mg, the medicine requires the following warning statement on the medicine label: - (SODIUM) ‘The recommended daily dose of this medicine contains [state quantity and units] of sodium (or words to that effect).’ | |
1882 | DISODIUM ETHYLENE DICOCAMIDE PEG-15 DISULFATE | E | Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye or on damaged skin. The concentration in the medicine must be no more than 1%. | |
1883 | DISODIUM GUANYLATE | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. | |
1884 | DISODIUM INOSINATE | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. | |
1885 | DISODIUM LAURIMINODIPROPIONATE TOCOPHERYL PHOSPHATES | E | Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 3%. | |
DISODIUM NADH | E | Only for use in topical medicines for dermal application. The concentration in the medicine must be no more than 0.02%. | ||
1887 | DISODIUM OLEAMIDO PEG-2 SULFOSUCCINATE | E | Only for use in topical medicines for dermal application and not to be included in medicines for use in the eye. The concentration in the medicine must be no more than 1%. | |
1888 | DISODIUM PHENYL DIBENZIMIDAZOLE TETRASULFONATE | A | Only for use as an active ingredient in sunscreens for dermal application. The concentration in a medicine must be no more than 10%. When used in primary sunscreen products, the medicine requires the following warning statements on the label: ‑ (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and ‑ (SUNPRO) 'Wear protective clothing ‑ hats and eyewear when exposed to the sun' (or words to this effect). | |
1889 | DISODIUM RICINOLEAMIDO MEA-SULFOSUCCINATE | E | Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 3%. | |
1890 | DISODIUM RUTINYL DISULFATE | E | Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.05%. | |
DISODIUM STEAROYL GLUTAMATE | E | Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 1%. | ||
1892 | DISPERSIBLE CELLULOSE | E |
| |
1893 | DISTARCH PHOSPHATE | E | Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 4%. | |
1894 | DISTEARDIMONIUM HECTORITE | E | Only for use in topical medicines for dermal application and not to be included for medicines intended for use in the eye. The concentration in the medicine must be no more than 2%. | |
1895 | DISTEARETH-6 DIMONIUM CHLORIDE | E | Only for use in topical medicines for dermal application. | |
1896 | DISTEARYL PHTHALIC ACID AMIDE | E | Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 5%. | |
1897 | DISTEARYLDIMONIUM CHLORIDE | E | Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 5%. | |
DIVINYLDIMETHICONE/DIMETHICONE COPOLYMER | E | Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 1.5%. | ||
1899 | DL-ALPHA-TOCOPHEROL | A,E | When used as an active ingredient and the route of administration is oral or sublingual, the medicine requires the following warning statement on the medicine label: - (VIT) ‘Vitamins can only be of assistance if the dietary vitamin intake is inadequate.’ or ‘Vitamin supplements should not replace a balanced diet.’ | |
1900 | DL-ALPHA-TOCOPHERYL ACETATE | A,E,H | When used as an active ingredient and the route of administration is oral or sublingual, the medicine requires the following warning statement on the medicine label: - (VIT) ‘Vitamins can only be of assistance if the dietary vitamin intake is inadequate.’ or ‘Vitamin supplements should not replace a balanced diet.’ | |
1901 | DL-ALPHA-TOCOPHERYL ACID SUCCINATE | A,E,H | When used as an active ingredient and the route of administration is oral or sublingual, the medicine requires the following warning statement on the medicine label: - (VIT) ‘Vitamins can only be of assistance if the dietary vitamin intake is inadequate.’ or ‘Vitamin supplements should not replace a balanced diet.’ | |
1902 | DL-BORNEOL | E |
| |
1903 | DL-LIMONENE | E | Only for use in topical medicines for dermal application. | |
1904 | DL-THREONINE | A,E |
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DOCOSAHEXAENOIC ACID (DHA)-RICH OIL DERIVED FROM MICROALGAE SCHIZOCHYTRIUM SP. | A | Only for use in oral medicines and must be present in combination with other ingredients. | ||
1906 | DOCUSATE SODIUM | E |
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1907 | DODECAHYDRO-3A,6,6,9A-TETRAMETHYLNAPHTHO(2,1-B)FURAN | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. | |
1908 | DODECANENITRILE | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. | |
1909 | DODECENAL | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. | |
