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

Note: See sections 5 and 6.

Permissible ingredients and requirements

Column 1

Column 2

Column 3

Column 4

Item

Ingredient Name

Purpose

Specific requirements

2170

FABIANA IMBRICATA

A, H

 

2171

FAGOPYRUM ESCULENTUM

A, H

 

2172

FAGUS GRANDIFOLIA

A, H

 

2173

FAGUS SYLVATICA

A, H

 

2174

FARNESOL

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%.

 

2175

FARNESYL ACETATE

E

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

When used in a flavour, the total flavour proprietary excipient formulation in a medicine must be no more than 5%.

When used in a fragrance, the total fragrance proprietary excipient formulation in a medicine must be no more than 1%.

 

2176

FAST GREEN FCF

E

Permitted for use only as a colour in medicines limited to topical and oral routes of administration.

 

2177

FENCHONE

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%.

 

2178

FENCHYL 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%.

 

2179

FENCHYL 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%.

 

2180

FENNEL BITTER SEED DRY

A, E, H

When used in oral medicines, the following warning statements are required on the label:

- (CHILD3) ‘Use in children under 12 years is not recommended’

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

- (BREASF) 'Do not use while breastfeeding.'

 

2181

FENNEL LEAF

E

 

2182

FENNEL OIL

A, E, H

Methyl chavicol is a mandatory component of fennel oil.

When the concentration of methyl chavicol in the medicine is more than 5%, the nominal capacity of the container must be no more than 25mL, a restricted flow insert must be fitted on the container, and the following warning statement is required on the label:

- (CHILD) 'Keep out of reach of children (or words to that effect).'

The maximum daily dose must provide no more than 150 mg of fennel oil.

When used in oral medicines, the following warning statements are required on the label:

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

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

- (BREASF) 'Do not use while breastfeeding.'

 

2183

FENNEL SWEET SEED DRY

A, E, H

When used in oral medicines, the following warning statements are required on the label:

- (CHILD3) ‘Use in children under 12 years is not recommended’

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

- (BREASF) 'Do not use while breastfeeding.'

 

2184

FENUGREEK

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%.

 

2185

FENUGREEK OIL

E

Fenugreek oil is 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%.

 

2186

FERRIC AMMONIUM CITRATE

A, E, H

When for internal use, iron is a mandatory component of ferric ammonium citrate.

When for internal use, the medicine must contain a daily dose of no more than 24 mg of iron.

If the divided dosage form contains more than 5 mg of iron per dosage unit (excluding up to 10 mg of iron oxide when used as an excipient), the primary pack must contain no more than 750 mg of iron.

In undivided preparations, the primary pack must contain no more than 750 mg of iron (excluding iron oxides when present as an excipient at a quantity of no more than 1%).

Divided preparations with a dose of more than 5 mg of elemental iron per dosage unit and more than 250 mg of elemental iron in the total contents of the container are required to have a child resistant closure.

Undivided preparations containing more than 250 mg of elemental iron in the total contents of the container are required to have a child resistant closure.

When for internal use except for iron-containing multivitamin/mineral products indicated for general nutritional support that do not make specific iron-deficiency related claims, the following warning statement is required on the label:

- (IRONDEF) 'Not for the treatment of iron deficiency conditions' (or words to that effect).

 

2187

FERRIC CHLORIDE

A, E, H

When for internal use, iron is a mandatory component of ferric chloride.

When for internal use, the medicine must contain a daily dose of no more than 24 mg of iron.

If the divided dosage form contains more than 5 mg of iron per dosage unit (excluding up to 10 mg of iron oxide when used as an excipient), the primary pack must contain no more than 750 mg of iron.

In undivided preparations, the primary pack must contain no more than 750 mg of iron (excluding iron oxides when present as an excipient at a quantity of no more than 1%).

Divided preparations with a dose of more than 5 mg of elemental iron per dosage unit and more than 250 mg of elemental iron in the total contents of the container are required to have a child resistant closure.

Undivided preparations containing more than 250 mg of elemental iron in the total contents of the container are required to have a child resistant closure.

When for internal use except for iron-containing multivitamin/mineral products indicated for general nutritional support that do not make specific iron-deficiency related claims, the medicine requires the following statement on the medicine label:

- (IRONDEF) 'Not for the treatment of iron deficiency conditions' (or words to that effect).

