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
3608	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%.
3609	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%.
3610	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 be no more than 8%. When used in primary sunscreen products and listed in the Register on or after 1 January 2018, the medicine must have the following statements on the medicine 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). When used in primary sunscreen products and listed in the Register before 1 January 2018, the medicine requires the following statements on the medicine label if supplied after 1 July 2019: - (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).
3611	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%.
3612	PAEONIA LACTIFLORA	A, E, H
3613	PAEONIA OBOVATA	A, H
3614	PAEONIA SUFFRUTICOSA	A, E, H
3615	PAEONIA VEITCHII	A, H
3616	PALIURUS SPINA-CHRISTI	A, H
3617	PALLADIUM	H	Only for use as an active homoeopathic ingredient.
3618	PALM FRUIT OIL	A, E, H
3619	PALM GLYCERIDES	E
3620	PALM KERNEL OIL	A, E, H
3621	PALM TOCOTRIENOLS COMPLEX	A, H
3622	PALMARIA PALMATA	A, H
3623	PALMAROSA OIL	A, E, H
3624	PALMITIC ACID	E
3625	PALMITOLEIC ACID-RICH FATTY ACID ETHYL ESTERS	A
3626	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%.
3627	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%
3628	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%.
3629	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%.
3630	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%.
3631	PANAX GINSENG	A, E, H
3632	PANAX JAPONICUS	A, H
3633	PANAX NOTOGINSENG	A, H
3634	PANAX PSEUDOGINSENG	A, H
3635	PANAX QUINQUEFOLIUS	A, H
3636	PANICUM MILIACEUM	A, H
3637	PANTETHINE	E	Only for use in topical medicines for dermal application.
3638	PANTHENOL	A, E
3639	PANTHENYL ETHYL ETHER	E	Only for use in topical medicines for dermal application.
3640	PANTOLACTONE	E
3641	PANTOTHENIC ACID	A, E	When used topically, the concentration in the medicine must be no more than 0.1%.
3642	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%.
3643	PAPAIN	A, E
3644	PAPER	E	Only for use in topical medicines for dermal application.
3645	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%.
3646	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%.
3647	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%.
3648	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%.
3649	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%.
3650	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%.
3651	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%.
3652	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%.
3653	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%.
3654	PARA-HYDROXYBENZOIC ACID	E
3655	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%.
3656	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%.
3657	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%.
3658	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%.
3659	PARA-PROPYL 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%.
3660	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%.
3661	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%.
3662	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%.
3663	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%.
3664	PARAMERIA LAEVIGATA	A, H
3665	PARIETARIA JUDAICA	A, H
3666	PARIS POLYPHYLLA	A, H
3667	PARIS QUADRIFOLIA	A, H
3668	PARSLEY	E, H
3669	PARSLEY HERB DRY	A, E, H
3670	PARSLEY HERB OIL	A, E, H
3671	PARSLEY HERB POWDER	A, E, H
3672	PARSLEY SEED OIL	A, E, H
3673	PARTHENOCISSUS TRICUSPIDATA	A, H
3674	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%.
3675	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%.
3676	PASPALUM NOTATUM	A, H
3677	PASSIFLORA CAERULEA	A, H
3678	PASSIFLORA EDULIS	E
3679	PASSIFLORA HERB DRY	A, H
3680	PASSIFLORA INCARNATA	A, E, H
3681	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%.
3682	PATENT BLUE V	E	Permitted for use only as a colour for oral and topical use.
3683	PATENT BLUE V ALUMINIUM LAKE	E	Permitted for use only as a colour for oral and topical use.
3684	PATRINIA SCABIOSIFOLIA	A, H
3685	PATRINIA VILLOSA	A, H
3686	PAULLINIA CUPANA	A, E, H	Caffeine is a mandatory component of Paullinia cupana when used for oral ingestion. When the route of administration is oral or sublingual and the medicine provides a maximum recommended daily dose of more than 1 mg but no more than 10 mg of caffeine in the medicine requires the following warning statement on the medicine label: - (CAFFR) ‘The recommended dose of this medicine provides small amounts of caffeine.’ When the route of administration is oral or sublingual and the medicine provides a maximum recommended daily dose of more than 10 mg of caffeine in the medicine requires the following warning statement on the medicine label: - (CAFF) ‘Contains caffeine [state quantity per dosage unit or per mL or per gram of product]’.
3687	PAULLINIA PINNATA	A, H
3688	PAWPAW	E
3689	PEA	E
3690	PEA STARCH	E
3691	PEACH	E
3692	PEANUT	E	The medicine requires the following warning statement on the medicine label: - (PEANUT) ‘Contains Peanut’ (or words to that effect).
3693	PEAR	E
3694	PECAN	E
3695	PECTIN	A, E
3696	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%.
3697	PEG-10 SOYA STEROL	E	Only for use in topical medicines for dermal application.
3698	PEG-100 STEARATE	E	Only for use in topical medicines for dermal application.
3699	PEG-12 DILAURATE	E
3700	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%.
3701	PEG-120 METHYL GLUCOSE DIOLEATE	E	Only for use in topical medicines for dermal application.
3702	PEG-120 STEARATE	E	Only for use in topical medicines for dermal application.
3703	PEG-15 COCAMINE	E	Only for use in topical medicines for dermal application.
3704	PEG-150 DISTEARATE	E	Only for use in topical medicines for dermal application.
3705	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%.
3706	PEG-20 METHYL GLUCOSE DISTEARATE	E	Only for use in topical medicines for dermal application.
3707	PEG-20 METHYL GLUCOSE SESQUISTEARATE	E	Only for use in topical medicines for dermal application.
3708	PEG-20 SORBITAN ISOSTEARATE	E	Only for use in topical medicines for dermal application.
3709	PEG-20 STEARATE	E	Only for use in topical medicines for dermal application.
3710	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 be no more than 10%. When used in primary sunscreen products and listed in the Register on or after 1 January 2018, the medicine must have the following statements on the medicine 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). When used in primary sunscreen products and listed in the Register before 1 January 2018, the medicine requires the following statements on the medicine label if supplied after 1 July 2019: - (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).
3711	PEG-30 DIPOLYHYDROXYSTEARATE	E	Only for use in topical medicines for dermal application.
3712	PEG-30 STEARATE	E	Only for use in topical medicines for dermal application.
3713	PEG-35 CASTOR OIL	E
3714	PEG-4 DILAURATE	E	Only for use in topical medicines for dermal application.
3715	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%.
3716	PEG-4 STEARATE	E	Only for use in topical medicines for dermal application.
3717	PEG-40 CASTOR OIL	E
3718	PEG-40 HYDROGENATED CASTOR OIL	E
3719	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%.
3720	PEG-40 STEARATE	E	Only for use in topical medicines for dermal application.
3721	PEG-45/DODECYL GLYCOL COPOLYMER	E	Only for use in topical medicines for dermal application.
3722	PEG-5 GLYCERYL STEARATE	E	Only for use in topical medicines for dermal application.
3723	PEG-50 STEARATE	E	Only for use in topical medicines for dermal application.
3724	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%.
3725	PEG-6 LAURAMIDE	E	Only for use in topical medicines for dermal application.
3726	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%.
3727	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%.
3728	PEG-60 HYDROGENATED CASTOR OIL	E	Only for use in topical medicines for dermal application.
3729	PEG-7 COCAMIDE	E	Only for use in topical medicines for dermal application.
3730	PEG-7 GLYCERYL COCOATE	E	Only for use in topical medicines for dermal application.
3731	PEG-7 HYDROGENATED CASTOR OIL	E	Only for use in topical medicines for dermal application.
3732	PEG-75 LANOLIN	E	Only for use in topical medicines for dermal application.
3733	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%.
3734	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%.
3735	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%.
3736	PEG-8 DISTEARATE	E	Only for use in topical medicines for dermal application.
3737	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.
3738	PEG-8 PROPYLENE GLYCOL COCOATE	E
3739	PEG-8 STEARATE	E	Only for use in topical medicines for dermal application.
3740	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%.
3741	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%.
3742	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%.
3743	PELARGONIUM GRAVEOLENS	A, E, H
3744	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%.
3745	PELTIGERA CANINA	A, H
3746	PENICILLIUM EXPANSUM	A, H
3747	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.
3748	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%
3749	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%.
3750	PENTAERYTHRITYL TETRALAURATE	E	Only for use in topical medicines for dermal application. The concentration in the medicine must be no more than 80%.
3751	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%.
3752	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%.
3753	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%.
3754	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%.
3755	PEPPER BLACK	E, H
3756	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%.
3757	PEPPER WHITE	E, H
3758	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 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; - (EYE) Avoid contact with eyes (or words to that effect). d) 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.
3759	PEPPERMINT LEAF DRY	A, E, H	When the ingredient is included in a medicine that is listed in the Register: - on or after 1 July 2018, the medicine must comply with all requirements under (a)-(c); - before 1 July 2018 and supplied on or after 1 January 2020, the medicine must comply with all requirements under (a)-(c); or - before 1 July 2018 and supplied before 1 January 2020, the medicine may comply with requirements under (a)-(c). a) Menthol is a mandatory component of peppermint leaf dry. b) 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 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; - (EYE) Avoid contact with eyes (or words to that effect). (iv) 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. c) When the medicine is for internal use, the maximum recommended daily dose must not contain more than 1 gram of menthol.
3760	PEPPERMINT LEAF POWDER	A, E, H	When the ingredient is included in a medicine that is listed in the Register: - on or after 1 July 2018, the medicine must comply with all requirements under (a)-(c); - before 1 July 2018 and supplied on or after 1 January 2020, the medicine must comply with all requirements under (a)-(c); or - before 1 July 2018 and supplied before 1 January 2020, the medicine may comply with requirements under (a)-(c). a) Menthol is a mandatory component of peppermint leaf powder. b) 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 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; - (EYE) Avoid contact with eyes (or words to that effect). (iv) 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. c) When the medicine is for internal use, the maximum recommended daily dose must not contain more than 1 gram of menthol.
3761	PEPPERMINT OIL	A, E, H	When the ingredient is included in a medicine that is listed in the Register: - on or after 1 July 2018, the medicine must comply with all requirements under (a)-(c); - before 1 July 2018, and supplied on or after 1 January 2020 the medicine must comply with all requirements under (a)-(c); or - before 1 July 2018 and supplied before 1 January 2020, the medicine may comply with requirements under (a)-(c). a) Menthol is a mandatory component of peppermint oil. b) 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 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; - (EYE) Avoid contact with eyes (or words to that effect). (iv) 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. c) When the medicine is for internal use, the maximum recommended daily dose must not contain more than 1 gram of menthol.
3762	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: 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 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; - (EYE) Avoid contact with eyes (or words to that effect). d) 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.
3763	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: 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 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; - (EYE) Avoid contact with eyes (or words to that effect). d) 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.
3764	PERFLUOROPOLYMETHYLISOPROPYL ETHER	E	Only for use in topical medicines for dermal application.
3765	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%.
3766	PERILLA FRUTESCENS	A, E, H	Rosmarinic acid and vicenin-2 are only permitted for use if the plant part of Perilla frutescens is leaf.
3767	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%.
3768	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%.
3769	PERMETHRIN	E	The concentration of in the medicine must be no more than 2%.
3770	PERSEA AMERICANA	A, E, H
3771	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%.
3772	PERSICARIA CHINENSIS	A, H
3773	PERSICARIA TINCTORIA	A, H
3774	PERSIMMON	E
3775	PERU BALSAM	A, E, H
3776	PERU BALSAM OIL	A, E, H
3777	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%
3778	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%.
3779	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%.
3780	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.
3781	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%.
3782	PETROSELINUM CRISPUM	A, E, H
3783	PEUCEDANUM PRAERUPTORUM	A, E, H
3784	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).
3785	PHALARIS ARUNDINACEA	A, H
3786	PHALARIS CANARIENSIS	A, H
3787	PHASEOLUS COCCINEUS	A, H
3788	PHASEOLUS VULGARIS	A, H
3789	PHELLINUS ROBINIAE	A, E, H
3790	PHELLODENDRON AMURENSE	A, E, H
3791	PHELLODENDRON CHINENSE	A, H
3792	PHENACETIN	E	Only for use in topical medicines for dermal application. The concentration in the medicine must be no more than 0.1%.
3793	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%.
3794	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%.
3795	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%.
3796	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%.
3797	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%
3798	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%.
3799	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%.
3800	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%.
3801	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%.
3802	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%.
3803	PHENOL	E	Only for use in topical medicines for dermal application. The concentration of phenol in the medicine must be no more than 1%.
3804	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%.
3805	PHENOXYETHANOL	E	Only for use in topical medicines for dermal application. The concentration of phenoxyethanol in the preparation must not exceed 15%.
3806	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%.