1910 | DODECENE | E | Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.2%. | |
DODECYL ACETATE | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. | ||
1912 | DODECYL ISOBUTYRATE | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. | |
1913 | DOLICHOS LABLAB | A,H |
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1914 | DOLOMITE | A,E,H | The following indications are only permitted for use when the medicine is for oral and sublingual use: (SCI-BONDIOP-PR) 'Provides a minimum daily dose of 290mg of elemental calcium. A diet deficient in calcium can lead to osteoporosis in later life' (SCI-NUMCALE-AP) 'Provides a minimum daily dose of 290mg of elemental calcium which may assist in the prevention of osteoporosis when dietary intake is inadequate.' | |
1915 | DRACAENA DRACO | A,H |
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1916 | DRECHSLERA SOROKINIANA | A,H |
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1917 | DRIED BUTTERMILK | E |
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1918 | DRIED CALCIUM SULFATE | A,E,H | When used as an active ingredient and the medicine is intended as a mineral supplementation, calcium is a mandatory component of dried calcium sulfate. The percentage of calcium from dried calcium sulfate should be calculated based on the molecular weight of dried calcium sulfate. The following indications are only permitted when the medicine is for oral and sublingual use: - (OSPOR1) ‘Source of calcium. May assist in the prevention and/or treatment of osteoporosis’ - (OSPOR2) ‘Source of calcium. Women's calcium requirements are increased after menopause. Calcium supplementation may be of assistance in the prevention and/or treatment of osteoporosis’ - (CALC1) ‘Source of calcium. Women's calcium requirements are increased after menopause’ - (CALC2) ‘Source of calcium. A calcium supplement formulated to strengthen bone and tissue in growing and mature users. (or) Source of calcium. A calcium supplement formulated to strengthen bone and tissue for children and older adults’ - (CALC3) ‘Source of calcium. Adequate dietary calcium in our youth and throughout life is required to maximise bone’ - (CALC4) ‘Source of calcium. A diet deficient in calcium can lead to osteoporosis in later life.’ The indication ‘For mineral (may state the mineral) supplementation’ is only permitted for use when the medicine is for oral or sublingual use. | |
1919 | DRIED MAGNESIUM SULFATE | A,E,H | When used internally, the maximum recommended daily dose must be no more than 1.5g. When used as an active ingredient and the medicine is intended as a mineral supplementation, magnesium is a mandatory component of dried magnesium sulfate. The percentage of magnesium from dried magnesium sulfate should be calculated based on the molecular weight of dried magnesium sulfate. The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use. | |
1920 | DRIMIA INDICA | A,H |
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DRIMIA MARITIMA | A,H |
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1922 | DROMETRIZOLE TRISILOXANE | A | Only for use as an active ingredient in sunscreens for dermal application. The concentration in a medicine must be no more than 10%. When used in primary sunscreen products, the medicine requires the following warning statements on the label: ‑ (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and ‑ (SUNPRO) 'Wear protective clothing ‑ hats and eyewear when exposed to the sun' (or words to this effect). | |
1923 | DROSERA ANGLICA | A,H |
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1924 | DROSERA BURMANNI | A,H |
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1925 | DROSERA INTERMEDIA | A,H |
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1926 | DROSERA RAMENTACIA | A,H |
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1927 | DROSERA ROTUNDIFOLIA | A,E,H |
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1928 | DROSERA ROTUNDIFOLIA MIS | A,H |
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1929 | DRY WHOLE MILK | E | If the product is for oral ingestion and contains lactose, then the medicine requires the following warning statement on the medicine label: - (LACT) 'Contains lactose' (or words to that effect). | |
1930 | DRYNARIA FORTUNEI | A,H |
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1931 | DRYOBALANOPS AROMATICA | A,H |
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1932 | DRYOPTERIS FILIX-MAS | H | Only for use as an active homoeopathic ingredient.
