Schedule 1—Specified permissible ingredients and requirements applying to these ingredients when contained in a medicine

Note: See sections 5 and 6.

Permissible ingredients and requirements
Column 1	Column 2	Column 3	Column 4
Item	Ingredient name	Purpose	Specific requirements
3649	P-ALPHA-DIMETHYL STYRENE	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%.
3650	P-ANISIC 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 be no more than 0.3%.
3651	PADIMATE O	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 not be more than 8%. When used in primary sunscreen products, the following warning statements are required 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).
3652	PADINA PAVONICA THALLUS PHYTOSTEROLS	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%.
3653	PAEONIA LACTIFLORA	A, E, H
3654	PAEONIA OBOVATA	A, H
3655	PAEONIA SUFFRUTICOSA	A, E, H
3656	PAEONIA VEITCHII	A, H
3657	PALIURUS SPINA-CHRISTI	A, H
3658	PALLADIUM	H	Only for use as an active homoeopathic ingredient.
3659	PALM FRUIT OIL	A, E, H
3660	PALM GLYCERIDES	E
3661	PALM KERNEL OIL	A, E, H
3662	PALM TOCOTRIENOLS COMPLEX	A, H
3663	PALMARIA PALMATA	A, H
3664	PALMAROSA OIL	A, E, H
3665	PALMIDROL	A	Only to be used in a medicine where Pharmako Biotechnologies Pty Ltd (Client ID 62358), who applied to have the ingredient included in this Determination, is the sponsor of the medicine or has given written authorisation to the sponsor of a medicine to include the ingredient in the medicine. This paragraph ceases to be a requirement for this ingredient after 02 December 2021. Only permitted for use in medicines limited to oral routes of administration. The maximum recommended daily dose of the medicine must not provide more than 600 mg of palmidrol. The following warning statements (or words to the same effect) are required on the medicine label: - (ANALG) 'The medicine may interact with other prescription analgesic medicines, please consult your healthcare practitioner before use.' - (ADULT) ‘Adults only.’ - (21DAYS) ‘Not to be used for more than 21 consecutive days.’
3666	PALMITIC ACID	E
3667	PALMITOLEIC ACID-RICH FATTY ACID ETHYL ESTERS	A
3668	PALMITOYL DIPEPTIDE-7	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 0.002%.
3669	PALMITOYL HYDROXYPROPYLTRIMONIUM AMYLOPECTIN/GLYCERIN 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 0.01%
3670	PALMITOYL OLIGOPEPTIDE	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 0.002%.
3671	PALMITOYL PENTAPEPTIDE-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 0.0005%.
3672	PALMITOYL TETRAPEPTIDE-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 0.001%.
3673	PANAX GINSENG	A, E, H
3674	PANAX JAPONICUS	A, H
3675	PANAX NOTOGINSENG	A, H
3676	PANAX PSEUDOGINSENG	A, H
3677	PANAX QUINQUEFOLIUS	A, H
3678	PANICUM MILIACEUM	A, H
3679	PANTETHINE	E	Only for use in topical medicines for dermal application.
3680	PANTHENOL	A, E
3681	PANTHENYL ETHYL ETHER	E	Only for use in topical medicines for dermal application.
3682	PANTOLACTONE	E
3683	PANTOTHENIC ACID	A, E	When used topically, the concentration in the medicine must be no more than 0.1%.
3684	PANTOTHENIC ACID POLYPEPTIDE	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%.
3685	PAPAIN	A, E
3686	PAPER	E	Only for use in topical medicines for dermal application.
3687	PAPRIKA OLEORESIN	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%.
3688	PARA-CRESOL	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%.
3689	PARA-CRESYL 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%.
3690	PARA-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%.
3691	PARA-CRESYL PHENYLACETATE	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%.
3692	PARA-CYMENE	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%.
3693	PARA-ETHOXYBENZALDEHYDE	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%.
3694	PARA-ETHYL CRESOXYACETATE	E	Para-ethyl cresoxyacetate must only be included in medicines when in combination with other permitted ingredients as a fragrance proprietary excipient formulation. The total concentration of the fragrance proprietary excipient formulation containing para-ethyl cresoxyacetate must not be more than 1% of the total medicine.
3695	PARA-ETHYLPHENOL	E	Permitted for use only in combination with other permitted ingredients as part of a flavour proprietary excipient formulation. The maximum recommended daily dose must contain no more than 0.12 mg of para-ethylphenol. The total flavour proprietary excipient formulation in a medicine must be no more than 5%.
3696	PARA-HYDROXY BENZALACETONE	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%.
3697	PARA-HYDROXYBENZOIC ACID	E
3698	PARA-MENTHA-8-THIOL-3-ONE	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%.
3699	PARA-METHYL ACETOPHENONE	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%.
3700	PARA-METHYL ANISOLE	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%.
3701	PARA-METHYL DIMETHYLBENZYL CARBINOL	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%.
3702	PARA-PROPYL ANISOLE	E	Para-propyl anisole must only be included in medicines when in combination with other permitted ingredients as a fragrance and/or flavour proprietary excipient formulation. The total concentration of fragrance proprietary excipient formulations containing para-propyl anisole must not be more than 1% of the total medicine. The total concentration of flavour proprietary excipient formulations containing para-propyl anisole must not be more than 5% of the total medicine.
3703	PARA-TERT-BUTYLCYCLOHEXYL 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%.
3704	PARA-TERT-BUTYLPHENYL-ALPHA-METHYLHYDROCINNAMIC ALDEHYDE	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%.
3705	PARA-TOLUALDEHYDE	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%.
3706	PARA-TOLYL ACETALDEHYDE	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%.
3707	PARAMERIA LAEVIGATA	A, H
3708	PARIETARIA JUDAICA	A, H
3709	PARIS POLYPHYLLA	A, H
3710	PARIS QUADRIFOLIA	A, H
3711	PARSLEY	E, H
3712	PARSLEY HERB DRY	A, E, H
3713	PARSLEY HERB OIL	A, E, H
3714	PARSLEY HERB POWDER	A, E, H
3715	PARSLEY SEED OIL	A, E, H
3716	PARTHENOCISSUS TRICUSPIDATA	A, H
3717	PARTIALLY DEHYDRATED LIQUID SORBITOL	E	Sorbitol is a mandatory component of partially dehydrated liquid sorbitol. Permitted for use only as part of the capsule in medicines where the dosage form is a soft capsule.
3718	PARTIALLY HYDROGENATED SOYA 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 the medicine must be no more than 5%.
3719	PARTIALLY REFINED PORPHYRA YEZOENSIS CYTOPLASM 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 0.00002%.
3720	PASPALUM NOTATUM	A, H
3721	PASSIFLORA CAERULEA	A, H
3722	PASSIFLORA EDULIS	E
3723	PASSIFLORA HERB DRY	A, H
3724	PASSIFLORA INCARNATA	A, E, H
3725	PATCHOULI 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%.
3726	PATENT BLUE V	E	Permitted for use only as a colour in medicines limited to topical and oral routes of administration.
3727	PATENT BLUE V ALUMINIUM LAKE	E	Permitted for use only as a colour in medicines limited to topical and oral routes of administration.
3728	PATRINIA SCABIOSIFOLIA	A, H
3729	PATRINIA VILLOSA	A, H
3730	PAULLINIA CUPANA	A, E, H	Caffeine is a mandatory component of Paullinia cupana. When the medicine is packaged for supply as an undivided preparation and is for internal use or oral application, the medicine must not contain a concentration of total caffeine greater than 4%. When the medicine is packaged for supply as a divided preparation and is for internal use or oral application, the medicine must not contain a concentration of total caffeine greater than 33%. When for internal use or oral application, the maximum recommended daily dose of the medicine must provide no more than 400 mg of total caffeine. When the medicine is packaged for supply as an undivided preparation and is for internal use or oral application, the medicine must not contain a concentration of total caffeine greater than 1%. When the medicine is for internal use or oral application, a maximum recommended dose of the medicine must not provide more than 100 mg of total caffeine within a 3 hour period. When the maximum recommended daily dose of the medicine provides greater than 10 mg of total caffeine and the medicine is for internal use or oral application, the following warning statements are required on the label: - (ADULT) 'Adults only' (or words to that effect). - (CAFF) 'Contains [state quantity per dosage unit or per mL or per gram of product] total caffeine [per dosage unit or per mL or per gram]. A cup of instant coffee contains approximately 80mg of caffeine.' - (CAFFPREG) ‘Caffeine intake more than 200 mg per day is not recommended during pregnancy or breastfeeding.’ When the maximum recommended daily dose of the medicine provides greater than 80 mg of total caffeine and the medicines is for internal use or oral application, the following warning statements are required on the label: - (CAFFLMT) 'Limit the use of caffeine-containing products (including tea and coffee) when taking this product.' - (CAFFCYP) ‘Caffeine interacts with enzyme CYP1A2 in the liver. Consult your health professional before taking with other medicines’ (or words to that effect).
3731	PAULLINIA PINNATA	A, H
3732	PAWPAW	E
3733	PEA	E
3734	PEA STARCH	E
3735	PEACH	E
3736	PEANUT	E
3737	PEAR	E
3738	PECAN	E
3739	PECTIN	A, E
3740	PEG-10 DIMETICONE	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye or damaged skin. The concentration in the medicine must be no more than 4.0%.
3741	PEG-10 SOYA STEROL	E	Only for use in topical medicines for dermal application.
3742	PEG-100 STEARATE	E	Only for use in topical medicines for dermal application.
3743	PEG-12 DILAURATE	E
3744	PEG-12 DIMETICONE/PPG-20 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 2%.
3745	PEG-120 METHYL GLUCOSE DIOLEATE	E	Only for use in topical medicines for dermal application.
3746	PEG-120 STEARATE	E	Only for use in topical medicines for dermal application.
3747	PEG-15 COCAMINE	E	Only for use in topical medicines for dermal application.
3748	PEG-150 DISTEARATE	E	Only for use in topical medicines for dermal application.
3749	PEG-20 ALMOND GLYCERIDES	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%.
3750	PEG-20 METHYL GLUCOSE DISTEARATE	E	Only for use in topical medicines for dermal application.
3751	PEG-20 METHYL GLUCOSE SESQUISTEARATE	E	Only for use in topical medicines for dermal application.
3752	PEG-20 SORBITAN ISOSTEARATE	E	Only for use in topical medicines for dermal application.
3753	PEG-20 STEARATE	E	Only for use in topical medicines for dermal application.
3754	PEG-25 PABA	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 not be more than 10%. When used in primary sunscreen products, the following warning statements are required 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).
3755	PEG-30 DIPOLYHYDROXYSTEARATE	E	Only for use in topical medicines for dermal application.
3756	PEG-30 STEARATE	E	Only for use in topical medicines for dermal application.
3757	PEG-35 CASTOR OIL	E
3758	PEG-4 DILAURATE	E	Only for use in topical medicines for dermal application.
3759	PEG-4 LAURATE	E	Only for use in topical medicines for dermal application. Dioxane and Ethylene oxide are mandatory components of PEG-4 laurate. The concentration of Dioxane in the medicine must be no more than 10 mg/kg or 10 mg/L or 0.001%. The concentration of Ethylene oxide in the medicine must be no more than 1 mg/kg or 1 mg/L or 0.0001%.
3760	PEG-4 STEARATE	E	Only for use in topical medicines for dermal application.
3761	PEG-40 CASTOR OIL	E
3762	PEG-40 HYDROGENATED CASTOR OIL	E
3763	PEG-40 SORBITAN DIISOSTEARATE	E	Only for use in topical medicines for dermal application. Dioxane and Ethylene oxide are mandatory components of PEG-40 sorbitan diisostearate. The concentration of Dioxane in the medicine must be no more than 10 mg/kg or 10 mg/L or 0.001%. The concentration of Ethylene oxide in the medicine must be no more than 1 mg/kg or 1 mg/L or 0.0001%.
3764	PEG-40 STEARATE	E	Only for use in topical medicines for dermal application.
3765	PEG-45/DODECYL GLYCOL COPOLYMER	E	Only for use in topical medicines for dermal application.
3766	PEG-5 GLYCERYL STEARATE	E	Only for use in topical medicines for dermal application.
3767	PEG-50 STEARATE	E	Only for use in topical medicines for dermal application.
3768	PEG-55 PROPYLENE GLYCOL OLEATE	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 0.6%.
3769	PEG-6 LAURAMIDE	E	Only for use in topical medicines for dermal application.
3770	PEG-60 ALMOND GLYCERIDES	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 when used in medicines applied directly to the skin must be no more than 10%. The concentration when used in bath oil medicines must be no more than 30%.
3771	PEG-60 GLYCERYL ISOSTEARATE	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%.
3772	PEG-60 HYDROGENATED CASTOR OIL	E	Only for use in topical medicines for dermal application.
3773	PEG-7 COCAMIDE	E	Only for use in topical medicines for dermal application.
3774	PEG-7 GLYCERYL COCOATE	E	Only for use in topical medicines for dermal application.
3775	PEG-7 HYDROGENATED CASTOR OIL	E	Only for use in topical medicines for dermal application.
3776	PEG-75 LANOLIN	E	Only for use in topical medicines for dermal application.
3777	PEG-75 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 1.5%.
3778	PEG-8 CETYL DIMETHICONE	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%.
3779	PEG-8 DILAURATE	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%.
3780	PEG-8 DISTEARATE	E	Only for use in topical medicines for dermal application.
3781	PEG-8 LAURATE	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%. The levels of possible impurities such as ethylene oxide (and related material) must be kept below the level of detection.
3782	PEG-8 PROPYLENE GLYCOL COCOATE	E
3783	PEG-8 STEARATE	E	Only for use in topical medicines for dermal application.
3784	PEG-9 POLYDIMETHYLSILOXYETHYL DIMETICONE	E	Only for use in topical medicines for dermal application and not to be included in medicines for use in the eye or on damaged skin. The concentration in the medicine must be no more than 3.5%.
3785	PEG/PPG-14/7 DIMETHYL ETHER	E	Only for use in topical medicines for dermal application and not to be included in medicines for use in the eye or on damaged skin. The concentration in the medicine must be no more than 7%.
3786	PEG/PPG-18/18 DIMETHICONE	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%.
3787	PELARGONIUM GRAVEOLENS	A, E, H
3788	PELLITORINE	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%.
3789	PELTIGERA CANINA	A, H
3790	PENICILLIUM EXPANSUM	A, H
3791	PENNYROYAL OIL	E	D-Pulegone/Pulegone is a mandatory component of Pennyroyal Oil. The concentration of D Pulegone/ Pulegone in the medicine must be no more than 4%. 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 the medicine must be no more than 5%. If used in a fragrance the total fragrance concentration in the medicine must be no more than 1%. When the medicine is for a use other than topical, the maximum recommended daily dose must be no more than 50 mg of Pennyroyal Oil.
3792	PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE	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 0.018%
3793	PENTAERYTHRITYL 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 61%.
3794	PENTAERYTHRITYL TETRALAURATE	E	Only for use in topical medicines for dermal application. The concentration in the medicine must be no more than 80%.
3795	PENTAMETHYLHEPTENONE	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%.
3796	PENTANE	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%.
3797	PENTASODIUM ETHYLENEDIAMINE TETRAMETHYLENE PHOSPHONATE	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%.
3798	PENTYLENE 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 5%.
3799	PEPPER BLACK	E, H
3800	PEPPER OIL TERPENELESS	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%.
3801	PEPPER WHITE	E, H
3802	PEPPERMINT AMERICAN EXT.	E	Menthol is a mandatory component of peppermint american ext. When the medicine is for topical use for dermal application: a) the medicine must not be intended for use in the eye or on damaged skin; b) the medicine must not deliver more than 25% total menthol when administered according to the directions for use; c) the following warning statement is required on the medicine label: - (EYE) Avoid contact with eyes (or words to that effect). d) if the medicine delivers more than 1% total menthol when administered according to the directions for use, the following warning statements are required on the medicine label: - (SKTEST) If you have sensitive skin, test this product on a small area of skin before applying it to a large area; - (IRRIT) If irritation develops, discontinue use. e) if the medicine delivers more than 5% total menthol when administered according to the directions for use, the following warning statement is required on the medicine label: – (MENTH) Contains a high concentration of menthol, which can cause severe skin irritation. When the medicine is for internal use, the maximum recommended daily dose must not contain more than 1 gram of menthol.
3803	PEPPERMINT LEAF DRY	A, E, H	Menthol is a mandatory component of peppermint leaf dry. When the medicine is for topical use for dermal application: (i) the medicine must not be intended for use in the eye or on damaged skin; (ii) the medicine must not deliver more than 25% total menthol when administered according to the directions for use; (iii) the following warning statement is required on the medicine label: - (EYE) Avoid contact with eyes (or words to that effect). (iv) if the medicine delivers more than 1% total menthol when administered according to the directions for use, the following warning statements are required on the medicine label: - (SKTEST) If you have sensitive skin, test this product on a small area of skin before applying it to a large area; - (IRRIT) If irritation develops, discontinue use. (v) if the medicine delivers more than 5% total menthol when administered according to the directions for use, the following warning statement is required on the medicine label: – (MENTH) Contains a high concentration of menthol, which can cause severe skin irritation. When the medicine is for internal use, the maximum recommended daily dose must not contain more than 1 gram of menthol.
3804	PEPPERMINT LEAF POWDER	A, E, H	Menthol is a mandatory component of peppermint leaf powder. When the medicine is for topical use for dermal application: (i) the medicine must not be intended for use in the eye or on damaged skin; (ii) the medicine must not deliver more than 25% total menthol when administered according to the directions for use; (iii) the following warning statement is required on the medicine label: - (EYE) Avoid contact with eyes (or words to that effect). (iv) if the medicine delivers more than 1% total menthol when administered according to the directions for use, the following warning statements are required on the medicine label: - (SKTEST) If you have sensitive skin, test this product on a small area of skin before applying it to a large area; - (IRRIT) If irritation develops, discontinue use. (v) if the medicine delivers more than 5% total menthol when administered according to the directions for use, the following warning statement is required on the medicine label: – (MENTH) Contains a high concentration of menthol, which can cause severe skin irritation. When the medicine is for internal use, the maximum recommended daily dose must not contain more than 1 gram of menthol.
3805	PEPPERMINT OIL	A, E, H	Menthol is a mandatory component of peppermint oil. When the medicine is for topical use for dermal application: (i) the medicine must not be intended for use in the eye or on damaged skin; (ii) the medicine must not deliver more than 25% total menthol when administered according to the directions for use; (iii) the following warning statement is required on the medicine label: - (EYE) Avoid contact with eyes (or words to that effect). (iv) if the medicine delivers more than 1% total menthol when administered according to the directions for use, the following warning statements are required on the medicine label: - (SKTEST) If you have sensitive skin, test this product on a small area of skin before applying it to a large area; - (IRRIT) If irritation develops, discontinue use. (v) if the medicine delivers more than 5% total menthol when administered according to the directions for use, the following warning statement is required on the medicine label: – (MENTH) Contains a high concentration of menthol, which can cause severe skin irritation. When the medicine is for internal use, the maximum recommended daily dose must not contain more than 1 gram of menthol.
3806	PEPPERMINT OIL TERPENELESS	E	Permitted for use only in combination with other permitted ingredients as a flavour proprietary excipient formulation or fragrance proprietary excipient formulation. The total flavour proprietary excipient formulation in a medicine must be no more than 5%. The total fragrance proprietary excipient formulation in a medicine must be no more 1%. Menthol is a mandatory component of peppermint oil terpeneless. When the medicine is for topical use for dermal application: i) the medicine must not be intended for use in the eye or on damaged skin; ii) the medicine must not deliver more than 25% total menthol when administered according to the directions for use; iii) the following warning statement is required on the medicine label: - (EYE) Avoid contact with eyes (or words to that effect). iv) if the medicine delivers more than 1% total menthol when administered according to the directions for use, the following warning statements are required on the medicine label: - (SKTEST) If you have sensitive skin, test this product on a small area of skin before applying it to a large area; - (IRRIT) If irritation develops, discontinue use. v) if the medicine delivers more than 5% total menthol when administered according to the directions for use, the following warning statement is required on the medicine label: – (MENTH) Contains a high concentration of menthol, which can cause severe skin irritation. When the medicine is for internal use, the maximum recommended daily dose must not contain more than 1 gram of menthol.