3807	PHENOXYETHYLPARABEN	E	Only for use in topical medicines for dermal application.
3808	PHENYL DIMETHICONE	E	Only for use in topical medicines for dermal application.
3809	PHENYL TRIMETHICONE	E	Only for use in topical medicines for dermal application.
3810	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%.
3811	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%.
3812	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%.
3813	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%.
3814	PHENYLALANINE	A, E	When for oral ingestion the medicine requires the following warning statement on the medicine label: - (PKU) 'Phenylketonurics are warned that this medicine contains phenylalanine' (or words to that effect). When the medicine contains more than 500mg in the maximum recommended daily dose it requires the following warning statement on the medicine label: - (PREGNT2) 'Do not use if pregnant or likely to become pregnant'.
3815	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 be no more than 4%. When used in primary sunscreen products and listed in the Register on or after 1 January 2018, the medicine must have the following statements on the medicine 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). When used in primary sunscreen products and listed in the Register before 1 January 2018, the medicine requires the following statements on the medicine label if supplied after 1 July 2019: - (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).
3816	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%.
3817	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%.
3818	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%.
3819	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%.
3820	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%.
3821	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%.
3822	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%.
3823	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%.
3824	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%.
3825	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%.
3826	PHLEUM PRATENSE	A, H
3827	PHLOXINE B	E	Permitted for use only as a colour for oral and topical use.
3828	PHLOXINE B ALUMINIUM LAKE	E	Permitted for use only as a colour for oral and topical use.
3829	PHOENIX DACTYLIFERA	A, E, H
3830	PHOSPHATIDYL CHOLINE	E
3831	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%.
3832	PHOSPHORIC ACID	E, H	The concentration in liquid medicines must be no more than 15%.
3833	PHOSPHORUS	H	Only for use as an active homoeopathic ingredient.
3834	PHOTINIA SERRULATA	A, H
3835	PHRAGMITES AUSTRALIS	A, H
3836	PHYLLANTHUS AMARUS	A, H
3837	PHYLLANTHUS EMBLICA	A, E, H	When used as an excipient, only for use in topical medicines for dermal application. When ascorbic acid is claimed as a component the plant part is restricted to fruit.
3838	PHYLLOSTACHYS NIGRA	A, E, H
3839	PHYSALIS ALKEKENGI	A, H
3840	PHYSALIS PUBESCENS	A, H
3841	PHYTANTRIOL	E	Only for use in topical medicines for dermal application. The concentration in the medicine must be no more than 0.5%.
3842	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%.
3843	PHYTOLACCA AMERICANA	A, H	The maximum recommended daily dose of the medicine must contain no more than 1mg of the equivalent dry herb.
3844	PHYTOMENADIONE	A, E
3845	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%.
3846	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%.
3847	PICEA ABIES	A, H
3848	PICEA MARIANA	A, H
3849	PICRASMA EXCELSA	A, E, H
3850	PICRORRHIZA KURROA	A, E, H
3851	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%.
3852	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%.
3853	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%.
3854	PIGMENT RED 4	E	Permitted for use only as a colour for topical use.
3855	PIGMENT RED 53	E	Permitted for use only as a colour for topical use.
3856	PIGMENT RED 57	E	Permitted for use only as a colour for topical use.
3857	PIGMENT RED 57 ALUMINIUM LAKE	E	Permitted for use only as a colour for topical use.
3858	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.
3859	PIGMENT RED 63	E	Permitted for use only as a colour for topical use.
3860	PIGMENT WHITE 26	E	Permitted for use only as a colour for topical use.
3861	PIGMENT YELLOW 12	E	Permitted for use only as a colour for topical use.
3862	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%.
3863	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%.
3864	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%.
3865	PIMENTA FRUIT OIL	A, E, H
3866	PIMENTA LEAF OIL	A, E, H
3867	PIMENTA OFFICINALIS	A, E, H
3868	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'.
3869	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).
3870	PIMPINELLA SAXIFRAGA	A, E, H
3871	PINE NEEDLE OIL SCOTCH	A, E, H
3872	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%.
3873	PINE OIL AROMATIC	A, E, H
3874	PINE OIL PUMILIO	A, E, H
3875	PINEAPPLE	E
3876	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%.
3877	PINELLIA TERNATA	A, H
3878	PINUS CONTORTA	A, E, H
3879	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%.
3880	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%.
3881	PINUS MONTICOLA	A, E, H
3882	PINUS MUGO	A, E, H
3883	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%.
3884	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%.
3885	PINUS PONDEROSA	A, E, H
3886	PINUS RADIATA	A, E, H
3887	PINUS STROBUS	A, E, H
3888	PINUS SYLVESTRIS	A, E, H
3889	PINUS TABULIFORMIS	A, E, H
3890	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%.
3891	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%.
3892	PIPER CHABA	A, E, H
3893	PIPER CUBEBA	A, E, H
3894	PIPER KADSURA	A, E, H
3895	PIPER LONGUM	A, E, H
3896	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.
3897	PIPER NIGRUM	A, E, H
3898	PIPER SARMENTOSUM	A, E, H
3899	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%.
3900	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%.
3901	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%.
3902	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%.
3903	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%.
3904	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).
3905	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.
3906	PISCIDIA PISCIPULA	A, E, H
3907	PISTACIA LENTISCUS	A, E, H
3908	PISUM SATIVUM	A, E, H
3909	PLACENTA	H	Only for use as an active homoeopathic ingredient.
3910	PLANTAGO AFRA	A, E, H	When a dose for children is stated and the plant part is flower, seed or pollen, the medicine requires the following warning statement on the medicine label: - (PSYLL) 'On medical advice' (or words to that effect).
3911	PLANTAGO ARENARIA	A, H	When a dose for children is stated and the plant part is flower, seed or pollen, the medicine requires the following warning statement on the medicine label: - (PSYLL) 'On medical advice' (or words to that effect).
3912	PLANTAGO ASIATICA	A, H	When a dose for children is stated and the plant part is flower, seed or pollen, the medicine requires the following warning statement on the medicine label: - (PSYLL) 'On medical advice' (or words to that effect).
3913	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 medicine requires the following warning statement on the medicine label: - (PSYLL) 'On medical advice' (or words to that effect).
3914	PLANTAGO MAJOR	A, E, H	When a dose for children is stated and the plant part is flower, seed or pollen, the medicine requires the following warning statement on the medicine label: - (PSYLL) 'On medical advice' (or words to that effect).
3915	PLANTAGO OVATA	A, H	When a dose for children is stated and the plant part is flower, seed or pollen, the medicine requires the following warning statement on the medicine label: - (PSYLL) 'On medical advice' (or words to that effect).
3916	PLANTAGO SEED DRY	A, H	When a dose for children is stated, the medicine requires the following warning statement on the medicine label: - (PSYLL) 'On medical advice' (or words to that effect).
3917	PLATANUS OCCIDENTALIS	A, E, H
3918	PLATANUS RACEMOSA	A, H
3919	PLATANUS X ACERIFOLIA	A, H
3920	PLATYCODON GRANDIFLORUS	A, E, H
3921	PLECTRANTHUS BARBATUS	A, E, H
3922	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%.
3923	PLUM	E
3924	PLUMBAGO EUROPAEA	A, H
3925	PLUMERIA ALBA	A, E, H
3926	PLUMERIA RUBRA	A, E, H
3927	POA NEMORALIS	A, H
3928	POA PRATENSIS	A, H
3929	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%.
3930	POGOSTEMON CABLIN	A, E, H
3931	POLACRILIN	E
3932	POLACRILIN POTASSIUM	E
3933	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).
3934	POLIGLUSAM	A, E	When for internal use, the following warning statements are 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); and - (SFOOD) 'Derived from seafood'. When for internal use and the dosage form is a powdered preparation, the medicine requires the following warning statements 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. In addition, when the ingredient is included in a medicine that is listed in the Register: - on or after 1 July 2018, the medicine must comply with all requirements under (a) & (b); - before 1 July 2018 and supplied on or after 1 January 2020, the medicine must comply with all requirements under (a) & (b); or - before 1 July 2018 and supplied before 1 January 2020, the medicine may comply with requirements under (a) & (b). a) The average molecular mass of poliglusam must be greater than 2 kilodaltons. b) When for internal use, the medicine must not contain more than 1750 milligrams of poliglusam per maximum recommended daily dose.
3935	POLIGLUSAM DERIVED FROM ASPERGILLUS NIGER	A, E	When for oral use, the medicine must provide no more than 2000 milligrams of Poliglusam derived from Aspergillus niger per maximum recommended daily dose and requires the following warning statement 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). If the medicine is a powdered dosage form, the medicine also requires the following warning statement on the medicine label: - '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.
3936	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.
3937	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).
3938	POLOXAMER	E	Only for use in topical medicines for dermal application.
3939	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%.
3940	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%.
3941	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%.
3942	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%.
3943	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%.
3944	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%.
3945	POLYACRYLIC ACID	E
3946	POLYAMINO SUGAR CONDENSATE	E	Only for use in topical medicines for dermal application.
3947	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%.
3948	POLYBUTENE	E	Only for use in topical medicines for dermal application.
3949	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%.
3950	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%.
3951	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%.
3952	POLYDEXTROSE	E
3953	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%.
3954	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%
3955	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%.
3956	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%.
3957	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%.
3958	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%.
3959	POLYETHYLENE	E
3960	POLYGALA CHINENSIS	A, H
3961	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.
3962	POLYGALA SIBIRICA	A, E, H	Only for use when the plant part is root or root bark.
3963	POLYGALA TENUIFOLIA	A	Only for use when the plant part is root or root bark.
3964	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%.
3965	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%.
3966	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%.
3967	POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE	E	Only for use in topical medicines for dermal application. The concentration in the medicine must be no more than 5%.
3968	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%.
3969	POLYGLYCERYL-2-PEG-4 STEARATE	E	Only for use in topical medicines for dermal application.
3970	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%.
3971	POLYGLYCERYL-3 DIISOSTEARATE	E	Only for use in topical medicines for dermal application.
3972	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%.
3973	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%.
3974	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%.
3975	POLYGLYCERYL-3 POLYRICINOLEATE	E
3976	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%.
3977	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%.
3978	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%.
3979	POLYGLYCERYL-4 OLEATE	E	Only for use in topical medicines for dermal application.
3980	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%.
3981	POLYGLYCERYL-6 RICINOLEATE	E	Only for use in topical medicines for dermal application.
3982	POLYGONATUM MULTIFLORUM	A, H
3983	POLYGONATUM OFFICINALE	A, H
3984	POLYGONATUM SIBIRICUM	A, E, H
3985	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%.
3986	POLYGONUM BISTORTA	A, H
3987	POLYGONUM ODORATUM	A, H
3988	POLYHYDROXYSTEARIC ACID	E	Only for use in topical medicines for dermal application.
3989	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.
3990	POLYISOPRENE	E	Only for use in topical medicines for dermal application.
3991	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%.
3992	POLYMETHACRYLIC ACID	E
3993	POLYMETHYL METHACRYLATE	E	Only for use in topical medicines for dermal application.
3994	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%.
3995	POLYPORUS UMBELLATUS	A, H
3996	POLYPROPYLENE	E	Only for use in topical medicines for dermal application.
3997	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%.
3998	POLYQUATERNIUM-10	E	Only for use in topical medicines for dermal application.
3999	POLYQUATERNIUM-11	E	Only for use in topical medicines for dermal application.
4000	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%.
4001	POLYQUATERNIUM-24	E	Only for use in topical medicines for dermal application.
4002	POLYQUATERNIUM-28	E	Only for use in topical medicines for dermal application.
4003	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%.
4004	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%.
4005	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%.
4006	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%.
4007	POLYQUATERNIUM-7	E	Only for use in topical medicines for dermal application.
4008	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%
4009	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%.
4010	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 be no more than 10%. When used in primary sunscreen products and listed in the Register on or after 1 January 2018, the medicine must have the following statements on the medicine 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). When used in primary sunscreen products and listed in the Register before 1 January 2018, the medicine requires the following statements on the medicine label if supplied after 1 July 2019: - (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).
4011	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%.
4012	POLYSORBATE 20	E
4013	POLYSORBATE 40	E
4014	POLYSORBATE 60	E
4015	POLYSORBATE 65	E
4016	POLYSORBATE 80	E
4017	POLYSORBATE 85	E	Only for use in topical medicines for dermal application.
4018	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%.
4019	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.
4020	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%.
4021	POLYVINYL ACETATE	E	Only permitted for use in medicines that are for oral routes of administration.
4022	POLYVINYL ACETATE PHTHALATE	E
4023	POLYVINYL ALCOHOL	E
4024	POLYVINYL CHLORIDE	E	Only for use in topical medicines for dermal application.
4025	POMEGRANATE	E
4026	PONCEAU SX	E	Permitted for use only as a colour for topical use.
4027	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.