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1933 | DULACIA INOPIFLORA | A,H |
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1934 | DUNALIELLA SALINA | A,E,H |
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1935 | DUPICAL | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. | |
DURVILLAEA ANTARCTICA EXTRACT | E | Only for use in topical medicines for dermal application. The concentration in the medicine must be no more than 0.1%. | ||
1937 | DWARF PINE-NEEDLE OIL | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. | |
1938 | DYSPHANIA AMBROSIOIDES | A,H | Volatile oil components (of Dysphania ambrosioides) are mandatory components of Dysphania ambrosioides. | |
1939 | ECAMSULE | A | Only for use as an active ingredient in sunscreens for dermal application. The concentration in a medicine must be no more than 10%. When used in primary sunscreen products, the medicine requires the following warning statements on the label: ‑ (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and ‑ (SUNPRO) 'Wear protective clothing ‑ hats and eyewear when exposed to the sun' (or words to this effect). | |
1940 | ECHINACEA ANGUSTIFOLIA | A,E,H |
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1941 | ECHINACEA PALLIDA | A,E,H |
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1942 | ECHINACEA PURPUREA | A,E,H |
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1943 | ECHINOPS SPINOSUS | A,H |
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ECLIPTA PROSTRATA | A,H |
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1945 | ECTOIN | E | Only for use as an excipient ingredient in topical medicines for dermal application and not to be used in topical medicines intended for use in the eye. The concentration in the medicine must be no more than 3%. | |
1946 | EDETATE SODIUM | E | Only for use in topical medicines for dermal application and nasal medicines. The concentration in the medicine must be no more than 0.2%. | |
1947 | EDETIC ACID | E | The concentration in the medicine must be no more than 0.25%. | |
1948 | EGG LECITHIN | A,E |
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1949 | EICHHORNIA CRASSIPES | A,H |
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1950 | ELAEAGNUS ANGUSTIFOLIA | A,H |
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1951 | ELAEIS GUINEENSIS | A,E,H |
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1952 | ELASTIN | E | Only for use in topical medicines for dermal application. | |
1953 | ELDER FLOWER ABSOLUTE | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. | |
1954 | ELDER FLOWER BLACK DRY | A,E,H |
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1955 | ELDER FLOWER BLACK POWDER | A,H |
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1956 | ELECAMPANE RHIZOME DRY | A,H |
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ELECAMPANE RHIZOME POWDER | A,H |
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1958 | ELEMI OIL | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. | |
1959 | ELEMI RESINOID | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. | |
1960 | ELEMOL | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. | |
1961 | ELEOCHARIS TUBEROSA | A,H |
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1962 | ELETTARIA CARDAMOMUM | A,E,H |
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1963 | ELEUTHEROCOCCUS NODIFLORUS | A,H |
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1964 | ELEUTHEROCOCCUS ROOT DRY | A,H |
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1965 | ELEUTHEROCOCCUS ROOT POWDER | A,H |
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1966 | ELEUTHEROCOCCUS SENTICOSUS | A,H |
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1967 | ELSHOLTZIA SPLENDENS | A,H |
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ELYMUS REPENS | A,E,H |
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1969 | EMU OIL | A,E | Emu oil ingredients must meet the following two requirements: 1) the manufacturing process is to include steps such as cooking, fat drying or deodorising which ensures the temperature of the oil reaches at least 60 degrees C for a minimum 5 minutes or at least 100 degrees C for a minimum of 1 minute, and 2) the sponsor is to hold a veterinary certificate indicating that the emus from which the raw material was extracted were healthy and fit for human consumption. | |
1970 | EMULSIFYING WAX | E |
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1971 | ENOXOLONE | E | Only for use in topical medicines for dermal application. | |
1972 | ENZYME MODIFIED CREAM | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. | |
1973 | EPHEDRA DISTACHYA | A,H | Ephedrine and Pseudoephedrine (of Ephedra distachya) are mandatory components of Ephedra distachya and must be declared in the application. The concentration of ephedrine from all ingredients in the product must be no more than 10 mg/kg or 10 mg/L or 0.001%. | |