3807	PEPPERMINT OIL TERPENES AND TERPENOIDS	E	Permitted for use only in combination with other permitted ingredients as a flavour proprietary excipient formulation. The total flavour proprietary excipient formulation in a medicine must be no more than 5%. Menthol is a mandatory component of peppermint oil terpenes and terpenoids. When the medicine is for topical use for dermal application: i) the medicine must not be intended for use in the eye or on damaged skin; ii) the medicine must not deliver more than 25% total menthol when administered according to the directions for use; iii) the following warning statement is required on the medicine label: - (EYE) Avoid contact with eyes (or words to that effect). iv) if the medicine delivers more than 1% total menthol when administered according to the directions for use, the following warning statements are required on the medicine label: - (SKTEST) If you have sensitive skin, test this product on a small area of skin before applying it to a large area; - (IRRIT) If irritation develops, discontinue use. v) if the medicine delivers more than 5% total menthol when administered according to the directions for use, the following warning statement is required on the medicine label: – (MENTH) Contains a high concentration of menthol, which can cause severe skin irritation. When the medicine is for internal use, the maximum recommended daily dose must not contain more than 1 gram of menthol.
3808	PERFLUOROPOLYMETHYLISOPROPYL ETHER	E	Only for use in topical medicines for dermal application.
3809	PERHYDRO-3,6-DIMETHYL-BENZO [B] FURAN-2-ONE	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%.
3810	PERILLA FRUTESCENS	A, E, H
3811	PERILLALDEHYDE	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%.
3812	PERLITE	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%.
3813	PERMETHRIN	E	The total concentration of permethrin in the medicine must not be more than 2%.
3814	PERSEA AMERICANA	A, E, H
3815	PERSIC OIL	A, E, H	Amygdalin and Hydrocyanic acid are mandatory components of Persic oil. The concentration of amygdalin in the medicine must be no more than 0%. The concentration of Hydrocyanic acid in the medicine must be no more than 1 microgram/kg or 1 microgram/L or 0.0000001%.
3816	PERSICARIA CHINENSIS	A, H
3817	PERSICARIA TINCTORIA	A, H
3818	PERSIMMON	E
3819	PERU BALSAM	A, E, H
3820	PERU BALSAM OIL	A, E, H
3821	PETITGRAIN MANDARIN OIL	E	Permitted for use only in combination with other permitted ingredients as a flavour The final concentration of the oil in the flavour does not exceed 30% If used in a flavour the total flavour concentration in a medicine must be no more than 5%
3822	PETITGRAIN 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%.
3823	PETITGRAIN OIL CITRONNIER	E	Permitted for use only in combination with other permitted ingredients as part of a fragrance proprietary excipient formulation. When included in a medicine for use on the lips the concentration of petitgrain oil citronnier must be no more than 0.1%. When included in dermal creams for infant use the concentration of petitgrain oil citronnier must be no more than 0.5% The total fragrance proprietary excipient formulation in a medicine must be no more than 1%.
3824	PETITGRAIN OIL PARAGUAY	A, E, H	When used internally, oxedrine is a mandatory component of petitgrain oil paraguay. The quantity of oxedrine in the maximum recommended daily dose must be no more than 30 milligrams.
3825	PETITGRAIN OIL TERPENELESS	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%.
3826	PETROSELINUM CRISPUM	A, E, H
3827	PEUCEDANUM PRAERUPTORUM	A, E, H
3828	PEUMUS BOLDUS	A, H	Volatile oil components (of Peumus boldus) is a mandatory component. The maximum recommended daily dose must be no more than 100 mg of volatile oil components (of Peumus boldus).
3829	PHALARIS ARUNDINACEA	A, H
3830	PHALARIS CANARIENSIS	A, H
3831	PHASEOLUS COCCINEUS	A, H
3832	PHASEOLUS VULGARIS	A, H
3833	PHELLINUS ROBINIAE	A, E, H
3834	PHELLODENDRON AMURENSE	A, E, H
3835	PHELLODENDRON CHINENSE	A, H
3836	PHENACETIN	E	Only for use in topical medicines for dermal application. The concentration in the medicine must be no more than 0.1%.
3837	PHENETHYL 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%.
3838	PHENETHYL 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%.
3839	PHENETHYL ALCOHOL	E	Permitted for use only: a) in topical medicines for dermal application; and b) for internal use in combination with other permitted ingredients as part of a flavour proprietary excipient formulation. The total flavour proprietary excipient formulation concentration in a medicine must be no more than 5%.
3840	PHENETHYL BENZOATE	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 6%.
3841	PHENETHYL DIMETHICONE	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%
3842	PHENETHYL ISOAMYL ETHER	E	Permitted for use only in combination with other permitted ingredients as a fragrance. If used as in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
3843	PHENETHYL 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%.
3844	PHENETHYL 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%.
3845	PHENETHYL 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%.
3846	PHENETHYL 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%.
3847	PHENOL	E	Only for use in topical medicines for dermal application. The concentration of phenol in the medicine must be no more than 1%.
3848	PHENOXYACETALDEHYDE	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%.
3849	PHENOXYETHANOL	E	Only for use in topical medicines for dermal application. The concentration of phenoxyethanol in the preparation must not exceed 15%.
3850	PHENOXYETHYL 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%.
3851	PHENOXYETHYLPARABEN	E	Only for use in topical medicines for dermal application.
3852	PHENYL DIMETHICONE	E	Only for use in topical medicines for dermal application.
3853	PHENYL TRIMETHICONE	E	Only for use in topical medicines for dermal application.
3854	PHENYLACETALDEHYDE	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%.
3855	PHENYLACETALDEHYDE DIMETHYL ACETAL	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%.
3856	PHENYLACETALDEHYDE GLYCERYLACETAL	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%.
3857	PHENYLACETIC 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%.
3858	PHENYLALANINE	A, E	When the maximum recommended daily dose of the medicine provides more than 500 mg phenylalanine, the following warning statement is required on the medicine label: - (PREGNT2) 'Do not use if pregnant or likely to become pregnant'.
3859	PHENYLBENZIMIDAZOLE SULFONIC ACID	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 not be more than 4%. When used in primary sunscreen products, the following warning statements are required 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).
3860	PHENYLETHYL 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%.
3861	PHENYLETHYL CAPROATE	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%.
3862	PHENYLETHYL CAPRYLATE	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%.
3863	PHENYLETHYL CINNAMATE	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%.
3864	PHENYLETHYL 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%.
3865	PHENYLETHYL METHYLETHYL CARBINOL	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%.
3866	PHENYLETHYL 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 than 1%.
3867	PHENYLETHYL 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%.
3868	PHENYLISOPROPYL DIMETICONE	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%.
3869	PHENYLPROPANOL	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 0.16%.
3870	PHLEUM PRATENSE	A, H
3871	PHLOXINE B	E	Permitted for use only as a colour in medicines limited to topical and oral routes of administration.
3872	PHLOXINE B ALUMINIUM LAKE	E	Permitted for use only as a colour in medicines limited to topical and oral routes of administration.
3873	PHOENIX DACTYLIFERA	A, E, H
3874	PHOSPHATIDYL CHOLINE	E
3875	PHOSPHOLIPIDS	E	Only for use in topical medicines for dermal application and not intended for use in the eye. The concentration in the medicine must be no more than 20%.
3876	PHOSPHORIC ACID	E, H	The concentration in liquid medicines must be no more than 15%.
3877	PHOSPHORUS	H	Only for use as an active homoeopathic ingredient.
3878	PHOTINIA SERRULATA	A, H
3879	PHRAGMITES AUSTRALIS	A, H
3880	PHYLLANTHUS AMARUS	A, H
3881	PHYLLANTHUS EMBLICA	A, E, H	When used as an excipient, only for use in topical medicines for dermal application.
3882	PHYLLOSTACHYS NIGRA	A, E, H
3883	PHYSALIS ALKEKENGI	A, H
3884	PHYSALIS PUBESCENS	A, H
3885	PHYTANTRIOL	E	Only for use in topical medicines for dermal application. The concentration in the medicine must be no more than 0.5%.
3886	PHYTOL	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%.
3887	PHYTOLACCA AMERICANA	A, H	The maximum recommended daily dose of the medicine must contain no more than 1mg of the equivalent dry herb.
3888	PHYTOMENADIONE	A, E
3889	PHYTOSPHINGOSINE	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%.
3890	PHYTOSTERYL/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 0.1%.
3891	PICEA ABIES	A, H
3892	PICEA MARIANA	A, H
3893	PICRASMA EXCELSA	A, E, H
3894	PICRORRHIZA KURROA	A, E, H
3895	PIGMENT BLUE 15	E	Permitted for use only as a colour for topical and dental use. The concentration in medicine must be no more than 0.003%.
3896	PIGMENT BLUE 15:1	E	Permitted for use only as a colour for topical use. 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 0.21%.
3897	PIGMENT GREEN 7	E	Permitted for use only as a colour for topical and dental use. When for dental use, the concentration in the medicine must be no more than 0.003%. When for topical use, the concentration in the medicine must be no more than 0.17%.
3898	PIGMENT RED 4	E	Permitted for use only as a colour for topical use.
3899	PIGMENT RED 53	E	Permitted for use only as a colour for topical use.
3900	PIGMENT RED 57	E	Permitted for use only as a colour for topical use.
3901	PIGMENT RED 57 ALUMINIUM LAKE	E	Permitted for use only as a colour for topical use.
3902	PIGMENT RED 57 BARIUM LAKE	E	Permitted for excipient use as a colour in topical medicines for dermal application. Not to be included in medicines intended for use in the eye.
3903	PIGMENT RED 63	E	Permitted for use only as a colour for topical use.
3904	PIGMENT WHITE 26	E	Permitted for use only as a colour for topical use.
3905	PIGMENT YELLOW 12	E	Permitted for use only as a colour for topical use.
3906	PILOCARPUS JABORANDI	A, H	Pilocarpine is a mandatory component of Pilocarpus jaborandi. The concentration of pilocarpine in the medicine must be no more than 0.025%.
3907	PILOCARPUS MICROPHYLLUS	A, H	Pilocarpine is a mandatory component of Pilocarpus microphyllus. The concentration of pilocarpine in the medicine must be no more than 0.025%.
3908	PILOCARPUS PINNATIFOLIUS	A, H	Pilocarpine is a mandatory component of Pilocarpus pinnatifolius. The concentration of pilocarpine in the medicine must be no more than 0.025%.
3909	PIMENTA FRUIT OIL	A, E, H
3910	PIMENTA LEAF OIL	A, E, H
3911	PIMENTA OFFICINALIS	A, E, H
3912	PIMENTA RACEMOSA	A, E, H	When the plant preparation for Pimenta racemosa is an oil and the concentration of this oil in the medicine is more than 25%, the nominal capacity of the container must be no more than 25 mL. When the plant preparation for Pimenta racemosa is an oil, the concentration of this oil in the medicine 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. When the plant preparation for Pimenta racemosa is an oil, the concentration of this oil in the medicine is more than 25%, and the nominal capacity of the container is more than 15 mL but no more than 25 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'.
3913	PIMPINELLA ANISUM	A, E, H	When the plant preparation for Pimpinella anisum is an oil or distillate and the concentration of this oil or distillate in the medicine is more than 50%: a) the nominal capacity of the container must be no more than 50 millilitres; and b) a restricted flow insert is must be fitted on the container; and c) the medicine requires the following warning statement on the medicine label: - (CHILD) ‘Keep out of reach of children’ (or words to that effect).
3914	PIMPINELLA SAXIFRAGA	A, E, H
3915	PINE NEEDLE OIL SCOTCH	A, E, H
3916	PINE NEEDLE OIL TERPENELESS	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%.
3917	PINE OIL AROMATIC	A, E, H
3918	PINE OIL PUMILIO	A, E, H
3919	PINEAPPLE	E
3920	PINEAPPLE OILS	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%.
3921	PINELLIA TERNATA	A, H
3922	PINUS CONTORTA	A, E, H
3923	PINUS ELLIOTTII	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%.
3924	PINUS MASSONIANA	A, E, H	When the plant preparation is oil or distillate the total concentration of Pinus massoniana oil or distillate in the preparation must be no more than 25%.
3925	PINUS MONTICOLA	A, E, H
3926	PINUS MUGO	A, E, H
3927	PINUS PALUSTRIS	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%.
3928	PINUS PINASTER	A, E, H	When the plant preparation is oil or distillate the total concentration of Pinus pinaster oil or distillate in the preparation must be no more than 25%.
3929	PINUS PONDEROSA	A, E, H
3930	PINUS RADIATA	A, E, H
3931	PINUS STROBUS	A, E, H
3932	PINUS SYLVESTRIS	A, E, H
3933	PINUS TABULIFORMIS	A, E, H
3934	PINUS YUNNANENSIS	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%.
3935	PIPENZOLATE BROMIDE	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%.
3936	PIPER CHABA	A, E, H
3937	PIPER CUBEBA	A, E, H
3938	PIPER KADSURA	A, E, H
3939	PIPER LONGUM	A, E, H
3940	PIPER METHYSTICUM	A, H	Kavalactones (of Piper methysticum) is a mandatory component of Piper methysticum. Only for oral use when the dosage form is 'tablet' or 'capsule'; or when the container type is 'tea bag'. When used in oral medicines, the maximum daily dose of kavalactones (of Piper methysticum) must be no more than 250 mg. If the dosage form is tablet or capsule then the quantity of kavalactones (of Piper methysticum) must be no more than 125 mg per tablet or capsule. Oral medicines containing more than 25 mg of kavalactones (of Piper methysticum) per dose require the following warning statement on the medicine label: - (PIPER) 'Not for prolonged use. If symptoms persist - seek advice from a healthcare practitioner. Not recommended for pregnant or lactating women (or words to that effect). May harm the liver'. The plant part must be root or rhizome. When for oral use, the medicine may only contain dried whole or peeled root or rhizome or aqueous dispersions or aqueous extracts of whole or peeled root or rhizome. When for topical use on the rectum, vagina or throat, the medicine may only contain dried whole or peeled root or rhizome or aqueous dispersions or aqueous extracts of whole or peeled root or rhizome. When the container type is tea bag the maximum quantity per tea bag must be no more than 3 grams of dried whole or peeled root or rhizomes.
3941	PIPER NIGRUM	A, E, H
3942	PIPER SARMENTOSUM	A, E, H
3943	PIPERIDINE	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%.
3944	PIPERINE	E	Permitted for use only in combination with other permitted ingredients as a flavour proprietary formulation. The total flavour proprietary formulation in a medicine must not be more than 5% and the concentration of piperine in the medicine must not be more than 0.15%.
3945	PIPERITONE	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%.
3946	PIPERONAL	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%.
3947	PIPERONYL ACETONE	E	Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance. If used as a flavour the total flavour concentration in a medicine must be no more than 5%. If used as in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
3948	PIPERONYL BUTOXIDE	E	Only for use in topical medicines for dermal application. The medicine requires the following warning statement on the medicine label: - (PIPBUT) 'Contains piperonyl butoxide' (or words to that effect).
3949	PIROCTONE OLAMINE	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% in wash-on/wash-off medicines and 0.5% in leave-on medicines.
3950	PISCIDIA PISCIPULA	A, E, H
3951	PISTACIA LENTISCUS	A, E, H
3952	PISUM SATIVUM	A, E, H
3953	PLACENTA	H	Only for use as an active homoeopathic ingredient.
3954	PLANTAGO AFRA	A, E, H	When a dose for children is stated and the plant part is flower, seed or pollen, the following warning statement is required on the label: - (PSYLL1) 'Should only be used for children on medical advice' (or words to that effect).
3955	PLANTAGO ARENARIA	A, H	When a dose for children is stated and the plant part is flower, seed or pollen, the following warning statement is required on the label: - (PSYLL1) 'Should only be used for children on medical advice' (or words to that effect).
3956	PLANTAGO ASIATICA	A, H	When a dose for children is stated and the plant part is flower, seed or pollen, the following warning statement is required on the label: - (PSYLL1) 'Should only be used for children on medical advice' (or words to that effect).
3957	PLANTAGO LANCEOLATA	A, E, H	The medicine requires the following warning statement on the medicine label: - (CHILD5) 'Use in children under 3 years is not recommended’ When a dose for children is stated and the plant part is flower, seed or pollen, the following warning statement is required on the label: - (PSYLL1) 'Should only be used for children on medical advice' (or words to that effect).
3958	PLANTAGO MAJOR	A, E, H	When a dose for children is stated and the plant part is flower, seed or pollen, the following warning statement is required on the label: - (PSYLL1) 'Should only be used for children on medical advice' (or words to that effect).
3959	PLANTAGO OVATA	A, H	When a dose for children is stated and the plant part is flower, seed or pollen, the following warning statement is required on the label: - (PSYLL1) 'Should only be used for children on medical advice' (or words to that effect).
3960	PLANTAGO SEED DRY	A, H	When a dose for children is stated and the plant part is flower, seed or pollen, the following warning statement is required on the label: - (PSYLL1) 'Should only be used for children on medical advice' (or words to that effect).
3961	PLATANUS OCCIDENTALIS	A, E, H
3962	PLATANUS RACEMOSA	A, H
3963	PLATANUS × HISPANICA	A, H
3964	PLATYCODON GRANDIFLORUS	A, E, H
3965	PLECTRANTHUS BARBATUS	A, E, H
3966	PLICATONE	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%.
3967	PLUM	E
3968	PLUMBAGO EUROPAEA	A, H
3969	PLUMERIA ALBA	A, E, H
3970	PLUMERIA RUBRA	A, E, H
3971	POA NEMORALIS	A, H
3972	POA PRATENSIS	A, H
3973	PODOPHYLLUM PELTATUM	A, H	Podophyllin and podophyllotoxin are mandatory components of Podophyllum peltatum. The concentration of podophyllin in the medicine must be no more than 1 mg/kg or 1 mg/L or 0.0001%. The concentration of podophyllotoxin in the medicine must be no more than 10 mg/kg or 10 mg/L or 0.001%.
3974	POGOSTEMON CABLIN	A, E, H
3975	POLACRILIN	E
3976	POLACRILIN POTASSIUM	E
3977	POLAPREZINC	A	Only for use in oral medicines. Zinc is a mandatory component of Polaprezinc. The maximum recommended daily dose must be no more than 34 milligrams of zinc sourced from polaprezinc. When for internal use, the maximum recommended daily dose must be no more than 50mg of zinc. When for internal use and the maximum recommended daily dose is more than 25mg but no more than 50mg of zinc, the medicine requires the following warning statement on the medicine label: - (ZINC) 'WARNING: May be dangerous if taken in large amounts or for a long period.' OR 'WARNING: Contains zinc which may be dangerous if taken in large amounts or for a long period' (or words to that effect).
3978	POLIGLUSAM	A, E	The average molecular mass of poliglusam must be greater than 2 kilodaltons. When for internal use: (a) the maximum recommended daily dose of the medicine must not provide more than 1750 milligrams poliglusam; and (b) the following warning statement is required on the medicine label: - (CHITO) 'Poliglusam should be taken at least one hour after any other medication as it may reduce the effect of other medication' (or words to that effect). When for internal use and the dosage form is a powdered preparation, the following warning statement is required on the medicine label: - (DNTPOW) 'Do not take powder alone. Mix with food or fluid'. When used as an excipient, only for use in topical medicines for dermal application.
3979	POLIGLUSAM DERIVED FROM ASPERGILLUS NIGER	A, E	When for oral use: (a) the maximum recommended daily dose of the medicine must not provide more than 2000 mg of Poliglusam derived from Aspergillus niger; (b) the following warning statement (or words to the same effect) is required on the medicine label: - (CHITO) 'Poliglusam should be taken at least one hour after any other medication as it may reduce the effect of other medication.'; and (c) if the medicine is a powdered dosage form, the following warning statement is also required on the medicine label: - (DNTPOW) 'Do not take powder alone. Mix with food or fluid.' When used as an excipient, Poliglusam derived from Aspergillus niger is only permitted for use in topical medicines for dermal application.
3980	POLLACK-LIVER OIL	A, E	Colecalciferol and Vitamin A are mandatory components of Pollack-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. When preparations for internal use in adults contain more than 33 micrograms of retinol equivalents per dosage unit in divided preparations or per gram of an undivided preparation, 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 Vitamin D.
3981	POLLEN	E	The medicine requires the following warning statement on the medicine label: - (POLLEN) 'This medicine can cause severe allergic reactions' (or words to that effect).
3982	POLOXAMER	E	Only for use in topical medicines for dermal application.
3983	POLOXAMINE	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%.
3984	POLOXAMINE 1301	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%.
3985	POLY C10-30 ALKYL ACRYLATE	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%.
3986	POLYACRYLAMIDE	E	Only for use in topical medicines for dermal application. Acrylamide is a mandatory component of Polyacrylamide. The concentration of Acrylamide in the medicine must be no more than 0.01%.