4028	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%.
4029	POPPY SEED	E, H
4030	POPPY SEED OIL	E, H
4031	POPULUS ALBA	A, H
4032	POPULUS BALSAMIIFERA	A, E, H
4033	POPULUS CANDICANS	A, H
4034	POPULUS DELTOIDES	A, H
4035	POPULUS NIGRA	A, H
4036	POPULUS TREMULA	A, H
4037	POPULUS TREMULOIDES	A, H
4038	PORCINE	H	Only for use as an active homoeopathic ingredient.
4039	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%.
4040	PORTULACA OLERACEA	A, E, H
4041	POTABLE WATER	E
4042	POTASSIUM ACETATE	E
4043	POTASSIUM ARSENITE	H	Only for use as an active homoeopathic ingredient.
4044	POTASSIUM ASCORBATE	A, E, H	When for oral or sublingual use, potassium is a mandatory component of potassium ascorbate.
4045	POTASSIUM ASCORBATE DIHYDRATE	A, E, H	When for oral or sublingual use, potassium is a mandatory component of potassium ascorbate dihydrate.
4046	POTASSIUM ASCORBYL TOCOPHERYL PHOSPHATE	E	Only for use in topical medicines for dermal application.
4047	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.
4048	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.
4049	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.
4050	POTASSIUM BICARBONATE	E
4051	POTASSIUM BROMIDE	H	Only for use as an active homoeopathic ingredient.
4052	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.
4053	POTASSIUM CETYL PHOSPHATE	E	Only for use in topical medicines for dermal application.
4054	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: - (POTAS) 'Contains potassium. 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) other than when used for oral rehydration therapy, the concentration must be no more than 550 mg per dosage unit. Medicines 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 medicine requires the warning statements: - (UOAD) 'Use only as directed' - (DIAR3) 'If diarrhoea persists, seek medical advice.' When for dental use, the concentration in the medicine must be no more than 3.75%.
4055	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.
4056	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%.
4057	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%.
4058	POTASSIUM DICHROMATE	H	Only for use as an active homoeopathic ingredient.
4059	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.
4060	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.
4061	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.
4062	POTASSIUM HYDROXYCITRATE	A, H
4063	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.
4064	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%.
4065	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%.
4066	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%.
4067	POTASSIUM NITRATE	A, H	Only for dental use. The concentration in the medicine must be no more than 5%.
4068	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.
4069	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%.
4070	POTASSIUM SORBATE	E	The medicine requires the following warning statement on the medicine label: - (SORB8) 'Contains sorbates' (or word to this effect) if medicine contains two or more sorbate sources OR 'Contains [insert the approved name of sorbate source used]' (or words to this effect) if medicine contains one sorbate source.
4071	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%.
4072	POTASSIUM STEARATE	E	Only for use in topical medicines for dermal application.
4073	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.
4074	POTATO STARCH	E
4075	POTENTILLA ANSERINA	A, H
4076	POTENTILLA CHINENSIS	A, H
4077	POTENTILLA DISCOLOR	A, H
4078	POTENTILLA ERECTA	A, E, H
4079	POTENTILLA REPTANS	A, H
4080	POTERIUM OFFICINALE	A, E, H
4081	POTERIUM SANGUISORBA	A, H
4082	POVIDONE	E
4083	POWDERED CELLULOSE	E
4084	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%.
4085	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%.
4086	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%.
4087	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%.
4088	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%.
4089	PPG-2 LANOLIN ALCOHOL ETHER	E	Only for use in topical medicines for dermal application.
4090	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%.
4091	PPG-20 LANOLIN ALCOHOL ETHER	E	Only for use in topical medicines for dermal application.
4092	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%.
4093	PPG-20 METHYL GLUCOSE ETHER DISTEARATE	E	Only for use in topical medicines for dermal application.
4094	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%.
4095	PPG-3 MYRISTYL ETHER	E	Only for use in topical medicines for dermal application.
4096	PPG-5-CETETH-20	E	Only for use in topical medicines for dermal application.
4097	PPG-5-LAUROMACROGOL 250	E	Only for use in topical medicines for dermal application.
4098	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%.
4099	PREGELATINISED MAIZE STARCH	E
4100	PREGELATINISED POTATO STARCH	E
4101	PREGELATINISED RICE STARCH	E
4102	PREGELATINISED WHEAT STARCH	E	When the route of administration is other than topical or mucosal, gluten is a mandatory component of pregelatinised wheat starch. When the route of administration is other than topical or mucosal, the medicine requires the following warning statement on the medicine label: - (GLUTEN) 'Contains [insert name of ingredient]' (or words to that effect).
4103	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%.
4104	PRICKLY ASH BARK DRY	A, H
4105	PRICKLY ASH BARK POWDER	A, H
4106	PRIMULA VERIS	A, E, H
4107	PRIMULA VULGARIS	A, E, H
4108	PRINSEPIA UNIFLORA	A, H
4109	PROBOSCIDEA PARVIFLORA	A, H
4110	PROGESTERONE	H	Only for use as an active homoeopathic ingredient.
4111	PROLINE	A, E
4112	PROPAN-1-OL	E	Only for use in topical medicines for dermal application. The concentration in the medicine must be no more than 18%.
4113	PROPANE	E	Only for use as an excipient propellant ingredient.
4114	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%.
4115	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%.
4116	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%.
4117	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%.
4118	PROPIONYLLEVOCARNITINE HYDROCHLORIDE	A, H
4119	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.'
4120	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.'
4121	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.'
4122	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.'
4123	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.'
4124	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.'
4125	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%.
4126	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%.
4127	PROPYL GALLATE	E
4128	PROPYL HYDROXYBENZOATE	E	Medicines containing hydroxybenzoates require the following warning statement on the medicine label: - (TOTBNZ) ‘Contains hydroxybenzoates’ (or words to this effect) if the medicine contains more than one hydroxybenzoate source OR ‘Contains [insert the approved name of hydroxybenzoate used]’ (or words to this effect) if product contains one hydroxybenzoate source.
4129	PROPYLENE CARBONATE	E	Only for use in topical medicines for dermal application.
4130	PROPYLENE GLYCOL	E
4131	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%.
4132	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%.
4133	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%.
4134	PROPYLENE GLYCOL DIOCTANOATE	E	Only for use in topical medicines for dermal application.
4135	PROPYLENE GLYCOL DIOCTANOATE/DIDECANOATE	E	Only for use in topical medicines for dermal application.
4136	PROPYLENE GLYCOL DIPELARGONATE	E	Only for use in topical medicines for dermal application.
4137	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%.
4138	PROPYLENE GLYCOL ISOSTEARATE	E	Only for use in topical medicines for dermal application.
4139	PROPYLENE GLYCOL MONOLAURATE	E	Only for use in topical medicines for dermal application.
4140	PROPYLENE GLYCOL MONOSTEARATE	E	Only for use in topical medicines for dermal application.
4141	PROPYLENE GLYCOL MYRISTYL ETHER ACETATE	E	Only for use in topical medicines for dermal application.
4142	PROSOPIS JULIFLORA	A, H
4143	PROTEASE	A	Must be derived from Aspergillus oryzae or Aspergillus niger. When the dosage form is undivided, the units 'haemoglobin unit on the tyrosine basis per gram' and 'Thousand haemoglobin units on the tyrosine basis per gram' are permitted. When the dosage form is divided, the units 'haemoglobin units on the tyrosine basis' and 'thousand haemoglobin units on the tyrosine basis' are permitted.
4144	PROTEIN HYDROLYSATE	E
4145	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%.
4146	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%.
4147	PRUNELLA VULGARIS	A, H
4148	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%.
4149	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%.
4150	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%.
4151	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%.
4152	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%.
4153	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%.
4154	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%.
4155	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%.
4156	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%.
4157	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%.
4158	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%.
4159	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%.
4160	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%.
4161	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%.
4162	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%.
4163	PRUSSIAN BLUE	E	Permitted for use only as a colour for topical use.
4164	PSEUDOCYDONIA SINENSIS	A, H
4165	PSEUDOSTELLARIA HETEROPHYLLA	A, E, H
4166	PSEUDOTSUGA MENZIESII	A, H
4167	PSEUDOWINTERA COLORATA	A, H	Only for use when the plant part is leaf.
4168	PSIDIUM GUAJAVA	A, E, H
4169	PSORALEN (OF CULLEN CORYLIFOLIUM)	E
4170	PSORINUM	H	Only for use as an active homoeopathic ingredient.
4171	PSYLLIUM HUSK DRY	A, H	When a dose for children is stated, the medicine requires the following warning statement on the medicine label: - (PSYLL) 'On medical advice' (or words to that effect).
4172	PSYLLIUM HUSK POWDER	A, E, H	When a dose for children is stated, the medicine requires the following warning statement on the medicine label: - (PSYLL) 'On medical advice' (or words to that effect).
4173	PSYLLIUM SEED DRY	A, E, H	When a dose for children is stated, the medicine requires the following warning statement on the medicine label: - (PSYLL) 'On medical advice' (or words to that effect).
4174	PTELEA TRIFOLIATA	A, H
4175	PTEROCARPUS MARSUPIUM	A, H
4176	PTEROCARPUS SANTALINUS	A, E, H
4177	PUERARIA LOBATA	A, E, H
4178	PUERARIA MONTANA VAR. LOBATA	A, E, H
4179	PULLULAN	E
4180	PUMICE	E
4181	PUMPKIN	E
4182	PUMPKIN SEED	E, H
4183	PUMPKIN SEED OIL	E, H
4184	PUNICA GRANATUM	A, E, H
4185	PURE BEE VENOM	H	Only for use as an active homoeopathic ingredient.
4186	PURIFIED HONEY	A, E	When the route of administration is oral, the medicine requires the following warning statement on the medicine label: - (BABY2) 'Not suitable for infants under the age of twelve months' (or words to that effect). When the medicine is for oral ingestion and the total amount of all sugars (monosaccharides and disaccharides such as glucose, honey, invert sugar, lactose, maltose, and sucrose) is more than 100mg in the maximum daily dose, then the medicine requires the following warning statement on the medicine label: - (SUGARS) ‘Contains [insert name of sugar]’ if medicine contains one sugar OR ‘Contains sugars' (or words to that effect) if medicine contains two or more sugars. If one of the sugars is lactose then the medicine also requires the following warning statement on the medicine label: - (LACT) ‘Contains lactose' (or words to that effect).
4187	PURIFIED SILICEOUS EARTH	E, H
4188	PURIFIED TALC	E
4189	PURIFIED WATER	E
4190	PVM/MA COPOLYMER	E
4191	PVM/MA DECADIENE CROSSPOLYMER	E	Only for use in topical medicines for dermal application.
4192	PVP/EICOSENE COPOLYMER	E	Only for use in topical medicines for dermal application.
4193	PVP/HEXADECENE COPOLYMER	E	Only for use in topical medicines for dermal application.
4194	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).
4195	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].'
4196	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].'
4197	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].'
4198	PYROGLUTAMIC ACID	E
4199	PYROLA DECORATA	A, H
4200	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%.
4201	PYRROSIA LINGUA	A, H
4202	PYRROSIA PETIOLOSA	A, H
4203	PYRROSIA SHEARERI	A, H
4204	PYRUS COMMUNIS	A, E, H	Arbutin is a mandatory component of Pyrus communis. The concentration of arbutin in the medicine must be no more than 25 mg/Kg or 25mg /L or 0.0025 % unless used on the hair. When for use on hair, the concentration of arbutin in the medicine must be no more than 0.74 %.
4205	PYRUS PYRIFOLIA	A, H	Arbutin is a mandatory component of Pyrus pyrifolia. The concentration of arbutin in the medicine must be no more than 25 mg/Kg or 25mg /L or 0.0025 % unless used on the hair. When for use on hair, the concentration of arbutin in the medicine must be no more than 0.74 %.
4206	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%.
4207	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%.
4208	QUASSIA AMARA	A, E, H
4209	QUASSIA WOOD JAMAICAN DRY	A, H
4210	QUASSIA WOOD JAMAICAN POWDER	A, H
4211	QUATERNIUM-15	E	Only for use in topical medicines for dermal application.
4212	QUATERNIUM-18 BENTONITE	E	Only for use in topical medicines for dermal application.
4213	QUATERNIUM-18 HECTORITE	E	Only for use in topical medicines for dermal application.
4214	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.
4215	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%.