EPHEDRA SINICA | A,H | Ephedrine and Pseudoephedrine (of Ephedra sinica) are mandatory components of Ephedra sinica. The concentration of ephedrine from all ingredients in the product must be no more than 10 mg/kg or 10 mg/L or 0.001%. | ||
1975 | EPIGAEA REPENS | A,H |
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1976 | EPILOBIUM ANGUSTIFOLIUM | E | Only for use in topical sunscreens for dermal application and not to be included in medicines intended for use in the eye. The extract must be processed from the flower, leaf and stem (herb top flowering) of the plant. The extracts used must be: 1:20 in 100% water or 1:2 in 100% water. The concentrations of Epilobium angustifolium must be no more than 0.75% for a 1:2 extract in 100% water, and 5% for a 1:20 extract in 100% water. | |
1977 | EPILOBIUM PALUSTRE | A,H |
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1978 | EPILOBIUM PARVIFLORUM | A,H |
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1979 | EPIMEDIUM BREVICORNU | A,H |
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1980 | EPIMEDIUM GRANDIFLORUM | A,H |
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1981 | EPIMEDIUM SAGITTATUM | A,H |
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1982 | EPOXY CEDRENE | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. | |
EQUISETUM ARVENSE | A,E,H |
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1984 | EQUISETUM HIEMALE | A,H |
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1985 | ERGOCALCIFEROL | A,E | When for internal use, the maximum recommended daily dose must be no more than 25 micrograms of Vitamin D. When used as an active ingredient and the route of administration is oral or sublingual, the medicine requires the following warning statement on the medicine label: - (VIT) ‘Vitamins can only be of assistance if the dietary vitamin intake is inadequate.’ or ‘Vitamin supplements should not replace a balanced diet.’ The indication 'Vitamin D helps calcium absorption (or words of like intent) and a diet deficient in calcium can lead to osteoporosis in later life' is permitted only for oral use. | |
1986 | ERGOTHIONEINE | E | Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.0005%. | |
1987 | ERIGERON BREVISCAPUS | A,H |
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1988 | ERIOBOTRYA JAPONICA | A,H |
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1989 | ERIOCAULON BUERGERIANUM | A,H |
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ERIODICTYON CRASSIFOLIUM | A,H |
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1991 | ERIODICTYON GLUTINOSUM | A,H |
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1992 | ERODIUM CICUTARIUM | A,H |
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1993 | ERUCA SATIVA | A,H |
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1994 | ERYTHORBIC ACID | E |
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1995 | ERYTHRITOL | E | Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 0.1%. | |
1996 | ERYTHROSINE | E | Only for use as a colour for oral and topical use. | |
1997 | ERYTHROSINE ALUMINIUM LAKE | E | Only for use as a colour for oral and topical use. | |
1998 | ERYTHRULOSE | E | Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 2%. The medicine requires the following warning statement on the medicine label: - (EYE) 'Avoid contact with eyes'. | |
1999 | ESCHSCHOLZIA CALIFORNICA | A,H |
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ESTRONE | H | Only for use as an active homoeopathic ingredient. | ||
2001 | ETHANOL | A,E | When used as an active ingredient, can only be supplied as an uncompounded medicine substance packed for retail sale and must comply with an uncompounded substance monograph of the British Pharmacopoeia, as in force or existing from time to time. When the concentration of ethanol from all ingredients in the medicine is more than 3%, the medicine requires the following warning statement on the medicine label: - (ETHAN) 'Contains ethanol or contains alcohol'. | |
2002 | ETHANOL ABSOLUTE | A,E | When used as an active ingredient, can only be supplied as an uncompounded medicine substance packed for retail sale and must comply with an uncompounded substance monograph of the British Pharmacopoeia, as in force or existing from time to time. When the concentration of ethanol from all ingredients in the medicine is more than 3%, the medicine requires the following warning statement on the medicine label: - (ETHAN) 'Contains ethanol or contains alcohol' | |
2003 | ETHER | E | The concentration of ether in the medicine must be no more than 10%. | |
ETHOHEXADIOL | E | Only for use in topical medicines for dermal application. The medicine requires the following warning statement on the medicine label: - (EHEXAD) 'Contains ethohexadiol' (or words to that effect). | ||
2005 | ETHOXYLATED HYDROGENATED CASTOR OIL | E |
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2006 | ETHOXYLATED NONYLPHENOL | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. | |
2007 | ETHOXYMETHOXY CYCLODODECANE | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. | |