3987	POLYACRYLATE CROSSPOLYMER-6	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%.
3988	POLYACRYLATE-1 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 0.4%.
3989	POLYACRYLIC ACID	E
3990	POLYAMINO SUGAR CONDENSATE	E	Only for use in topical medicines for dermal application.
3991	POLYAMINOPROPYL BIGUANIDE	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 0.3%.
3992	POLYBUTADIENE	E	Only for use as part of an adhesive in topical medicines for dermal application.
3993	POLYBUTENE	E	Only for use in topical medicines for dermal application.
3994	POLYBUTYLENE GLYCOL/PPG-9/1 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 2%.
3995	POLYCAPROLACTONE	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%.
3996	POLYDECENE	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 6%.
3997	POLYDEXTROSE	E
3998	POLYDIETHYLSILOXANE	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%.
3999	POLYDIMETHYL SILOXANE	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%
4000	POLYESTER-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 1.5%.
4001	POLYESTER-25	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 10%.
4002	POLYESTER-7	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%.
4003	POLYESTER-8	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 of Polyester-8 must be no more than 5%.
4004	POLYETHYLENE	E
4005	POLYGALA CHINENSIS	A, H
4006	POLYGALA SENEGA	A, E, H	Except when used in a medicine containing only homoeopathic preparations, a child resistant closure and restricted flow insert must be fitted onto the container.
4007	POLYGALA SIBIRICA	A, E, H	Only for use when the plant part is root or root bark.
4008	POLYGALA TENUIFOLIA	A	Only for use when the plant part is root or root bark.
4009	POLYGLYCERYL-10 PENTASTEARATE	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%.
4010	POLYGLYCERYL-2 CAPRATE	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use on damaged skin or in the eye. The concentration in the medicine must not be more than 0.5%.
4011	POLYGLYCERYL-2 DIISOSTEARATE	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 3.0%.
4012	POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE	E	Only for use in topical medicines for dermal application. The concentration in the medicine must be no more than 5%.
4013	POLYGLYCERYL-2 DISTEARATE	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 3%.
4014	POLYGLYCERYL-2 TRIISOSTEARATE	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. When the concentration of polyglyceryl-2 triisostearate is greater than 3%, the medicine must not be intended for use on damaged skin. The concentration in the medicine must not be more than 5%.
4015	POLYGLYCERYL-2-PEG-4 STEARATE	E	Only for use in topical medicines for dermal application.
4016	POLYGLYCERYL-3 BEESWAX	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%.
4017	POLYGLYCERYL-3 DIISOSTEARATE	E	Only for use in topical medicines for dermal application.
4018	POLYGLYCERYL-3 DISTEARATE	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%.
4019	POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE	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 6%.
4020	POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE	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 5.5%.
4021	POLYGLYCERYL-3 POLYRICINOLEATE	E
4022	POLYGLYCERYL-3 STEARATE/ISOSTEARATE/DIMER DILINOLEATE 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 5%.
4023	POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE	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%.
4024	POLYGLYCERYL-4 ISOSTEARATE	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%.
4025	POLYGLYCERYL-4 OLEATE	E	Only for use in topical medicines for dermal application.
4026	POLYGLYCERYL-6 POLYRICINOLEATE	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%.
4027	POLYGLYCERYL-6 RICINOLEATE	E	Only for use in topical medicines for dermal application.
4028	POLYGONATUM MULTIFLORUM	A, H
4029	POLYGONATUM OFFICINALE	A, H
4030	POLYGONATUM SIBIRICUM	A, E, H
4031	POLYGONUM AVICULARE	A, E, H	When used as an excipient, the medicine is only for use in topical medicines for dermal application and not to be included in medicines intended for use on damaged skin or in the eye. When used as an excipient, the concentration in the medicine must be no more than 0.16%.
4032	POLYGONUM BISTORTA	A, H
4033	POLYGONUM ODORATUM	A, H
4034	POLYHYDROXYSTEARIC ACID	E	Only for use in topical medicines for dermal application.
4035	POLYISOBUTYLENE	E	Only for use when the dosage form is 'chewing gum'. Must comply with: a) the Polyisobutylene monograph in the Food Chemicals Codex published by the United States Pharmacopeial Convention, as in force or existing from time to time; and b) the requirements for residual solvents and catalysts in the British Pharmacopoeia or the United States Pharmacopeia National Formulary, as in force or existing from time to time.
4036	POLYISOPRENE	E	Only for use in topical medicines for dermal application.
4037	POLYLIMONENE	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%.
4038	POLYMETHACRYLIC ACID	E
4039	POLYMETHYL METHACRYLATE	E	Only for use in topical medicines for dermal application.
4040	POLYMETHYLSILSESQUIOXANE	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%.
4041	POLYPORUS UMBELLATUS	A, H
4042	POLYPROPYLENE	E	Only for use in topical medicines for dermal application.
4043	POLYPROPYLENE GLYCOL	E	Permitted for use only in combination with other permitted ingredients as part of a flavour or fragrance proprietary excipient formulation. When used in a flavour, the total flavour proprietary excipient formulation in a medicine must be no more than 5%. When used in a fragrance, the total fragrance proprietary excipient formulation in a medicine must be no more than 1%.
4044	POLYQUATERNIUM-10	E	Only for use in topical medicines for dermal application.
4045	POLYQUATERNIUM-11	E	Only for use in topical medicines for dermal application.
4046	POLYQUATERNIUM-22	E	Only for use in wash-off 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%.
4047	POLYQUATERNIUM-24	E	Only for use in topical medicines for dermal application.
4048	POLYQUATERNIUM-28	E	Only for use in topical medicines for dermal application.
4049	POLYQUATERNIUM-37	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 2.5%.
4050	POLYQUATERNIUM-4	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 0.4%.
4051	POLYQUATERNIUM-44	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 0.3%.
4052	POLYQUATERNIUM-51	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%.
4053	POLYQUATERNIUM-7	E	Only for use in topical medicines for dermal application.
4054	POLYSILICONE-11	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 2.1%
4055	POLYSILICONE-14	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 of Polysilicone-14 must be no more than 1%.
4056	POLYSILICONE-15	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 not be more than 10%. When used in primary sunscreen products, the following warning statements are required 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).
4057	POLYSILICONE-2	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 0.13%.
4058	POLYSORBATE 20	E
4059	POLYSORBATE 40	E
4060	POLYSORBATE 60	E
4061	POLYSORBATE 65	E
4062	POLYSORBATE 80	E
4063	POLYSORBATE 85	E	Only for use in topical medicines for dermal application.
4064	POLYSTYRENE	E	Only for use as part of an adhesive in topical medicines for dermal application.
4065	POLYTEF	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%.
4066	POLYURETHANE-34	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% in spray applications and 6% in non-spray applications.
4067	POLYURETHANE-62	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%.
4068	POLYVINYL ACETATE	E	Only permitted for use in medicines that are for oral routes of administration.
4069	POLYVINYL ACETATE PHTHALATE	E
4070	POLYVINYL ALCOHOL	E
4071	POLYVINYL CHLORIDE	E	Only for use in topical medicines for dermal application.
4072	POMEGRANATE	E
4073	PONCEAU SX	E	Permitted for use only as a colour for topical use.
4074	PONCIRUS TRIFOLIATA	A, H	When used internally, oxedrine is a mandatory component of Poncirus trifoliata. The quantity of Oxedrine in the maximum recommended daily dose must be no more than 30 mg.
4075	PONGAMOL	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%.
4076	PONTEDERIA CRASSIPES	A, H
4077	POPPY SEED	E, H
4078	POPPY SEED OIL	E, H
4079	POPULUS ALBA	A, H
4080	POPULUS BALSAMIIFERA	A, E, H
4081	POPULUS CANDICANS	A, H
4082	POPULUS DELTOIDES	A, H
4083	POPULUS NIGRA	A, H
4084	POPULUS TREMULA	A, H
4085	POPULUS TREMULOIDES	A, H
4086	PORCINE	H	Only for use as an active homoeopathic ingredient.
4087	PORPHYRIDIUM PURPUREUM 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 0.5%.
4088	PORTULACA OLERACEA	A, E, H
4089	POTABLE WATER	E
4090	POTASSIUM ACETATE	E
4091	POTASSIUM ARSENITE	H	Only for use as an active homoeopathic ingredient.
4092	POTASSIUM ASCORBATE	A, E, H	When for oral or sublingual use, potassium is a mandatory component of potassium ascorbate.
4093	POTASSIUM ASCORBATE DIHYDRATE	A, E, H	When for oral or sublingual use, potassium is a mandatory component of potassium ascorbate dihydrate.
4094	POTASSIUM ASCORBYL TOCOPHERYL PHOSPHATE	E	Only for use in topical medicines for dermal application.
4095	POTASSIUM ASPARTATE	A, E, H	When used as an active ingredient and the medicine is intended as a mineral supplementation, potassium is a mandatory component of potassium aspartate.
4096	POTASSIUM ASPARTATE DIHYDRATE	A, E, H	If used as an active ingredient and the preparation is intended as a mineral supplementation, potassium is a mandatory component of Potassium aspartate dihydrate. The percentage of potassium from potassium aspartate dihydrate should be calculated based on the molecular weight of potassium aspartate dihydrate.
4097	POTASSIUM ASPARTATE MONOHYDRATE	A, E	If used as an active ingredient and the preparation is intended as a mineral supplementation, potassium is a mandatory component of Potassium aspartate monohydrate. The percentage of potassium from potassium aspartate monohydrate should be calculated based on the molecular weight of potassium aspartate monohydrate.
4098	POTASSIUM BICARBONATE	E
4099	POTASSIUM BROMIDE	H	Only for use as an active homoeopathic ingredient.
4100	POTASSIUM CARBONATE	E, H	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.
4101	POTASSIUM CETYL PHOSPHATE	E	Only for use in topical medicines for dermal application.
4102	POTASSIUM CHLORIDE	A, E, H	When for oral use: (a) potassium is a mandatory component of potassium chloride; (b) the medicine requires the following warning statement on the medicine label: - (POTAS1) 'If you have kidney disease or are taking heart or blood pressure medicines - consult your doctor or pharmacist before use. Keep out of reach of children.'; and (c) except when the medicine is for use as oral rehydration therapy, the amount of potassium chloride per dosage unit must not be more than 550 mg. Medicines containing potassium chloride for use as oral rehydration therapy, are subject to the following conditions: (a) the medicine complies with the requirements specified in the British Pharmacopoeia, as in force or existing from time to time, for Oral Rehydration Salts; (b) the sodium, potassium and glucose content, and total osmolarity of the solution after it has been prepared according to the instructions on the packet are consistent with the criteria specified by the World Health Organisation (WHO) and the United Nations Children's Fund (UNICEF) in the document 'Expert consultation on oral rehydration salts formulation' 18 July 2001; and (c) the following warning statements are required on the medicine label: - (UOAD) 'Use only as directed' - (DIAR3) 'If diarrhoea persists, seek medical advice.' When for dental use, the concentration of potassium chloride in the medicine must not be more than 3.75%.
4103	POTASSIUM CITRATE	A, E, H	When used as an active ingredient and the medicine is intended as a mineral supplementation, potassium is a mandatory component of potassium citrate.
4104	POTASSIUM COCOYL HYDROLYSED COLLAGEN	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%.
4105	POTASSIUM COCOYL HYDROLYSED SOY PROTEIN	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%.
4106	POTASSIUM DICHROMATE	H	Only for use as an active homoeopathic ingredient.
4107	POTASSIUM GLUCONATE	A, E, H	When used as an active ingredient and the medicine is intended as a mineral supplementation, potassium is a mandatory component of potassium gluconate.
4108	POTASSIUM GLYCEROPHOSPHATE	A, E, H	When used as an active ingredient and the medicine is intended as a mineral supplementation, potassium is a mandatory component of potassium glycerophosphate.
4109	POTASSIUM HYDROXIDE	E	The concentration in the medicine must be no more than 5%. 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.
4110	POTASSIUM HYDROXYCITRATE	A, H
4111	POTASSIUM IODATE	A, H	Iodine is a mandatory component of potassium iodate. The percentage of iodine from potassium iodate should be calculated based on the molecular weight of potassium iodate. When for use in adults, the medicine must contain a daily dose of no more than 505 micrograms of potassium iodate. When for use in children aged 1-3 years, the medicine must contain a daily dose of no more than 337 micrograms of potassium iodate.
4112	POTASSIUM IODIDE	A, E, H	Iodine is a mandatory component of potassium iodide. The percentage of iodine from potassium iodide should be calculated based on the molecular weight of potassium iodide. When for internal use, the maximum recommended daily dose of the medicine must contains less than 300 micrograms of iodine. When for external use, the concentration of iodine in the medicine (excluding salts derivatives or iodophors) must not exceed 2.5%.
4113	POTASSIUM METABISULFITE	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%.
4114	POTASSIUM METAPHOSPHATE	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%.
4115	POTASSIUM NITRATE	A, H	Only for dental use. The concentration in the medicine must be no more than 5%.
4116	POTASSIUM OROTATE	A, E, H	When used as an active ingredient and the medicine is intended as a mineral supplementation, potassium is a mandatory component of potassium orotate. 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.
4117	POTASSIUM PYROPHOSPHATE	E	Only for oral application, dental or topical use. Not to be included in topical medicines intended for use in the eye. The concentration in the medicine must be no more than 3%.
4118	POTASSIUM SORBATE	E
4119	POTASSIUM STANNATE	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%.
4120	POTASSIUM STEARATE	E	Only for use in topical medicines for dermal application.
4121	POTASSIUM SULFATE	A, E, H	When used as an active ingredient and the medicine is intended as a mineral supplementation, potassium is a mandatory component of potassium sulfate. 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.
4122	POTATO STARCH	E
4123	POTENTILLA ANSERINA	A, H
4124	POTENTILLA CHINENSIS	A, H
4125	POTENTILLA DISCOLOR	A, H
4126	POTENTILLA ERECTA	A, E, H
4127	POTENTILLA REPTANS	A, H
4128	POTERIUM OFFICINALE	A, E, H
4129	POTERIUM SANGUISORBA	A, H
4130	POVIDONE	E
4131	POWDERED CELLULOSE	E
4132	PPG-1-PEG-9 LAURYL GLYCOL ETHER	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%.
4133	PPG-12/SMDI 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 2%.
4134	PPG-15 STEARYL ETHER	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%.
4135	PPG-15 STEARYL ETHER BENZOATE	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 1.4%.
4136	PPG-17/IPDI/DMPA COPOLYMER	E	Only for use in topical medicines for dermal application and not to be included in topical medicines intended for use in the eye or on damaged skin. The concentration of PPG-17/IPDI/DMPA Copolymer in the medicine must be no more than 10%.
4137	PPG-2 LANOLIN ALCOHOL ETHER	E	Only for use in topical medicines for dermal application.
4138	PPG-2 MYRISTYL ETHER PROPIONATE	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%.
4139	PPG-20 LANOLIN ALCOHOL ETHER	E	Only for use in topical medicines for dermal application.
4140	PPG-20 METHYL GLUCOSE ETHER	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%.
4141	PPG-20 METHYL GLUCOSE ETHER DISTEARATE	E	Only for use in topical medicines for dermal application.
4142	PPG-3 HYDROGENATED CASTOR OIL	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 6%.
4143	PPG-3 MYRISTYL ETHER	E	Only for use in topical medicines for dermal application.
4144	PPG-5-CETETH-20	E	Only for use in topical medicines for dermal application.
4145	PPG-5-LAUROMACROGOL 250	E	Only for use in topical medicines for dermal application.
4146	PRALINE	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%.
4147	PREGELATINISED MAIZE STARCH	E
4148	PREGELATINISED POTATO STARCH	E
4149	PREGELATINISED RICE STARCH	E
4150	PREGELATINISED STARCH	E
4151	PREGELATINISED WHEAT STARCH	E	When the route of administration is other than topical or mucosal, gluten is a mandatory component of pregelatinised wheat starch.
4152	PRENYL 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%.
4153	PRICKLY ASH BARK DRY	A, H
4154	PRICKLY ASH BARK POWDER	A, H
4155	PRIMULA VERIS	A, E, H
4156	PRIMULA VULGARIS	A, E, H
4157	PRINSEPIA UNIFLORA	A, H
4158	PROBOSCIDEA PARVIFLORA	A, H
4159	PROGESTERONE	H	Only for use as an active homoeopathic ingredient.
4160	PROLINE	A, E
4161	PROPAN-1-OL	E	Only for use in: - topical medicines for dermal application; or - in combination with other permitted ingredients as a flavour proprietary excipient formulation. The concentration of propan-1-ol in the medicine must not be more than 18%. When used in medicines in combination with other permitted ingredients as a flavour proprietary excipient formulation, the total flavour proprietary excipient formulation in a medicine must not be more than 5%.
4162	PROPANE	E	Only for use as an excipient propellant ingredient.
4163	PROPANEDIOL	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 10%.
4164	PROPENYL GUAETHOL	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%.
4165	PROPIONALDEHYDE	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%.
4166	PROPIONIC 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%.
4167	PROPIONYLLEVOCARNITINE HYDROCHLORIDE	A, H
4168	PROPOLIS	A, E	Lead is a mandatory component of Propolis. The concentration of lead in the medicine must be no more than 0.001%. When used topically, the medicine requires the following warning statement on the medicine label: -(PROP1) 'WARNING: Propolis may cause skin irritation. Test before use' When used for other than for topical, the medicine requires the following warning statement on the medicine label: - (PROP2) 'Warning: Propolis may cause allergic reactions. If irritation or swelling of the mouth or throat occurs, discontinue use.'
4169	PROPOLIS BALSAM	A, E	Lead is a mandatory component of Propolis balsam. The concentration of lead in the medicine must be no more than 0.001%. When used topically, the medicine requires the following warning statement on the medicine label: -(PROP1) 'WARNING: Propolis may cause skin irritation. Test before use' When used for other than for topical, the medicine requires the following warning statement on the medicine label: - (PROP2) 'Warning: Propolis may cause allergic reactions. If irritation or swelling of the mouth or throat occurs, discontinue use.'
4170	PROPOLIS DRY EXTRACT	A, E	Lead is a mandatory component of Propolis dry extract. The concentration of lead in the medicine must be no more than 0.001%. When used topically, the medicine requires the following warning statement on the medicine label: -(PROP1) 'WARNING: Propolis may cause skin irritation. Test before use' When used for other than for topical, the medicine requires the following warning statement on the medicine label: - (PROP2) 'Warning: Propolis may cause allergic reactions. If irritation or swelling of the mouth or throat occurs, discontinue use.'
4171	PROPOLIS LIQUID EXTRACT	A, E	Lead is a mandatory component of Propolis liquid extract. The concentration of lead in the medicine must be no more than 0.001%. When used topically, the medicine requires the following warning statement on the medicine label: -(PROP1) 'WARNING: Propolis may cause skin irritation. Test before use' When used for other than for topical, the medicine requires the following warning statement on the medicine label: - (PROP2) 'Warning: Propolis may cause allergic reactions. If irritation or swelling of the mouth or throat occurs, discontinue use.'
4172	PROPOLIS RESIN	A, E	Lead is a mandatory component of propolis resin. The concentration of lead in the medicine must be no more than 0.001%. When used topically, the medicine requires the following warning statement on the medicine label: -(PROP1) 'WARNING: Propolis may cause skin irritation. Test before use' When used for other than for topical, the medicine requires the following warning statement on the medicine label: - (PROP2) 'Warning: Propolis may cause allergic reactions. If irritation or swelling of the mouth or throat occurs, discontinue use.'
4173	PROPOLIS TINCTURE	A, E	Lead is a mandatory component of Propolis tincture. The concentration of lead in the medicine must be no more than 0.001%. When used topically, the medicine requires the following warning statement on the medicine label: -(PROP1) 'WARNING: Propolis may cause skin irritation. Test before use' When used for other than for topical, the medicine requires the following warning statement on the medicine label: - (PROP2) 'Warning: Propolis may cause allergic reactions. If irritation or swelling of the mouth or throat occurs, discontinue use.'
4174	PROPYL 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%.
4175	PROPYL 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%.
4176	PROPYL GALLATE	E
4177	PROPYL HYDROXYBENZOATE	E
4178	PROPYLENE CARBONATE	E	Only for use in topical medicines for dermal application.
4179	PROPYLENE GLYCOL	E
4180	PROPYLENE GLYCOL ALGINATE	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%.
4181	PROPYLENE GLYCOL DIBENZOATE	E	Only for use in topical medicines for dermal application only and not to be used in topical medicines intended for use in the eye. The concentration in the medicine must be no more than 20%.
4182	PROPYLENE GLYCOL DIDECANOATE	E	Only for use in topical medicines for dermal application only and not to be used in topical medicines intended for use in the eye. The concentration in the medicine must be no more than 1%.
