Permissible ingredients and requirements

Column 1

Column 2

Column 3

Column 4

Item

Ingredient Name

Purpose

Specific requirements

5073

UBIDECARENONE

A, E

When used as an excipient, the route of administration must be topical and the concentration in the medicine must not be more than 0.05%.

Not to be included in medicines intended for use in the eye.

When for internal use, the maximum recommended daily dose must not provide more than 300 milligrams of ubidecarenone.

When for internal use in combination with Ubiquinol-10, the maximum recommended daily dose must not provide more than 300 milligrams of ubiquinol-10 and ubidecarenone combined.

When for internal use, the following warning statement is required on the medicine label:

- (WARF) 'Do not take while on warfarin therapy without medical advice'.

5074

UBIQUINOL-10

A, E

When used as an excipient, the route of administration must be topical and the concentration in the medicine must be no more than 0.05%.

Not to be included in medicines intended for use in the eye.

When for internal use, the maximum recommended daily dose must provide no more than 300 milligrams of ubiquinol-10.

When used in combination with ubidecarenone, the maximum recommended daily dose must provide no more than 300 mg of ubiquinol-10 and ubidecarenone combined.

The medicine requires the following warning statement on the medicine label:

- (WARF) 'Do not take while on warfarin therapy without medical advice.'

5075

ULEX EUROPAEUS

A, H

5076

ULMUS AMERICANA

A, H

5077

ULMUS CAMPESTRIS

A, H

5078

ULMUS GLABRA

A, H

5079

ULMUS MINOR

A, H

5080

ULMUS PARVIFOLIA

A, H

5081

ULMUS PUMILA

A, H

5082

ULMUS RUBRA

A, H

5083

ULTRALIDE

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%.

5084

ULTRAMARINE BLUE

E

Permitted for use only as a colour for topical use.

5085

ULVA LACTUCA

A, H

Iodine is a mandatory component of Ulva lactuca.

Only for use in topical medicines for dermal 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%.

5086

UMBELLULARIA CALIFORNICA

A, H

5087

UNCARIA GAMBIR

A, H

5088

UNCARIA RHYNCOPHYLLA

A, H

5089

UNCARIA SINENSIS

A, H

5090

UNCARIA TOMENTOSA

A, H

5091

UNDARIA PINNATIFIDA

A, H

Whole dried Undaria pinnatifida must not contain the holdfast.

Only for use in oral medicines.

5092

UNDECANAL

E

Permitted for use only in combination with other permitted ingredients 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%.

5093

UNDECANOIC ACID

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%.

5094

UNDECENOIC ACID

E

5095

UNDECYL ALCOHOL

E

Permitted for use only in combination with other permitted ingredients as a flavour or a fragrance.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must be no more 1%.

5096

UNDECYLCRYLENE 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 10%.

5097

UNDECYLENAMIDE DEA

E

5098

UNDECYLENOYL PEG-5 PARABEN

E

Only for use in topical medicines for dermal application.

5099

URANIUM NITRATE

H

Only for use as an active homoeopathic ingredient. 

5100

UREA

A, E, H

Only for use in topical medicines for dermal application.

The concentration in the medicine must be no more than 10% (w/w).

5101

URTICA DIOICA

A, E, H

5102

URTICA URENS

A, H

5103

USNEA BARBATA

A, H

5104

UVA URSI LEAF DRY

A, H

5105

UVA URSI LEAF POWDER

A, E, H

5106

VA/BUTYL MALEATE/ISOBORNYL ACRYLATE COPOLYMER

E

Vinyl acetate is a mandatory component of VA/butyl maleate/isobornyl acrylate copolymer.

The concentration of vinyl acetate in the medicine must be no more than 0.01% or 100 ppm.

Only for use in topical medicines for dermal 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%.

5107

VACCARIA SEGATALIS

A, H

5108

VACCINIUM BRACTEATUM

A, H

5109

VACCINIUM CORYMBOSUM

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%.

5110

VACCINIUM MACROCARPON

A, E, H

5111

VACCINIUM MYRTILLOIDES

A, H

5112

VACCINIUM MYRTILLUS

A, E, H

5113

VACCINIUM OXYCOCCUS

A, H

5114

VACCINIUM VITIS-IDAEA

A, H

Beta-arbutin is a mandatory component of Vaccinium vitis-idaea.

When for oral use, the maximum recommended daily dose must not provide more than 500 mg of beta-arbutin.