2008 | ETHYL-2-METHYL-1,3-DIOXOLANE-2-ACETATE | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. | |
2009 | ETHYL-2-METHYL-4-PENTENOATE | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. | |
ETHYL-2-METHYLPENTENOATE | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. | ||
2011 | ETHYL (2,4-DIMETHYL-[1,3] DIOXOLAN-2-YL) ACETATE | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. | |
2012 | ETHYL (3AR,4S,7R,7AR)-REL- OCTAHYDRO-4,7-METHANO[3AH]INDENE-3A-CARBOXYLATE | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. | |
2013 | ETHYL 2-BUTENOATE | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. | |
2014 | ETHYL 2-ETHYL-6,6-DIMETHYL-2-CYCLOHEXENECARBOXYLATE | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. | |
2015 | ETHYL 2-HEXYL ACETOACETATE | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. | |
ETHYL 2-METHYLBUTYRATE | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. | ||
2017 | ETHYL 2-METHYLPENTANOATE | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. | |
2018 | ETHYL 2,3,6,6-TETRAMETHYL-2-CYCLOHEXENECARBOXYLATE | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. | |
2019 | ETHYL 2,6,6,TRIMETHYL-1,3-CYCLOHEXADIENE-1-CARBOXYLATE | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. | |
2020 | ETHYL 3-HEXENOATE | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. | |
ETHYL 3-HYDROXYBUTYRATE | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. | ||
2022 | ETHYL 3-HYDROXYHEXANOATE | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. | |
2023 | ETHYL 3-MERCAPTOPROPIONATE | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. | |
2024 | ETHYL 3-METHYLTHIOPROPIONATE | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. | |
2025 | ETHYL 4,7-OCTADIENOATE | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. | |
ETHYL ACETATE | E | The residual solvent limit for ethyl acetate is 50 mg per recommended daily dose. The concentration in the medicine must be no more than 0.5%. | ||
2027 | ETHYL ACETOACETATE | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. | |
2028 | ETHYL ACRYLATE | E |
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2029 | ETHYL AMYL KETONE | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. | |
2030 | ETHYL ANTHRANILATE | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. | |
ETHYL BENZOATE | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. | ||
2032 | ETHYL BENZOYL ACETATE | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. | |
2033 | ETHYL BUTYLACETYLAMINOPROPIONATE | E | Only for use in topical medicines for dermal application. The concentration in the medicine must be no more than 7.5%. The medicine requires the following warning statement on the medicine label: - (EYE2) 'May be irritant to the eyes (or words to that effect)'. | |
2034 | ETHYL BUTYRATE | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. | |
ETHYL CAPRATE | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. | ||
2036 | ETHYL CAPROATE | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. | |
2037 | ETHYL CAPRYLATE | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. | |
2038 | ETHYL CINNAMATE | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. | |
2039 | ETHYL CROTONATE | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. | |
ETHYL ENANTATE | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. | ||
2041 | ETHYL FORMATE | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. | |
2042 | ETHYL HYDROXYBENZOATE | E | Medicines containing hydroxybenzoates require the following warning statement on the medicine label: - (TOTBNZ) ‘Contains hydroxybenzoates’ (or words to this effect) if the medicine contains more than one hydroxybenzoate source OR ‘Contains [insert the approved name of hydroxybenzoate used]’ (or words to this effect) if product contains one hydroxybenzoate source. | |
2043 | ETHYL ISOBUTYRATE | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. | |
ETHYL ISOVALERATE | E |
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2045 | ETHYL LACTATE | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. | |
2046 | ETHYL LAURATE | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. | |
2047 | ETHYL LEVULATE | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. | |
2048 | ETHYL LEVULINATE | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. | |
ETHYL LINALOOL | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. | ||
2050 | ETHYL LINALYL ACETATE | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. | |
2051 | ETHYL LINOLEATE | E | Only for use in topical medicines for dermal application. | |
2052 | ETHYL LINOLENATE | E | Only for use in topical medicines for dermal application. | |
2053 | ETHYL MACADAMIATE | E | Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 10%. | |
2054 | ETHYL MALTOL | E |
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2055 | ETHYL MENTHANE CARBOXAMIDE | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. | |
2056 | ETHYL METHACRYLATE | E | Only for use in topical medicines for dermal application. | |