4183	PROPYLENE GLYCOL DIOCTANOATE	E	Only for use in topical medicines for dermal application.
4184	PROPYLENE GLYCOL DIOCTANOATE/DIDECANOATE	E	Only for use in topical medicines for dermal application.
4185	PROPYLENE GLYCOL DIPELARGONATE	E	Only for use in topical medicines for dermal application.
4186	PROPYLENE GLYCOL ISOCETETH-3 ACETATE	E	Only for use in topical medicines for dermal application only and not to be used in topical medicines intended for use in the eye. The concentration in the medicine must be no more than 1%.
4187	PROPYLENE GLYCOL ISOSTEARATE	E	Only for use in topical medicines for dermal application.
4188	PROPYLENE GLYCOL MONOLAURATE	E	Only for use in topical medicines for dermal application.
4189	PROPYLENE GLYCOL MONOSTEARATE	E	Only for use in topical medicines for dermal application.
4190	PROPYLENE GLYCOL MYRISTYL ETHER ACETATE	E	Only for use in topical medicines for dermal application.
4191	PROSOPIS JULIFLORA	A, H
4192	PROTEASE	A	Must be derived from Aspergillus oryzae or Aspergillus niger.
4193	PROTEIN HYDROLYSATE	E
4194	PRUNE JUICE	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%.
4195	PRUNE JUICE CONCENTRATE	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%.
4196	PRUNELLA VULGARIS	A, H
4197	PRUNUS AFRICANA	A, E, H	Amygdalin and hydrocyanic acid are mandatory components of Prunus africana. The concentration of Amygdalin in the medicine must be 0%. The concentration of Hydrocyanic acid in the medicine must be no more than 1 microgram/kg or 1 microgram/L or 0.0000001%.
4198	PRUNUS ARMENIACA	A, E, H	Amygdalin and hydrocyanic acid are mandatory components of Prunus armeniaca and must be declared in the application. The concentration of Amygdalin in the medicine must be 0%. The concentration of Hydrocyanic acid in the medicine must be no more than 1 microgram/kg or 1 microgram/L or 0.0000001%.
4199	PRUNUS AVIUM	A, E, H	Amygdalin and hydrocyanic acid are mandatory components of Prunus avium. The concentration of Amygdalin in the medicine must be 0%. The concentration of Hydrocyanic acid in the medicine must be no more than 1 microgram/kg or 1 microgram/L or 0.0000001%.
4200	PRUNUS CERASIFERA	A, E, H	Amygdalin and hydrocyanic acid are mandatory components of Prunus cerasifera. The concentration of Amygdalin in the medicine must be 0%. The concentration of Hydrocyanic acid in the medicine must be no more than 1 microgram/kg or 1 microgram/L or 0.0000001%.
4201	PRUNUS CERASUS	A, E, H	Amygdalin and hydrocyanic acid are mandatory components of Prunus cerasus. The concentration of Amygdalin in the medicine must be 0%. The concentration of Hydrocyanic acid in the medicine must be no more than 1 microgram/kg or 1 microgram/L or 0.0000001%.
4202	PRUNUS DOMESTICA	A, E, H	Amygdalin and hydrocyanic acid are mandatory components of Prunus domestica. The concentration of Amygdalin in the medicine must be 0%. The concentration of Hydrocyanic acid in the medicine must be no more than 1 microgram/kg or 1 microgram/L or 0.0000001%.
4203	PRUNUS DULCIS	A, E, H	Amygdalin and hydrocyanic acid are mandatory components of Prunus dulcis when the plant part is seed. When the plant part is seed, the maximum recommended daily dose must be no more than the equivalent of 1mg of the dry seed. The concentration of Amygdalin in the medicine must be 0%. The concentration of Hydrocyanic acid in the medicine must be no more than 1 microgram/kg or 1 microgram/L or 0.0000001%.
4204	PRUNUS HUMILIS	A, E, H	Amygdalin and hydrocyanic acid are mandatory components of Prunus humilis. The concentration of Amygdalin in the medicine must be 0%. The concentration of Hydrocyanic acid in the medicine must be no more than 1 microgram/kg or 1 microgram/L or 0.0000001%.
4205	PRUNUS JAPONICA	A, E, H	Amygdalin and hydrocyanic acid are mandatory components of Prunus japonica. The concentration of Amygdalin in the medicine must be 0%. The concentration of Hydrocyanic acid in the medicine must be no more than 1 microgram/kg or 1 microgram/L or 0.0000001%.
4206	PRUNUS LAUROCERASUS	A, E, H	Amygdalin and hydrocyanic acid are mandatory components of Prunus laurocerasus. The concentration of Amygdalin in the medicine must be 0%. The concentration of Hydrocyanic acid in the medicine must be no more than 1 microgram/kg or 1 microgram/L or 0.0000001%.
4207	PRUNUS MUME	A, E, H	Amygdalin and hydrocyanic acid are mandatory components of Prunus mume. The concentration of Amygdalin in the medicine must be 0%. The concentration of Hydrocyanic acid in the medicine must be no more than 1 microgram/kg or 1 microgram/L or 0.0000001%.
4208	PRUNUS PERSICA	A, E, H	Amygdalin and hydrocyanic acid are mandatory components of Prunus persica. The concentration of Amygdalin in the medicine must be 0%. The concentration of Hydrocyanic acid in the medicine must be no more than 1 microgram/kg or 1 microgram/L or 0.0000001%.
4209	PRUNUS SALICINA	A, E, H	Amygdalin and hydrocyanic acid are mandatory components of Prunus salicina. The concentration of Amygdalin in the medicine must be 0%. The concentration of Hydrocyanic acid in the medicine must be no more than 1 microgram/kg or 1 microgram/L or 0.0000001%.
4210	PRUNUS SEROTINA	A, E, H	Amygdalin and hydrocyanic acid are mandatory components of Prunus serotina. The concentration of Amygdalin in the medicine must be 0%. The concentration of Hydrocyanic acid in the medicine must be no more than 1 microgram/kg or 1 microgram/L or 0.0000001%.
4211	PRUNUS SPINOSA	A, E, H	Amygdalin and hydrocyanic acid are mandatory components of Prunus spinosa. The concentration of Amygdalin in the medicine must be 0%. The concentration of Hydrocyanic acid in the medicine must be no more than 1 microgram/kg or 1 microgram/L or 0.0000001%.
4212	PRUSSIAN BLUE	E	Permitted for use only as a colour for topical use.
4213	PSEUDOCYDONIA SINENSIS	A, H
4214	PSEUDOSTELLARIA HETEROPHYLLA	A, E, H
4215	PSEUDOTSUGA MENZIESII	A, H
4216	PSEUDOWINTERA COLORATA	A, H	Only for use when the plant part is leaf.
4217	PSIDIUM GUAJAVA	A, E, H
4218	PSORINUM	H	Only for use as an active homoeopathic ingredient.
4219	PSYLLIUM HUSK DRY	A, H	When a dose for children is stated, the following warning statement is required on the label: - (PSYLL1) 'Should only be used for children on medical advice' (or words to that effect).
4220	PSYLLIUM HUSK POWDER	A, E, H	When a dose for children is stated, the following warning statement is required on the label: - (PSYLL1) 'Should only be used for children on medical advice' (or words to that effect).
4221	PSYLLIUM SEED DRY	A, E, H	When a dose for children is stated the following warning statement is required on the label: - (PSYLL1) 'Should only be used for children on medical advice' (or words to that effect).
4222	PTELEA TRIFOLIATA	A, H
4223	PTEROCARPUS MARSUPIUM	A, H
4224	PTEROCARPUS SANTALINUS	A, E, H
4225	PUERARIA LOBATA	A, E, H
4226	PUERARIA MONTANA VAR. LOBATA	A, E, H
4227	PULLULAN	E
4228	PUMICE	E
4229	PUMPKIN	E
4230	PUMPKIN SEED	E, H
4231	PUMPKIN SEED OIL	E, H
4232	PUNICA GRANATUM	A, E, H
4233	PURE BEE VENOM	H	Only for use as an active homoeopathic ingredient.
4234	PURIFIED HONEY	A, E	When the route of administration is oral, the following warning statement is required on the medicine label: - (BABY2) 'Not suitable for infants under the age of twelve months' (or words to that effect).
4235	PURIFIED SILICEOUS EARTH	E, H
4236	PURIFIED TALC	E
4237	PURIFIED WATER	E
4238	PVM/MA COPOLYMER	E
4239	PVM/MA DECADIENE CROSSPOLYMER	E	Only for use in topical medicines for dermal application.
4240	PVP/EICOSENE COPOLYMER	E	Only for use in topical medicines for dermal application.
4241	PVP/HEXADECENE COPOLYMER	E	Only for use in topical medicines for dermal application.
4242	PYRETHRINS	E	Only for use in topical medicines for dermal application. The concentration in the medicine must be no more than 10%. The medicine requires the following warning statement on the medicine label: - (PYRTH3) 'Contains pyrethrins [insert quantity]' (or words to that effect).
4243	PYRIDOXAL 5-PHOSPHATE	A, E	Pyridoxine is a mandatory component of Pyridoxal 5-phosphate. The percentage of pyridoxine from pyridoxal 5-phosphate should be calculated based on the molecular weight of pyridoxal 5-phosphate. The maximum recommended daily dose must provide no more than 200 mg of pyridoxine. If the medicine contains more than 50 mg and no more than 200 mg of pyridoxine per maximum recommended daily dose the medicine requires the following warning statement on the medicine label: - (VITB6SX) 'WARNING - Stop taking this medication if you experience tingling, burning or numbness and see your healthcare practitioner as soon as possible. [Contains vitamin B6].'
4244	PYRIDOXAL 5-PHOSPHATE MONOHYDRATE	A	Pyridoxine is a mandatory component of Pyridoxal 5-phosphate monohydrate. The percentage of pyridoxine from pyridoxal 5-phosphate monohydrate should be calculated based on the molecular weight of pyridoxal 5-phosphate monohydrate. The maximum recommended daily dose must provide no more than 200 mg of pyridoxine. If the medicine contains more than 50 mg and no more than 200 mg of pyridoxine per maximum recommended daily dose the medicine requires the following warning statement on the medicine label: - (VITB6SX) 'WARNING - Stop taking this medication if you experience tingling, burning or numbness and see your healthcare practitioner as soon as possible. [Contains vitamin B6].'
4245	PYRIDOXINE HYDROCHLORIDE	A, E, H	When not used as an active homoeopathic ingredient, pyridoxine is a mandatory component of Pyridoxine hydrochloride. The percentage of pyridoxine from pyridoxine hydrochloride should be calculated based on the molecular weight of pyridoxine hydrochloride. The maximum recommended daily dose must provide no more than 200 mg of pyridoxine. If the medicine contains more than 50 mg and no more than 200 mg of pyridoxine per maximum recommended daily dose the medicine requires the following warning statement on the medicine label: - (VITB6SX) 'WARNING - Stop taking this medication if you experience tingling, burning or numbness and see your healthcare practitioner as soon as possible. [Contains vitamin B6].'
4246	PYROGLUTAMIC ACID	E
4247	PYROLA DECORATA	A, H
4248	PYROLIGNEOUS 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%.
4249	PYRROSIA LINGUA	A, H
4250	PYRROSIA PETIOLOSA	A, H
4251	PYRROSIA SHEARERI	A, H
4252	PYRUS COMMUNIS	A, E, H	Beta-arbutin is a mandatory component of Pyrus communis. When for oral use, the maximum recommended daily dose must not provide more than 500 mg of beta-arbutin. When for dermal application exclusively to the face: a) the concentration of beta-arbutin in the medicine must not be more than 7%; b) hydroquinone is a mandatory component; and c) the concentration of hydroquinone must not be more than 10 mg/kg or 10 mg/L or 0.001%. When for use other than oral or dermal application exclusively to the face, the concentration of beta-arbutin in the medicine must not be more than 10 mg/kg or 10 mg/L or 0.001%.
4253	PYRUS PYRIFOLIA	A, H	Beta-arbutin is a mandatory component of Pyrus pyrifolia. When for oral use, the maximum recommended daily dose must not provide more than 500 mg of beta-arbutin. When for dermal application exclusively to the face: a) the concentration of beta-arbutin in the medicine must not be more than 7%; b) hydroquinone is a mandatory component; and c) the concentration of hydroquinone must not be more than 10 mg/kg or 10 mg/L or 0.001%. When for use other than oral or dermal application exclusively to the face, the concentration of beta-arbutin in the medicine must not be more than 10 mg/kg or 10 mg/L or 0.001%.
4254	PYRUVIC 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%.
4255	QUASSIA	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%.
4256	QUASSIA AMARA	A, E, H
4257	QUASSIA WOOD JAMAICAN DRY	A, H
4258	QUASSIA WOOD JAMAICAN POWDER	A, H
4259	QUATERNIUM-15	E	Only for use in topical medicines for dermal application.
4260	QUATERNIUM-18 BENTONITE	E	Only for use in topical medicines for dermal application.
4261	QUATERNIUM-18 HECTORITE	E	Only for use in topical medicines for dermal application.
4262	QUATERNIUM-52	E	Only for use in wash-on/wash-off 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%. Not be used in medicines in which N-nitroso compounds may be formed.
4263	QUATERNIUM-80	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 2.5%.
4264	QUERCETIN	A
4265	QUERCETIN DIHYDRATE	A
4266	QUERCUS ACUTISSIMA	A, H
4267	QUERCUS ALBA	A, E, H
4268	QUERCUS PALUSTRIS	A, H
4269	QUERCUS ROBUR	A, H
4270	QUERCUS RUBRA	A, H
4271	QUERCUS VIRGINIANA	A, H
4272	QUILLAIA DRY	A, H
4273	QUILLAIA POWDER	A, E, H
4274	QUILLAJA SAPONARIA	A, H
4275	QUINCE	E
4276	QUININE ARSENITE	H	Only for use as an active homoeopathic ingredient. Quinine is a mandatory component of Quinine arsenite. The maximum recommended daily dose must be no more than 50 mg of quinine.
4277	QUININE SULFATE DIHYDRATE	H	Only for use as an active homoeopathic ingredient. Quinine is a mandatory component of quinine sulfate dihydrate. The maximum recommended daily dose must be no more than 50 mg of quinine.
4278	QUINOLINE YELLOW	E	Permitted for use only as a colour for oral and topical use.
4279	QUINOLINE YELLOW ALUMINIUM LAKE	E	Permitted for use only as a colour for oral and topical use.
4280	QUISQUALIS INDICA	A, H
4281	R-ALPHA LIPOIC ACID	A
4282	RACEMENTHOL	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%.
4283	RACEMIC CAMPHOR	E, H	Only for use as an active homoeopathic or excipient ingredient. 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'. If the concentration of camphor is more than 2.5%, the nominal capacity of the container must be no more than 25 millilitres.
4284	RADISH	E
4285	RAISIN JUICE CONCENTRATE	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%.
4286	RANUNCULUS BULBOSUS	A, H
4287	RANUNCULUS FICARIA	A, H
4288	RANUNCULUS TERNATUS	A, H
4289	RAPE SEED OIL	A, E, H	Allyl isothiocyanate is a mandatory component of rape seed oil when the plant part is seed. The concentration of allyl isothiocyanate from all ingredients in the product must be no more than 10 mg/kg or 10 mg/L or 0.001%.
4290	RAPHANUS SATIVUS	A, H
4291	RASPBERRY	E
4292	RASPBERRY BRANDY	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%.
4293	RASPBERRY DISTILLATE	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%.
4294	RASPBERRY FRUIT 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%.
4295	RASPBERRY JUICE CONCENTRATE	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%.
4296	RAUWOLFIA SERPENTINA	A, H	The concentration of equivalent dry Rauwolfia serpentina in the medicine must be no more than 10mg/Kg or 10mg/L or 0.001%.
4297	RAUWOLFIA SERPENTINA DRY	A, H	The concentration of Rauwolfia Serpentina Dry in the medicine must be no more than 10mg/Kg or 10mg/L or 0.001%.
4298	RAUWOLFIA SERPENTINA POWDER	A, H	The concentration of Rauwolfia Serpentina Powder in the medicine must be no more than 10mg/Kg or 10mg/L or 0.001%.
4299	RED 27	E	Permitted for use only as a colour in medicines limited to topical and oral routes of administration. The concentration in the medicine must be no more than 0.5%.
4300	RED 27 ALUMINIUM LAKE	E	Permitted for use only as a colour in medicines limited to topical and oral routes of administration. The concentration in the medicine must be no more than 0.5%.
4301	RED ANT	H	Only for use as an active homoeopathic ingredient.
4302	RED CLOVER FLOWER DRY	A, H
4303	RED CLOVER FLOWER POWDER	A, H
4304	RED CORAL	H	Only for use as an active homoeopathic ingredient.
4305	RED DEER	A
4306	RED MERCURIC IODIDE	H	Only for use as an active homoeopathic ingredient.
4307	RED MERCURIC OXIDE	H	Only for use as an active homoeopathic ingredient.
4308	RED MERCURIC SULFIDE	H	Only for use as an active homoeopathic ingredient.
4309	REHMANNIA GLUTINOSA	A, E, H
4310	REL-1-((1R,2S)-1,2,3,4,5,6,7,8-OCTAHYDRO-1,2,8,8-TETRAMETHYL-2-NAPHTHALENYL)-1-ETHANONE	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%.
4311	RESORCINOL	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%.
4312	RESORCINOL DIMETHYLETHER	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%.
4313	RESVERATROL	A	Only permitted for use in medicines that are for oral routes of administration. The maximum recommended daily dose of the medicine must not contain more than 150 milligrams of resveratrol. The following warning statements are required on the medicine label: - (RESVER) 'Resveratrol may affect the way some medicines work, including Warfarin. Consult your health professional before taking with other medicines (or words to that effect).'; - (PREGNT) ‘Not recommended for use by pregnant and lactating women’ (or words to that effect)’; and - (CHILD2) ‘Not suitable for children’.
4314	RETINOL	A, E	Vitamin A is a mandatory component of retinol. 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. When preparations for internal use in adults contain more than 33 micrograms of retinol equivalents per dosage unit in divided preparations or per gram of an undivided preparation, 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.’
4315	RETINOL ACETATE	A, E	Vitamin A is a mandatory component of retinol acetate. 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. When preparations for internal use in adults contain more than 33 micrograms of retinol equivalents per dosage unit in divided preparations or per gram of an undivided preparation, 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.’
4316	RETINOL PALMITATE	A, E	Vitamin A is a mandatory component of retinol palmitate. 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. When preparations for internal use in adults contain more than 33 micrograms of retinol equivalents per dosage unit in divided preparations or per gram of an undivided preparation, 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.’
4317	REYNOUTRIA JAPONICA	A, E, H	When used as an excipient, only for use in topical medicines for dermal application.
4318	RHAMNOSE	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%.
4319	RHAMNUS CATHARTICA	A, H	When the route of administration is oral, Hydroxyanthracene derivatives is a mandatory component of Rhamnus cathartica. 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'; and - (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). 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)]'; and - (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); and - (LAX2) 'Prolonged use may cause serious bowel problems'.
4320	RHAMNUS FRANGULA	A, H	Glucofrangulins calculated as glucofrangulin A is a mandatory component of Rhamnus frangula. 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'; and - (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). 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)]'; and - (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); and - (LAX2) 'Prolonged use may cause serious bowel problems'.
4321	RHATANY ROOT DRY	A, H
4322	RHATANY ROOT POWDER	A, H
4323	RHEUM OFFICINALE	A, E, H	The plant part must not be leaf. When the route of administration is oral, Hydroxyanthracene derivatives calculated as rhein is a mandatory component of Rheum officinale. 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'; and - (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). 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)]'; and - (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); and - (LAX2) 'Prolonged use may cause serious bowel problems'.
4324	RHEUM PALMATUM	A, E, H	The plant part must not be leaf. When the route of administration is oral, Hydroxyanthracene derivatives calculated as rhein is a mandatory component of Rheum palmatum. 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’; and - (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). 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)]’; and - (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); and - (LAX2) ‘Prolonged use may cause serious bowel problems’.
4325	RHEUM RHAPONTICUM	A, E, H	The plant part must not be leaf. When the route of administration is oral, Hydroxyanthracene derivatives is a mandatory component of Rheum rhaponticum. 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'; and - (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). 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)]'; and - (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); and - (LAX2) 'Prolonged use may cause serious bowel problems'.
4326	RHEUM TANGUTICUM	A, H	The plant part must not be leaf. When the route of administration is oral, Hydroxyanthracene derivatives calculated as rhein is a mandatory component of Rheum tanguticum. 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'; and - (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). 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)]'; and - (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); and - (LAX2) 'Prolonged use may cause serious bowel problems'.
4327	RHODAMINE B	E	Permitted for use only as a colour for topical use.
4328	RHODINOL	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%.
4329	RHODINYL ACETATE	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%.
4330	RHODIOLA ROSEA	A	Only for use in oral medicines. Only available for use when the plant preparation is dry root powder, dry root powder as an aqueous extract or dry root powder as a hydroethanolic extract with no more than 70% ethanol v/v.
