Item

Ingredient Name

Purpose

Specific requirements

5074

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'.

5075

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.'

5076

ULEX EUROPAEUS

A, H

5077

ULMUS AMERICANA

A, H

5078

ULMUS CAMPESTRIS

A, H

5079

ULMUS GLABRA

A, H

5080

ULMUS MINOR

A, H

5081

ULMUS PARVIFOLIA

A, H

5082

ULMUS PUMILA

A, H

5083

ULMUS RUBRA

A, H

5084

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%.

5085

ULTRAMARINE BLUE

E

Permitted for use only as a colour for topical use.

5086

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%.

5087

UMBELLULARIA CALIFORNICA

A, H

5088

UNCARIA GAMBIR

A, H

5089

UNCARIA RHYNCOPHYLLA

A, H

5090

UNCARIA SINENSIS

A, H

5091

UNCARIA TOMENTOSA

A, H

5092

UNDARIA PINNATIFIDA

A, H

Whole dried Undaria pinnatifida must not contain the holdfast.

Only for use in oral medicines.

5093

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%.

5094

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%.

5095

UNDECENOIC ACID

E

5096

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%.

5097

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%.

5098

UNDECYLENAMIDE DEA

E

5099

UNDECYLENOYL PEG-5 PARABEN

E

Only for use in topical medicines for dermal application.

5100

URANIUM NITRATE

H

Only for use as an active homoeopathic ingredient.

5101

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).

5102

UROLITHIN A

A

Until 19 September 2027, urolithin A must only be used in a medicine where:

(a) Timeline Nutrition Australia Pty Ltd (Client ID 84148) is the sponsor of the medicine (the primary sponsor); or

(b) another person is the sponsor of the medicine (the secondary sponsor) and the TGA has been notified that the secondary sponsor has been authorised by the primary sponsor to use the ingredient in the medicine.

The route of administration for medicines that contain urolithin A must be oral.

The maximum recommended daily dose of a medicine must not exceed 1000 mg of urolithin A.

Medicines that contain urolithin A must be indicated for use in adults only and not in pregnant or lactating women.

The recommended duration for use for a medicine containing urolithin A must be four months or less.

5103

URTICA DIOICA

A, E, H

5104

URTICA URENS

A, H

5105

USNEA BARBATA

A, H

5106

UVA URSI LEAF DRY

A, H

5107

UVA URSI LEAF POWDER

A, E, H

5108

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%.

5109

VACCARIA SEGATALIS

A, H

5110

VACCINIUM BRACTEATUM

A, H

5111

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%.

5112

VACCINIUM MACROCARPON

A, E, H

5113

VACCINIUM MYRTILLOIDES

A, H

5114

VACCINIUM MYRTILLUS

A, E, H

5115

VACCINIUM OXYCOCCUS

A, H

5116

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%.

5117

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%.

5118

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%.

5119

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.'

5120

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%.

5121

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.'

5122

VALERIANA EDULIS

A, H

5123

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.'

5124

VALERIANA SORBIFOLIA

A, H

5125

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%.

5126

VALINE

A, E

5127

VANADIUM

H

5128

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%.

5129

VANILLA DRY

A, E, H

5130

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%.

5131

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%.

5132

VANILLA PLANIFOLIA

A, E, H

5133

VANILLA POWDER

A, E, H

5134

VANILLA TAHITENSIS

A, H

5135

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%.

5136

VANILLIN

E

5137

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.

5138

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%.

5139

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%.

5140

VAT RED 1

E

Permitted for use only as a colour for topical use.

5141

VAT RED 1 ALUMINIUM LAKE

E

Permitted for use only as a colour for topical use.

5142

VAT RED 5

E

Permitted for use only as a colour for topical use.

5143

VEGETABLE OIL

E

5144

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).'

5145

VEIN

H

Only for use as an active homoeopathic ingredient.

5146

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%.

5147

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%.

5148

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%.

5149

VERBASCUM DENSIFLORUM

A, H

5150

VERBASCUM THAPSUS

A, H

5151

VERBENA OFFICINALIS

A, H

5152

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%.

5153

VERONICA CHAMAEDRYS

A, H

5154

VERONICA OFFICINALIS

A, H

5155

VERONICASTRUM VIRGINICUM

A, E, H

5156

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%.

5157

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%.

5158

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%.

5159

VIBURNUM OPULUS

A, E, H

5160

VIBURNUM PRUNIFOLIUM

A, E, H

5161

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%.

5162

VIGNA ANGULARIS VAR. ANGULARIS

A, H

5163

VIGNA RADIATA

A, H

5164

VIGNA UMBELLATA

A, H

5165

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%.