4216	QUERCETIN	A
4217	QUERCETIN DIHYDRATE	A
4218	QUERCUS ACUTISSIMA	A, H
4219	QUERCUS ALBA	A, E, H
4220	QUERCUS PALUSTRIS	A, H
4221	QUERCUS ROBUR	A, H
4222	QUERCUS RUBRA	A, H
4223	QUERCUS VIRGINIANA	A, H
4224	QUILLAIA DRY	A, H
4225	QUILLAIA POWDER	A, E, H
4226	QUILLAJA SAPONARIA	A, H
4227	QUINCE	E
4228	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.
4229	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.
4230	QUINOLINE YELLOW	E	Permitted for use only as a colour for oral and topical use.
4231	QUINOLINE YELLOW ALUMINIUM LAKE	E	Permitted for use only as a colour for oral and topical use.
4232	QUISQUALIS INDICA	A, H
4233	R-ALPHA LIPOIC ACID	A
4234	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%.
4235	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.
4236	RADISH	E
4237	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%.
4238	RANUNCULUS BULBOSUS	A, H
4239	RANUNCULUS FICARIA	A, H
4240	RANUNCULUS TERNATUS	A, H
4241	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%.
4242	RAPHANUS SATIVUS	A, H
4243	RASPBERRY	E
4244	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%.
4245	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%.
4246	RASPBERRY ESSENCE	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%.
4247	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%.
4248	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%.
4249	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%.
4250	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%.
4251	RED 27	E	Permitted for use only as a colour for oral and topical use. The concentration in the medicine must be no more than 0.5%.
4252	RED 27 ALUMINIUM LAKE	E	Permitted for use only as a colour for oral and topical use. The concentration in the medicine must be no more than 0.5%.
4253	RED ANT	H	Only for use as an active homoeopathic ingredient.
4254	RED CLOVER FLOWER DRY	A, H
4255	RED CLOVER FLOWER POWDER	A, H
4256	RED CORAL	H	Only for use as an active homoeopathic ingredient.
4257	RED DEER	A
4258	RED MERCURIC IODIDE	H	Only for use as an active homoeopathic ingredient.
4259	RED MERCURIC OXIDE	H	Only for use as an active homoeopathic ingredient.
4260	RED MERCURIC SULFIDE	H	Only for use as an active homoeopathic ingredient.
4261	REHMANNIA GLUTINOSA	A, E, H
4262	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%.
4263	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%.
4264	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%.
4265	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’.
4266	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.’
4267	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.’
4268	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.’
4269	REYNOUTRIA JAPONICA	A, E, H	When used as an excipient, only for use in topical medicines for dermal application.
4270	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%.
4271	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'.
4272	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'.
4273	RHATANY ROOT DRY	A, H
4274	RHATANY ROOT POWDER	A, H
4275	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'.
4276	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’.
4277	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'.
4278	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'.
4279	RHODAMINE B	E	Permitted for use only as a colour for topical use.
4280	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%.
4281	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%.
4282	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.
4283	RHODODENDRON AUREUM	A, H
4284	RHODODENDRON FERRUGINEUM	A, H	Arbutin is a mandatory component of Rhododendron ferrugineum. The concentration of arbutin in the medicine must be no more than 25 mg/Kg or 25mg /L or 0.0025 % unless used on the hair. When for use on hair, the concentration of arbutin in the medicine must be no more than 0.74 %.
4285	RHODODENDRON MOLLE	A, H	The maximum recommended daily dose of the medicine must be no more than 1mg of the dry herbal material.
4286	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'.
4287	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'.
4288	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'.
4289	RHUS AROMATICA	A, E, H
4290	RHUS CHINENSIS	A, H
4291	RHUS GLABRA	A, E, H
4292	RHUS VENENATA	H	Only for use as an active homoeopathic ingredient.
4293	RIBES GROSSULARIA	A, E, H
4294	RIBES NIGRUM	A, E, H
4295	RIBOFLAVIN	A, E
4296	RIBOFLAVIN SODIUM PHOSPHATE	A, E	When for oral or sublingual use and the total amount of sodium from all ingredients in the maximum daily dose is more than 120 mg, the medicine requires the following warning statement on the medicine label: - (SODIUM) ‘The recommended daily dose of this medicine contains [state quantity and units] of sodium (or words to that effect).’
4297	RIBOFLAVIN TETRAACETATE	E	Only for use in topical medicines for dermal application.
4298	RIBOFLAVINE	A, E
4299	RIBOFLAVINE SODIUM PHOSPHATE	A, E
4300	RIBONUCLEIC ACID	E	Only for use in topical medicines for dermal application.
4301	RIBOSE	A	Only for use in oral medicines. When the medicine is for oral ingestion and the total amount of all sugars (monosaccharides and disaccharides such as glucose, honey, invert sugar, lactose, maltose, and sucrose) is more than 100mg in the maximum daily dose, then the medicine requires the following warning statement on the medicine label: - (SUGARS) ‘Contains [insert name of sugar]’ if medicine contains one sugar OR ‘Contains sugars' (or words to that effect) if medicine contains two or more sugars. If one of the sugars is lactose then the medicine also requires the following warning statement on the medicine label: - (LACT) ‘Contains lactose' (or words to that effect).
4302	RICE	E
4303	RICE BRAN	E
4304	RICE BRAN OIL	E
4305	RICE BRAN WAX	A, E, H
4306	RICE STARCH	E
4307	RICE VINEGAR	E
4308	RICE WINE	E	Ethanol is a mandatory component of Rice wine. When the concentration of ethanol in the medicine is more than 3%, the medicine requires the following warning statement on the medicine label: - (ETHAN) ‘Contains ethanol’ or ‘contains alcohol’
4309	RICINOLEIC ACID	E	Only for use in topical medicines for dermal application.
4310	RICINUS COMMUNIS	A, H	Only for use when the plant part must be seed and the plant preparation is oil fixed.
4311	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.
4312	ROHDEA JAPONICA	A, H	The maximum recommended daily dose must be no more than the equivalent of 1mg of the dry herbal material.
4313	ROSA ARVENSIS	A, E, H
4314	ROSA CANINA	A, E, H
4315	ROSA CYMOSA	A, E, H
4316	ROSA EGLANTERIA	A, E, H
4317	ROSA GALLICA	A, E, H
4318	ROSA LAEVIGATA	A, E, H
4319	ROSA MULTIFLORA	A, E, H
4320	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%.
4321	ROSA RUGOSA	A, E, H
4322	ROSA VILLOSA	A, E, H
4323	ROSA X CENTIFOLIA	A, E, H
4324	ROSA X DAMASCENA	A, E, H
4325	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%.
4326	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%.
4327	ROSE FRUIT FRESH	A, E, H
4328	ROSE HIP	E
4329	ROSE OIL	A, E, H
4330	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%.
4331	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%.
4332	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.
4333	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'.
4334	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'.
4335	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'.
4336	RUBBER NATURAL	E	Only for use in topical medicines for dermal application.
4337	RUBIA CORDIFOLIA	A, H
4338	RUBIA TINCTORUM	A, H
4339	RUBUS CHINGII	A, H
4340	RUBUS CORCHORIFOLIUS	A, H
4341	RUBUS COREANUS	A, E, H
4342	RUBUS FRUTICOSUS	A, E, H
4343	RUBUS IDAEUS	A, E, H
4344	RUBUS OCCIDENTALIS	A, E, H
4345	RUBUS PARVIFOLIUS	A, H
4346	RUBUS ROSIFOLIUS	A, H
4347	RUDBECKIA HIRTA	A, H
4348	RUE OIL	A, H
4349	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%.
4350	RUMEX ACETOSA	A, H
4351	RUMEX ACETOSELLA	A, H
4352	RUMEX CONGLOMERATUS	A, H
4353	RUMEX CRISPUS	A, E, H
4354	RUMEX PULCHER	A, H
4355	RUMEX SCUTATUS	A, H
4356	RUSCUS ACULEATUS	A, H
4357	RUTA GRAVEOLENS	A, E, H
4358	RUTOSIDE	A, E
4359	RYE	E	Gluten is a mandatory component of Rye when the route of administration is other than topical and mucosal. When the route of administration is other than topical or mucosal, the medicine requires the following warning statement on the medicine label: - (GLUTEN) 'Contains [insert name of ingredient]' (or words to that effect).
4360	RYE BRAN	E	Gluten is a mandatory component of Rye bran when the route of administration is other than topical and mucosal. When the route of administration is other than topical or mucosal, the medicine requires the following warning statement on the medicine label: - (GLUTEN) 'Contains [insert name of ingredient]' (or words to that effect).
4361	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%.
4362	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%.
4363	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%.
4364	SACCHARIN	E	The medicine requires the following warning statement on the medicine label: - (SACCH) 'Contains saccharin' (or words to that effect).
4365	SACCHARIN SODIUM	E	The medicine requires the following warning statement on the medicine label: - (SACCH) 'Contains saccharin' (or words to that effect). When for oral or sublingual use and the total amount of sodium from all ingredients in the maximum daily dose is more than 120 mg, the medicine requires the following warning statement on the medicine label: - (SODIUM) ‘The recommended daily dose of this medicine contains [state quantity and units] of sodium (or words to that effect).’
4366	SACCHAROMYCES CEREVISIAE	A, E	When for topical use, the concentration in the medicine must be no more than 1%.
4367	SACCHAROMYCES CEREVISIAE (BOULARDII)	A
4368	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%.
4369	SACCHAROMYCES/ZINC FERMENT	E	Only for use in topical medicines for dermal application.
4370	SACCHARUM OFFICINARUM	A, E, H
4371	SAFFLOWER OIL	A, E, H
4372	SAFFRON	E	Permitted for use only as a colour for either topical use or with an oral route of administration.
4373	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%.
4374	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%.
4375	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’
4376	SAGE OIL SPANISH	A, E, H
4377	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%.
4378	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%.
4379	SALICYLIC ACID	E, H	Only for use in topical medicines for dermal application. The concentration in the medicine must be no more than 40%.
4380	SALIX ALBA	A, E, H
4381	SALIX DAPHNOIDES	A, H
4382	SALIX DISCOLOR	A, H
4383	SALIX FRAGILIS	A, H
4384	SALIX NIGRA	A, H
4385	SALIX PURPUREA	A, H
4386	SALSOLA KALI	A, H
4387	SALVIA CHINENSIS	A, H
4388	SALVIA FRUTICOSA	A, H
4389	SALVIA HISPANICA	A, E, H
4390	SALVIA LAVANDULAEFOLIA	A, H
4391	SALVIA MILTIORRHIZA	A, H
4392	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%.
4393	SALVIA SCLAREA	A, E, H
4394	SAMBUCUS CANADENSIS	A, H
4395	SAMBUCUS EBULUS	A, H
4396	SAMBUCUS NIGRA	A, E, H
4397	SANDALWOOD OIL EAST INDIAN	A, E, H
4398	SANGUINARIA CANADENSIS	H	Only for use as an active homoeopathic ingredient. The potency must be more than 4X.
4399	SANICULA EUROPAEA	A, H
4400	SANTALUM ALBUM	A, E, H
4401	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.
4402	SAPINDUS MUKOROSSI	A, H
4403	SAPONARIA OFFICINALIS	A, H
4404	SAPOSHNIKOVIA DIVARICATA	A, H
4405	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%.
4406	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.
4407	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.
4408	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%.
4409	SATUREIA HORTENSIS	A, H
4410	SATUREIA MONTANA	A, H
4411	SAUROPUS SPATULIFOLIUS	A, H
4412	SAURURUS CHINENSIS	A, H
4413	SAUSSUREA COSTUS	A, H
4414	SAVORY OIL SUMMER	A, H
4415	SAXIFRAGA GRANULATA	A, E, H
4416	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%.
4417	SCAPHIUM SCAPHIGERUM	A, H
4418	SCHEFFLERA HEPTAPHYLLA	A, H
4419	SCHINOPSIS QUEBRACHO-COLORADO	A, H
4420	SCHINUS MOLLE	A, H
4421	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%.
4422	SCHISANDRA CHINENSIS	A, E, H
4423	SCHIZONEPETA TENUIFOLIA	A, E, H
4424	SCHOENOCAULON OFFICINALE	A, H	The maximum recommended daily dose must contain no more than the equivalent of 1mg of the dry herbal material.
4425	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%.
4426	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%.
4427	SCLERANTHUS ANNUUS	A, H
4428	SCLEROTIUM GUM	E	Only for use in topical medicines for dermal application.
4429	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%.
4430	SCROPHULARIA NINGPOENSIS	A, H
4431	SCROPHULARIA NODOSA	A, H
4432	SCURRULA PARASITICA VAR. GRACILIFLORA	A, H
4433	SCUTELLARIA BAICALENSIS	A, E, H
4434	SCUTELLARIA BARBATA	A, H
4435	SCUTELLARIA LATERIFLORA	A, E, H
4436	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%.
4437	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%.
4438	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%.