When for dermal application exclusively to the face:

a) the concentration of beta-arbutin in the medicine must not be more than 7%;

b) hydroquinone is a mandatory component; and

c) the concentration of hydroquinone must not be more than 10 mg/kg or 10 mg/L or 0.001%.

When for use other than oral or dermal application exclusively to the face, the concentration of beta-arbutin in the medicine must not be more than 10 mg/kg or 10 mg/L or 0.001%.

5115

VALENCENE

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%.

5116

VALERALDEHYDE

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%.

5117

VALERIAN DRY

A, H

The following warning statement is required on the medicine label when the medicine is for oral use:

(VALER) 'In rare cases, valerian may harm the liver. Stop use and see a doctor if you have yellowing skin/eyes or unusual: fatigue, nausea, appetite loss, abdominal pain, dark urine or itching.'

5118

VALERIAN OIL

E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

5119

VALERIAN POWDER

A, H

The following warning statement is required on the medicine label when the medicine is for oral use:

(VALER) 'In rare cases, valerian may harm the liver. Stop use and see a doctor if you have yellowing skin/eyes or unusual: fatigue, nausea, appetite loss, abdominal pain, dark urine or itching.'

5120

VALERIANA EDULIS

A, H

5121

VALERIANA OFFICINALIS

A, H

The following warning statement is required on the medicine label when the medicine is for oral use:

(VALER) 'In rare cases, valerian may harm the liver. Stop use and see a doctor if you have yellowing skin/eyes or unusual: fatigue, nausea, appetite loss, abdominal pain, dark urine or itching.'

5122

VALERIANA SORBIFOLIA

A, H

5123

VALERIC 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%.

5124

VALINE

A, E

5125

VANADIUM

H

5126

VANILLA

E

Permitted for use only in combination with other permitted ingredients 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%.

5127

VANILLA DRY

A, E, H

5128

VANILLA 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%.

5129

VANILLA OLEORESIN

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%.

5130

VANILLA PLANIFOLIA

A, E, H

5131

VANILLA POWDER

A, E, H

5132

VANILLA TAHITENSIS

A, H

5133

VANILLIC 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%.

5134

VANILLIN

E

5135

VANILLIN ACETATE

E

Vanillin acetate must only be included in medicines when in combination with other permitted ingredients as a flavour proprietary excipient formulation.

The total concentration of flavour proprietary excipient formulations containing vanillin acetate must not be more than 5% of the total medicine.

The maximum recommended daily dose of the medicine must not provide more than 1.8 micrograms of vanillin acetate.

5136

VANILLIN 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%.

5137

VANILLYL ALCOHOL

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%.

5138

VAT RED 1

E

Permitted for use only as a colour for topical use.

5139

VAT RED 1 ALUMINIUM LAKE

E

Permitted for use only as a colour for topical use.

5140

VAT RED 5

E

Permitted for use only as a colour for topical use.

5141

VEGETABLE OIL

E

5142

VEGETABLE OIL PHYTOSTEROL ESTERS

A

Only for use in oral medicines.

The medicine requires the following warning statement on the medicine label:

- (PREGNT) 'Not recommended for use by pregnant and lactating women (or words to that effect).'

5143

VEIN

H

Only for use as an active homoeopathic ingredient.

5144

VERATRALDEHYDE

E

Permitted for use only in combination with other permitted ingredients 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%.

5145

VERATROL

E

Permitted for use only in combination with other permitted ingredients as part of a fragrance proprietary excipient formulation.

The total fragrance proprietary excipient formulation in a medicine must be no more than 1%.

5146

VERATRUM ALBUM

A, H

Solanidine is a mandatory component of Veratrum album.

The concentration of equivalent dry Veratrum album in the medicine must be no more than 10mg/Kg or 10mg/L or 0.001%.

5147

VERBASCUM DENSIFLORUM

A, H

5148

VERBASCUM THAPSUS

A, H

5149

VERBENA OFFICINALIS

A, H

5150

VERBENA OIL

E

Permitted for use only in combination with other permitted ingredients as a flavour.

If used in a flavour the total flavour concentration in a medicine must be no more than 5%.

5151

VERONICA CHAMAEDRYS

A, H

5152

VERONICA OFFICINALIS

A, H

5153

VERONICASTRUM VIRGINICUM

A, E, H

5154

VERTONAL

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 vertonal must be no more than 0.2%.

The total fragrance proprietary excipient formulation in a medicine must be no more than 1%.

5155

VETIVER 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%.

5156

VETIVERYL 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%.