4331	RHODODENDRON AUREUM	A, H
4332	RHODODENDRON FERRUGINEUM	A, H	Beta-arbutin is a mandatory component of Rhododendron ferrugineum. When for oral use, the maximum recommended daily dose must not provide more than 500 mg of beta-arbutin. When for dermal application exclusively to the face: a) the concentration of beta-arbutin in the medicine must not be more than 7%; b) hydroquinone is a mandatory component; and c) the concentration of hydroquinone must not be more than 10 mg/kg or 10 mg/L or 0.001%. When for use other than oral or dermal application exclusively to the face, the concentration of beta-arbutin in the medicine must not be more than 10 mg/kg or 10 mg/L or 0.001%.
4333	RHODODENDRON GROENLANDICUM	A, H
4334	RHODODENDRON MOLLE	A, H	The maximum recommended daily dose of the medicine must be no more than 1mg of the dry herbal material.
4335	RHUBARB	E, H	When the route of administration is oral, Hydroxyanthracene derivatives is a mandatory component of Rhubarb. 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'; and - (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). 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)]'; and - (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); and - (LAX2) 'Prolonged use may cause serious bowel problems'.
4336	RHUBARB ROOT DRY	A, H	When the route of administration is oral, Hydroxyanthracene derivatives calculated as rhein is a mandatory component of rhubarb root dry. 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'; and - (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). 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)]'; and - (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); and - (LAX2) 'Prolonged use may cause serious bowel problems'.
4337	RHUBARB ROOT POWDER	A, H	When the route of administration is oral, Hydroxyanthracene derivatives calculated as rhein is a mandatory component of rhubarb root powder. 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'; and - (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). 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)]'; and - (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); and - (LAX2) 'Prolonged use may cause serious bowel problems'.
4338	RHUS AROMATICA	A, E, H
4339	RHUS CHINENSIS	A, H
4340	RHUS GLABRA	A, E, H
4341	RHUS VENENATA	H	Only for use as an active homoeopathic ingredient.
4342	RIBES GROSSULARIA	A, E, H
4343	RIBES NIGRUM	A, E, H
4344	RIBOFLAVIN	A, E
4345	RIBOFLAVIN SODIUM PHOSPHATE	A, E
4346	RIBOFLAVIN TETRAACETATE	E	Only for use in topical medicines for dermal application.
4347	RIBOFLAVINE	A, E
4348	RIBOFLAVINE SODIUM PHOSPHATE	A, E
4349	RIBONUCLEIC ACID	E	Only for use in topical medicines for dermal application.
4350	RIBOSE	A	Only for use in oral medicines.
4351	RICE	E
4352	RICE BRAN	E
4353	RICE BRAN OIL	E
4354	RICE BRAN WAX	A, E, H
4355	RICE STARCH	E
4356	RICE VINEGAR	E
4357	RICE WINE	E	Ethanol is a mandatory component of rice wine.
4358	RICINOLEIC ACID	E	Only for use in topical medicines for dermal application.
4359	RICINUS COMMUNIS	A, H	Only for use when the plant part must be seed and the plant preparation is oil fixed.
4360	ROBINIA PSEUDOACACIA	A, E, H	When the herbal substance is derived from plant parts other than the leaf or flower, the maximum recommended daily dose of the medicine must be no more than 1mg of the dry herbal material.
4361	ROHDEA JAPONICA	A, H	The maximum recommended daily dose must be no more than the equivalent of 1mg of the dry herbal material.
4362	ROSA ARVENSIS	A, E, H
4363	ROSA CANINA	A, E, H
4364	ROSA CYMOSA	A, E, H
4365	ROSA EGLANTERIA	A, E, H
4366	ROSA GALLICA	A, E, H
4367	ROSA LAEVIGATA	A, E, H
4368	ROSA MULTIFLORA	A, E, H
4369	ROSA ROXBURGHII FRUIT 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 0.002%.
4370	ROSA RUGOSA	A, E, H
4371	ROSA VILLOSA	A, E, H
4372	ROSA X CENTIFOLIA	A, E, H
4373	ROSA X DAMASCENA	A, E, H
4374	ROSANA	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%.
4375	ROSE 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%.
4376	ROSE FRUIT FRESH	A, E, H
4377	ROSE HIP	E
4378	ROSE OIL	A, E, H
4379	ROSE 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%.
4380	ROSEMARY OIL	A, E, H	Safrole is a mandatory component of Rosemary oil. When for internal use then the concentration of safrole in the medicine must be no more than 0.1%. When for topical use then the concentration of safrole in the medicine must be no more than 1%.
4381	ROSMARINUS OFFICINALIS	A, E, H	Camphor and cineole are mandatory components of Rosmarinus officinalis. 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%. 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. 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 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 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 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'. If the concentration of camphor is more than 2.5%, the nominal capacity of the container must be no more than 25 millilitres.
4382	ROYAL JELLY	A, E	10-Hydroxy-2-decenoic acid is a mandatory component of Royal jelly. The medicine requires the following warning statements on the medicine label: - (CHILD2) 'Not suitable for children' - (ROYJ) 'Not to be taken by asthma and allergy sufferers' in 3 mm type, prominent on front and 'This product contains royal jelly which has been reported to cause severe allergic reactions and in rare cases fatalities, especially in asthma and allergy sufferers'.
4383	ROYAL JELLY FRESH	A, E	10-Hydroxy-2-decenoic acid is a mandatory component of Royal jelly fresh. The medicine requires the following warning statements on the medicine label: - (CHILD2) 'Not suitable for children' - (ROYJ) 'Not to be taken by asthma and allergy sufferers' in 3 mm type, prominent on front and 'This product contains royal jelly which has been reported to cause severe allergic reactions and in rare cases fatalities, especially in asthma and allergy sufferers'.
4384	ROYAL JELLY LYOPHILISED	A, E	10-Hydroxy-2-decenoic acid is a mandatory component of Royal jelly lyophilised. The medicine requires the following warning statements on the medicine label: - (CHILD2) 'Not suitable for children' - (ROYJ) 'Not to be taken by asthma and allergy sufferers' in 3 mm type, prominent on front and 'This product contains royal jelly which has been reported to cause severe allergic reactions and in rare cases fatalities, especially in asthma and allergy sufferers'.
4385	RUBBER NATURAL	E	Only for use in topical medicines for dermal application.
4386	RUBIA CORDIFOLIA	A, H
4387	RUBIA TINCTORUM	A, H
4388	RUBUS CHINGII	A, H
4389	RUBUS CORCHORIFOLIUS	A, H
4390	RUBUS COREANUS	A, E, H
4391	RUBUS FRUTICOSUS	A, E, H
4392	RUBUS IDAEUS	A, E, H
4393	RUBUS OCCIDENTALIS	A, E, H
4394	RUBUS PARVIFOLIUS	A, H
4395	RUBUS ROSIFOLIUS	A, H
4396	RUDBECKIA HIRTA	A, H
4397	RUE OIL	A, H
4398	RUM	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%.
4399	RUMEX ACETOSA	A, H
4400	RUMEX ACETOSELLA	A, H
4401	RUMEX CONGLOMERATUS	A, H
4402	RUMEX CRISPUS	A, E, H
4403	RUMEX PULCHER	A, H
4404	RUMEX SCUTATUS	A, H
4405	RUSCUS ACULEATUS	A, H
4406	RUTA GRAVEOLENS	A, E, H
4407	RUTOSIDE	A, E
4408	RYE	E	Gluten is a mandatory component of Rye when the route of administration is other than topical and mucosal.
4409	RYE BRAN	E	Gluten is a mandatory component of Rye bran when the route of administration is other than topical and mucosal.
4410	S-ISOPROPYL 3-METHYLTHIOCROTONATE	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%.
4411	SABINENE	E	Sabinene must only be included in medicines when in combination with other permitted ingredients as a flavour proprietary excipient formulation. The total concentration of flavour proprietary excipient formulations containing sabinene must not be more than 5% of the total medicine.
4412	SABINENE HYDRATE	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%.
4413	SACCHARIDE ISOMERATE	E	Only for use in topical medicines for dermal application and not to be included in medicines for use in the eye or on damaged skin. The concentration in the medicine must be no more than 3.66%.
4414	SACCHARIN	E
4415	SACCHARIN SODIUM	E
4416	SACCHAROMYCES CEREVISIAE	A, E	When for topical use, the concentration in the medicine must be no more than 1%.
4417	SACCHAROMYCES CEREVISIAE (BOULARDII)	A
4418	SACCHAROMYCES CERVISIAE POLYSACCHARIDES	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%.
4419	SACCHAROMYCES/ZINC FERMENT	E	Only for use in topical medicines for dermal application.
4420	SACCHARUM OFFICINARUM	A, E, H
4421	SAFFLOWER OIL	A, E, H
4422	SAFFRON	E	Permitted for use only as a colour for either topical use or with an oral route of administration.
4423	SAGE LEAF DRY	A, E, H	Thujone is a mandatory component of Sage leaf dry. The concentration of thujone in the medicine must be no more than 4%.
4424	SAGE LEAF POWDER	A, H	Thujone is a mandatory component of Sage leaf powder. The concentration of thujone in the medicine must be no more than 4%.
4425	SAGE OIL DALMATIAN	A	Thujone is a mandatory component of Sage oil dalmatian. The concentration of thujone in the medicine must be no more than 4%. When the concentration of Sage oil dalmatian in the medicine is more than 10% and the nominal capacity of the container is no more than 15 mL, a restricted flow insert and child resistant closure must be 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’
4426	SAGE OIL SPANISH	A, E, H
4427	SALICORNIA EUROPAEA EXTRACT	E	Only for use in topical medicines for dermal use 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 0.002%.
4428	SALICYLALDEHYDE	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%.
4429	SALICYLIC ACID	E, H	Only for use in topical medicines for dermal application. The concentration in the medicine must be no more than 40%.
4430	SALIX ALBA	A, E, H
4431	SALIX DAPHNOIDES	A, H
4432	SALIX DISCOLOR	A, H
4433	SALIX FRAGILIS	A, H
4434	SALIX NIGRA	A, H
4435	SALIX PURPUREA	A, H
4436	SALSOLA KALI	A, H
4437	SALVIA CHINENSIS	A, H
4438	SALVIA FRUTICOSA	A, H
4439	SALVIA HISPANICA	A, E, H
4440	SALVIA LAVANDULAEFOLIA	A, H
4441	SALVIA MILTIORRHIZA	A, H
4442	SALVIA OFFICINALIS	A, E, H	Thujone is a mandatory component of Salvia officinalis. The concentration of thujone in the medicine must be no more than 4%.
4443	SALVIA SCLAREA	A, E, H
4444	SAMBUCUS CANADENSIS	A, H
4445	SAMBUCUS EBULUS	A, H
4446	SAMBUCUS NIGRA	A, E, H
4447	SANDALWOOD OIL EAST INDIAN	A, E, H
4448	SANGUINARIA CANADENSIS	H	Only for use as an active homoeopathic ingredient. The potency must be more than 4X.
4449	SANICULA EUROPAEA	A, H
4450	SANTALUM ALBUM	A, E, H
4451	SANTALUM SPICATUM	A, E, H	The route of administration must be topical or inhalation. The plant preparation must be oil. The plant part must be root or stem wood including heartwood.
4452	SAPINDUS MUKOROSSI	A, H
4453	SAPONARIA OFFICINALIS	A, H
4454	SAPOSHNIKOVIA DIVARICATA	A, H
4455	SARCOSINE	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%.
4456	SARGASSUM FUSIFORME	A, H	Iodine is a mandatory component of Sargassum fusiforme. 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.
4457	SARGASSUM SILIQUASTRUM	A, H	Iodine is a mandatory component of Sargassum siliquastrum. 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.
4458	SASSAFRAS ALBIDUM	A, H	Safrole is a mandatory component of Sassafras albidum. When for internal use then the concentration of safrole in the medicine must be no more than 0.1%. When for topical use then the concentration of safrole in the medicine must be no more than 1%.
4459	SATUREIA HORTENSIS	A, H
4460	SATUREIA MONTANA	A, H
4461	SAUROPUS SPATULIFOLIUS	A, H
4462	SAURURUS CHINENSIS	A, H
4463	SAUSSUREA COSTUS	A, H
4464	SAVORY OIL SUMMER	A, H
4465	SAXIFRAGA GRANULATA	A, E, H
4466	SAXIFRAGA STOLONIFERA	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 0.0816%.
4467	SCAPHIUM SCAPHIGERUM	A, H
4468	SCHEFFLERA HEPTAPHYLLA	A, H
4469	SCHINOPSIS QUEBRACHO-COLORADO	A, H
4470	SCHINUS MOLLE	A, H
4471	SCHINUS MOLLE 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%.
4472	SCHISANDRA CHINENSIS	A, E, H
4473	SCHIZONEPETA TENUIFOLIA	A, E, H
4474	SCHOENOCAULON OFFICINALE	A, H	The maximum recommended daily dose must contain no more than the equivalent of 1mg of the dry herbal material.
4475	SCLAREOL	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%.
4476	SCLAREOLIDE	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%.
4477	SCLERANTHUS ANNUUS	A, H
4478	SCLEROTIUM GUM	E	Only for use in topical medicines for dermal application.
4479	SCOPOLIA CARNIOLICA	A, H	The concentration of equivalent dry Scopolia carniolica in the medicine must be no more than 10mg/Kg or 10mg/L or 0.001%.
4480	SCROPHULARIA NINGPOENSIS	A, H
4481	SCROPHULARIA NODOSA	A, H
4482	SCURRULA PARASITICA VAR. GRACILIFLORA	A, H
4483	SCUTELLARIA BAICALENSIS	A, E, H
4484	SCUTELLARIA BARBATA	A, H
4485	SCUTELLARIA LATERIFLORA	A, E, H
4486	SEA WHIP 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 0.02%.
4487	SEC BUTYL 3-METHYLBUT-2-ENETHIOATE	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%.
4488	SEC-BUTYL THIOISOVALERATE	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%.
4489	SECALE CEREALE	A, H	Gluten is a mandatory component of Secale cereale when the plant part is seed and the route of administration is other than topical and mucosal.
4490	SEDUM ACRE	A, H
4491	SELAGINELLA TAMARISCINA	A, H
4492	SELENICEREUS GRANDIFLORUS	A, E, H
4493	SELENIUM	H	Only for use as an active homoeopathic ingredient. Oral medicines must contain no more than 150 micrograms of selenium per maximum recommended daily dose. When for oral use, the medicine requires the following warning statement on the medicine label: - (SELE) 'This medicine contains selenium which is toxic in high doses. A daily dose of 150 micrograms for adults of selenium from dietary supplements should not be exceeded.'
4494	SELENOCYSTEINE	A	Selenium is a mandatory component of Selenocysteine for oral and sublingual use. Oral medicines must contain no more than 150 micrograms of selenium per maximum recommended daily dose. When for oral use, the medicine requires the following warning statement on the medicine label: - (SELE) 'This medicine contains selenium which is toxic in high doses. A daily dose of 150 mcg for adults of selenium from dietary supplements should not be exceeded.'
4495	SELENOMETHIONINE	A	Selenium is a mandatory component of Selenomethionine for oral and sublingual use. Oral medicines must contain no more than 150 micrograms of selenium per maximum recommended daily dose. When for oral use, the medicine requires the following warning statement on the medicine label: - (SELE) 'This medicine contains selenium which is toxic in high doses. A daily dose of 150 micograms for adults of selenium from dietary supplements should not be exceeded.’
4496	SELF-EMULSIFYING GLYCERYL MONOSTEARATE	E
4497	SEMECARPUS ANACARDIUM	A, H	When the plant part is other than seed, the maximum recommended daily dose must be no more than 1mg of the equivalent dry herbal material.
4498	SEMOLINA	E
4499	SEMPERVIVUM TECTORUM	A, H
4500	SENEGA ROOT DRY	A, H
4501	SENEGA ROOT POWDER	A, H
4502	SENNA ALEXANDRINA	A, H	When for oral or sublingual use, Hydroxyanthracene glycosides calculated as sennoside B is a mandatory component of Senna alexandrina. 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'; and - (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). 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)]'; and - (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); and - (LAX2) 'Prolonged use may cause serious bowel problems'.
4503	SENNA FRUIT ALEXANDRIAN DRY	A, H	When for oral or sublingual use, Hydroxyanthracene glycosides calculated as sennoside B is a mandatory component of Senna fruit alexandrian dry. 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'; and - (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). 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)]'; and - (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); and - (LAX2) 'Prolonged use may cause serious bowel problems'.
4504	SENNA FRUIT ALEXANDRIAN POWDER	A, H	When for oral or sublingual use, Hydroxyanthracene glycosides calculated as sennoside B is a mandatory component of Senna fruit alexandrian powder. 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'; and - (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). 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)]'; and - (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); and - (LAX2) 'Prolonged use may cause serious bowel problems'.
4505	SENNA FRUIT TINNEVELLY DRY	A, H	When for oral or sublingual use, Hydroxyanthracene glycosides calculated as sennoside B is a mandatory component of Senna fruit tinnevelly dry. 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'; and - (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). 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)]'; and - (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); and - (LAX2) 'Prolonged use may cause serious bowel problems'.
4506	SENNA FRUIT TINNEVELLY POWDER	A, H	When for oral or sublingual, Hydroxyanthracene glycosides calculated as sennoside B is a mandatory component of Senna fruit tinnevelly powder. 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'; and - (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). 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)]'; and - (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); and - (LAX2) 'Prolonged use may cause serious bowel problems'.
4507	SENNA LEAF DRY	A, H	When for oral or sublingual use, Hydroxyanthracene glycosides calculated as sennoside B is a mandatory component of Senna leaf dry. 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'; and - (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). 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); and - (LAX2) 'Prolonged use may cause serious bowel problems'.
4508	SENNA LEAF POWDER	A, H	When for oral or sublingual use, Hydroxyanthracene glycosides calculated as sennoside B is a mandatory component of Senna Leaf Powder. 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'; and - (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). 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)]'; and - (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); and - (LAX2) 'Prolonged use may cause serious bowel problems'.
4509	SENNA OCCIDENTALIS	A, H	Hydroxyanthracene glycosides calculated as sennoside B is a mandatory component of Senna 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'; and - (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]. 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)]'; and - (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]; and - (LAX2) 'Prolonged use may cause serious bowel problems'.
4510	SENNA TORA	A, H	When for oral or sublingual use, Hydroxyanthracene glycosides calculated as sennoside B is a mandatory component of Senna tora. 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'; and - (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). 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)]'; and - (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); and - (LAX2) 'Prolonged use may cause serious bowel problems'.
4511	SEPIA	H	Only for use as an active homoeopathic ingredient.
4512	SEQUOIA SEMPERVIRENS	A, H
4513	SEQUOIADENDRON GIGANTEUM	A, H
4514	SERENOA REPENS	A, H
4515	SERINE	A, E
4516	SERUM ANGUILLAE	H	Only for use as an active homoeopathic ingredient.
4517	SESAME OIL	A, E, H
4518	SESAME SEED	E
4519	SESAMUM INDICUM	A, E, H
4520	SETARIA ITALICA	A, H
4521	SHARK CALCIUM CHONDROITIN SULFATE	A
4522	SHARK CARTILAGE	A, E	The medicine requires the following warning statement on the medicine label: - (SHARK) 'Children, pregnant or breastfeeding women, and those who have recently had a heart attack, surgery or a major accident should not consume this product without medical advice' (or words to that effect)
4523	SHARK CHONDROITIN SULFATE	A, E	When used as an excipient: - only for use in topical medicines for dermal application; - not to be included in medicines intended for use in the eye; and - the concentration in the medicine must be no more than 0.001%.
4524	SHARK POTASSIUM CHONDROITIN SULFATE	A
4525	SHARK SODIUM CHONDROITIN SULFATE	A, E	When used as an excipient: - only for use in topical medicines for dermal application; - not to be included in medicines intended for use in the eye; and - the concentration in the medicine must be no more than 0.001%.
4526	SHARK-LIVER OIL	A, E	Vitamin A and Colecalciferol are mandatory components of Shark-liver oil. When for internal use, the maximum recommended daily dose must be no more than 25 micrograms of Vitamin D. 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. When preparations for internal use in adults contain more than 33 micrograms of retinol equivalents per dosage unit in divided preparations or per gram of an undivided preparation, 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.’