 

2188

FERRIC CHLORIDE HEXAHYDRATE

A, E, H

When for internal use, iron is a mandatory component of ferric chloride hexahydrate.

When for internal use, the medicine must contain a daily dose of no more than 24 mg of iron.

If the divided dosage form contains more than 5 mg of iron per dosage unit (excluding up to 10 mg of iron oxide when used as an excipient), the primary pack must contain no more than 750 mg of iron.

In undivided preparations, the primary pack must contain no more than 750 mg of iron (excluding iron oxides when present as an excipient at a quantity of no more than 1%).

Divided preparations with a dose of more than 5 mg of elemental iron per dosage unit and more than 250 mg of elemental iron in the total contents of the container are required to have a child resistant closure.

Undivided preparations containing more than 250 mg of elemental iron in the total contents of the container are required to have a child resistant closure.

When for internal use except for iron-containing multivitamin/mineral products indicated for general nutritional support that do not make specific iron-deficiency related claims, the medicine requires the following statement on the medicine label:

- (IRONDEF) 'Not for the treatment of iron deficiency conditions' (or words to that effect).

 

2189

FERRIC GLYCEROPHOSPHATE

A, E, H

When for internal use, iron is a mandatory component of ferric glycerophosphate.

When for internal use, the medicine must contain a daily dose of no more than 24 mg of iron.

If the divided dosage form contains more than 5 mg of iron per dosage unit (excluding up to 10 mg of iron oxide when used as an excipient), the primary pack must contain no more than 750 mg of iron.

In undivided preparations, the primary pack must contain no more than 750 mg of iron (excluding iron oxides when present as an excipient at a quantity of no more than 1%).

Divided preparations with a dose of more than 5 mg of elemental iron per dosage unit and more than 250 mg of elemental iron in the total contents of the container are required to have a child resistant closure.

Undivided preparations containing more than 250 mg of elemental iron in the total contents of the container are required to have a child resistant closure.

When for internal use except for iron-containing multivitamin/mineral products indicated for general nutritional support that do not make specific iron-deficiency related claims, the medicine requires the following statement on the medicine label:

 - (IRONDEF) 'Not for the treatment of iron deficiency conditions' (or words to that effect).

 

2190

FERRIC OXIDE

E

 

2191

FERRIC PHOSPHATE

H

Only for use as an active homoeopathic ingredient.

 

2192

FERRIC PYROPHOSPHATE

A, H

When for internal use, iron is a mandatory component of ferric pyrophosphate.

When for internal use, the medicine must contain a daily dose of no more than 24 mg of iron.

If the divided dosage form contains more than 5 mg of iron per dosage unit (excluding up to 10 mg of iron oxide when used as an excipient), the primary pack must contain no more than 750 mg of iron.

In undivided preparations, the primary pack must contain no more than 750 mg of iron (excluding iron oxides when present as an excipient at a quantity of no more than 1%).

Divided preparations with a dose of more than 5 mg of elemental iron per dosage unit and more than 250 mg of elemental iron in the total contents of the container are required to have a child resistant closure.

Undivided preparations containing more than 250 mg of elemental iron in the total contents of the container are required to have a child resistant closure.

When for internal use except for iron-containing multivitamin/mineral products indicated for general nutritional support that do not make specific iron-deficiency related claims, the medicine requires the following statement on the medicine label:

- (IRONDEF) 'Not for the treatment of iron deficiency conditions' (or words to that effect).

 

2193

FERROSOFERRIC OXIDE

E

When used in undivided preparations for internal use and the concentration of iron oxide in the medicine is more than 1%, it is considered part of the total iron content.

When used in divided preparations for internal use, the concentration in the medicine must be no more than 10 mg per dosage unit.

 

2194

FERROSOFERRIC PHOSPHATE

H

Only for use as an active homoeopathic ingredient.

 

2195

FERROUS FUMARATE

A, H

When for internal use, iron is a mandatory component of ferrous fumarate.

When used as an active ingredient, the medicine must contain a daily dose of no more than 24 mg of iron.

If the divided dosage form contains more than 5 mg of iron per dosage unit (excluding up to 10 mg of iron oxide when used as an excipient), the primary pack must contain no more than 750 mg of iron.