ETHYL METHYLPHENYLGLYCIDATE | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. | ||
2058 | ETHYL METICONE | E | Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 3%. | |
2059 | ETHYL MYRISTATE | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. | |
2060 | ETHYL OLEATE | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. | |
2061 | ETHYL ORTHO-METHOXYBENZYL ETHER | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. | |
ETHYL OXYHYDRATE | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. | ||
2063 | ETHYL PALMITATE | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. | |
2064 | ETHYL PARA-ANISATE | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. | |
2065 | ETHYL PELARGONATE | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. | |
ETHYL PHENYLACETATE | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. | ||
2067 | ETHYL PROPIONATE | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. | |
2068 | ETHYL RICINOLEATE | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. | |
2069 | ETHYL SALICYLATE | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. | |
2070 | ETHYL SEBACATE | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. | |
ETHYL STEARATE | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. | ||
2072 | ETHYL SUCCINATE | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. | |
2073 | ETHYL TARTRATE | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. | |
2074 | ETHYL TRANS-2, CIS-4-DECADIENOATE | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. | |
2075 | ETHYL TRANS-3-HEXENOATE | E | Permitted for use only in combination with other permitted ingredients as a flavour. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. | |
2076 | ETHYL UNDECYLENATE | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. | |
ETHYL VALERATE | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. | ||
2078 | ETHYL VANILLIN | E |
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2079 | ETHYLBISIMINOMETHYL GUAIACOL MANGANESE CHLORIDE | E | Only for use in topical medicines for dermal application. The concentration in the medicine must be no more than 0.002%. | |
2080 | ETHYLCELLULOSE | E |
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2081 | ETHYLENE BRASSYLATE | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. | |
2082 | ETHYLENE GLYCOL | E | The residual solvent limit for ethylene glycol is 6.2 mg per recommended daily dose. The concentration in the medicine must be no more than 0.062%. | |
2083 | ETHYLENE GLYCOL MONOPALMITOSTEARATE | E | Only for use in topical medicines for dermal application. | |
2084 | ETHYLENE/ACRYLIC ACID COPOLYMER | E | Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye or on damaged skin. The concentration in the medicine must be no more than 2%. | |
ETHYLENE/VINYL ACETATE COPOLYMER | E | Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 16%. | ||
2086 | ETHYLENEDIAMINE | E | Only for use in topical medicines for dermal application. | |
2087 | ETHYLENEDIAMINE/HYDROGENATED DIMER DILINOLEATE COPOLYMER BIS-DI-C14-18 ALKYL AMIDE | E | Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 4%. | |
2088 | ETHYLENEDIAMINE/STEARYL DIMER DILINOLEATE COPOLYMER | E | Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye or on damaged skin. The concentration in the medicine must be no more than 6%. | |
2089 | ETHYLHEXYL BENZOATE | E | Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye or on damaged skin. The concentration in the medicine must be no more than 3.5%. | |
ETHYLHEXYL METHOXYCRYLENE | E | Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 10%. | ||
2091 | ETHYLHEXYL TRIAZONE | A | Only for use as an active ingredient in sunscreens. Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 5%. | |
2092 | ETHYLHEXYLGLYCERIN | E | Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. The concentration in the medicine must be no more than 5%. | |
ETIDRONIC ACID | E | Only for use in topical medicines for dermal application only. The concentration in the medicine must be no more than 1%. | ||
2094 | EUCALYPTUS DIVES | A,E,H | Cineole is a mandatory component of Eucalyptus dives. In liquid preparations when the concentration of cineole OR the concentration of oil or distillate in the preparation is more than 25%: a) the nominal capacity of the container must be no more than 25 millilitres; b) a restricted flow insert must be fitted on the container; and c) the container must include the following warning statements on the medicine label: - (CHILD) 'Keep out of reach of children' (or words to that effect); and - (NTAKEN) 'Not to be taken'. In liquid preparations, when the concentration of cineole OR the concentration of oil or distillate in the preparation is more than 25% and the nominal capacity of the container is more than 15 millilitres but less than or equal to 25 millilitres the medicine must also have a child resistant closure. | |
