4986

UBIDECARENONE

A, E

When used as an excipient, the route of administration must be topical.

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

When used as an excipient, the concentration in the medicine must be no more than 0.05%.

The maximum recommended daily dose must provide no more than 300 milligrams of ubidecarenone.

When used in combination with Ubiquinol-10, the maximum recommended daily dose must provide no more than 300 milligrams 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.'

4987

UBIQUINOL-10

A

Only for use in oral medicines.

The maximum recommended daily dose must provide no more than 300 mg 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.

requires the following warning statement on the medicine label:

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

4988

ULEX EUROPAEUS

A, H

4989

ULMUS AMERICANA

A, H

4990

ULMUS CAMPESTRIS

A, H

4991

ULMUS GLABRA

A, H

4992

ULMUS PARVIFOLIA

A, H

4993

ULMUS PROCERA

A, H

4994

ULMUS PUMILA

A, H

4995

ULMUS RUBRA

A, H

4996

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%.

4997

ULTRAMARINE BLUE

E

Permitted for use only as a colour for topical use.

4998

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%.

4999

UNCARIA GAMBIR

A, H

5000

UNCARIA RHYNCOPHYLLA

A, H

5001

UNCARIA SINENSIS

A, H

5002

UNCARIA TOMENTOSA

A, H

5003

UNDARIA PINNATIFIDA

A, H

Whole dried Undaria pinnatifida must not contain the holdfast.

Only for use in oral medicines.

5004

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%.

5005

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%.

5006

UNDECENOIC ACID

E

5007

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%.

5008

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%.

5009

UNDECYLENAMIDE DEA

E

5010

UNDECYLENOYL PEG-5 PARABEN

E

Only for use in topical medicines for dermal application.

5011

URANIUM NITRATE

H

Only for use as an active homoeopathic ingredient. 

5012

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).

5013

URTICA DIOICA

A, E, H

5014

URTICA URENS

A, H

5015

USNEA BARBATA

A, H

5016

UVA URSI LEAF DRY

A, H

5017

UVA URSI LEAF POWDER

A, E, H

5018

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%.

5019

VACCARIA SEGATALIS

A, H

5020

VACCINIUM BRACTEATUM

A, H

5021

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%.

5022

VACCINIUM MACROCARPON

A, E, H

5023

VACCINIUM MYRTILLOIDES

A, H

5024

VACCINIUM MYRTILLUS

A, E, H

5025

VACCINIUM OXYCOCCUS

A, H

5026

VACCINIUM VITIS-IDAEA

A, H

5027

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%.

5028

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%.

5029

VALERIAN DRY

A, H

5030

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%.

5031

VALERIAN POWDER

A, H

5032

VALERIANA EDULIS

A, H

5033

VALERIANA OFFICINALIS

A, H

5034

VALERIANA SORBIFOLIA

A, H

5035

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%.

5036

VALINE

A, E

5037

VANADIUM

H

5038

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%.

5039

VANILLA DRY

A, E, H

5040

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%.

5041

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%.

5042

VANILLA PLANIFOLIA

A, E, H

5043

VANILLA POWDER

A, E, H

5044

VANILLA TAHITENSIS

A, H

5045

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%.

5046

VANILLIN

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%.

5047

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%.

5048

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%.

5049

VAT RED 1

E

Permitted for use only as a colour for topical use.

5050

VAT RED 1 ALUMINIUM LAKE

E

Permitted for use only as a colour for topical use.

5051

VAT RED 5

E

Permitted for use only as a colour for topical use.

5052

VEGETABLE OIL

E

5053

VEGETABLE OIL PHYTOSTEROL ESTERS

A

Only for use in oral medicines.

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

- (VOPE) 'There is no benefit from taking more than 3g/day of phytosterols from all sources'

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

5054

VEIN

H

Only for use as an active homoeopathic ingredient.

5055

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%.

5056

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%.

5057

VERBASCUM DENSIFLORUM

A, H

5058

VERBASCUM THAPSUS

A, H

5059

VERBENA OFFICINALIS

A, H

5060

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%.

5061

VERONICA CHAMAEDRYS

A, H

5062

VERONICA OFFICINALIS

A, H

5063

VERONICASTRUM VIRGINICUM

A, E, H

5064

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%.

5065

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%.

5066

VIBURNUM OPULUS

A, E, H

5067

VIBURNUM PRUNIFOLIUM

A, E, H

5068

VICIA FABA

A, H

Levodopa (of Vicia faba) is a mandatory component of Vicia faba.

The concentration of Levodopa (of Vicia faba) from all ingredients in the medicine must be no more than 1mg/kg or 1mg/L or 0.1%.

5069

VIGNA ANGULARIS VAR. ANGULARIS

A, H

5070

VIGNA RADIATA

A, H

5071

VIGNA UMBELLATA

A, H

5072

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%.