In undivided preparations, the primary pack must contain no more than 750 mg of iron (excluding iron oxides when present as an excipient at a quantity of no more than 1%).

Divided preparations with a dose of more than 5mg of elemental iron per dosage unit and more than 250 milligrams of elemental iron in the total contents of the container are required to have a child resistant closure.

Undivided preparations containing more than 250 milligrams of elemental iron in the total contents of the container are required to have a child resistant closure.

When for internal use except for iron-containing multivitamin/mineral products indicated for general nutritional support that do not make specific iron-deficiency related claims, the medicine requires the following statement on the medicine label:

- (IRONDEF) 'Not for the treatment of iron deficiency conditions' (or words to that effect).

 

2196

FERROUS GLUCONATE

A, E, H

When for internal use, iron is a mandatory component of ferrous gluconate.

When for internal use, the medicine must contain a daily dose of no more than 24 mg of iron.

If the divided dosage form contains more than 5 mg of iron per dosage unit (excluding up to 10 mg of iron oxide when used as an excipient), the primary pack must contain no more than 750 mg of iron.

In undivided preparations, the primary pack must contain no more than 750 mg of iron (excluding iron oxides when present as an excipient at a quantity of no more than 1%).

Divided preparations with a dose of more than 5 mg of elemental iron per dosage unit and more than 250 mg of elemental iron in the total contents of the container are required to have a child resistant closure.

Undivided preparations containing more than 250 mg of elemental iron in the total contents of the container are required to have a child resistant closure.

When for internal use except for iron-containing multivitamin/mineral products indicated for general nutritional support that do not make specific iron-deficiency related claims, the medicine requires the following statement on the medicine label:

- (IRONDEF) 'Not for the treatment of iron deficiency conditions' (or words to that effect).

 

2197

FERROUS GLUCONATE DIHYDRATE

A, E, H

When for internal use, iron is a mandatory component of ferrous gluconate dihydrate.

When for internal use, the medicine must contain a daily dose of no more than 24 mg of iron.

If the divided dosage form contains more than 5 mg of iron per dosage unit (excluding up to 10 mg of iron oxide when used as an excipient), the primary pack must contain no more than 750 mg of iron.

In undivided preparations, the primary pack must contain no more than 750 mg of iron (excluding iron oxides when present as an excipient at a quantity of no more than 1%).

Divided preparations with a dose of more than 5 mg of elemental iron per dosage unit and more than 250 mg of elemental iron in the total contents of the container are required to have a child resistant closure.

Undivided preparations containing more than 250 mg of elemental iron in the total contents of the container are required to have a child resistant closure.

When for internal use except for iron-containing multivitamin/mineral products indicated for general nutritional support that do not make specific iron-deficiency related claims, the medicine requires the following statement on the medicine label:

- (IRONDEF) 'Not for the treatment of iron deficiency conditions' (or words to that effect).

 

2198

FERROUS IODIDE

H

Only for use as an active homoeopathic ingredient.

 

2199

FERROUS LACTATE TRIHYDRATE

A, E, H

When for internal use, iron is a mandatory component of ferrous lactate trihydrate.

When used as an active ingredient, the medicine must contain a daily dose of no more than 24 mg of iron.

If the divided dosage form contains more than 5 mg of iron per dosage unit (excluding up to 10 mg of iron oxide when used as an excipient), the primary pack must contain no more than 750 mg of iron.

In undivided preparations, the primary pack must contain no more than 750 mg of iron (excluding iron oxides when present as an excipient at a quantity of no more than1%).

Divided preparations with a dose of more than 5mg of elemental iron per dosage unit and more than 250 milligrams of elemental iron in the total contents of the container are required to have a child resistant closure.

Undivided preparations containing more than 250 milligrams of elemental iron in the total contents of the container are required to have a child resistant closure.

When for internal use except for iron-containing multivitamin/mineral products indicated for general nutritional support that do not make specific iron-deficiency related claims, the medicine requires the following statement on the medicine label:

- (IRONDEF) 'Not for the treatment of iron deficiency conditions' (or words to that effect).

 

2200

FERROUS PHOSPHATE OCTAHYDRATE

A, E, H

When for internal use, iron is a mandatory component of ferrous phosphate octahydrate.

When used as an active ingredient, the medicine must contain a daily dose of no more than 24 mg of iron.