EUCALYPTUS FRUTICETORUM | A,E,H | Cineole is a mandatory component of Eucalyptus fruticetorum. In liquid preparations when the concentration of cineole OR the concentration of oil or distillate in the preparation is more than 25%: a) the nominal capacity of the container must be no more than 25 millilitres; b) a restricted flow insert must be fitted on the container; and c) the container must include the following warning statements on the medicine label: - (CHILD) 'Keep out of reach of children' (or words to that effect); and - (NTAKEN) 'Not to be taken'. In liquid preparations, when the concentration of cineole OR the concentration of oil or distillate in the preparation is more than 25% and the nominal capacity of the container is more than 15 millilitres but less than or equal to 25 millilitres the medicine must also have a child resistant closure. | ||
EUCALYPTUS GLOBULUS | A,E,H | Cineole is a mandatory component of Eucalyptus globulus. In liquid preparations when the concentration of cineole OR the concentration of oil or distillate in the preparation is more than 25%: a) the nominal capacity of the container must be no more than 25 millilitres; b) a restricted flow insert must be fitted on the container; and c) the container must include the following warning statements on the medicine label: - (CHILD) 'Keep out of reach of children' (or words to that effect); and - (NTAKEN) 'Not to be taken'. In liquid preparations, when the concentration of cineole OR the concentration of oil or distillate in the preparation is more than 25% and the nominal capacity of the container is more than 15 millilitres but less than or equal to 25 millilitres the medicine must also have a child resistant closure. | ||
EUCALYPTUS MACRORHYNCHA | A,E,H | Cineole is a mandatory component of Eucalyptus macrorhyncha. In liquid preparations when the concentration of cineole OR the concentration of oil or distillate in the preparation is more than 25%: a) the nominal capacity of the container must be no more than 25 millilitres; b) a restricted flow insert must be fitted on the container; and c) the container must include the following warning statements on the medicine label: - (CHILD) 'Keep out of reach of children' (or words to that effect); and - (NTAKEN) 'Not to be taken'. In liquid preparations, when the concentration of cineole OR the concentration of oil or distillate in the preparation is more than 25% and the nominal capacity of the container is more than 15 millilitres but less than or equal to 25 millilitres the medicine must also have a child resistant closure. | ||
EUCALYPTUS OIL | A,E,H | Cineole is a mandatory component of Eucalyptus oil. When the plant preparation is oil and the total concentration of the oil in the preparation is more than 25%, the nominal capacity of the container must be no more than 25 mL. When the plant preparation is oil and the total concentration of the oil in the preparation is more than 25% and the nominal capacity of the container is more than 15 mL but no more than 25mL, a child resistant closure and restricted flow insert must be fitted on the container. The medicine requires the following warning statements on the medicine label: - (CHILD) ‘Keep out of reach of children’ (or words to that effect) - (NTAKEN) ‘Not to be taken’ When the concentration of the oil in the preparation is more than 25% and the nominal capacity of the container is no more than 15 mL, a restricted flow insert must be fitted on the container. The medicine requires the following warning statements on the medicine label: - (CHILD) ‘Keep out of reach of children’ (or words to that effect) - (NTAKEN) ‘Not to be taken’ | ||
EUCALYPTUS RADIATA | A,E,H | Cineole is a mandatory component of Eucalyptus radiata. In liquid preparations when the concentration of cineole OR the concentration of oil or distillate in the preparation is more than 25%: a) the nominal capacity of the container must be no more than 25 millilitres; b) a restricted flow insert must be fitted on the container; and c) the container must include the following warning statements on the medicine label: - (CHILD) 'Keep out of reach of children' (or words to that effect); and - (NTAKEN) 'Not to be taken'. In liquid preparations, when the concentration of cineole OR the concentration of oil or distillate in the preparation is more than 25% and the nominal capacity of the container is more than 15 millilitres but less than or equal to 25 millilitres the medicine must also have a child resistant closure. | ||
EUCALYPTUS ROSTRATA | A,E,H | Cineole is a mandatory component of Eucalyptus rostrata. In liquid preparations when the concentration of cineole OR the concentration of oil or distillate in the preparation is more than 25%: a) the nominal capacity of the container must be no more than 25 millilitres; b) a restricted flow insert must be fitted on the container; and c) the container must include the following warning statements on the medicine label: - (CHILD) 'Keep out of reach of children' (or words to that effect); and - (NTAKEN) 'Not to be taken'. In liquid preparations, when the concentration of cineole OR the concentration of oil or distillate in the preparation is more than 25% and the nominal capacity of the container is more than 15 millilitres but less than or equal to 25 millilitres the medicine must also have a child resistant closure. | ||