4527	SHEA BUTTER	E
4528	SHEA BUTTER UNSAPONIFIABLES	E	Only for use in topical medicines for dermal application.
4529	SHELLAC	E
4530	SHEPHERD'S PURSE HERB DRY	A, H
4531	SHEPHERD'S PURSE HERB POWDER	A, H
4532	SHERRY WINE	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%.
4533	SIGESBECKIA ORIENTALIS	A, E, H
4534	SILICA	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%.
4535	SILICA DIMETHYL 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 4%.
4536	SILICA SILYLATE	E	Only for use in topical medicines for dermal application.
4537	SILICIFIED MICROCRYSTALLINE CELLULOSE	E	Only for use when the route of administration is other than inhalation.
4538	SILICON DIOXIDE	A, E, H	Only for use when the route of administration is other than inhalation.
4539	SILICONE QUATERNIUM-8	E	Only for use in wash-off 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 2.5%. The medicine requires the following warning statement on the medicine label: - (EYE) 'Avoid contact with eyes' (or words to that effect).
4540	SILVER	H	Only for use as an active homoeopathic ingredient. The concentration in the medicine must be no more than 1%.
4541	SILVER BEET	E, H
4542	SILVER BOROSILICATE	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 should be no more than 0.6%. Silver is a mandatory component of Silver borosilicate when the route of administration is topical. The concentration of silver in the medicine must be no more than 1%.
4543	SILVER NITRATE	H	Only for use as an active homoeopathic ingredient.
4544	SILYBUM MARIANUM	A, E, H
4545	SIMABA CEDRON	A, H
4546	SIMETHICONE	E
4547	SIMMONDSIA CHINENSIS	A, E, H
4548	SINAPIS ALBA	A, H	Allyl isothiocyanate is a mandatory component of Sinapis alba when the plant part is seed. The concentration of allyl isothiocyanate from all ingredients in the product must be no more than 10 mg/kg or 10 mg/L or 0.001%.
4549	SINAPIS ARVENSIS	A, H
4550	SINOMENIUM ACUTUM	A, H
4551	SIPHONESTEGIA CHINENSIS	A, H
4552	SIRAITIA GROSVENORII	A, E, H
4553	SISYMBRIUM OFFICINALE	A, H
4554	SKATOLE	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%.
4555	SKIPJACK-LIVER OIL	A, E	Vitamin A and Colecalciferol are mandatory components of Skipjack-liver oil. When for internal use, the maximum recommended daily dose must be no more than 25 micrograms of Vitamin D. 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. When preparations for internal use in adults contain more than 33 micrograms of retinol equivalents per dosage unit in divided preparations or per gram of an undivided preparation, 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.’
4556	SLIPPERY ELM BARK DRY	A, H
4557	SLIPPERY ELM BARK POWDER	A, E, H
4558	SMILAX ARISTOLOCHIIFOLIA	A, H
4559	SMILAX CHINA	A, H
4560	SMILAX GLABRA	A, H
4561	SMILAX OFFICINALIS	A, E, H
4562	SMILAX ORNATA	A, E, H
4563	SMOKE 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%.
4564	SODIUM ACETATE	E
4565	SODIUM ACETYLATED HYALURONATE	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%.
4566	SODIUM ACID CITRATE	A, E, H	When sodium acid citrate is used as an active ingredient, only for use in oral medicines.
4567	SODIUM ACRYLATES 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 0.8%.
4568	SODIUM ACRYLATES CROSSPOLYMER-2	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 0.7 % (w/w).
4569	SODIUM ACRYLOYDIMETHYLTAURATE/VP 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 2% (w/w).
4570	SODIUM ALGINATE	E
4571	SODIUM ASCORBATE	A, E, H
4572	SODIUM ASCORBYL PHOSPHATE	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. When used in a sunscreen, the concentration in the medicine must be no more than 0.1%. When used in products other than sunscreens, the concentration in the medicine must be no more than 0.5%.
4573	SODIUM ASCORBYL/CHOLESTERYL 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 5%.
4574	SODIUM BENZOATE	E
4575	SODIUM BETA-HYDROXY-BETA-METHYLBUTYRATE	A, H
4576	SODIUM BETA-HYDROXY-BETA-METHYLBUTYRATE MONOHYDRATE	A, H
4577	SODIUM BICARBONATE	A, E	When used as an active ingredient, the medicine may only be for oral rehydration salts in powdered and effervescent tablet dosage forms. Medicines containing sodium bicarbonate for use as oral rehydration therapy are subject to the following conditions: a) the medicine complies with the requirements specified in the British Pharmacopoeia, as in force or existing from time to time, for Oral Rehydration Salts; b) the sodium content and total osmolarity of the solution after it has been prepared according to the instructions on the packet are consistent with the criteria specified by the World Health Organisation (WHO) and the United Nations Childrens Fund (UNICEF) in the document 'Expert consultation on oral rehydration salts formulation 18 July 2001.' c) the following warning statements are required on the medicine label: - (UOAD) 'Use only as directed.' - (DIAR) 'If diarrhoea persists for more than 6 hours in infants under 6 months - 12 hours in children under 3 years - 24 hours in children aged 3-6 years or 48 hours in adults and children over 6 years - seek medical advice (or words to that effect).' - (DIAR3) 'If diarrhoea persists, seek medical advice.'
4578	SODIUM BISULFITE	E
4579	SODIUM BROMIDE	H	Only for use as an active homoeopathic ingredient.
4580	SODIUM BUTYRATE	A, E	The route of administration for medicines that contain sodium butyrate must be limited to oral. The maximum recommended daily dose of the medicine must not provide more than 1200 mg sodium butyrate. The following warning statement (or words to the same effect) is required on the medicine label: - (ADULT) 'Adults only’.
4581	SODIUM C14-16 OLEFIN SULFONATE	E	Only for use in topical medicines for dermal application.
4582	SODIUM CALCIUM EDETATE	E	When for oral use, sodium is a mandatory component of sodium calcium edetate. Sodium calcium edetate must only be included in medicines when: (a) the route of administration is limited to topical for dermal use; or (b) in combination with other permitted ingredients as a flavour proprietary excipient formulation. The total concentration of sodium calcium edetate in the medicine must not exceed 0.32%. The total concentration of flavour proprietary excipient formulations containing sodium calcium edetate must not be more than 5% of the total medicine.
4583	SODIUM CARBOMER	E	Only for use as an excipient in topical medicines for dermal application.
4584	SODIUM CARBONATE	E
4585	SODIUM CARBONATE MONOHYDRATE	E
4586	SODIUM CARBOXYMETHYL 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 0.005%.
4587	SODIUM CARRAGEENAN	E
4588	SODIUM CASEINATE	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%.
4589	SODIUM CETOSTEARYL SULFATE	E	Only for use in topical medicines for dermal application.
4590	SODIUM CHLORIDE	A, E, H
4591	SODIUM CHONDROITIN SULFATE	A, E	When used as an excipient ingredient: a) only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye; b) the concentration in the medicine must not be more than 0.001%. When used as an active ingredient: a) the route of administration must only be oral; b) the maximum daily dose must not provide more than 1,200 mg of sodium chondroitin sulfate; c) the following statements must be included on the medicine label: - (ADULT) ‘Adults only' (or words to that effect); - (PREGNT) ‘Not recommended for use by pregnant and lactating women’ (or words to that effect).
4592	SODIUM CITRATE	A, E	When for use as an active ingredient, only for oral use.
4593	SODIUM CITRATE DIHYDRATE	A, E	When for use as an active ingredient, only for oral use.
4594	SODIUM COCO PG-DIMONIUM CHLORIDE 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 0.05%.
4595	SODIUM COCOAMPHOACETATE	E	Only for use in topical medicines for dermal application.
4596	SODIUM COCOYL SARCOSINATE	E	Only for use in topical medicines for dermal application.
4597	SODIUM CYCLAMATE	E
4598	SODIUM DEHYDROACETATE	E	Only for use in topical medicines for dermal application.
4599	SODIUM DNA	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%.
4600	SODIUM DODECYLBENZENESULFONATE	E	Only for use in topical medicines for dermal application. The concentration in the medicine must be no more than 30%.
4601	SODIUM ERYTHORBATE	E
4602	SODIUM ETHYL HYDROXYBENZOATE	E
4603	SODIUM FLUORIDE	A, E, H	Fluoride is a mandatory component of sodium fluoride. The route of administration must be limited to dental. The dosage form must be limited to pastes, powders and/or gels for dental hygiene. When used as an active ingredient, the medicine is subject to the following conditions: (a) only for use in combination with at least one other active ingredient; and (b) the concentration of fluoride ion in the medicine must not be more than 1,500 mg/kg. When the concentration of fluoride ion is more than 1000 mg/kg, the medicine requires the following statements on the medicine label: - (DNTSW) 'Do not swallow.' - (CHILD4) 'Do not use [this product/insert name of product] in children 6 years of age or less.'
4604	SODIUM FUMARATE	E
4605	SODIUM HYALURONATE	A, E	When for use as an excipient ingredient, sodium hyaluronate must only be used in medicines with a topical route of administration for dermal application. When for use as an active ingredient: (a) the molecular mass of sodium hyaluronate must be between 600 and 1600 kilodaltons; and (b) sodium hyaluronate must only be used in medicines when the route of administration is limited to: (i) topical for dermal application; or (ii) oral. When for use in a topical medicine for dermal application the concentration of sodium hyaluronate in the medicine must not exceed 2.0%. When for use as an active ingredient and the route of administration is oral: (a) the maximum recommended daily dose must not provide more than 200 milligrams sodium hyaluronate; (b) the recommended duration of use of the medicine must be limited to three months; and (c) the following warning statements (or words to the same effect) are required on the medicine label : - (ADULT) 'Adults only’; and - (PREGNT) ' Not recommended for use by pregnant and lactating women'.
4606	SODIUM HYDROGENATED TALLOW GLUTAMATE	E	Only for use in topical medicines for dermal application.
4607	SODIUM HYDROXIDE	E	The concentration of sodium hydroxide in the medicine must not be more than 5%. 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.
4608	SODIUM HYDROXYCITRATE	A
4609	SODIUM HYDROXYETHYL ACRYLATE/ACRYLOYLDIMETHYL TAURATE 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%.
4610	SODIUM HYDROXYMETHYLGLYCINATE	E	Only for use in topical medicines for dermal application.
4611	SODIUM HYPOCHLORITE	E	Chlorine is a mandatory component of sodium hypochlorite. The concentration of chlorine in the medicine must not be more than 4%.
4612	SODIUM ISOSTEAROYL LACTYLATE	E	Only for use in topical medicines for dermal application.
4613	SODIUM LACTATE	E
4614	SODIUM LAURETH SULFATE	E
4615	SODIUM LAUROAMPHOACETATE	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%.
4616	SODIUM LAUROYL METHYL ISETHIONATE	E	Only for use in wash-off 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 11%.
4617	SODIUM LAUROYL SARCOSINATE	E	Only for use in topical medicines for dermal application.
4618	SODIUM LAURYL PHOSPHATE	E
4619	SODIUM LAURYL SULFATE	E
4620	SODIUM LAURYL SULFOACETATE	E	Only for use in topical medicines for dermal application.
4621	SODIUM MAGNESIUM SILICATE	E	Only for use in topical medicines for dermal application.
4622	SODIUM MANNOSE 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 0.5%.
4623	SODIUM METABISULFITE	E
4624	SODIUM METAPHOSPHATE	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye or damaged skin. The concentration in the medicine must not be more than 0.1%.
4625	SODIUM METHYL COCOYL TAURATE	E	Only for dental use. The concentration in the medicine must be no more than 2%.
4626	SODIUM METHYL HYDROXYBENZOATE	E
4627	SODIUM MOLYBDATE DIHYDRATE	A	Only for use in oral medicines. Molybdenum is a mandatory component of Sodium molybdate dihydrate. The percentage of molybdenum from sodium molybdate dihydrate should be calculated based on the molecular weight of sodium molybdate dihydrate. The maximum daily dose of molybdenum from Sodium molybdate dihydrate must be no more than 125 micrograms.
4628	SODIUM MONOFLUOROPHOSPHATE	A	Fluoride is a mandatory component of sodium monofluorophosphate. The route of administration must be limited to dental. The dosage form must be limited to pastes, powders and/or gels for dental hygiene. When sodium monofluorophosphate is used as an active ingredient, it is subject to the following conditions: (a) only for use in combination with at least one other active ingredient; and (b) the concentration of fluoride ion in the medicine must not be more than 1,500 mg/kg. When the concentration of fluoride ion is more than 1000 mg/kg, the following warning statements are required on the medicine label: - (DNTSW) 'Do not swallow.' - (CHILD4) 'Do not use [this product/insert name of product] in children 6 years of age or less.'
4629	SODIUM MYRISTOYL 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 0.0164%.
4630	SODIUM NITRATE	H	Only for use as an active homoeopathic ingredient.
4631	SODIUM NONOXYNOL-4 SULFATE	E	Only for use in topical medicines for dermal application.
4632	SODIUM PANTOTHENATE	A, E, H
4633	SODIUM PCA	E	Only for use in topical medicines for dermal application.
4634	SODIUM PERBORATE	A, H	Boron is a mandatory component of sodium perborate. When for internal use, the maximum recommended daily dose must not provide more than 6 mg of boron. When used in preparations for dermal use, which are not for paediatric or antifungal use, the concentration of boron from all ingredients in the product must not exceed 3500 mg/kg or 3500 mg/L or 0.35%. When the maximum recommended daily dose of the medicine provides more than 3 mg of boron and the medicine is for internal use and/or oral application, one of the following warning statements is required on the label: - (NTAKEN12) 'Not to be taken by children under 12 years old' (or words to that effect); or - (ADULT) 'Adults only' (or words to that effect). When the maximum recommended daily dose of the medicine provides more than 1 mg boron and up to, and including, 3 mg of boron, and the medicine is for internal use and/or oral application, one of the following warning statements is required on the label: - (NTAKEN2) 'Not to be taken by children under 2 years old' (or words to that effect); or - (ADULT) 'Adults only' (or words to that effect). When for excipient use and the maximum recommended daily dose of the medicine provides more than 1 mg of boron and the medicine is for internal use and/or oral application, the following warning statement is required on the label: - (BORON) 'Contains boron' (or words to that effect). When the medicine is for topical use for dermal application, the following warning statement is required on the label: - (BROKEN) 'Use on unbroken skin only' (or words to that effect).
4635	SODIUM PERCARBONATE	E	Only for use in topical medicines for dermal application. The concentration in the medicine must be no more than 15%.
4636	SODIUM POLYACRYLATE	E	Only for use in topical medicines for dermal application.
4637	SODIUM POLYACRYLATE STARCH	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 1%.
4638	SODIUM POLYMETAPHOSPHATE	E
4639	SODIUM PROPIONATE	E
4640	SODIUM PROPYL HYDROXYBENZOATE	E
4641	SODIUM RNA	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%.
4642	SODIUM SELENATE	A, H	Selenium is a mandatory component of sodium selenate. Oral medicines must contain no more than 150 micrograms of selenium per maximum recommended daily dose. When for oral use, the medicine requires the following warning statement on the medicine label: - (SELE) 'This medicine contains selenium which is toxic in high doses. A daily dose of 150 micrograms for adults of selenium from dietary supplements should not be exceeded.'
4643	SODIUM SELENATE DECAHYDRATE	A	Selenium is a mandatory component of sodium selenate decahydrate. Oral medicines must contain no more than 150 micrograms of selenium per maximum recommended daily dose. When for oral use, the medicine requires the following warning statement on the medicine label: - (SELE) 'This medicine contains selenium which is toxic in high doses. A daily dose of 150 micrograms for adults of selenium from dietary supplements should not be exceeded.'
4644	SODIUM SELENITE	A, H	Selenium is a mandatory component of Sodium selenite. Oral medicines must contain no more than 150 micrograms of selenium per maximum recommended daily dose. When for oral use, the medicine requires the following warning statement on the medicine label: - (SELE) 'This medicine contains selenium which is toxic in high doses. A daily dose of 150 micrograms for adults of selenium from dietary supplements should not be exceeded.’
4645	SODIUM SELENITE PENTAHYDRATE	A	Selenium is a mandatory component of Sodium selenite pentahydrate. Oral medicines must contain no more than 150 micrograms of selenium per maximum recommended daily dose. When for oral use, the medicine requires the following warning statement on the medicine label: - (SELE) 'This medicine contains selenium which is toxic in high doses. A daily dose of 150 micrograms for adults of selenium from dietary supplements should not be exceeded.’
4646	SODIUM SILICATE	E
4647	SODIUM STARCH GLYCOLLATE	E
4648	SODIUM STARCH GLYCOLLATE TYPE A	E
4649	SODIUM STEARATE	E	Only for use in topical medicines for dermal application.
4650	SODIUM STEAROXY PG-HYDROXYETHYLCELLULOSE SULFONATE	E	Only for use 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 2%.
4651	SODIUM STEAROYL GLUTAMATE	E	Only for use 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 2.5%.
4652	SODIUM STEAROYL LACTYLATE	E	Only for use in topical medicines for dermal application.
4653	SODIUM STEARYL PHTHALAMATE	E	Only for use in 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 1.5%.
4654	SODIUM SUCCINATE	E	Only for use in topical medicines for dermal application.
4655	SODIUM SULFATE	A, E, H	When it is not intended to be a laxative, the following warning statement is required on the medicine label: - (LAX4) 'Substance may have a laxative effect'.
4656	SODIUM SULFATE DECAHYDRATE	A, E, H	When it is not intended to be a laxative, the following warning statement is required on the medicine label: - (LAX4) 'Substance may have a laxative effect'.
4657	SODIUM SULFITE	E
4658	SODIUM SULFITE HEPTAHYDRATE	E	Only for use in topical medicines for dermal application.
4659	SODIUM TRIPOLYPHOSPHATE	E	Only for use when the route of administration is topical for dermal application, mucous membrane (buccal mucosa) or dental. Not to be included in topical medicines intended for use in the eye. The concentration in the medicine must be no more than 5%.
4660	SOLANUM DULCAMARA	A, H	When for internal use, steroidal alkaloids calculated as solanine is a mandatory component of Solanum dulcamara. When for internal use, the maximum recommended daily dose must not provide more than 10mg of steroidal alkaloids calculated as solanine.
4661	SOLANUM FEROX	A, H	When for internal use, steroidal alkaloids calculated as solanine is a mandatory component of Solanum ferox. When for internal use, the maximum recommended daily dose must not provide more than 10mg of steroidal alkaloids calculated as solanine.
4662	SOLANUM LYCOCARPUM FRUIT EXTRACT	E	Only for use in topical medicines for dermal use and not to be included in topical medicines intended for use in the eye. The concentration in the medicine must be no more than 0.02%.
4663	SOLANUM MELONGENA	A, H	When for internal use, steroidal alkaloids calculated as solanine is a mandatory component of Solanum melongena. When for internal use, the maximum recommended daily dose must not provide more than 10mg of steroidal alkaloids calculated as solanine.
4664	SOLANUM NIGRUM	A, H	When for internal use, steroidal alkaloids calculated as solanine is a mandatory component of Solanum nigrum. When for internal use, the maximum recommended daily dose must not provide more than 10mg of steroidal alkaloids calculated as solanine.
4665	SOLANUM TUBEROSUM	A, H	When for internal use, steroidal alkaloids calculated as solanine is a mandatory component of Solanum tuberosum. When for internal use, the maximum recommended daily dose must not provide more than 10mg of steroidal alkaloids calculated as solanine.
4666	SOLIDAGO GIGANTEA	A, H
4667	SOLIDAGO GIGANTEA MIS	A, E, H
4668	SOLIDAGO VIRGAUREA	A, E, H
4669	SOLUBLE MAIZE STARCH	E
4670	SOLUBLE POTATO STARCH	E
4671	SOLVENT GREEN 3	E	Permitted for use only as a colour for topical use.
4672	SOLVENT RED 1	E	Permitted for use only as a colour for topical use.
4673	SOLVENT VIOLET 13	E	Permitted for use only as a colour for topical use.
4674	SOLVENT YELLOW 172	E	Permitted for use only as a colour for topical use. The concentration in the medicine must be no more than 0.3%.
4675	SOLVENT YELLOW 33	E	Permitted for use only as a colour for topical use.
4676	SOPHORA FLAVESCENS	A, E, H
4677	SOPHORA TONKINENSIS	A, H
4678	SORBIC ACID	E
4679	SORBITAN ISOSTEARATE	E	Only for use in topical medicines for dermal application.
4680	SORBITAN MONO-OLEATE	E
4681	SORBITAN MONOLAURATE	E
4682	SORBITAN MONOSTEARATE	E
4683	SORBITAN OLEATE	E
4684	SORBITAN OLIVATE	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%.
4685	SORBITAN PALMITATE	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%.
4686	SORBITAN SESQUIISOSTEARATE	E	Only for use in topical medicines for dermal application.
4687	SORBITAN SESQUIOLEATE	E	Only for use in topical medicines for dermal application.
4688	SORBITAN STEARATE	E
4689	SORBITAN TRISTEARATE	E	Only for use in topical medicines for dermal application.
4690	SORBITOL	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.
4691	SORBITOL SOLUTION (70 PER CENT) (CRYSTALLISING)	A, E	Sorbitol is a mandatory component of sorbitol solution (70 per cent) (crystallising). 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.