5157

VIBURNUM OPULUS

A, E, H

5158

VIBURNUM PRUNIFOLIUM

A, E, H

5159

VICIA FABA

A, H

Levodopa is a mandatory component of Vicia faba.

The concentration of levodopa in the medicine must not be more than 10 mg/kg or 10 mg/L or 0.001%.

5160

VIGNA ANGULARIS VAR. ANGULARIS

A, H

5161

VIGNA RADIATA

A, H

5162

VIGNA UMBELLATA

A, H

5163

VINCA MAJOR

A, H

Vincamine is a mandatory component of Vinca major.

The concentration of vincamine in the medicine must be no more than 10mg/kg or 10 mg/L or 0.001%.

5164

VINCA MINOR

A, H

Vincamine and vincristine are mandatory components of Vinca minor.

The concentration of vincamine in the medicine must be no more than 10mg/kg or 10 mg/L or 0.001%.

The concentration of Vincristine in the medicine must be no more than 10mg/kg or 10mg/L or 0.001%

5165

VINCETOXICUM OFFICINALE

A, H

5166

VINEGAR

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%.

5167

VIOLA ODORATA

A, E, H

5168

VIOLA TRICOLOR

A, H

5169

VIOLA YEDOENSIS

A, H

5170

VIOLET LEAF 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 than 1%.

5171

VIPER

H

Only for use as an active homoeopathic ingredient. 

5172

VISCUM ALBUM

A, E, H

5173

VISCUM COLORATUM

A, H

5174

VISCUM FLAVESCENS

A, H

5175

VITELLARIA PARADOXA

A, E, H

5176

VITEX AGNUS-CASTUS

A, E, H

When the ingredient is in a medicine that is for internal use, the following warning statement is required on the label:

- (VAC) 'Vitex agnus-castus may affect hormones and medicines such as oral contraceptives. Consult your health professional before use' (or words to that effect).

5177

VITEX NEGUNDO

A, H

5178

VITEX ROTUNDIFOLIA

A, H

5179

VITEX TRIFOLIA

A, H

5180

VITIS VINIFERA

A, E, H

5181

VITREOSCILLA CONCENTRATE

E

Only for use in topical medicines for dermal application.

The concentration in the medicine must be no more than 0.1%.

5182

VP/ACRYLATES/LAURYL METHACRYLATE 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.

The concentration in the medicine must not be more than 2.00%.

5183

WAHLENBERGIA GRACILIS

A, H

5184

WALNUT

E

5185

WALNUT OIL

E

5186

WHEAT

E

Gluten is a mandatory component of Wheat when the route of administration is other than topical and mucosal.

5187

WHEAT BRAN

E

Gluten is a mandatory component of Wheat bran when the route of administration is other than topical and mucosal.

5188

WHEAT DEXTRIN

A, E

Gluten is a mandatory component of wheat dextrin.

Only for use when the dosage form is capsule, tablet or pill.

5189

WHEAT GERM

E

Gluten is a mandatory component of Wheat germ when the route of administration is other than topical and mucosal.

5190

WHEAT GERM GLYCERIDES

E

Gluten is a mandatory component of wheat germ glycerides when the route of administration is other than topical and mucosal.

5191

WHEAT LEAF

E

5192

WHEAT STARCH

E

When the route of administration is other than topical or mucosal, gluten is a mandatory component of wheat starch.

5193

WHEATGERM OIL

A, E, H

5194

WHEY POWDER

E

Lactose is a mandatory component of Whey powder when the route of administration is oral.

5195

WHEY PROTEIN

E

Lactose is a mandatory component of Whey protein when the route of administration is oral.

5196

WHEY PROTEIN 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%.

5197

WHITE BEESWAX

E

5198

WHITE HOREHOUND HERB DRY

A, H

5199

WHITE HOREHOUND HERB POWDER

A, H

5200

WHITE SOFT PARAFFIN

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.

5201

WHOLE DRY MILK

E

5202

WIKSTROEMIA VIRIDIFLORA

A, H

5203

WILD CARROT HERB DRY

A, E, H

5204

WILD CARROT HERB POWDER

A, H

5205

WILD CHERRY BARK DRY

A, H

Amygdalin and hydrocyanic acid are mandatory components of wild cherry bark dry.

The concentration of amygdalin in the medicine must not be more than 10 mg/kg.

The concentration of hydrocyanic acid in the medicine must not be more than 10 mg/kg.

5206

WILD CHERRY BARK POWDER

A, H

Amygdalin and hydrocyanic acid are mandatory components of wild cherry bark powder.