2101 | EUCALYPTUS TERETICORTIS | A,E,H | Cineole is a mandatory component of Eucalyptus tereticortis. In liquid preparations when the concentration of cineole OR the concentration of oil or distillate in the preparation is more than 25%: a) the nominal capacity of the container must be no more than 25 millilitres; b) a restricted flow insert must be fitted on the container; and c) the container must include the following warning statements on the medicine label: - (CHILD) 'Keep out of reach of children' (or words to that effect); and - (NTAKEN) 'Not to be taken'. In liquid preparations, when the concentration of cineole OR the concentration of oil or distillate in the preparation is more than 25% and the nominal capacity of the container is more than 15 millilitres but less than or equal to 25 millilitres the medicine must also have a child resistant closure. | |
2102 | EUCOMMIA ULMOIDES | A,H |
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EUGENOL | E | Only for use in topical medicines for dermal application. When the concentration of Eugenol in the preparation is more than 25%, the nominal capacity of the container must be no more than than 25 mL. When the concentration of Eugenol in the preparation is more than 25% and the nominal capacity of the container is more than 15 mL but no more than 25mL, a child resistant closure and restricted flow insert must be fitted on the container. The medicine requires the following warning statements on the medicine label: - (CHILD) ‘Keep out of reach of children’ (or words to that effect) - (NTAKEN) ‘Not to be taken’ When the concentration of Eugenol in the preparation is more than 25% and the nominal capacity of the container is no more than 15mL, a restricted flow insert must be fitted on the container. The medicine requires the following warning statements on the medicine label: - (CHILD) ‘Keep out of reach of children’ (or words to that effect) - (NTAKEN) ‘Not to be taken’ | ||
2104 | EUGENYL ACETATE | E | Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used in a flavour the total flavour concentration in a medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in a medicine must be no more 1%. | |
2105 | EUONYMUS ATROPURPUREUS | A,H |
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2106 | EUONYMUS EUROPAEUS | A,H | The maximum recommended daily dose must be no more than the equivalent of 1mg of the dry herbal material. | |
2107 | EUPATORIUM FORTUNEI | A,H |
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2108 | EUPATORIUM JAPONICUM | A,H |
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2109 | EUPATORIUM PERFOLIATUM | A,H |
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2110 | EUPATORIUM PURPUREUM | A,H |
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2111 | EUPHAUSIA SUPERBA OIL | A | Only for use in oral medicines. The medicine requires the following warning statement on the medicine label: - (SFOOD) 'Derived from seafood' or - (SHELL) 'Contains crustacean shellfish'. | |
2112 | EUPHORBIA CYPARISSIAS | A,H |
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2113 | EUPHORBIA DRY | A,H |
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EUPHORBIA HETERODOXA | A,H |
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2115 | EUPHORBIA HIRTA | A,H |
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2116 | EUPHORBIA LATHYRIS | A,H | Levodopa (of Euphorbia lathyris) is a mandatory component of Euphorbia lathyris. The concentration of Levodopa (of Euphorbia lathyris) in the medicine must be no more than 10mg/kg or 10mg/L or 0.001%. | |
2117 | EUPHORBIA PEKINENSIS | A,H |
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2118 | EUPHORBIA PEPLUS | H | Only for use as an active homoeopathic ingredient. | |
2119 | EUPHORBIA POWDER | A,H |
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2120 | EUPHORBIA RESINIFERA | A,H |
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2121 | EUPHORBIA SIEBOLDIANA | A,H |
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2122 | EUPHRASIA OFFICINALIS | A,H |
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2123 | EUROPEAN GARDEN SPIDER | H | Only for use as an active homoeopathic ingredient. | |
2124 | EUROPEAN HORNET | H | Only for use as an active homoeopathic ingredient. | |
2125 | EURYALE FEROX | A,H |
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2126 | EUTERPE OLERACEA | A | The herbal substance must be derived from the fruit only. | |
2127 | EVENING PRIMROSE OIL | A,E,H |
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EVERNIA PRUNASTRA EXTRACT | E | Permitted for use only in combination with other permitted ingredients as a fragrance. If used in a fragrance the total fragrance concentration in a medicine must be no more than 1%. | ||