If the divided dosage form contains more than 5 mg of iron per dosage unit (excluding up to 10 mg of iron oxide when used as an excipient), the primary pack must contain no more than 750 mg of iron.

In undivided preparations, the primary pack must contain no more than 750 mg of iron (excluding iron oxides when present as an excipient at a quantity of no more than 1%).

Divided preparations with a dose of more than 5mg of elemental iron per dosage unit and more than 250 milligrams of elemental iron in the total contents of the container are required to have a child resistant closure.

Undivided preparations containing more than 250 milligrams of elemental iron in the total contents of the container are required to have a child resistant closure.

When for internal use except for iron-containing multivitamin/mineral products indicated for general nutritional support that do not make specific iron-deficiency related claims, the medicine requires the following statement on the medicine label:

- (IRONDEF) 'Not for the treatment of iron deficiency conditions' (or words to that effect).

 

2201

FERROUS PICRATE

H

Only for use as an active homoeopathic ingredient.

 

2202

FERROUS SULFATE

A, E, H

When used as an active ingredient, the medicine must contain a daily dose of no more than 24 mg of iron.

If the divided dosage form contains more than 5 mg of iron per dosage unit (excluding up to 10 mg of iron oxide when used as an excipient), the primary pack must contain no more than 750 mg of iron.

In undivided preparations, the primary pack must contain no more than 750 mg of iron (excluding iron oxides when present as an excipient at a quantity of no more than 1%).

Divided preparations with a dose of more than 5mg of elemental iron per dosage unit and more than 250 milligrams of elemental iron in the total contents of the container are required to have a child resistant closure.

Undivided preparations containing more than 250 milligrams of elemental iron in the total contents of the container are required to have a child resistant closure.

When for internal use except for iron-containing multivitamin/mineral products indicated for general nutritional support that do not make specific iron-deficiency related claims, the medicine requires the following statement on the medicine label:

- (IRONDEF) 'Not for the treatment of iron deficiency conditions' (or words to that effect).

 

2203

FERROUS SULFATE HEPTAHYDRATE

A, E, H

When for internal use, iron is a mandatory component of ferrous sulfate heptahydrate.

When for internal use, the medicine must contain a daily dose of no more than 24 mg of iron.

If the divided dosage form contains more than 5 mg of iron per dosage unit (excluding up to 10 mg of iron oxide when used as an excipient), the primary pack must contain no more than 750 mg of iron.

In undivided preparations, the primary pack must contain no more than 750 mg of iron (excluding iron oxides when present as an excipient at a quantity of no more than 1%).

Divided preparations with a dose of more than 5 mg of elemental iron per dosage unit and more than 250 mg of elemental iron in the total contents of the container are required to have a child resistant closure.

Undivided preparations containing more than 250 mg of elemental iron in the total contents of the container are required to have a child resistant closure.

When for internal use except for iron-containing multivitamin/mineral products indicated for general nutritional support that do not make specific iron-deficiency related claims, the medicine requires the following statement on the medicine label:

- (IRONDEF) 'Not for the treatment of iron deficiency conditions' (or words to that effect).

 

2204

FERULA ASSA-FOETIDA

A, E, H

 

2205

FERULA FOETIDA

A, E, H

 

2206

FERULA GALBANIFLUA

A, E, H

 

2207

FERULA RUBRICAULIS

A, E, H

 

2208

FERULA SUMBUL

A, H

 

2209

FERULIC ACID

E

Only for use in topical medicines for dermal application.

 

2210

FESTUCA ELATIOR

A, H

 

2211

FEVERFEW HERB DRY

A, H

 

2212

FEVERFEW HERB POWDER

A, H

 

2213

FICUS CARICA

A, E, H

 

2214

FICUS PUMILA

A, H

 

2215

FIG

E

 

2216

FIG DRY

A, H

 

2217

FILIPENDULA ULMARIA

A, H

Methyl salicylate is a mandatory component of Filipendula ulmaria.

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'.

 

2218

FIR BALSAM ABSOLUTE

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%.

 

2219

FIR NEEDLE OIL CANADIAN

A, E

 

2220

FIR NEEDLE OIL SIBERIAN

A, E

 

2221

FIRMIANA SIMPLEX

A, E, H

 

2222

FISH OIL - RICH IN OMEGA-3 ACIDS

A

Only for use in oral medicines.