5166

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%

5167

VINCETOXICUM OFFICINALE

A, H

5168

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%.

5169

VIOLA ODORATA

A, E, H

5170

VIOLA TRICOLOR

A, H

5171

VIOLA YEDOENSIS

A, H

5172

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%.

5173

VIPER

H

Only for use as an active homoeopathic ingredient.

5174

VISCUM ALBUM

A, E, H

5175

VISCUM COLORATUM

A, H

5176

VISCUM FLAVESCENS

A, H

5177

VITELLARIA PARADOXA

A, E, H

5178

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).

5179

VITEX NEGUNDO

A, H

5180

VITEX ROTUNDIFOLIA

A, H

5181

VITEX TRIFOLIA

A, H

5182

VITIS VINIFERA

A, E, H

5183

VITREOSCILLA CONCENTRATE

E

Only for use in topical medicines for dermal application.

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

5184

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%.

5185

WAHLENBERGIA GRACILIS

A, H

5186

WALNUT

E

5187

WALNUT OIL

E

5188

WHEAT

E

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

5189

WHEAT BRAN

E

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

5190

WHEAT DEXTRIN

A, E

Gluten is a mandatory component of wheat dextrin.

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

5191

WHEAT GERM

E

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

5192

WHEAT GERM GLYCERIDES

E

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

5193

WHEAT LEAF

E

5194

WHEAT STARCH

E

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

5195

WHEATGERM OIL

A, E, H

5196

WHEY POWDER

E

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

5197

WHEY PROTEIN

E

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

5198

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%.

5199

WHITE BEESWAX

E

5200

WHITE HOREHOUND HERB DRY

A, H

5201

WHITE HOREHOUND HERB POWDER

A, H

5202

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.

5203

WHOLE DRY MILK

E

5204

WIKSTROEMIA VIRIDIFLORA

A, H

5205

WILD CARROT HERB DRY

A, E, H

5206

WILD CARROT HERB POWDER

A, H

5207

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.

5208

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.

5209

WILD LETTUCE LEAF DRY

A, H

5210

WILD LETTUCE LEAF POWDER

A, H

5211

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'.

5212

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.

5213

WOLFIPORIA COCOS

A, E, H

5214

WOOL ALCOHOLS

E

Only for use in topical medicines for dermal application.

5215

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.

5216

XANTHAN GUM

E

5217

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.

5218

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.

5219

XANTHOMONA CAMPESTRIS

A, H

5220

XEROPHYLLUM ASPHODELOIDES

A, H

5221

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%.

5222

XYLITOL

E

5223

XYLOSE

E

5224

YAM

E

5225

YARROW HERB DRY

A, H

5226

YARROW HERB POWDER

A, H

5227

YEAST AUTOLYSATE

E

5228

YEAST DRIED

A, E, H

5229

YELLOW 2G

E

Permitted for use only as a colour for topical use.

5230

YELLOW BEESWAX

E

5231

YELLOW MERCURIC OXIDE

H

Only for use as an active homoeopathic ingredient.

5232

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.

5233

YLANG YLANG OIL

A, E, H

5234

YUCCA BACCATA

A, H

5235

YUCCA ELATA

A, H

5236

YUCCA FILAMENTOSA

A, H

5237

YUCCA GLORIOSA

A, H

5238

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.

5239

ZANTHOXYLUM AMERICANUM

A, H

5240

ZANTHOXYLUM BUNGEANUM

A, E, H

5241

ZANTHOXYLUM CLAVA-HERCULIS

A, H

5242

ZANTHOXYLUM NITIDUM

A, H

5243

ZANTHOXYLUM PIPERITUM

A, H

5244

ZANTHOXYLUM SIMULANS

A, H

5245

ZEA MAYS

A, E, H

5246

ZEAXANTHIN

A, E

5247

ZEIN

E

5248

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)'.

5249

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).'

5250

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).'

5251

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)'.

5252

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).'

5253

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).'

5254

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).'

5255

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).'

5256

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).'

5257

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).'

5258

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).'

5259

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)'.

5260

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'.

5261

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'.

5262

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).'

5263

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).'

5264

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%.

5265

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).

5266

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%.

5267

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’.

5268

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).'

5269

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).'

5270

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).'

5271

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).'

5272

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).'

5273

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’.

5274

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%.

5275

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'.

5276

ZIZIPHUS JUJUBA

A, H

5277

ZIZIPHUS JUJUBA VAR. SPINOSA

A, H

5278

ZIZYPHUS SATIVA

A, H

5279

ZOSTERA MARINA

A, H