4439	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. When the route of administration is other than topical or mucosal, the medicine requires the following warning statement on the medicine label: - (GLUTEN) 'Contains [insert name of ingredient]' (or words to that effect).
4440	SEDUM ACRE	A, H
4441	SELAGINELLA TAMARISCINA	A, H
4442	SELENICEREUS GRANDIFLORUS	A, E, H
4443	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.'
4444	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.'
4445	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.’
4446	SELF-EMULSIFYING GLYCERYL MONOSTEARATE	E
4447	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.
4448	SEMOLINA	E
4449	SEMPERVIVUM TECTORUM	A, H
4450	SENEGA ROOT DRY	A, H
4451	SENEGA ROOT POWDER	A, H
4452	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'.
4453	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'.
4454	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'.
4455	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'.
4456	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'.
4457	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'.
4458	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'.
4459	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'.
4460	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'.
4461	SEPIA	H	Only for use as an active homoeopathic ingredient.
4462	SEQUOIA SEMPERVIRENS	A, H
4463	SEQUOIADENDRON GIGANTEUM	A, H
4464	SERENOA REPENS	A, H
4465	SERINE	A, E
4466	SERUM ANGUILLAE	H	Only for use as an active homoeopathic ingredient.
4467	SESAME OIL	A, E, H
4468	SESAME SEED	E
4469	SESAMUM INDICUM	A, E, H
4470	SETARIA ITALICA	A, H
4471	SHARK CALCIUM CHONDROITIN SULFATE	A
4472	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)
4473	SHARK CHONDROITIN SULFATE	A
4474	SHARK POTASSIUM CHONDROITIN SULFATE	A
4475	SHARK SODIUM CHONDROITIN SULFATE	A
4476	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.’
4477	SHEA BUTTER	E
4478	SHEA BUTTER UNSAPONIFIABLES	E	Only for use in topical medicines for dermal application.
4479	SHELLAC	E
4480	SHEPHERD'S PURSE HERB DRY	A, H
4481	SHEPHERD'S PURSE HERB POWDER	A, H
4482	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%.
4483	SIGESBECKIA ORIENTALIS	A, E, H
4484	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%.
4485	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%.
4486	SILICA SILYLATE	E	Only for use in topical medicines for dermal application.
4487	SILICIFIED MICROCRYSTALLINE CELLULOSE	E	Only for use when the route of administration is other than inhalation.
4488	SILICON DIOXIDE	A, E, H	Only for use when the route of administration is other than inhalation.
4489	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).
4490	SILVER	H	Only for use as an active homoeopathic ingredient. The concentration in the medicine must be no more than 1%.
4491	SILVER BEET	E, H
4492	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%.
4493	SILVER NITRATE	H	Only for use as an active homoeopathic ingredient.
4494	SILYBUM MARIANUM	A, E, H
4495	SIMABA CEDRON	A, H
4496	SIMETHICONE	E
4497	SIMMONDSIA CHINENSIS	A, E, H
4498	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%.
4499	SINAPIS ARVENSIS	A, H
4500	SINOMENIUM ACUTUM	A, H
4501	SIPHONESTEGIA CHINENSIS	A, H
4502	SIRAITIA GROSVENORII	A, E, H
4503	SISYMBRIUM OFFICINALE	A, H
4504	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%.
4505	SKIPJACK-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.’
4506	SLIPPERY ELM BARK DRY	A, H
4507	SLIPPERY ELM BARK POWDER	A, E, H
4508	SMILAX ARISTOLOCHIIFOLIA	A, H
4509	SMILAX CHINA	A, H
4510	SMILAX GLABRA	A, H
4511	SMILAX OFFICINALIS	A, E, H
4512	SMILAX ORNATA	A, E, H
4513	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%.
4514	SODIUM ACETATE	E	When for oral or sublingual use and the total amount of sodium from all ingredients in the maximum daily dose is more than 120 mg, the medicine requires the following warning statement on the medicine label: - (SODIUM) ‘The recommended daily dose of this medicine contains [state quantity and units] of sodium (or words to that effect).’
4515	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%.
4516	SODIUM ACID CITRATE	A, E, H	When used as an active ingredient, only for use in oral medicines. When used as an active, only for use in oral medicines. When for oral or sublingual use and the total amount of sodium from all ingredients in the maximum daily dose is more than 120 mg, the medicine requires the following warning statement on the medicine label: - (SODIUM) ‘The recommended daily dose of this medicine contains [state quantity and units] of sodium (or words to that effect).’
4517	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%.
4518	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).
4519	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).
4520	SODIUM ALGINATE	E
4521	SODIUM ASCORBATE	A, E, H	When for oral or sublingual use and the total amount of sodium from all ingredients in the maximum daily dose is more than 120 mg, the medicine requires the following warning statement on the medicine label: - (SODIUM) 'The recommended daily dose of this medicine contains [state quantity and units] of sodium (or words to that effect).'
4522	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%.
4523	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%.
4524	SODIUM BENZOATE	E	Medicines containing benzoates require the following warning statement on the medicine label: - (TBNZO8) ‘Contains benzoates' (or words to this effect) if the medicine contains two or more benzoate sources or ‘Contains [insert the approved name of benzoate used]’ (or words to this effect) if product contains one benzoate source. When for oral or sublingual use and the total amount of sodium from all ingredients in the maximum daily dose is more than 120 mg, the medicine requires the following warning statement on the medicine label: - (SODIUM) ‘The recommended daily dose of this medicine contains [state quantity and units] of sodium (or words to that effect).’
4525	SODIUM BETA-HYDROXY-BETA-METHYLBUTYRATE	A, H	When for oral or sublingual use and the total amount of sodium from all ingredients in the maximum daily dose is more than 120 mg, the medicine requires the following warning statement on the medicine label: - (SODIUM) ‘The recommended daily dose of this medicine contains [state quantity and units] of sodium’ (or words to that effect).
4526	SODIUM BETA-HYDROXY-BETA-METHYLBUTYRATE MONOHYDRATE	A, H
4527	SODIUM BICARBONATE	A, E	When for oral or sublingual use and the total amount of sodium from all ingredients in the maximum daily dose is more than 120 mg, the medicine requires the following warning statement on the medicine label: - (SODIUM) ‘The recommended daily dose of this medicine contains [state quantity and units] of sodium (or words to that effect).' When used as an active ingredient, the medicine may only be for oral rehydration salts in powdered and effervescent tablet dosage forms. Medicines 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 medicine requires the following warning statements 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.'
4528	SODIUM BISULFITE	E	When for oral or sublingual use and the total amount of sodium from all ingredients in the maximum daily dose is more than 120 mg, the medicine requires the following warning statement on the medicine label: - (SODIUM) ‘The recommended daily dose of this medicine contains [state quantity and units] of sodium’ (or words to that effect). Medicines containing sulfites salts require the following warning statement on the medicine label: - (SULF) 'Contains sulfites' (or words to this effect) if medicine contains two or more sulfite sources or 'Contains (insert the approved name of sulfites used)' (or words to this effect) if medicine contains one sulfite source.
4529	SODIUM BROMIDE	H	Only for use as an active homoeopathic ingredient.
4530	SODIUM C14-16 OLEFIN SULFONATE	E	Only for use in topical medicines for dermal application.
4531	SODIUM CARBOMER	E	Only for use as an excipient in topical medicines for dermal application.
4532	SODIUM CARBONATE	E	When for oral or sublingual use and the total amount of sodium from all ingredients in the maximum daily dose is more than 120 mg, the medicine requires the following warning statement on the medicine label: - (SODIUM) ‘The recommended daily dose of this medicine contains [state quantity and units] of sodium’ (or words to that effect).
4533	SODIUM CARBONATE MONOHYDRATE	E	When for oral or sublingual use and the total amount of sodium from all ingredients in the maximum daily dose is more than 120 mg, the medicine requires the following warning statement on the medicine label: - (SODIUM) ‘The recommended daily dose of this medicine contains [state quantity and units] of sodium (or words to that effect).'
4534	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%.
4535	SODIUM CARRAGEENAN	E
4536	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%.
4537	SODIUM CETOSTEARYL SULFATE	E	Only for use in topical medicines for dermal application.
4538	SODIUM CHLORIDE	A, E, H	When for oral or sublingual use and the total amount of sodium from all ingredients in the maximum daily dose is more than 120 mg, the medicine requires the following warning statement on the medicine label: - (SODIUM) 'The recommended daily dose of this medicine contains [state quantity and units] of sodium' (or words to that effect). 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.
4539	SODIUM CHONDROITIN SULFATE	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%.
4540	SODIUM CITRATE	A, E	Only for oral use when used as an active ingredient. When for oral or sublingual use and the total amount of sodium from all ingredients in the maximum daily dose is more than 120 mg, the medicine requires the following warning statement on the medicine label: - (SODIUM) ‘The recommended daily dose of this medicine contains [state quantity and units] of sodium’ (or words to that effect).
4541	SODIUM CITRATE DIHYDRATE	A, E	Only for oral use when used as an active ingredient. When for oral or sublingual use and the total amount of sodium from all ingredients in the maximum daily dose is more than 120 mg, the medicine requires the following warning statement on the medicine label: - (SODIUM) ‘The recommended daily dose of this medicine contains [state quantity and units] of sodium’ (or words to that effect).
4542	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%.
4543	SODIUM COCOAMPHOACETATE	E	Only for use in topical medicines for dermal application.
4544	SODIUM COCOYL SARCOSINATE	E	Only for use in topical medicines for dermal application.
4545	SODIUM CYCLAMATE	E	When for oral or sublingual use and the total amount of sodium from all ingredients in the maximum daily dose is more than 120 mg, the medicine requires the following warning statement on the medicine label: - (SODIUM) ‘The recommended daily dose of this medicine contains [state quantity and units] of sodium’ (or words to that effect).
4546	SODIUM DEHYDROACETATE	E	Only for use in topical medicines for dermal application.
4547	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%.
4548	SODIUM DODECYLBENZENESULFONATE	E	Only for use in topical medicines for dermal application. The concentration in the medicine must be no more than 30%.
4549	SODIUM ERYTHORBATE	E	When for oral or sublingual use and the total amount of sodium from all ingredients in the maximum daily dose is more than 120 mg, the medicine requires the following warning statement on the medicine label: - (SODIUM) ‘The recommended daily dose of this medicine contains [state quantity and units] of sodium’ (or words to that effect).
4550	SODIUM ETHYL HYDROXYBENZOATE	E
4551	SODIUM FLUORIDE	A, E, H	Fluoride is a mandatory component of Sodium fluoride. Only for use when the route of administration is dental and the dosage form is pastes, powders or gels for dental hygiene. When used as an active ingredient, it is subject to the following conditions: a) Only for use in combination with at least one other listable therapeutically active ingredient. b) The concentration of fluoride ion must be no 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.' When for oral or sublingual use and the total amount of sodium from all ingredients in the maximum daily dose is more than 120 mg, the medicine requires the following warning statement on the medicine label: - (SODIUM) ‘The recommended daily dose of this medicine contains [state quantity and units] of sodium (or words to that effect).'
4552	SODIUM FUMARATE	E	When for oral or sublingual use and the total amount of sodium from all ingredients in the maximum daily dose is more than 120 mg, the medicine requires the following warning statement on the medicine label: - (SODIUM) ‘The recommended daily dose of this medicine contains [state quantity and units] of sodium’ (or words to that effect).
4553	SODIUM GLYCEROPHOSPHATE	A, E, H	When for oral or sublingual use and the total amount of sodium from all ingredients in the maximum daily dose is more than 120 mg, the medicine requires the following warning statement on the medicine label: - (SODIUM) ‘The recommended daily dose of this medicine contains [state quantity and units] of sodium (or words to that effect).'
4554	SODIUM HYALURONATE	E	Only for use in topical medicines for dermal application.
4555	SODIUM HYDROGENATED TALLOW GLUTAMATE	E	Only for use in topical medicines for dermal application.
4556	SODIUM HYDROXIDE	E	The concentration in the medicine must be no more than 5%. When for oral or sublingual use and the total amount of sodium from all ingredients in the maximum daily dose is more than 120 mg, the medicine requires the following warning statement on the medicine label: - (SODIUM) ‘The recommended daily dose of this medicine contains [state quantity and units] of sodium’ (or words to that effect). 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.
4557	SODIUM HYDROXYCITRATE	A
4558	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%.
4559	SODIUM HYDROXYMETHYLGLYCINATE	E	Only for use in topical medicines for dermal application.
4560	SODIUM HYPOCHLORITE	E	Chlorine is a mandatory component of Sodium hypochlorite. The concentration of chlorine in the medicine must be no more than 4%. When for oral or sublingual use and the total amount of sodium from all ingredients in the maximum daily dose is more than 120 mg, the medicine requires the following warning statement on the medicine label: - (SODIUM) ‘The recommended daily dose of this medicine contains [state quantity and units] of sodium’ (or words to that effect).