The concentration of amygdalin in the medicine must not be more than 10 mg/kg.

The concentration of hydrocyanic acid in the medicine must not be more than 10 mg/kg.

5207

WILD LETTUCE LEAF DRY

A, H

5208

WILD LETTUCE LEAF POWDER

A, H

5209

WINTERGREEN OIL

A, E, H

Methyl salicylate is a mandatory component of wintergreen oil.

Not to be included in medicines for use in the eye or on damaged skin.

When used internally, the concentration of methyl salicylate in the medicine must not be more than 0.001%.

When the concentration of methyl salicylate in a liquid preparation is more than 5% and the dosage form is other than spray, the medicine requires child resistant packaging.

When the concentration of methyl salicylate in a liquid preparation is more than 5%, and the dosage form is spray, the medicine does not require child resistant packaging if:

- the delivery device is engaged into the container in such a way that prevents it from being readily removed;

- direct suction through the delivery device results in delivery of no more than one dosage unit; and

- actuation of the spray device is ergonomically difficult for young children to accomplish.

The following warning statement is required on the medicine label:

- (METSAL) 'Contains methyl salicylate' (or words to that effect).

When for use in topical medicines for dermal application:

i) the concentration of methyl salicylate in the medicine must not be more than 25%;

ii) the following warning statements are required on the medicine label:

- (PREGNT2) 'Do not use if pregnant or likely to become pregnant' (or words to that effect);

- (CHILD4) 'Do not use [this product/insert name of product] in children 6 years of age or less';

- (SENS) 'Application to skin may increase sensitivity to sunlight' (or words to that effect);

- (AVOID) 'Avoid prolonged exposure in the sun' (or words to that effect);

iii) if the concentration of methyl salicylate in the medicine is greater than 1%, the following warning statement is required on the medicine label:

- (IRRIT) 'If irritation develops, discontinue use'.

5210

WITHANIA SOMNIFERA

A, E, H

The medicine requires the following warning statement on the label:

- (WITHANIA) 'If you are pregnant, or considering becoming pregnant, do not take without consulting a health professional' (or words to that effect)

unless:

(a) the plant part is root;

(b) the plant preparation is an extract;

(c) the extraction solvents are only water, ethanol or methanol; and

(d) the maximum recommended daily dose of the medicine contains no more than the equivalent quantity of 12 g dry root.

5211

WOLFIPORIA COCOS

A, E, H

5212

WOOL ALCOHOLS

E

Only for use in topical medicines for dermal application.

5213

WOOL FAT

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.

5214

XANTHAN GUM

E

5215

XANTHIUM SIBIRICUM

A, H

The requirements specified in paragraphs (a) to (h) below apply to a medicine that contains the ingredient that is:

- listed in the Register on or after 1 March 2025; or

- released for supply on or after 1 March 2026.

(a) Carboxyatractyloside and atractyloside are mandatory components of Xanthium sibiricum.

(b) The concentration of carboxyatractyloside must not be more than 0.35% of Xanthium sibiricum.

(c) The concentration of atractyloside must not be more than 0.3% of Xanthium sibiricum.

(d) The route of administration for medicines that contain Xanthium sibiricum must be limited to oral.

(e) The plant part must be limited to fruit that is dried, cooked and had the spines removed.

(f) The plant preparation must be limited to dry, powder, and extraction preparations with water as the only solvent.

(g) The maximum recommended daily dose of the medicine must not provide more than 10 g of Xanthium sibiricum.

(h) The medicine must not be directed for use in children, those who are pregnant, likely to become pregnant, or lactating. 

5216

XANTHIUM STRUMARIUM

A, H

The requirements specified in paragraphs (a) to (h) below apply to a medicine that contains the ingredient that is:

- listed in the Register on or after 1 March 2025; or

- released for supply on or after 1 March 2026.

(a) Carboxyatractyloside and atractyloside are mandatory components of Xanthium strumarium.

(b) The concentration of carboxyatractyloside must not be more than 0.35% of Xanthium strumarium.

(c) The concentration of atractyloside must not be more than 0.3% of Xanthium strumarium.

(d) The route of administration for medicines that contain Xanthium strumarium must be limited to oral.

(e) The plant part must be limited to fruit that is dried, cooked and had the spines removed.

(f) The plant preparation must be limited to dry, powder, and extraction preparations with water as the only solvent.

(g) The maximum recommended daily dose of the medicine must not provide more than 10 g of Xanthium strumarium.