4692	SORBITOL SOLUTION (70 PER CENT) (NON-CRYSTALLISING)	A, E	Sorbitol is a mandatory component of sorbitol solution (70 per cent) (non-crystallising). 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.
4693	SORBUS AUCUPARIA	A, H
4694	SORGHUM	E
4695	SORGHUM VULGARE	A, H
4696	SOY PHOSPHATIDYLSERINE-ENRICHED SOY LECITHIN LIQUID	A	Soy phosphatidylserine is a mandatory component of soy phosphatidylserine-enriched soy lecithin liquid. The concentration of soy phosphatidylserine in the medicine must be no more than 15%.
4697	SOY PHOSPHATIDYLSERINE-ENRICHED SOY LECITHIN POWDER	A	Soy phosphatidylserine is a mandatory component of soy phosphatidylserine-enriched soy lecithin powder. The concentration of soy phosphatidylserine in the medicine must be no more than 15%.
4698	SOY POLYSACCHARIDE	E
4699	SOY PROTEIN	E
4700	SOY STEROL	E
4701	SOYA BEAN	E
4702	SOYA BRAN	E
4703	SOYA OIL	A, E, H
4704	SOYBEAN FLOUR	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%.
4705	SOYBEAN GLYCERIDES	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%.
4706	SPARGANIUM STOLONIFERUM	A, H
4707	SPARTIUM JUNCEUM	A, H
4708	SPATHOLOBUS SUBERECTUS	A, H
4709	SPEARMINT OIL	A, E, H	Menthol is a mandatory component of spearmint oil. When the medicine is for topical use for dermal application: (i) the medicine must not be intended for use in the eye or on damaged skin; (ii) the medicine must not deliver more than 25% total menthol when administered according to the directions for use; (iii) the following warning statement is required on the medicine label: - (EYE) Avoid contact with eyes (or words to that effect). (iv) if the medicine delivers more than 1% total menthol when administered according to the directions for use, the following warning statements are required on the medicine label: - (SKTEST) If you have sensitive skin, test this product on a small area of skin before applying it to a large area; - (IRRIT) If irritation develops, discontinue use. (v) if the medicine delivers more than 5% total menthol when administered according to the directions for use, the following warning statement is required on the medicine label: – (MENTH) Contains a high concentration of menthol, which can cause severe skin irritation. When the medicine is for internal use, the maximum recommended daily dose must not contain more than 1 gram of menthol.
4710	SPEARMINT OIL TERPENELESS	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%. Menthol is a mandatory component of spearmint oil terpeneless. When the medicine is for topical use for dermal application: i) the medicine must not be intended for use in the eye or on damaged skin; ii) the medicine must not deliver more than 25% total menthol when administered according to the directions for use; iii) the following warning statement is required on the medicine label: - (EYE) Avoid contact with eyes (or words to that effect). iv) if the medicine delivers more than 1% total menthol when administered according to the directions for use, the following warning statements are required on the medicine label: - (SKTEST) If you have sensitive skin, test this product on a small area of skin before applying it to a large area; - (IRRIT) If irritation develops, discontinue use. v) if the medicine delivers more than 5% total menthol when administered according to the directions for use, the following warning statement is required on the medicine label: – (MENTH) Contains a high concentration of menthol, which can cause severe skin irritation. When the medicine is for internal use, the maximum recommended daily dose must not contain more than 1 gram of menthol.
4711	SPHINGOLIPIDS	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%.
4712	SPIGELIA ANTHELMIA	A, H
4713	SPIGELIA MARILANDICA	A, H	The maximum recommended daily dose must be no more than the equivalent of 1mg of the dry herbal material.
4714	SPIKE LAVENDER OIL	A, E, H	Camphor is a mandatory component of spike lavender oil. 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'. If the concentration of camphor is more than 2.5%, the nominal capacity of the container must be no more than 25 millilitres.
4715	SPINACH	E
4716	SPINACIA OLERACEA	A, E, H
4717	SPIRODELA POLYRRHIZA	A, H
4718	SPIRULINA	E
4719	SPRAY-DRIED GLUCOSE 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%.
4720	SPRAY-DRIED LIQUID GLUCOSE	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%.
4721	SPRUCE 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%.
4722	SQUALANE	E	Only for use in topical medicines for dermal application.
4723	SQUALENE	A, E
4724	SQUID OIL	A	Only for use in oral medicines. The medicine requires the following warning statement on the medicine label: - (SFOOD) 'Derived from seafood'. Must be obtained from species of the order Teuthida of the class Cephalopoda, be used in combination with other ingredients in the medicine and be presented in a therapeutic dosage form for therapeutic use.
4725	SQUILL DRY	A, H
4726	SQUILL INDIAN DRY	A, H
4727	SQUILL INDIAN POWDER	A, H
4728	SQUILL POWDER	A, H
4729	ST JOHN'S WORT DRY EXTRACT QUANTIFIED	A	When used for oral ingestion, the medicine requires the following warning statement on the medicine label: - (STJOHN) 'St John's Wort affects the way many prescription medicines work - including oral contraceptives. Consult your doctor.'
4730	ST JOHN'S WORT HERB DRY	A, H	When used for oral ingestion, the medicine requires the following warning statement on the medicine label: - (STJOHN) 'St John's Wort affects the way many prescription medicines work - including oral contraceptives. Consult your doctor.'
4731	ST JOHN'S WORT HERB POWDER	A, H	When used for oral ingestion, the medicine requires the following warning statement on the medicine label: - (STJOHN) 'St John's Wort affects the way many prescription medicines work - including oral contraceptives. Consult your doctor.'
4732	STACHYS OFFICINALIS	A, E, H
4733	STACHYS PALUSTRIS	A, H
4734	STACHYURUS HIMALAICUS	A, H
4735	STANNIC OXIDE	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 0.005%.
4736	STANNOUS CHLORIDE	H	Only for use as an active homoeopathic ingredient.
4737	STAR ANISE OIL	A, E	When the concentration in the medicine is more than 50% and the nominal capacity of the container is equal to or less than 50mL, a restricted flow insert must be 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).
4738	STARCH	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%.
4739	STARCH SODIUM OCTENYL SUCCINATE	E
4740	STEARALKONIUM CHLORIDE	E	Only for use in topical medicines for dermal application.
4741	STEARALKONIUM HECTORITE	E	Only for use in topical medicines for dermal application.
4742	STEARAMIDE	E	Only for use in topical medicines for dermal application.
4743	STEARAMIDOETHYL DIETHYLAMINE	E	Only for use in topical medicines for dermal application.
4744	STEARAMIDOPROPYL DIMETHYLAMINE	E	Only for use in topical medicines for dermal application.
4745	STEARAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE	E	Only for use in topical medicines for dermal application. The concentration in the medicine must be no more than 2%. When the medicine is intended to be used on the eye, the medicine requires the following warning statement on the medicine label: - (EYE2) 'May be irritant to the eyes' (or words to that effect).
4746	STEARETH-10	E	Only for use in topical medicines for dermal application.
4747	STEARETH-100	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%.
4748	STEARETH-2	E	Only for use in topical medicines for dermal application.
4749	STEARETH-20	E	Only for use in topical medicines for dermal application.
4750	STEARETH-21	E	Only for use in topical medicines for dermal application.
4751	STEARETH-5	E	Only for use in topical medicines for dermal application.
4752	STEARIC ACID	E
4753	STEAROPTENES	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%.
4754	STEAROXY DIMETHICONE	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%.
4755	STEAROXYTRIMETHYLSILANE	E	Only for use in topical medicines for dermal application.
4756	STEAROYL MACROGOLGLYCERIDES	E	Only for use in oral medicines. The concentration in the medicine must be no more than 0.6%.
4757	STEARYL ACETATE	E	Only for use in topical medicines for dermal application.
4758	STEARYL ALCOHOL	E
4759	STEARYL BEHENATE	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 not be more than 3.5% in the final formulation.
4760	STEARYL DIMETHICONE	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 4.5%. The medicine requires the following warning statements on the medicine label: - (EYE2) 'May be irritant to the eyes' (or words to that effect) - (EYE) 'Avoid contact with eyes' (or words to that effect).
4761	STEARYL GLYCYRRHETINATE	E	Only for use in topical medicines for dermal application.
4762	STEARYL HEPTANOATE	E	Only for use in topical medicines for dermal application.
4763	STEARYL MYRISTATE	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%.
4764	STEARYL STEARATE	E	Only for use in topical medicines for dermal application.
4765	STELLARIA CHAMAEJASME	A, H
4766	STELLARIA DICHOTOMA	A, H
4767	STELLARIA MEDIA	A, E, H
4768	STEMONA JAPONICA	A, H
4769	STEMONA SESSILIFOLIA	A, H
4770	STENOTAPHRUM SECUNDATUM	A, H
4771	STEPHANIA TETRANDA	A, H
4772	STERCULIA	A, H
4773	STERCULIA TRAGACANTHA	A, H
4774	STERCULIA URENS	A, H
4775	STEVIA REBAUDIANA	A, E, H
4776	STEVIOL GLYCOSIDES	E	Only for use in oral medicines.
4777	STILLINGIA SYLVATICA	A, H
4778	STORAX PREPARED	A, E, H
4779	STRAWBERRY	E
4780	STRAWBERRY ESSENCE	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%.
4781	STREPTOCOCCUS SALIVARIUS	A	Only permitted for use in medicines: - that are for oral routes of administration; and - when the strain of Streptococcus salivarius is confirmed to be K12 or M18. The name of the Streptococcus salivarius strain must be declared on the label. The following warning statement is required on the medicine label: - (CHILD5) 'Use in children under 3 years is not recommended'.
4782	STREPTOCOCCUS THERMOPHILUS	A
4783	STROBILANTHES CUSIA	A, H
4784	STRONG AMMONIA SOLUTION	E	Ammonia is a mandatory component of strong ammonia solution. The concentration of ammonia in the medicine must be no more than 0.5%. When for internal use, the concentration in the medicine must be no more than 0.25%.
4785	STRONTIUM CARBONATE	H	Only for use as an active homoeopathic ingredient.
4786	STROPHANTHUS GRATUS	H	Only for use as an active homoeopathic ingredient.
4787	STROPHANTHUS HISPIDUS	H	Only for use as an active homoeopathic ingredient.
4788	STRYCHNOS IGNATII	H	Only for use as an active homoeopathic ingredient. Strychnine (of Strychnos spp.) is a mandatory component of Strychnos ignatii. The concentration of Strychnine (of Strychnos spp.) must be no more than 1 milligram/Kg or 1 milligram/L or 0.1%.
4789	STRYCHNOS NUX-VOMICA	A, H	Strychnine (of Strychnos spp.) is a mandatory component of Strychnos nux-vomica. The concentration of Strychnine (of Strychnos spp.) must be no more than 1 milligram/Kg or 1 milligram/L or 0.1%.
4790	STYPHNOLOBIUM JAPONICUM	A, E, H
4791	STYRALLYL PROPIONATE	E	Only for use in medicines in combination with other permitted ingredients as a fragrance proprietary excipient formulation. The total fragrance proprietary excipient formulation in a medicine must not be more than 1%.
4792	STYRAX BENZOIN	A, E, H
4793	STYRAX 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%.
4794	STYRAX PARALLELONEURUM	A, H
4795	STYRAX TONKINENSIS	A, H
4796	STYRENE	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%.
4797	STYRENE/ACRYLATES COPOLYMER	E	Only for use in topical medicines for dermal application.
4798	STYROLYL 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%.
4799	SUBLIMED SULFUR	H	Only for use as an active homoeopathic ingredient.
4800	SUCCINIC ACID	E
4801	SUCRALOSE	E
4802	SUCROSE	E
4803	SUCROSE ACETATE 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%.
4804	SUCROSE ACETATE PALMITATE STEARATE	E	Only for use 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 0.3%.
4805	SUCROSE COCOATE	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%.
4806	SUCROSE DISTEARATE	E	Only for use in topical medicines for dermal application.
4807	SUCROSE LAURATE	E	When for oral or sublingual use, sucrose is a mandatory component of sucrose laurate.
4808	SUCROSE OCTAACETATE	E	When for oral or sublingual use, sucrose is a mandatory component of sucrose octaacetate.
4809	SUCROSE PALMITATE	E	Only for use in topical medicines for dermal application.
4810	SUCROSE POLYCOTTONSEEDATE	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%. The medicine requires the following warning statements on the medicine label: - (EYE) 'Avoid contact with the eyes' (or words to that effect) - (EYE2) 'May be irritant to the eyes' (or words to that effect).
4811	SUCROSE STEARATE	E	For use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. When for topical use, the concentration in the medicine must be no more than 0.25%. For oral use as a manufacturing aid only. When for oral use, the concentration in the medicine must be no more than 0.2 mg per dosage unit.
4812	SUCROSE TRISTEARATE	E	Only for use in topical medicines for dermal application and not to be included in medicines for use in the eye or on damaged skin. The concentration in the medicine must be no more than 2%.
4813	SUDAN III	E	Permitted for use only as a colour for topical use.
4814	SUGAR CANE WAX ALCOHOLS	A, H	The maximum recommended daily dose must not provide more than 12mg. The medicine requires the following warning statements on the medicine label: - (PREGNT) 'Not recommended for use by pregnant and lactating women' (or words to that effect).
4815	SUGARCANE	E, H	When for oral or sublingual use, sucrose is a mandatory component of sugarcane.
4816	SULFATED CASTOR OIL	E	Only for use in topical medicines for dermal application.
4817	SULFATED LOW MOLECULAR WEIGHT FUCANS	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%.
4818	SULFUR DIOXIDE	E
4819	SULFUR IODIDE	H	Only for use as an active homoeopathic ingredient.
4820	SULFURIC ACID	E, H	Only for use as an active homoeopathic ingredient or excipient ingredient. The concentration in the medicine must be no more than 0.5%.
4821	SULFURISED 1-METHYL-4-(1-METHYLETHENYL)-CYCLOHEXENE	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%.
4822	SULISOBENZONE	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 not be more than 10%. When used in primary sunscreen products, the following warning statements are required 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).
4823	SULISOBENZONE SODIUM	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 not be more than 10%. When used in primary sunscreen products, the following warning statements are required 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).
4824	SUNFLOWER OIL	A, E, H
4825	SUNFLOWER SEED	E, H
4826	SUNSET YELLOW FCF	E	Permitted for use only as a colour for either topical use or with an oral route of administration.
4827	SUNSET YELLOW FCF ALUMINIUM LAKE	E	Permitted for use only as a colour in medicines limited to topical and oral routes of administration.
4828	SUPEROXIDE DISMUTASE	E	Only for use in topical medicines for dermal application.
4829	SWEDE	E
4830	SWEET ORANGE OIL TERPENES AND TERPENOIDS	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%.
4831	SWEET POTATO	E
4832	SWERTIA CHIRATA	A, H
4833	SWIETENIA MAHOGANI	A, H
4834	SYAGRUS ROMANZOFFIANA	A, E, H
4835	SYMPHYOTRICHUM NOVI-BELGII	A, H
4836	SYMPHYTUM OFFICINALE	H	When used orally as an active homoeopathic ingredient, the concentration must be a dilution of 12X or more. When used in topical medicines for dermal application, the concentration in the preparation must be no more than 10mg/kg or 10mg/L or 0.001%.
4837	SYMPLOCARPUS FOETIDUS	A, H
4838	SYNTHETIC BEESWAX	E	Only for use in topical medicines for dermal applications.
4839	SYNTHETIC TERPENE RESIN	E	Only for use in topical, oral or oral application medicines. When the route of administration is oral, the dosage form must be chewing gum.
4840	SYNTHETIC WAX	E
4841	SYRINGA RETICULATA	A, H
4842	SYRINGA VULGARIS	A, H
4843	SYZYGIUM AROMATICUM	A, E, H	When the plant preparation is oil or distillate and the concentration of this oil or distillate in the product is greater 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'. When the plant preparation is oil or distillate, the concentration of this oil or distillate in the medicine is greater than 25% and the nominal capacity of the container is more than 15 millilitres but less than or equal to 25 millilitres, a child resistant closure and restricted flow insert must be fitted on the container. When the plant preparation is oil or distillate, the concentration of oil or distillate in the product is greater than 25% and the nominal capacity of the container is less than 15 millilitres, a restricted flow insert must be fitted on the container. When the plant preparation is oil or distillate and the preparation is for topical use in the mouth, the preparation may not contain more than 5 millilitres of the oil or distillate and the concentration of oil or distillate in the product must not be greater than 25%.
4844	SYZYGIUM CUMINI	A, H
4845	SYZYGIUM JAMBOS	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 0.0693%.
4846	TABEBUIA SERRATIFOLIA	A, E, H
4847	TAGETES ERECTA	A, E, H	When used as an excipient ingredient, only for use in combination with other permitted ingredients as a flavour proprietary excipient formulation. The total flavour proprietary excipient formulation in a medicine must not be more than 5%.
4848	TAGETES MINUTA	A, E, H
4849	TAGETES 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%.
4850	TAIPAN SNAKE	H	Only for use as an active homoeopathic ingredient.
4851	TALLOW	E	Only for use in topical medicines for dermal application.
4852	TALLOW GLYCERIDES	E
4853	TAMARINDUS INDICA	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%.
4854	TAMARIX APHYLLA	A, H
4855	TAMARIX CHINENSIS	A, H
4856	TAMARIX GALLICA	A, H
4857	TAMUS COMMUNIS	A, H	If the plant part is fruit or root, the maximum recommended daily dose must be no more than 1mg of the equivalent dry fruit or dry root of Tamus communis.
4858	TANACETUM CINERARIIFOLIUM	A, H	The concentration in the medicine must be no more than 10%.
4859	TANACETUM PARTHENIUM	A, E, H
4860	TANACETUM VULGARE	A, H	Oil (of Tanacetum vulgare) is a mandatory component of Tanacetum vulgare. The concentration of oil (of Tanacetum vulgare) in the medicine must be no more than 0.8%.
4861	TANGERINE 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%.
4862	TANGERINE OIL COLDPRESSED	A, E, H	When used internally, oxedrine is a mandatory component of tangerine oil coldpressed. The quantity of oxedrine in the maximum recommended daily dose must be no more than 30 milligrams.
4863	TANNIC ACID	E
4864	TAPIOCA STARCH	E
4865	TARAXACUM MONGOLICUM	A, E, H
4866	TARAXACUM OFFICINALE	A, E, H
4867	TARO	E
4868	TARRAGON OIL	A, E, H
4869	TARTARIC ACID	E
4870	TARTRAZINE	E	Only for use as a colour. Only for use in medicines for topical and oral administration.
4871	TARTRAZINE ALUMINIUM LAKE	E	Only for use as a colour. Only for use in medicines for topical and oral administration.
4872	TASMANNIA LANCEOLATA	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%.
4873	TAURINE	A, E
4874	TEA-STEARATE	E	Only for use in topical medicines for dermal application.
4875	TERMINALIA ARJUNA	A	Only for use in oral medicines. Only for use when the plant part is bark. The maximum recommended daily dose must be no more than 6 grams of Terminalia arjuna dried bark or its extract equivalents. The medicine requires the following warning statements on the medicine label: - (PREGNT) 'Not recommended for use by pregnant and lactating women' (or words to that effect) - (CHILD2) 'Not suitable for children'.
4876	TERMINALIA BELLIRICA	A	Only for use when the preparation is as an aqueous extract of the fruit pericarp.
4877	TERMINALIA CATAPPA	A, H
4878	TERMINALIA CHEBULA	A, H
4879	TERMINALIA FERDINANDIANA	A, E, H	Only for use when the plant part is fruit flesh, fruit flesh dry or the preparation is as an aqueous extract of the fruit flesh. When used as an excipient, the ingredient is only for use in topical medicines for dermal application and not to be included in medicines intended for use on damaged skin or in the eye. When used as an excipient, the concentration in the medicine must be no more than 0.3%.
4880	TERMINALIA SERICEA	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye. Only for use when the plant part is root bark. Only methanol/water (90:10; V/V) extract of Terminalia sericea bark of the root is approved. The concentration in the medicine must be no more than 0.1%.
4881	TERPENE RESIN	E	Terpene resin must only be included in medicines when in combination with other permitted ingredients as a proprietary excipient formulation in medicines with a dermal route of administration for topical application.