4561	SODIUM ISOSTEAROYL LACTYLATE	E	Only for use in topical medicines for dermal application.
4562	SODIUM LACTATE	E	When for oral or sublingual use and the total amount of sodium from all ingredients in the maximum daily dose is more than 120 mg, the medicine requires the following warning statement on the medicine label: - (SODIUM) ‘The recommended daily dose of this medicine contains [state quantity and units] of sodium’ (or words to that effect).
4563	SODIUM LAURETH SULFATE	E	When for oral or sublingual use and the total amount of sodium from all ingredients in the maximum daily dose is more than 120 mg, the medicine requires the following warning statement on the medicine label: - (SODIUM) ‘The recommended daily dose of this medicine contains [state quantity and units] of sodium’ (or words to that effect).
4564	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%.
4565	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%.
4566	SODIUM LAUROYL SARCOSINATE	E	Only for use in topical medicines for dermal application.
4567	SODIUM LAURYL PHOSPHATE	E	When for oral or sublingual use and the total amount of sodium from all ingredients in the maximum daily dose is more than 120 mg, the medicine requires the following warning statement on the medicine label: - (SODIUM) ‘The recommended daily dose of this medicine contains [state quantity and units] of sodium’ (or words to that effect).
4568	SODIUM LAURYL SULFATE	E	When for oral or sublingual use and the total amount of sodium from all ingredients in the maximum daily dose is more than 120 mg, the medicine requires the following warning statement on the medicine label: - (SODIUM) ‘The recommended daily dose of this medicine contains [state quantity and units] of sodium’ (or words to that effect).
4569	SODIUM LAURYL SULFOACETATE	E	Only for use in topical medicines for dermal application.
4570	SODIUM MAGNESIUM SILICATE	E	Only for use in topical medicines for dermal application.
4571	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%.
4572	SODIUM METABISULFITE	E	When for oral or sublingual use and the total amount of sodium from all ingredients in the maximum daily dose is more than 120 mg, the medicine requires the following warning statement on the medicine label: - (SODIUM) ‘The recommended daily dose of this medicine contains [state quantity and units] of sodium’ (or words to that effect). Medicines containing sulfites salts require the following warning statement on the medicine label: - (SULF) 'Contains sulfites' (or words to this effect) if medicine contains two or more sulfite sources or 'Contains (insert the approved name of sulfites used)' (or words to this effect) if medicine contains one sulfite source.
4573	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%.
4574	SODIUM METHYL COCOYL TAURATE	E	Only for dental use. The concentration in the medicine must be no more than 2%.
4575	SODIUM METHYL HYDROXYBENZOATE	E	When for oral or sublingual use and the total amount of sodium from all ingredients in the maximum daily dose is more than 120 mg, the medicine requires the following warning statement on the medicine label: - (SODIUM) ‘The recommended daily dose of this medicine contains [state quantity and units] of sodium’ (or words to that effect). Medicines containing hydroxybenzoates require the following warning statement on the medicine label: - (TOTBNZ) ‘Contains hydroxybenzoates’ (or words to this effect) if the medicine contains more than one hydroxybenzoate source OR ‘Contains [insert the approved name of hydroxybenzoate used]’ (or words to this effect) if product contains one hydroxybenzoate source.
4576	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.
4577	SODIUM MONOFLUOROPHOSPHATE	A	Fluoride is a mandatory component of sodium monofluorophosphate. Only for use when the route of administration is dental and the dosage form is pastes, powders or gels for dental hygiene. When used as an active ingredient, it is subject to the following conditions: a) Only for use in combination with at least one other listable therapeutically active ingredient. b) The concentration of fluoride ion must be no 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.' When for oral or sublingual use and the total amount of sodium from all ingredients in the maximum daily dose is more than 120 mg, the medicine requires the following warning statement on the medicine label: - (SODIUM) 'The recommended daily dose of this medicine contains [state quantity and units] of sodium (or words to that effect).'
4578	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%.
4579	SODIUM NITRATE	H	Only for use as an active homoeopathic ingredient.
4580	SODIUM NONOXYNOL-4 SULFATE	E	Only for use in topical medicines for dermal application.
4581	SODIUM PANTOTHENATE	A, E, H	When for oral or sublingual use and the total amount of sodium from all ingredients in the maximum daily dose is more than 120 mg, the medicine requires the following warning statement on the medicine label: - (SODIUM) ‘The recommended daily dose of this medicine contains [state quantity and units] of sodium’ (or words to that effect).
4582	SODIUM PCA	E	Only for use in topical medicines for dermal application.
4583	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 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 for oral or sublingual use and the total amount of sodium from all ingredients in the maximum daily dose is more than 120 mg, the medicine requires the following warning statement on the medicine label: - (SODIUM) ‘The recommended daily dose of this medicine contains [state quantity and units] of sodium (or words to that effect).'
4584	SODIUM PERCARBONATE	E	Only for use in topical medicines for dermal application. The concentration in the medicine must be no more than 15%.
4585	SODIUM POLYACRYLATE	E	Only for use in topical medicines for dermal application.
4586	SODIUM POLYACRYLATE STARCH	E	Only to be used in a medicine where Procter & Gamble Australia Pty Ltd (Client ID 11364), 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 27 September 2020. 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%.
4587	SODIUM POLYMETAPHOSPHATE	E
4588	SODIUM PROPIONATE	E	Only for use in topical medicines for dermal application.
4589	SODIUM PROPYL HYDROXYBENZOATE	E	When for oral or sublingual use and the total amount of sodium from all ingredients in the maximum daily dose is more than 120 mg, the medicine requires the following warning statement on the medicine label: - (SODIUM) ‘The recommended daily dose of this medicine contains [state quantity and units] of sodium’ (or words to that effect). Medicines containing hydroxybenzoates require the following warning statement on the medicine label: - (TOTBNZ) ‘Contains hydroxybenzoates’ (or words to this effect) if the medicine contains more than one hydroxybenzoate source OR ‘Contains [insert the approved name of hydroxybenzoate used]’ (or words to this effect) if product contains one hydroxybenzoate source.
4590	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%.
4591	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.'
4592	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.'
4593	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.’
4594	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.’
4595	SODIUM SILICATE	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. When for oral or sublingual use and the total amount of sodium from all ingredients in the maximum daily dose is more than 120 mg, the medicine requires the following warning statement on the medicine label: - (SODIUM) ‘The recommended daily dose of this medicine contains [state quantity and units] of sodium’ (or words to that effect).
4596	SODIUM STARCH GLYCOLLATE	E	When for oral or sublingual use and the total amount of sodium from all ingredients in the maximum daily dose is more than 120 mg, the medicine requires the following warning statement on the medicine label: - (SODIUM) ‘The recommended daily dose of this medicine contains [state quantity and units] of sodium’ (or words to that effect).
4597	SODIUM STARCH GLYCOLLATE TYPE A	E	When for oral or sublingual use and the total amount of sodium from all ingredients in the maximum daily dose is more than 120 mg, the medicine requires the following warning statement on the medicine label: - (SODIUM) ‘The recommended daily dose of this medicine contains [state quantity and units] of sodium’ (or words to that effect).
4598	SODIUM STEARATE	E	Only for use in topical medicines for dermal application.
4599	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%.
4600	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%.
4601	SODIUM STEAROYL LACTYLATE	E	Only for use in topical medicines for dermal application.
4602	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%.
4603	SODIUM SUCCINATE	E	Only for use in topical medicines for dermal application.
4604	SODIUM SULFATE	A, E, H	When it is not intended to be a laxative, the medicine requires the following warning statement on the medicine label: - (LAX4) 'Substance may have a laxative effect'. When for oral or sublingual use and the total amount of sodium from all ingredients in the maximum daily dose is more than 120 mg, the medicine requires the following warning statement on the medicine label: - (SODIUM) 'The recommended daily dose of this medicine contains [state quantity and units] of sodium' (or words to that effect).
4605	SODIUM SULFATE DECAHYDRATE	A, E, H	When it is not intended to be a laxative, the medicine requires the following warning statement on the medicine label: - (LAX4) 'Substance may have a laxative effect'. When for oral or sublingual use and the total amount of sodium from all ingredients in the maximum daily dose is more than 120 mg, the medicine requires the following warning statement on the medicine label: - (SODIUM) 'The recommended daily dose of this medicine contains [state quantity and units] of sodium' (or words to that effect).
4606	SODIUM SULFITE	E	When for oral or sublingual use and the total amount of sodium from all ingredients in the maximum daily dose is more than 120 mg, the medicine requires the following warning statement on the medicine label: - (SODIUM) ‘The recommended daily dose of this medicine contains [state quantity and units] of sodium’ (or words to that effect). Medicines containing sulfites salts require the following warning statement on the medicine label: - (SULF) 'Contains sulfites' (or words to this effect) if medicine contains two or more sulfite sources or 'Contains (insert the approved name of sulfites used)' (or words to this effect) if medicine contains one sulfite source.
4607	SODIUM SULFITE HEPTAHYDRATE	E	Only for use in topical medicines for dermal application. Medicines containing sulfites salts require the following warning statement on the medicine label: - (SULF) 'Contains sulfites' (or words to this effect) if medicine contains two or more sulfite sources or 'Contains (insert the approved name of sulfites used)' (or words to this effect) if medicine contains one sulfite source.
4608	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%.
4609	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.
4610	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.
4611	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%.
4612	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.
4613	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.
4614	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.
4615	SOLIDAGO GIGANTEA	A, H
4616	SOLIDAGO GIGANTEA MIS	A, E, H
4617	SOLIDAGO VIRGAUREA	A, E, H
4618	SOLUBLE MAIZE STARCH	E
4619	SOLUBLE POTATO STARCH	E
4620	SOLVENT GREEN 3	E	Permitted for use only as a colour for topical use.
4621	SOLVENT RED 1	E	Permitted for use only as a colour for topical use.
4622	SOLVENT VIOLET 13	E	Permitted for use only as a colour for topical use.
4623	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%.
4624	SOLVENT YELLOW 33	E	Permitted for use only as a colour for topical use.
4625	SOPHORA FLAVESCENS	A, E, H
4626	SOPHORA TONKINENSIS	A, H
4627	SORBIC ACID	E	The medicine requires the following warning statement on the medicine label: - (SORB8) 'Contains sorbates' (or word to this effect) if medicine contains two or more sorbate sources OR 'Contains [insert the approved name of sorbate source used]' (or words to this effect) if medicine contains one sorbate source.
4628	SORBITAN ISOSTEARATE	E	Only for use in topical medicines for dermal application.
4629	SORBITAN MONO-OLEATE	E
4630	SORBITAN MONOLAURATE	E
4631	SORBITAN MONOSTEARATE	E
4632	SORBITAN OLEATE	E
4633	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%.
4634	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%.
4635	SORBITAN SESQUIISOSTEARATE	E	Only for use in topical medicines for dermal application.
4636	SORBITAN SESQUIOLEATE	E	Only for use in topical medicines for dermal application.
4637	SORBITAN STEARATE	E
4638	SORBITAN TRISTEARATE	E	Only for use in topical medicines for dermal application.
4639	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.
4640	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. When the quantity of sugar alcohols per maximum recommended daily dose is more than 2 grams, the quantity of the sugar alcohols must be declared on the label and the medicine requires the following warning statement on the medicine label: - (SUGOLS) ‘Products containing [insert name of sugar alcohol(s)] may have a laxative effect or cause diarrhoea (or words to that effect).'
4641	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. When the quantity of sugar alcohols per maximum recommended daily dose is more than 2 grams, the quantity of the sugar alcohols must be declared on the label and the medicine requires the following warning statement on the medicine label: - (SUGOLS) ‘Products containing [insert name of sugar alcohol(s)] may have a laxative effect or cause diarrhoea (or words to that effect).'
4642	SORBUS AUCUPARIA	A, H
4643	SORBUS DOMESTICA	A, H
4644	SORGHUM	E
4645	SORGHUM VULGARE	A, H
4646	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%.
4647	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%.
4648	SOY POLYSACCHARIDE	E
4649	SOY PROTEIN	E
4650	SOY STEROL	E
4651	SOYA BEAN	E
4652	SOYA BRAN	E
4653	SOYA OIL	A, E, H
4654	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%.
4655	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%.
4656	SPARGANIUM STOLONIFERUM	A, H
4657	SPARTIUM JUNCEUM	A, H
4658	SPATHOLOBUS SUBERECTUS	A, H
4659	SPEARMINT OIL	A, E, H	When the ingredient is included in a medicine that is listed in the Register: - on or after 1 July 2018, the medicine must comply with all requirements under (a)-(c); - before 1 July 2018 and supplied on or after 1 January 2020, the medicine must comply with all requirements under (a)-(c); or - before 1 July 2018 and supplied before 1 January 2020, the medicine may comply with requirements under (a)-(c). a) Menthol is a mandatory component of spearmint oil. b) 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 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; - (EYE) Avoid contact with eyes (or words to that effect). (iv) 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. c) When the medicine is for internal use, the maximum recommended daily dose must not contain more than 1 gram of menthol.