(h) The medicine must not be directed for use in children, those who are pregnant, likely to become pregnant, or lactating. 

5217

XANTHOMONA CAMPESTRIS

A, H

5218

XEROPHYLLUM ASPHODELOIDES

A, H

5219

XYLENE

E

The residual solvent limit for xylene is 21.7 mg per maximum recommended daily dose.

 The concentration in the medicine must be no more than 0.217%.

5220

XYLITOL

E

5221

XYLOSE

E

5222

YAM

E

5223

YARROW HERB DRY

A, H

5224

YARROW HERB POWDER

A, H

5225

YEAST AUTOLYSATE

E

5226

YEAST DRIED

A, E, H

5227

YELLOW 2G

E

Permitted for use only as a colour for topical use.

5228

YELLOW BEESWAX

E

5229

YELLOW MERCURIC OXIDE

H

Only for use as an active homoeopathic ingredient.

5230

YELLOW SOFT PARAFFIN

A, E

Only for use in topical medicines for dermal application.

When used as an active ingredient, can only be supplied as an uncompounded medicine substance packed for retail sale, and must comply with an uncompounded substance monograph of the British Pharmacopoeia, as in force or existing from time to time.

5231

YLANG YLANG OIL

A, E, H

5232

YUCCA BACCATA

A, H

5233

YUCCA ELATA

A, H

5234

YUCCA FILAMENTOSA

A, H

5235

YUCCA GLORIOSA

A, H

5236

Z-BETA-DAMASCONE

E

Z – beta damascone must only be included in medicines when in combination with other permitted ingredients as a flavour proprietary excipient formulation.

The total concentration of flavour proprietary excipient formulations containing Z – beta damascone must not be more than 5% of the total medicine.

5237

ZANTHOXYLUM AMERICANUM

A, H

5238

ZANTHOXYLUM BUNGEANUM

A, E, H

5239

ZANTHOXYLUM CLAVA-HERCULIS

A, H

5240

ZANTHOXYLUM NITIDUM

A, H

5241

ZANTHOXYLUM PIPERITUM

A, H

5242

ZANTHOXYLUM SIMULANS

A, H

5243

ZEA MAYS

A, E, H

5244

ZEAXANTHIN

A, E

5245

ZEIN

E

5246

ZINC

H

Only for use as an active homoeopathic ingredient.

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)'.

5247

ZINC AMINO ACID CHELATE

A, E, H

When used internally, zinc is a mandatory component of zinc amino acid chelate.

The concentration of zinc in zinc amino acid chelate must be no more than 30%.

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).'

5248

ZINC ASCORBATE

A, E, H

When used internally, zinc is a mandatory component of zinc ascorbate.

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).'

5249

ZINC ASCORBATE MONOHYDRATE

A, E, H

When used internally, zinc is a mandatory component of zinc ascorbate monohydrate.

 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)'.

5250

ZINC CHLORIDE

A, E, H

The concentration of zinc chloride in the medicine must be no more than 5%.

When used internally, zinc is a mandatory component of zinc chloride.

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).'

5251

ZINC CITRATE

A, E, H

When used internally, zinc is a mandatory component of zinc citrate.

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).'

5252

ZINC CITRATE DIHYDRATE

A, E, H

When used internally, zinc is a mandatory component of zinc citrate dihydrate.

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).'

5253

ZINC CITRATE TRIHYDRATE

A, E, H

When used internally, zinc is a mandatory component of zinc citrate trihydrate.  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).'

5254

ZINC DIASPARTATE

A

When used internally, zinc is a mandatory component of zinc diaspartate.

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).'

5255

ZINC GLUCONATE

A, E, H

When used internally, zinc is a mandatory component of zinc gluconate.

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).'

5256

ZINC GLYCINATE

A

When used internally, zinc is a mandatory component of Zinc glycinate.

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).'

5257

ZINC GLYCINATE MONOHYDRATE

A

When used internally, zinc is a mandatory component of Zinc glycinate monohydrate.

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)'.

5258

ZINC LACTATE

E

Only for use in topical and dental medicines and not to be included in medicines intended for use in the eye.

The concentration of zinc lactate in a medicine intended for topical use should not be more than 2%.

The concentration of zinc lactate in a medicine for 'dental' use in toothpaste medicines must not be more than 2.5%.

Zinc lactate is not to be included in dental/toothpaste medicines intended for use by children less than 12 years old. 