5073

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%

5074

VINCETOXICUM OFFICINALE

A, H

5075

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%.

5076

VIOLA ODORATA

A, E, H

5077

VIOLA TRICOLOR

A, H

5078

VIOLA YEDOENSIS

A, H

5079

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 1%.

5080

VIOLET LEAVES

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%.

5081

VIPER

H

Only for use as an active homoeopathic ingredient. 

5082

VISCUM ALBUM

A, E, H

5083

VISCUM COLORATUM

A, H

5084

VISCUM FLAVESCENS

A, H

5085

VITELLARIA PARADOXA

A, E, H

5086

VITEX AGNUS-CASTUS

A, E, H

5087

VITEX NEGUNDO

A, H

5088

VITEX ROTUNDIFOLIA

A, H

5089

VITEX TRIFOLIA

A, H

5090

VITIS VINIFERA

A, E, H

5091

VITREOSCILLA CONCENTRATE

E

Only for use in topical medicines for dermal application.

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

5092

WAHLENBERGIA GRACILIS

A, H

5093

WALNUT

E

5094

WALNUT OIL

E

5095

WATER MELON

E

5096

WHEAT

E

Gluten is a mandatory component of Wheat 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.

5097

WHEAT BRAN

E

Gluten is a mandatory component of Wheat 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.

5098

WHEAT DEXTRIN

A, E

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

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.

5099

WHEAT GERM

E

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

When the route of administration is other than topical or mucosal, the medicine requires the following warning statement on the medicine label:

- (GLUTEN) 'Contains [insert name of ingredient]' or words to that effect.

5100

WHEAT GERM GLYCERIDES

E

Gluten is a mandatory component of Wheat germ glycerides 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.

5101

WHEAT LEAF

E

5102

WHEAT SPROUT

E

Gluten is a mandatory component of Wheat sprout 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.

5103

WHEAT STARCH

E

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

5104

WHEATGERM OIL

A, E, H

5105

WHEY POWDER

E

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

5106

WHEY PROTEIN

E

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

5107

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%.

5108

WHITE BEESWAX

E

5109

WHITE HOREHOUND HERB DRY

A, H

5110

WHITE HOREHOUND HERB POWDER

A, H

5111

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.

5112

WHOLE DRY MILK

E

If the product is for oral ingestion and contains lactose, then the medicine requires the following warning statement on the medicine label:

- (LACT) 'Contains lactose' (or words to that effect).

5113

WIKSTROEMIA VIRIDIFLORA

A, H

5114

WILD CARROT HERB DRY

A, E, H

5115

WILD CARROT HERB POWDER

A, H

5116

WILD CHERRY BARK DRY

A, H

5117

WILD CHERRY BARK POWDER

A, H

5118

WILD LETTUCE LEAF DRY

A, H

5119

WILD LETTUCE LEAF POWDER

A, H

5120

WINTERGREEN OIL

A, E, H

Methyl salicylate is a mandatory component of Wintergreen oil.

The concentration of Methyl salicylate in the medicine must be no more than 0.001%.

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

When the concentration of Methyl salicylate in a liquid preparation is more than 5%, and the dosage form is spray, the medicine does not require child resistant packaging but the delivery device must be engaged into the container in such a way that prevents it from being readily removed, direct suction through the delivery device results in delivery of no more than one dosage unit, and actuation of the spay device is ergonomically difficult for young children to accomplish.

5121

WITHANIA SOMNIFERA

A, E, H

5122

WOOL ALCOHOLS

E

Only for use in topical medicines for dermal application.

5123

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.

5124

XANTHAN GUM

E

5125

XANTHIUM SIBIRICUM

A, H

5126

XANTHIUM STRUMARIUM

A, H

5127

XANTHOMONA CAMPESTRIS

A, H

5128

XEROPHYLLUM ASPHODELOIDES

A, H

5129

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%.

5130

XYLITOL

E

When the quantity of sugar alcohols per maximum recommended daily dose is more than 2g, 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]’.

5131

XYLOSE

E

5132

YAM

E

5133

YARROW HERB DRY

A, H

5134

YARROW HERB POWDER

A, H

5135

YEAST AUTOLYSATE

E

5136

YEAST DRIED

A, E, H

5137

YELLOW 2G

E

Permitted for use only as a colour for topical use.

5138

YELLOW BEESWAX

E

5139

YELLOW MERCURIC OXIDE

H

Only for use as an active homoeopathic ingredient.

5140

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.