4660	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: 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 medicine requires the following warning statements 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; - (EYE) Avoid contact with eyes (or words to that effect). d) 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.
4661	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%.
4662	SPIGELIA ANTHELMIA	A, H
4663	SPIGELIA MARILANDICA	A, H	The maximum recommended daily dose must be no more than the equivalent of 1mg of the dry herbal material.
4664	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.
4665	SPINACH	E
4666	SPINACIA OLERACEA	A, E, H
4667	SPIRODELA POLYRRHIZA	A, H
4668	SPIRULINA	E
4669	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%.
4670	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%.
4671	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%.
4672	SQUALANE	E	Only for use in topical medicines for dermal application.
4673	SQUALENE	A, E
4674	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.
4675	SQUILL DRY	A, H
4676	SQUILL INDIAN DRY	A, H
4677	SQUILL INDIAN POWDER	A, H
4678	SQUILL POWDER	A, H
4679	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.'
4680	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.'
4681	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.'
4682	STACHYS OFFICINALIS	A, E, H
4683	STACHYS PALUSTRIS	A, H
4684	STACHYURUS HIMALAICUS	A, H
4685	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%.
4686	STANNOUS CHLORIDE	H	Only for use as an active homoeopathic ingredient.
4687	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).
4688	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%.
4689	STARCH SODIUM OCTENYL SUCCINATE	E
4690	STEARALKONIUM CHLORIDE	E	Only for use in topical medicines for dermal application.
4691	STEARALKONIUM HECTORITE	E	Only for use in topical medicines for dermal application.
4692	STEARAMIDE	E	Only for use in topical medicines for dermal application.
4693	STEARAMIDOETHYL DIETHYLAMINE	E	Only for use in topical medicines for dermal application.
4694	STEARAMIDOPROPYL DIMETHYLAMINE	E	Only for use in topical medicines for dermal application.
4695	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).
4696	STEARETH-10	E	Only for use in topical medicines for dermal application.
4697	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%.
4698	STEARETH-2	E	Only for use in topical medicines for dermal application.
4699	STEARETH-20	E	Only for use in topical medicines for dermal application.
4700	STEARETH-21	E	Only for use in topical medicines for dermal application.
4701	STEARETH-5	E	Only for use in topical medicines for dermal application.
4702	STEARIC ACID	E
4703	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%.
4704	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%.
4705	STEAROXYTRIMETHYLSILANE	E	Only for use in topical medicines for dermal application.
4706	STEAROYL MACROGOLGLYCERIDES	E	Only for use in oral medicines. The concentration in the medicine must be no more than 0.6%.
4707	STEARYL ACETATE	E	Only for use in topical medicines for dermal application.
4708	STEARYL ALCOHOL	E
4709	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).
4710	STEARYL GLYCYRRHETINATE	E	Only for use in topical medicines for dermal application.
4711	STEARYL HEPTANOATE	E	Only for use in topical medicines for dermal application.
4712	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%.
4713	STEARYL STEARATE	E	Only for use in topical medicines for dermal application.
4714	STELLARIA CHAMAEJASME	A, H
4715	STELLARIA DICHOTOMA	A, H
4716	STELLARIA MEDIA	A, E, H
4717	STEMONA JAPONICA	A, H
4718	STEMONA SESSILIFOLIA	A, H
4719	STENOTAPHRUM SECUNDATUM	A, H
4720	STEPHANIA TETRANDA	A, H
4721	STERCULIA	A, H
4722	STERCULIA TRAGACANTHA	A, H
4723	STERCULIA URENS	A, H
4724	STEVIA REBAUDIANA	A, E, H
4725	STEVIOL GLYCOSIDES	E	Only for use in oral medicines.
4726	STILLINGIA SYLVATICA	A, H
4727	STORAX PREPARED	A, E, H
4728	STRAWBERRY	E
4729	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%.
4730	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'.
4731	STREPTOCOCCUS THERMOPHILUS	A
4732	STROBILANTHES CUSIA	A, H
4733	STRONG AMMONIA SOLUTION	E	Ammonia is a mandatory component of dilute 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%.
4734	STRONTIUM CARBONATE	H	Only for use as an active homoeopathic ingredient.
4735	STROPHANTHUS GRATUS	H	Only for use as an active homoeopathic ingredient.
4736	STROPHANTHUS HISPIDUS	H	Only for use as an active homoeopathic ingredient.
4737	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%.
4738	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%.
4739	STYPHNOLOBIUM JAPONICUM	A, E, H
4740	STYRAX BENZOIN	A, E, H
4741	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%.
4742	STYRAX PARALLELONEURUM	A, H
4743	STYRAX TONKINENSIS	A, H
4744	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%.
4745	STYRENE/ACRYLATES COPOLYMER	E	Only for use in topical medicines for dermal application.
4746	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%.
4747	SUBLIMED SULFUR	H	Only for use as an active homoeopathic ingredient.
4748	SUCCINIC ACID	E
4749	SUCRALOSE	E
4750	SUCROSE	E	When the medicine is for oral ingestion and the total amount of all sugars (monosaccharides and disaccharides such as glucose, honey, invert sugar, lactose, maltose, and sucrose) is more than 100mg in the maximum daily dose, then the medicine requires the following warning statement on the medicine label: - (SUGARS) ‘Contains [insert name of sugar]’ if medicine contains one sugar OR ‘Contains sugars' (or words to that effect) if medicine contains two or more sugars. If one of the sugars is lactose then the medicine also requires the following warning statement on the medicine label: - (LACT) ‘Contains lactose' (or words to that effect).
4751	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%.
4752	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%.
4753	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%.
4754	SUCROSE DISTEARATE	E	Only for use in topical medicines for dermal application.
4755	SUCROSE LAURATE	E	When for oral or sublingual use, Sucrose is a mandatory component of Sucrose laurate. When the medicine is for oral ingestion and the total amount of all sugars (monosaccharides and disaccharides such as glucose, honey, invert sugar, lactose, maltose, and sucrose) is more than 100mg in the maximum daily dose, then the medicine requires the following warning statement on the medicine label: - (SUGARS) ‘Contains [insert name of sugar]’ if medicine contains one sugar OR ‘Contains sugars' (or words to that effect) if medicine contains two or more sugars. If one of the sugars is lactose then the medicine also requires the following warning statement on the medicine label: - (LACT) ‘Contains lactose' (or words to that effect).
4756	SUCROSE OCTAACETATE	E	When for oral or sublingual use, sucrose is a mandatory component of sucrose octaacetate. When the medicine is for oral ingestion and the total amount of all sugars (monosaccharides and disaccharides such as glucose, honey, invert sugar, lactose, maltose, and sucrose) is more than 100mg in the maximum daily dose, then the medicine requires the following warning statement on the medicine label: - (SUGARS) ‘Contains [insert name of sugar]’ if medicine contains one sugar OR ‘Contains sugars' (or words to that effect) if medicine contains two or more sugars. If one of the sugars is lactose then the medicine also requires the following warning statement on the medicine label: - (LACT) ‘Contains lactose' (or words to that effect).
4757	SUCROSE PALMITATE	E	Only for use in topical medicines for dermal application.
4758	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).
4759	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.
4760	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%.
4761	SUDAN III	E	Permitted for use only as a colour for topical use.
4762	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).
4763	SUGARCANE	E, H	When for oral or sublingual use, sucrose is a mandatory component of Sugarcane. When the medicine is for oral ingestion and the total amount of all sugars (monosaccharides and disaccharides such as glucose, honey, invert sugar, lactose, maltose, and sucrose) is more than 100mg in the maximum daily dose, then the medicine requires the following warning statement on the medicine label: - (SUGARS) ‘Contains [insert name of sugar]’ if medicine contains one sugar OR ‘Contains sugars' (or words to that effect) if medicine contains two or more sugars. If one of the sugars is lactose then the medicine also requires the following warning statement on the medicine label: - (LACT) ‘Contains lactose' (or words to that effect).
4764	SULFATED CASTOR OIL	E	Only for use in topical medicines for dermal application.
4765	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%.
4766	SULFUR DIOXIDE	E	Medicines containing sulfites salts require the following warning statement on the medicine label: - (SULF) 'Contains sulfites' (or words to this effect) if medicine contains two or more sulfite sources or 'Contains (insert the approved name of sulfites used)' (or words to this effect) if medicine contains one sulfite source.
4767	SULFUR IODIDE	H	Only for use as an active homoeopathic ingredient.
4768	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%.
4769	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%.
4770	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 be no more than 10%. When used in primary sunscreen products and listed in the Register on or after 1 January 2018, the medicine must have the following statements on the medicine 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). When used in primary sunscreen products and listed in the Register before 1 January 2018, the medicine requires the following statements on the medicine label if supplied after 1 July 2019: - (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).
4771	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 be no more than 10%. When used in primary sunscreen products and listed in the Register on or after 1 January 2018, the medicine must have the following statements on the medicine 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). When used in primary sunscreen products and listed in the Register before 1 January 2018, the medicine requires the following statements on the medicine label if supplied after 1 July 2019: - (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).
4772	SUNFLOWER OIL	A, E, H
4773	SUNFLOWER SEED	E, H
4774	SUNSET YELLOW FCF	E	Permitted for use only as a colour for either topical use or with an oral route of administration.
4775	SUNSET YELLOW FCF ALUMINIUM LAKE	E	Permitted for use only as a colour for oral and topical use.
4776	SUPEROXIDE DISMUTASE	E	Only for use in topical medicines for dermal application.
4777	SWEDE	E
4778	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%.
4779	SWEET POTATO	E
4780	SWERTIA CHIRATA	A, H
4781	SWIETENIA MAHOGANI	A, H
4782	SYAGRUS ROMANZOFFIANA	A, E, H
4783	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%.
4784	SYMPLOCARPUS FOETIDUS	A, H
4785	SYNTHETIC BEESWAX	E	Only for use in topical medicines for dermal applications.
4786	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.
4787	SYNTHETIC WAX	E
4788	SYRINGA RETICULATA	A, H
4789	SYRINGA VULGARIS	A, H
4790	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%.
4791	SYZYGIUM CUMINI	A, H
4792	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%.
4793	TABEBUIA SERRATIFOLIA	A, E, H
4794	TAGETES ERECTA	A, H
4795	TAGETES MINUTA	A, E, H
4796	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%.
4797	TAIPAN SNAKE	H	Only for use as an active homoeopathic ingredient.
4798	TALLOW	E	Only for use in topical medicines for dermal application.
4799	TALLOW GLYCERIDES	E
4800	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%.
4801	TAMARIX APHYLLA	A, H
4802	TAMARIX CHINENSIS	A, H
4803	TAMARIX GALLICA	A, H
4804	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.
4805	TANACETUM CINERARIIFOLIUM	A, H	The concentration in the medicine must be no more than 10%.
4806	TANACETUM PARTHENIUM	A, E, H
4807	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%.
4808	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%.
4809	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.
4810	TANNIC ACID	E
4811	TAPIOCA STARCH	E
4812	TARAXACUM MONGOLICUM	A, E, H
4813	TARAXACUM OFFICINALE	A, E, H
4814	TARO	E
4815	TARRAGON OIL	A, E, H
4816	TARTARIC ACID	E
4817	TARTRAZINE	E	Permitted for use only as a colour for oral and topical use. The medicine requires the following warning statement on the medicine label: - (TART) 'Contains tartrazine' (or words to that effect).
4818	TARTRAZINE ALUMINIUM LAKE	E	Permitted for use only as a colour for oral and topical use. The medicine requires the following warning statement on the medicine label: - (TART) 'Contains tartrazine' (or words to that effect).
4819	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%.
4820	TAURINE	A, E
4821	TEA-STEARATE	E	Only for use in topical medicines for dermal application.
4822	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'.
4823	TERMINALIA BELLIRICA	A	Only for use when the preparation is as an aqueous extract of the fruit pericarp.
4824	TERMINALIA CATAPPA	A, H
4825	TERMINALIA CHEBULA	A, H
4826	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%.
4827	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%.
4828	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%.
4829	TERPINEOL	E
4830	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%.
4831	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%.
4832	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%.
4833	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%.
4834	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%.
4835	TERT-BUTYL ALCOHOL	E	Only for use in topical medicines for dermal application.
4836	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%.
4837	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%.
4838	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%.
4839	TETRACLINIS ARTICULATA	A, E, H
4840	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%.