4882	TERPINEN-4-OL	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%.
4883	TERPINEOL	E
4884	TERPINEOL 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%.
4885	TERPINOLENE	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%.
4886	TERPINYL 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%.
4887	TERPINYL BUTYRATE	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%.
4888	TERPINYL 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%.
4889	TERT-BUTYL ALCOHOL	E	Only for use in topical medicines for dermal application.
4890	TERT-BUTYL HYDROQUINONE	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%.
4891	TERT-BUTYL 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%.
4892	TERT-BUTYLPYRAZINE	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%.
4893	TETRACLINIS ARTICULATA	A, E, H
4894	TETRADECYL AMINOBUTYROYLVALYLAMINOBUTYRIC UREA TRIFLUOROACETATE	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 0.002%.
4895	TETRADIUM RUTICARPUM	A, H	When for internal use, oxedrine is a mandatory component of Tetradium ruticarpum. The quantity of oxedrine in the maximum recommended daily dose must be no more than 30 mg.
4896	TETRAHEXYLDECYL ASCORBATE	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%.
4897	TETRAHYDRO LINALYLACETATE	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%.
4898	TETRAHYDRO PARA-METHYLQUINOLINE	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%.
4899	TETRAHYDRO-6-(3-PENTENYL)-2H-PYRAN-2-ONE	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%.
4900	TETRAHYDRODIFERULOYLMETHANE	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%.
4901	TETRAHYDROFURFURYL 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%.
4902	TETRAHYDROGERANYL 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%.
4903	TETRAHYDROLINALOOL	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%.
4904	TETRAHYDROMUGUOL	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%.
4905	TETRAHYDROMYRCENOL	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%.
4906	TETRAHYDROXYPROPYL ETHYLENEDIAMINE	E	Only for use in topical medicines for dermal application.
4907	TETRAMETHYL ACETYLOCTAHYDRONAPHTHALENES	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%.
4908	TETRAPANAX PAPYRIFER	A, H
4909	TETRASODIUM ETIDRONATE	E	Only for use in topical medicines for dermal application.
4910	TETRASODIUM PYROPHOSPHATE	E
4911	TEUCRIUM CHAMAEDRYS	A, H	The maximum recommended daily dose must be no more than 1mg of the equivalent dry herbal material of Teucrium chamaedrys.
4912	TEUCRIUM MARUM	A, H	The maximum recommended daily dose must be no more than 1mg of the equivalent dry herbal material of Teucrium marum.
4913	TEUCRIUM SCORODONIA	A, H	The maximum recommended daily dose must be no more than 1mg of the equivalent dry herbal material of Teucrium scorodonia.
4914	THAPSIA GARGANICA	A, H
4915	THAUMATIN	E
4916	THEASPIRANE	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%.
4917	THEMEDA TRIANDRA	A, H
4918	THEOBROMA CACAO	A, E, H	Caffeine is a mandatory component of Theobroma cacao. When the medicine is packaged for supply as an undivided preparation and is for internal use or oral application, the medicine must not contain a concentration of total caffeine greater than 4%. When the medicine is packaged for supply as a divided preparation and is for internal use or oral application, the medicine must not contain a concentration of total caffeine greater than 33%. When for internal use or oral application, the maximum recommended daily dose of the medicine must provide no more than 400 mg of total caffeine. When the medicine is packaged for supply as an undivided preparation and is for internal use or oral application, the medicine must not contain a concentration of total caffeine greater than 1%. When the medicine is for internal use or oral application, a maximum recommended dose of the medicine must not provide more than 100 mg of total caffeine within a 3 hour period. When the maximum recommended daily dose of the medicine provides greater than 10 mg of total caffeine and the medicine is for internal use or oral application, the following warning statements are required on the label: - (ADULT) 'Adults only' (or words to that effect). - (CAFF) 'Contains [state quantity per dosage unit or per mL or per gram of product] total caffeine [per dosage unit or per mL or per gram]. A cup of instant coffee contains approximately 80mg of caffeine.' - (CAFFPREG) ‘Caffeine intake more than 200 mg per day is not recommended during pregnancy or breastfeeding.’ When the maximum recommended daily dose of the medicine provides greater than 80 mg of total caffeine and the medicines is for internal use or oral application, the following warning statements are required on the label: - (CAFFLMT) 'Limit the use of caffeine-containing products (including tea and coffee) when taking this product.' - (CAFFCYP) ‘Caffeine interacts with enzyme CYP1A2 in the liver. Consult your health professional before taking with other medicines’ (or words to that effect).
4919	THEOBROMA OIL	A, E, H
4920	THIAMINE	A, E
4921	THIAMINE HYDROCHLORIDE	A, E
4922	THIAMINE NITRATE	A, E
4923	THIOCINEOLE	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%.
4924	THIOTAURINE	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 0.02%.
4925	THLASPI ARVENSE	A, E, H
4926	THREONINE	A, E
4927	THUJA OCCIDENTALIS	A, H
4928	THUJA PLICATA	A, E, H
4929	THYME HERB DRY	A, E, H
4930	THYME OIL	A, E, H	When the concentration of Thyme oil in the medicine is more than 50%, the nominal capacity of the container must be no more than 25 mL, a restricted flow insert must be fitted on the container and the medicine requires the warning statement: - (CHILD) 'Keep out of reach of children' (or words to that effect).
4931	THYMOL	A, E	When used as an active ingredient, the medicine must be medicated space spray or medicated throat lozenges. When used as an excipient, only for use in medicated throat lozenges or topical medicines for dermal applications.
4932	THYMOL METHYL ETHER	E	Thymol methyl ether must only be included in medicines when in combination with other permitted ingredients as a flavour proprietary excipient formulation. The total concentration of the flavour proprietary excipient formulation containing thymol methyl ether must not be more than 5% of the total medicine.
4933	THYMUS CAPITATUS	A, E, H	When the plant preparation is an oil, and the concentration in the medicine is more than 50%, the nominal capacity of the container must be no more than 25 mL, a restricted flow insert must be 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).
4934	THYMUS GLAND	H	Only for use as an active homoeopathic ingredient.
4935	THYMUS MASTICHINA	A, E, H	When the plant preparation is an oil, and the concentration in the medicine is more than 50%, the nominal capacity of the container must be no more than 25 mL, a restricted flow insert must be 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).
4936	THYMUS SERPYLLUM	A, E, H	When the plant preparation is an oil, and the concentration in the medicine is more than 50%, the nominal capacity of the container must be no more than 25 mL, a restricted flow insert must be 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).
4937	THYMUS VULGARIS	A, E, H	When the plant preparation is oil or distillate, and the concentration of Thymus vulgaris oil or distillate in the preparation is greater than 50%: (a) the nominal capacity of the container must not be more than 25 millilitres; (b) a restricted flow insert must be fitted on the container; and (c) the following warning statement is required on the medicine label: - (CHILD) 'Keep out of reach of children' (or words to that effect).
4938	THYMUS VULGARIS MIS	A, E, H	When the plant preparation is an oil or distillate, and the concentration of Thymus vulgaris MIS oil or distillate in the preparation is greater than 50%: (a) the nominal capacity of the container must not be more than 25 millilitres; (b) a restricted flow insert must be fitted on the container; and (c) the following warning statement is required on the label: - (CHILD) 'Keep out of reach of children' (or words to that effect).
4939	THYMUS ZYGIS	A, H	When the plant preparation is an oil or a distillate, and the concentration of Thymus zygis oil or distillate in the preparation is greater than 50%: (a) the nominal capacity of the container must not be more than 25 millilitres; (b) a restricted flow insert must be fitted on the container; and (c) the following warning statement is required on the label: - (CHILD) 'Keep out of reach of children' (or words to that effect).
4940	TIGER SNAKE	H	Only for use as an active homoeopathic ingredient.
4941	TILACTASE	A	Must be derived from Aspergillus oryzae and comply with the relevant USP monograph.
4942	TILIA CORDATA	A, E, H
4943	TILIA PLATYPHYLLOS	A, E, H
4944	TILIA TOMENTOSA	A, H
4945	TILIA X VULGARIS	A, E, H
4946	TILIANTOL	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%.
4947	TIN	H	Only for use as an active homoeopathic ingredient.
4948	TINOSPORA CORDIFOLIA	A, H
4949	TINOSPORA SINENSIS	A, H
4950	TITANIUM DIOXIDE	A, E	For use as an active ingredient only in sunscreens for dermal application. The concentration in sunscreens must be no more than 25%. For use as an excipient only as a colour and only in medicines limited to oral and topical routes of administration. Not to be included in medicines intended for use in the eye. When used in primary sunscreen products, the following warning statements are required 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).
4951	TOCOCYSTEAMIDE	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%.
4952	TOCOFERSOLAN	E	Only for oral and topical use. When for oral use, the concentration in the medicine must be no more than 10% w/w. When used in topical medicines for dermal application, it is not to be included in medicines intended for use in the eye. When for topical use, the concentration in the medicine must be no more than 0.1%
4953	TOCOPHEROL	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%.
4954	TOCOPHERYL GLUCOSIDE	E	Only for use in topical medicines for dermal application and not to be included in medicines intended for use on damaged skin or in the eye. The concentration in the medicine must be no more than 0.05%
4955	TOCOPHERYL LINOLEATE	E	Only for use in topical medicines for dermal application.
4956	TOCOPHERYL NICOTINATE	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 must not exceed 0.3%.
4957	TOLU BALSAM	A, E, H
4958	TOLUENE	E	The residual solvent limit for toluene is 8.9 mg per maximum recommended daily dose. The concentration in the medicine must be no more than 0.089%.
4959	TOLYL 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%.
4960	TOLYLALDEHYDE GLYCERYLACETAL	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%.
4961	TOMATO	E
4962	TONKA	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%.
4963	TONKA BEAN EXTRACT	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%.
4964	TONONE	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%.
4965	TOXICODENDRON DIVERSILOBUM	H	Only for use as an active homoeopathic ingredient.
4966	TOXICODENDRON PUBESCENS	H	Only for use as an active homoeopathic ingredient. The maximum recommended daily dose must be no more than 1mg of the equivalent dry herbal material of Toxicodendron pubescens.
4967	TOXICODENDRON RADICANS	A, H	The maximum recommended daily dose must be no more than 1mg of the equivalent dry herbal material of Toxicodendron radicans.
4968	TOXICODENDRON SUCCEDANEUM	H	Only for use as an active homoeopathic ingredient.
4969	TRACHELOSPERMUM JASMINOIDES	A, E, H
4970	TRACHYSPERMUM AMMI	A, E	Only for use in oral medicines when the plant part is fruit or seed. The medicine requires the following warning statements on the medicine label: - (PREGNT) 'Not recommended for use by pregnant and lactating women' (or words to that effect) - (PREGNT2) 'Do not use if pregnant or likely to become pregnant' (or words to that effect). 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%.
4971	TRAGACANTH	A, E
4972	TRAMETES VERSICOLOR	A, H
4973	TRAMETES VERSICOLOR PROTEOGLYCAN CONCENTRATE	A, H	Only for use in oral medicines.
4974	TRANS,TRANS-2,4-DECADIEN-1-AL	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%.
4975	TRANS,TRANS-2,4-HEXADIENAL	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 the medicine must be no more than 1%. The maximum daily dose must provide no more than 13.5 mg of Trans,Trans-2,4-Hexadienal.
4976	TRANS-1-(2,4,4-TRIMETHYL-2-CYCLOHEXEN-1-YL)-2-BUTEN-1-ONE	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%.
4977	TRANS-2-DECENAL	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%.
4978	TRANS-2-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%.
4979	TRANS-2-HEPTEN-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%.
4980	TRANS-2-HEXENAL	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%.
4981	TRANS-2-HEXENOIC 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%.
4982	TRANS-2-HEXENOL	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%.
4983	TRANS-2-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%.
4984	TRANS-2-HEXENYL PHENYLACETATE	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%.
4985	TRANS-2-HYDROXYCINNAMIC ACID	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%.
4986	TRANS-2-OCTENAL	E	trans-2-Octenal must only be included in medicines when in combination with other permitted ingredients as a fragrance proprietary excipient formulation. The total concentration of the fragrance proprietary excipient formulation containing trans-2-octenal must not be more than 1% of the total medicine.
4987	TRANS-2-UNDECENAL	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%.
4988	TRANS-3-HEXENOIC 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%.
4989	TRANS-4-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%.
4990	TRANS-8-(1-METHYLETHYL)-1-OXASPIRO(4.5)DECAN-2-ONE	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%.
4991	TRANS-ETHYL 2-OCTENOATE	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%.
4992	TRANS-METHYL-2-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%.
4993	TREACLE	E	When for oral or sublingual use, sucrose is a mandatory component of treacle.
4994	TREEMOSS ABSOLUTE	E	Permitted for use only in combination with other permitted ingredients as part of a fragrance proprietary excipient formulation. When included in a medicine for use on the lips the concentration of treemoss absolute must be no more than 0.02%. When for dermal use or use on the hair the concentration of treemoss absolute must be no more than 0.1% The total fragrance proprietary excipient formulation in a medicine must be no more than 1%.
4995	TREFRIW WELLS MINERAL WATER	A	When for internal use, iron is a mandatory component of Trefriw Wells mineral water. Solid dosage forms containing more than 5 milligrams of elemental iron in each dosage unit are required to have a child resistant closure. Liquid Preparations containing more than 250 milligrams of elemental iron in the total contents of the container are required to have a child resistant closure. Only able to be used when presented in single use sachets for therapeutic use as an iron supplement.
4996	TREHALOSE DIHYDRATE	E	When for oral use and the quantity of trehalose dihydrate per maximum recommended daily dose exceeds 20 grams, the quantity of trehalose dihydrate must be declared on the label.
4997	TREMELLA FUCIFORMIS	A, H
4998	TRIACETIN	E
4999	TRIACONTANYL PVP	E	Only for use in topical medicines for dermal application.
5000	TRIADICA SEBIFERA	A, H
5001	TRIBASIC 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 tribasic potassium phosphate. When used in a solid medicine containing this ingredient, 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 medicine containing this ingredient, the pH of the medicine must be no more than 11.5.
5002	TRIBASIC SODIUM PHOSPHATE	E	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.
5003	TRIBEHENIN	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 6%.
5004	TRIBEHENIN PEG-20 ESTERS	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 6%.
5005	TRIBULUS TERRESTRIS	A, E, H
5006	TRIBUTYL ACETYLCITRATE	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%.
5007	TRICALCIUM PHOSPHATE	E
5008	TRICAPRYLIN	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%.
5009	TRICAPRYLYL CITRATE	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%.
5010	TRICETEARETH-4 PHOSPHATE	E	Only for use in topical medicines for dermal application.
5011	TRICHLOROMETHYLPHENYLCARBINYL 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%.
5012	TRICHODERMA VIRIDE	A, E, H
5013	TRICHOSANTHES KIRILOWII	A, E, H
5014	TRICLOSAN	E	The concentration in the medicine must be no more than 1%.
5015	TRICYCLODECENYL 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%.
5016	TRIDECANAL	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%.
5017	TRIDECETH-4 PHOSPHATE	E	Only for use in topical medicines for dermal application.
5018	TRIDECETH-6	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%.
5019	TRIDECYL ALCOHOL	E	Permitted for use only in combination with other permitted ingredients as a fragrance. If used as in a fragrance the total fragrance concentration in a medicine must be no more than 1%.
5020	TRIDECYL BEHENATE	E	Behenic acid is a mandatory component of Tridecyl behenate. Only for use in topical medicines for dermal application.
5021	TRIDECYL NEOPENTANOATE	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 23%.
5022	TRIDECYL 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 5%.
5023	TRIDECYL STEARATE	E	Only for use in topical medicines for dermal application.
5024	TRIDECYL TRIMELLITATE	E	Only for use in topical medicines for dermal application.
5025	TRIETHOXYCAPRYLYLSILANE	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%.
5026	TRIETHYL CITRATE	E
5027	TRIETHYLENE GLYCOL	E
5028	TRIFOLIUM PRATENSE	A, E, H
5029	TRIFOLIUM REPENS	A, H
5030	TRIGONELLA FOENUM-GRAECUM	A, E, H
5031	TRIHYDROXYPALMITAMIDOHYDROXYPROPYL MYRISTYL ETHER	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 0.02%.
5032	TRIHYDROXYSTEARIN	E	Only for use in topical medicines for dermal application.
5033	TRIISOCETYL CITRATE	E	Only for use in topical medicines for dermal application.
5034	TRIISODECYL TRIMELLITATE	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%.
5035	TRIISONONANOIN	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%.
5036	TRIISOSTEARIN	E	Only for use in topical medicines for dermal application.
5037	TRILAURIN	E	Only for use in topical medicines for dermal application.
5038	TRILISA ODORATISSIMA	A, H
5039	TRILLIUM ERECTUM	A, H
5040	TRIMETHOXYCAPRYLYL SILANE	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%.
5041	TRIMETHYL HYDROXYPENTYL 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%.
5042	TRIMETHYL UNDECYLENIC ALDEHYDE	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%.
5043	TRIMETHYL-BICYCLO-HEPTANE-SPIROCYCLOHEXENONE	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%.
5044	TRIMETHYLBENZENEPROPANOL	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%.
5045	TRIMETHYLHEXANOL	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%.
5046	TRIMETHYLOPROPANE TRIOCTANOATE	E	Only for use in topical medicines for dermal application.
5047	TRIMETHYLPENTANEDIOL/ADIPIC ACID/GLYCERIN 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 5%.
5048	TRIMETHYLSILOXYSILICATE	E	Only for use in topical medicines for dermal application.
5049	TRINITROPHENOL	H	Only for use as an active homoeopathic ingredient.
5050	TRIOCTANOIN	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%.
5051	TRIOCTYLDODECYL CITRATE	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 12%.
5052	TRIOLEIN	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%.
5053	TRIOSTEUM PERFOLIATUM	A, H
5054	TRIOXAUNDECANEDIOIC ACID	E
5055	TRIPAL	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%.
5056	TRIPEPTIDE-1	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 0.002%.
5057	TRIS-BIPHENYL TRIAZINE	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 not be more than 10%. When used topically, the dosage form must not be spray. When used in primary sunscreen products, the following warning statements are required 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).
5058	TRISILOXANE	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 40%.
5059	TRISODIUM EDETATE	E	Only for use in topical medicines for dermal application.
5060	TRISODIUM ETHYLENEDIAMINE DISUCCINATE	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%.
5061	TRISODIUM NTA	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 0.005%.
5062	TRISTEARIN	E
5063	TRITICUM AESTIVUM	A, E, H	Gluten is a mandatory component when the plant part is seed and the route of administration is other than topical and mucosal.
5064	TRITICUM DURUM	A, E, H	Gluten is a mandatory component when the plant part is seed and the route of administration is other than topical and mucosal.
5065	TRIUNDECANOIN	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 11.2%.
5066	TROLAMINE	E	Only for use in topical medicines for dermal application. The concentration in the medicine must be no more than 5%.
5067	TROLAMINE LAURIL SULFATE	E	Only for use in topical medicines for dermal application.
5068	TROLAMINE SALICYLATE	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 not be more than 12%. When used in primary sunscreen products, the following warning statements are required 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).
5069	TROLLIUS CHINENSIS	A, H
5070	TROMETAMOL	E
5071	TROMETAMOL HYDROCHLORIDE	E
5072	TROPAEOLUM MAJUS	A, E, H
5073	TROPICAL RATTLESNAKE	H	Only for use as an active homoeopathic ingredient.
5074	TROPOLONE	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%.
5075	TSUGA CANADENSIS	A, H
5076	TULIPA EDULIS	A, H	Colchicine is a mandatory component of Tulipa edulis. The concentration of colchicine in the medicine must be no more than 10 mg/kg or 10 mg/L or 0.001%.
5077	TURMERIC	E	Permitted for use only in combination with other permitted ingredients as a colour.
5078	TURNERA DIFFUSA	A, E, H	Beta-arbutin is a mandatory component of Turnera diffusa. When for oral use, the maximum recommended daily dose must not provide more than 500 mg of beta-arbutin. When for dermal application exclusively to the face: a) the concentration of beta-arbutin in the medicine must not be more than 7%; b) hydroquinone is a mandatory component; and c) the concentration of hydroquinone must not be more than 10 mg/kg or 10 mg/L or 0.001%. When for use other than oral or dermal application exclusively to the face, the concentration of beta-arbutin in the medicine must not be more than 10 mg/kg or 10 mg/L or 0.001%.
5079	TURNIP	E
5080	TURPENTINE OIL	A, E	The concentration in the medicine must be no more than 25%.
5081	TYPHA ANGUSTIFOLIA	A, H
5082	TYPHA LATIFOLIA	A, H
5083	TYPHONIUM GIGANTEUM	A, H
5084	TYROSINE	A, E