Medicines containing zinc lactate for dental use require the following warning statement (or words to the same effect) on the medicine label:

- (CHILD3) 'Use in children under 12 years is not recommended'.

5259

ZINC LACTATE DIHYDRATE

E

Only for use in topical and dental medicines and not to be included in medicines intended for use in the eye.

The concentration of zinc lactate dihydrate in a medicine intended for topical use should not be more than 2%.

The concentration of zinc lactate dihydrate in a medicine for 'dental' use in toothpaste medicines must not be more than 2.5%.

Zinc lactate dihydrate is not to be included in dental/toothpaste medicines intended for use by children less than 12 years old.

Medicines containing zinc lactate dihydrate for dental use require the following warning statement (or words to the same effect) on the medicine label:

- (CHILD3) 'Use in children under 12 years is not recommended'.

5260

ZINC LYSINATE

A

When used internally, zinc is a mandatory component of Zinc lysinate.

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).'

5261

ZINC METHIONINE SULFATE

A

For topical use, the concentration of zinc methionine sulfate must be no more than 5%.

When used internally, zinc is a mandatory component of zinc methionine sulfate.

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).'

5262

ZINC MYRISTATE

E

Only for use in topical medicines for dermal 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%.

5263

ZINC OXIDE

A, E, H

When used internally, zinc is a mandatory component of zinc oxide.

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).

When used in primary sunscreen products, the following warning statements are required on the label:

- (AVOID) 'Avoid prolonged exposure in the sun' (or words to this effect); and

- (SUNPRO) 'Wear protective clothing - hats and eyewear when exposed to the sun' (or words to this effect).

5264

ZINC PARA-PHENOLSULFONATE

E

Only permitted for use in topical medicines for dermal use.

The concentration of zinc para-phenolsulfonate in the medicine must not exceed 5%.

5265

ZINC STEARATE

E

When used internally, zinc is a mandatory component of zinc stearate.

The percentage of zinc from zinc stearate should be calculated based on the molecular weight of zinc stearate.

When for internal use, the maximum recommended daily dose must not provide more than 50 milligrams of zinc.

When for internal use and the maximum recommended daily dose is more than 25 milligrams but not more than 50 milligrams of zinc, the medicine requires the following warning statement (or words to the same effect) 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’.

5266

ZINC SUCCINATE

A, E, H

When used internally, zinc is a mandatory component of zinc succinate.

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).'

5267

ZINC SULFATE

A, E

For topical use, the concentration of zinc sulfate must be no more than 5%.

For internal use, zinc is a mandatory component of zinc sulfate.

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).'

5268

ZINC SULFATE HEPTAHYDRATE

A, E

For topical use, the concentration of zinc sulfate must be no more than 5%.

For internal use, zinc is a mandatory component of zinc sulfate heptahydrate.

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).'

5269

ZINC SULFATE HEXAHYDRATE

A, E, H

For topical use, the concentration of zinc sulfate must be no more than 5%.

For internal use, zinc is a mandatory component of zinc sulfate hexahydrate.

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).'

5270

ZINC SULFATE MONOHYDRATE

A, E, H

When the route of administration is topical the concentration of zinc sulfate in the medicine must be no more than 5%.

When the medicine is for internal use, zinc is a mandatory component of zinc sulfate monohydrate.

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).'

5271

ZINC VALERATE

H

Only for use as an active homoeopathic ingredient.

When for internal use, zinc is a mandatory component of zinc valerate.

The percentage of zinc from zinc valerate should be calculated based on the molecular weight of zinc valerate.

When for internal use, the maximum recommended daily dose must not provide more than 50 milligrams of zinc.

When for internal use and the maximum recommended daily dose is more than 25 milligrams but not more than 50 milligrams of zinc, the medicine requires the following warning statement (or words to the same effect) 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’.

5272

ZINGERONE

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%.

5273

ZINGIBER OFFICINALE

A, E, H

When for oral use AND the extract ratio is equal to or more than 25:1 AND the equivalent dry weight per dosage unit is equal to or more than 2g, the medicine requires the following warning statement on the medicine label:

- (GINGER) 'Individuals taking anticoagulants should seek medical advice before taking this medicine.' AND 'Individuals at risk of bleeding problems should seek advice from their healthcare practitioner prior to taking this medicine'.

5274

ZIZIPHUS JUJUBA

A, H

5275

ZIZIPHUS JUJUBA VAR. SPINOSA

A, H

5276

ZIZYPHUS SATIVA

A, H

5277

ZOSTERA MARINA

A, H