4841	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.
4842	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%.
4843	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%.
4844	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%.
4845	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%.
4846	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%.
4847	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%.
4848	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%.
4849	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%.
4850	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%.
4851	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%.
4852	TETRAHYDROXYPROPYL ETHYLENEDIAMINE	E	Only for use in topical medicines for dermal application.
4853	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%.
4854	TETRAPANAX PAPYRIFER	A, H
4855	TETRASODIUM ETIDRONATE	E	Only for use in topical medicines for dermal application.
4856	TETRASODIUM PYROPHOSPHATE	E	When for oral or sublingual use and the total amount of sodium from all ingredients in the maximum daily dose is more than 120 mg, the medicine requires the following warning statement on the medicine label: - (SODIUM) ‘The recommended daily dose of this medicine contains [state quantity and units] of sodium’ (or words to that effect).
4857	TEUCRIUM CHAMAEDRYS	A, H	The maximum recommended daily dose must be no more than 1mg of the equivalent dry herbal material of Teucrium chamaedrys.
4858	TEUCRIUM MARUM	A, H	The maximum recommended daily dose must be no more than 1mg of the equivalent dry herbal material of Teucrium marum.
4859	TEUCRIUM SCORODONIA	A, H	The maximum recommended daily dose must be no more than 1mg of the equivalent dry herbal material of Teucrium scorodonia.
4860	THAPSIA GARGANICA	A, H
4861	THAUMATIN	E
4862	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%.
4863	THEMEDA TRIANDRA	A, H
4864	THEOBROMA CACAO	A, E, H	Caffeine is a mandatory component of Theobroma cacao. When the route of administration is oral or sublingual and the medicine provides a maximum recommended daily dose of more than 1 mg but no more than 10 mg of caffeine in the medicine requires the following warning statement on the medicine label: - (CAFFR) ‘The recommended dose of this medicine provides small amounts of caffeine.’ When the route of administration is oral or sublingual and the medicine provides a maximum recommended daily dose of more than 10 mg of caffeine in the medicine requires the following warning statement on the medicine label: - (CAFF) ‘Contains caffeine [state quantity per dosage unit or per mL or per gram of product]’.
4865	THEOBROMA OIL	A, E, H
4866	THIAMINE	A, E
4867	THIAMINE HYDROCHLORIDE	A, E
4868	THIAMINE NITRATE	A, E
4869	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%.
4870	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%.
4871	THLASPI ARVENSE	A, E, H
4872	THREONINE	A, E
4873	THUJA OCCIDENTALIS	A, H
4874	THUJA PLICATA	A, E, H
4875	THYME HERB DRY	A, E, H
4876	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).
4877	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 topical medicines for dermal applications.
4878	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).
4879	THYMUS GLAND	H	Only for use as an active homoeopathic ingredient.
4880	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).
4881	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).
4882	THYMUS VULGARIS	A, E, H	When the plant preparation is oil or distillate, the nominal capacity of the container must be no more than 25 millilitres. When the concentration of Thymus vulgaris oil or distillate in the preparation is greater than 50%, a restricted flow insert must be fitted on the container and the medicine must include the following warning statement on the medicine label: - (CHILD) 'Keep out of reach of children' (or words to that effect)
4883	THYMUS VULGARIS MIS	A, E, H	When the plant preparation is an oil or distillate, the nominal capacity of the container must be no more than 25 millilitres. When the concentration of Thymus vulgaris mis oil or distillate in the preparation is greated than 50%, a restricted flow insert must be fitted on the container and the medicine must include the following warning statement on the medicine label: - (CHILD) 'Keep out of reach of children' (or words to that effect)
4884	THYMUS ZYGIS	A, H	When the plant preparation is an oil or a distillate, the nominal capacity of the container must be no more than 25 millilitres. When the concentration of Thymus zygis oil or distillate in the preparation is greater than 50%, a restricted flow insert must be fitted on the container and the medicine must include the following warning statement on the medicine label: - (CHILD) 'Keep out of reach of children' (or words to that effect).
4885	TIGER SNAKE	H	Only for use as an active homoeopathic ingredient.
4886	TILACTASE	A	Must be derived from Aspergillus oryzae and comply with the relevant USP monograph. When the dosage form is undivided, the units 'acid lactase units per gram' and 'Thousand acid lactase units per gram' are permitted. When the dosage form is divided, the units 'acid lactase units' and 'thousand acid lactase units' are permitted.
4887	TILIA CORDATA	A, E, H
4888	TILIA PLATYPHYLLOS	A, E, H
4889	TILIA TOMENTOSA	A, H
4890	TILIA X VULGARIS	A, E, H
4891	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%.
4892	TIN	H	Only for use as an active homoeopathic ingredient.
4893	TINOSPORA CORDIFOLIA	A, H
4894	TINOSPORA SINENSIS	A, H
4895	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 in oral medicines and as a colour in topical medicines for dermal application. Not to be included in medicines intended for use in the eye. When used in primary sunscreen products and listed in the Register on or after 1 January 2018, the medicine must have the following statements on the medicine 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). When used in primary sunscreen products and listed in the Register before 1 January 2018, the medicine requires the following statements on the medicine label if supplied after 1 July 2019: - (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).
4896	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%.
4897	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%
4898	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%.
4899	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%
4900	TOCOPHERYL LINOLEATE	E	Only for use in topical medicines for dermal application.
4901	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%.
4902	TOLU BALSAM	A, E, H
4903	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%.
4904	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%.
4905	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%.
4906	TOMATO	E
4907	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%.
4908	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%.
4909	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%.
4910	TOXICODENDRON DIVERSILOBUM	H	Only for use as an active homoeopathic ingredient.
4911	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.
4912	TOXICODENDRON RADICANS	A, H	The maximum recommended daily dose must be no more than 1mg of the equivalent dry herbal material of Toxicodendron radicans.
4913	TOXICODENDRON SUCCEDANEUM	H	Only for use as an active homoeopathic ingredient.
4914	TRACHELOSPERMUM JASMINOIDES	A, E, H
4915	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%.
4916	TRAGACANTH	A, E
4917	TRAMETES VERSICOLOR	A, H
4918	TRAMETES VERSICOLOR PROTEOGLYCAN CONCENTRATE	A, H	Only for use in oral medicines.
4919	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%.
4920	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.
4921	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%.
4922	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%.
4923	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%.
4924	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%.
4925	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%.
4926	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%.
4927	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%.
4928	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%.
4929	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%.
4930	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%.
4931	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%.
4932	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%.
4933	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%.
4934	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%.
4935	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%.
4936	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%.
4937	TREACLE	E	When for oral or sublingual use, sucrose is a mandatory component of Treacle. When the medicine is for oral ingestion and the total amount of all sugars (monosaccharides and disaccharides such as glucose, honey, invert sugar, lactose, maltose, and sucrose) is more than 100mg in the maximum daily dose, then the medicine requires the following warning statement on the medicine label: - (SUGARS) ‘Contains [insert name of sugar]’ if medicine contains one sugar OR ‘Contains sugars' (or words to that effect) if medicine contains two or more sugars. If one of the sugars is lactose then the medicine also requires the following warning statement on the medicine label: - (LACT) ‘Contains lactose' (or words to that effect).
4938	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%.
4939	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.
4940	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.
4941	TREMELLA FUCIFORMIS	A, H
4942	TRIACETIN	E
4943	TRIACONTANYL PVP	E	Only for use in topical medicines for dermal application.
4944	TRIADICA SEBIFERA	A, H
4945	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.
4946	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. When for oral or sublingual use and the total amount of sodium from all ingredients in the maximum daily dose is more than 120 mg, the medicine requires the following warning statement on the medicine label: - (SODIUM) ‘The recommended daily dose of this medicine contains [state quantity and units] of sodium’ (or words to that effect).
4947	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%.
4948	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%.
4949	TRIBULUS TERRESTRIS	A, E, H
4950	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%.
4951	TRICALCIUM PHOSPHATE	E
4952	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%.
4953	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%.
4954	TRICETEARETH-4 PHOSPHATE	E	Only for use in topical medicines for dermal application.
4955	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%.
4956	TRICHODERMA VIRIDE	A, E, H
4957	TRICHOSANTHES KIRILOWII	A, E, H
4958	TRICLOSAN	E	The concentration in the medicine must be no more than 1%.
4959	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%.
4960	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%.
4961	TRIDECETH-4 PHOSPHATE	E	Only for use in topical medicines for dermal application.
4962	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%.
4963	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%.
4964	TRIDECYL BEHENATE	E	Behenic acid is a mandatory component of Tridecyl behenate. Only for use in topical medicines for dermal application.
4965	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%.
4966	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%.
4967	TRIDECYL STEARATE	E	Only for use in topical medicines for dermal application.
4968	TRIDECYL TRIMELLITATE	E	Only for use in topical medicines for dermal application.
4969	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%.
4970	TRIETHYL CITRATE	E
4971	TRIETHYLENE GLYCOL	E
4972	TRIFOLIUM PRATENSE	A, E, H
4973	TRIFOLIUM REPENS	A, H
4974	TRIGONELLA FOENUM-GRAECUM	A, E, H
4975	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%.
4976	TRIHYDROXYSTEARIN	E	Only for use in topical medicines for dermal application.
4977	TRIISOCETYL CITRATE	E	Only for use in topical medicines for dermal application.
4978	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%.
4979	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%.
4980	TRIISOSTEARIN	E	Only for use in topical medicines for dermal application.
4981	TRILAURIN	E	Only for use in topical medicines for dermal application.
4982	TRILISA ODORATISSIMA	A, H
4983	TRILLIUM ERECTUM	A, H
4984	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%.
4985	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%.
4986	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%.
4987	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%.
4988	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%.
4989	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%.
4990	TRIMETHYLOPROPANE TRIOCTANOATE	E	Only for use in topical medicines for dermal application.
4991	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%.
4992	TRIMETHYLSILOXYSILICATE	E	Only for use in topical medicines for dermal application.
4993	TRINITROPHENOL	H	Only for use as an active homoeopathic ingredient.
4994	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%.
4995	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%.
4996	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%.
4997	TRIOSTEUM PERFOLIATUM	A, H
4998	TRIOXAUNDECANEDIOIC ACID	E
4999	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%.
5000	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%.
5001	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 be no more than 10%. When used topically, the dosage form must not be spray. When used in primary sunscreen products and listed in the Register on or after 1 January 2018, the medicine must have the following statements on the medicine 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). When used in primary sunscreen products and listed in the Register before 1 January 2018, the medicine requires the following statements on the medicine label if supplied after 1 July 2019: - (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).
5002	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%.
5003	TRISODIUM EDETATE	E	Only for use in topical medicines for dermal application.
5004	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%.
5005	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%.
5006	TRISTEARIN	E
5007	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. When the route of administration is other than topical or mucosal, the medicine requires the following warning statement on the medicine label: - (GLUTEN) 'Contains [insert name of ingredient]' (or words to that effect).
5008	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. When the route of administration is other than topical or mucosal, the medicine requires the following warning statement on the medicine label: - (GLUTEN) 'Contains [insert name of ingredient]' (or words to that effect).
5009	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%.
5010	TROLAMINE	E	Only for use in topical medicines for dermal application. The concentration in the medicine must be no more than 5%.
5011	TROLAMINE LAURIL SULFATE	E	Only for use in topical medicines for dermal application.
5012	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 be no more than 12%. When used in primary sunscreen products and listed in the Register on or after 1 January 2018, the medicine must have the following statements on the medicine 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). When used in primary sunscreen products and listed in the Register before 1 January 2018, the medicine requires the following statements on the medicine label if supplied after 1 July 2019: - (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).
5013	TROLLIUS CHINENSIS	A, H
5014	TROMETAMOL	E
5015	TROMETAMOL HYDROCHLORIDE	E
5016	TROPAEOLUM MAJUS	A, E, H
5017	TROPICAL RATTLESNAKE	H	Only for use as an active homoeopathic ingredient.
5018	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%.
5019	TSUGA CANADENSIS	A, H
5020	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%.
5021	TURMERIC	E	Permitted for use only in combination with other permitted ingredients as a colour.
5022	TURNERA DIFFUSA	A, E, H	Arbutin is a mandatory component of Turnera diffusa. The concentration of arbutin in the medicine must be no more than 25 mg/Kg or 25mg /L or 0.0025 % unless used on the hair. When for use on hair, the concentration of arbutin in the medicine must be no more than 0.74 %.
5023	TURNIP	E
5024	TURPENTINE OIL	A, E	The concentration in the medicine must be no more than 25%.
5025	TYPHA ANGUSTIFOLIA	A, H
5026	TYPHA LATIFOLIA	A, H
5027	TYPHONIUM GIGANTEUM	A, H
5028	TYROSINE	A, E