5141

YLANG YLANG OIL

A, E, H

5142

YUCCA BACCATA

A, H

5143

YUCCA ELATA

A, H

5144

YUCCA FILAMENTOSA

A, H

5145

YUCCA GLORIOSA

A, H

5146

YUCCA WHIPPLEI

A, H

5147

ZANTHOXYLUM AMERICANUM

A, H

5148

ZANTHOXYLUM BUNGEANUM

A, E, H

5149

ZANTHOXYLUM CLAVA-HERCULIS

A, H

5150

ZANTHOXYLUM NITIDUM

A, H

5151

ZANTHOXYLUM PIPERITUM

A, H

5152

ZANTHOXYLUM SIMULANS

A, H

5153

ZEA MAYS

A, E, H

5154

ZEAXANTHIN

A, E

5155

ZEIN

E

5156

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)'.

5157

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%.

The indication 'For mineral (may state the mineral) supplementation' is only permitted when the medicine is for oral or sublingual use.

5158

ZINC ASCORBATE

A, E, H

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

The percentage of zinc from zinc ascorbate should be calculated based on the molecular weight 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)'.                                                                                                                                                  

The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.

5159

ZINC ASCORBATE MONOHYDRATE

A, E, H

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

The percentage of zinc from Zinc ascorbate monohydrate should be calculated based on the molecular weight 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)'.

The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.  

5160

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. The percentage of zinc from zinc chloride should be calculated based on the molecular weight 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)'.

The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.           

5161

ZINC CITRATE

A, E, H

When used internally, zinc is a mandatory component of zinc citrate . The percentage of zinc from zinc citrate should be calculated based on the molecular weight 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)'.

The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.                 

5162

ZINC CITRATE DIHYDRATE

A, E, H

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

The percentage of zinc from zinc citrate dihydrate should be calculated based on the molecular weight 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)'.

The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.           

5163

ZINC CITRATE TRIHYDRATE

A, E, H

When used internally, zinc is a mandatory component of zinc citrate trihydrate. The percentage of zinc from Zinc citrate trihydrate should be calculated based on the molecular weight 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)'.

The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.  

5164

ZINC DIASPARTATE

A

When used internally, zinc is a mandatory component of zinc diaspartate and availability is restricted to use as a source of the relevant mineral only.

The percentage of zinc from Zinc diaspartate should be calculated based on the molecular weight 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)'.

The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.  

5165

ZINC GLUCONATE

A, E, H

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

The percentage of zinc from Zinc gluconate should be calculated based on the molecular weight 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)'.

The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.  

5166

ZINC GLYCINATE

A

When used internally, zinc is a mandatory component of Zinc glycinate and availability is restricted to use as a source of the relevant mineral only.

The percentage of zinc from Zinc glycinate should be calculated based on the molecular weight 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)'.

The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.  

5167

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 be no more than 2%.

The concentration of Zinc lactate in a medicine for 'dental' use in toothpaste medicines must be no 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 on the medicine label:

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

5168

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 be no more than 2%.

The concentration of Zinc lactate dihydrate in a medicine for 'dental' use in toothpaste medicines must be no 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 for dental use require the following warning statement on the medicine label:

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

5169

ZINC LYSINATE

A

When used internally, zinc is a mandatory component of Zinc lysinate and availability is restricted to use as a source of the relevant mineral only.

The percentage of zinc from Zinc lysinate should be calculated based on the molecular weight 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)'.

The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.  

5170

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 and availability is restricted to use as a source of the relevant mineral only.

The percentage of zinc from zinc methionine sulfate should be calculated based on the molecular weight 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)'.

The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.

5171

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%.

5172

ZINC OXIDE

A, E, H

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

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

The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.

5173

ZINC PARA-PHENOLSULFONATE

E

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

When used internally, zinc is a mandatory component of zinc para-phenolsulfate.

The percentage of zinc from zinc para-phenolsulfonate should be calculated based on the molecular weight of zinc para-phenolsulfonate.

5174

ZINC STEARATE

E

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

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

5175

ZINC SUCCINATE

A, E, H

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

The percentage of zinc from Zinc succinate should be calculated based on the molecular weight 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)'.

The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.  

5176

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.

The percentage of zinc from Zinc sulfate should be calculated based on the molecular weight 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)'.

The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.  

5177

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.

The percentage of zinc from Zinc sulfate heptahydrate should be calculated based on the molecular weight 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)'.

The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.  

5178

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.

The percentage of zinc from Zinc sulfate heptahydrate should be calculated based on the molecular weight 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)'.

The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.  

5179

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)'.

The indication ‘For mineral (may state the mineral) supplementation’ is only permitted when the medicine is for oral or sublingual use.  

5180

ZINC VALERATE

H

Only for use as an active homoeopathic ingredient.

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.

5181

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%.

5182

ZINGIBER OFFICINALE

A, E, H

When for oral use AND the extract ratio is equal to or more than 25:1 OR 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'

5183

ZIZIPHUS JUJUBA

A, H

5184

ZIZIPHUS JUJUBA VAR. SPINOSA

A, H

5185

ZIZYPHUS SATIVA

A, H

5186

ZOSTERA MARINA

A, H

5187

ZUCCHINI

E