 

2223

FLEMINGIA MACROPHYLLA

A, H

 

2224

FLOUVE 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%.

 

2225

FLUORESCEIN SODIUM

E

 

2226

FOENICULUM VULGARE

A, E, H

When used in oral medicines, the following warning statements are required on the label:

- (CHILD3) ‘Use in children under 12 years is not recommended’

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

- (BREASF) 'Do not use while breastfeeding.'

When the plant preparation is oil or distillate, methyl chavicol is a mandatory component and the maximum daily dose must provide no more than 150 mg of the plant preparation.

When the plant preparation is oil or distillate and the concentration of methyl chavicol in the medicine is more than 5%, the nominal capacity of the container must be no more than 25mL, a restricted flow insert must be fitted on the container, and the following warning statement is required on the label:

- (CHILD) 'Keep out of reach of children' (or words to that effect).

 

2227

FOLIC ACID

A

When for internal use, the maximum recommended daily dose must not provide more than 500 micrograms of folic acid.

When the medicine contains a combination of folic acid, folinic acid or levomefolic acid, the medicine must not provide more than a combined total of 500 micrograms of folic acid, folinic acid and levomefolic acid per maximum recommended daily dose.

 

2228

FOOD ORANGE 6

E

Permitted for use only as a colour in medicines limited to topical and oral routes of administration.

 

2229

FOOD ORANGE 7

E

Permitted for use only as a colour in medicines limited to topical and oral routes of administration.

 

2230

FOOD RED 13

E

Permitted for use only as a colour for topical use.

 

2231

FORMALDEHYDE/MELAMINE/TOSYLAMIDE COPOLYMER

E

Only for use in topical medicines for dermal application.

The concentration in the medicine must be no more than 10%.

 

2232

FORMIC ACID

E, H

Formic acid must only be included in medicines:

(a) as an active homoeopathic ingredient; or

(b) when in combination with other permitted ingredients as a flavour proprietary excipient formulation.

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

The maximum recommended daily dose of the medicine must not provide more than 150 mg of formic acid.

The total concentration of formic acid in the medicine must not be more than 0.5%.

 

2233

FORSYTHIA SUSPENSA

A, H

 

2234

FORTIFIED WINE

E

Ethanol is a mandatory component of fortified wine.

 

2235

FRACTIONATED COCONUT OIL

E

 

2236

FRACTIONATED PALM KERNEL OIL

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.

 

2237

FRAGARIA CHILOENSIS

A, E, H

 

2238

FRAGARIA VESCA

A, E, H

 

2239

FRAGARIA VIRGINIANA

A, E, H

 

2240

FRAGARIA X ANANASSA

A, E, H

 

2241

FRANGULA BARK DRY

A, H

Glucofrangulins calculated as glucofrangulin A is a mandatory component of Frangula bark dry.

When used in oral medicines, if the maximum recommended daily dose contains more than 10 mg of hydroxyanthracene derivatives the medicine requires the following warning statements on the medicine label:

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

- (LAX2) 'Prolonged use may cause serious bowel problems'; and

- (LAX3) 'Do not use when abdominal pain, nausea or vomiting are present, or if you develop diarrhoea. If you are pregnant or breast feeding, seek the advice of a healthcare professional before taking this product' [or words to that effect].

When promoted or marketed as a laxative, the medicine requires the following warning statement on the medicine label:

- (LAX1) 'Drink plenty of water' [or words to that effect].

When not promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label:

- (LAX5) 'This product contains [name of the herb(s) or the chemical component(s)]'; and

- (LAX4) 'This product may have laxative effect'.

When used in oral medicines, if the maximum recommended daily dose contains less than 10 mg of hydroxyanthracene derivatives and is promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label:

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

- (LAX1) 'Drink plenty of water' [or words to that effect]; and

- (LAX2) 'Prolonged use may cause serious bowel problems'.

 

2242

FRANGULA BARK POWDER

A, H

Glucofrangulins calculated as glucofrangulin A is a mandatory component of Frangula bark powder.

When used in oral medicines, if the maximum recommended daily dose contains more than 10 mg of hydroxyanthracene derivatives the medicine requires the following warning statements on the medicine label:

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

- (LAX2) 'Prolonged use may cause serious bowel problems'; and

- (LAX3) 'Do not use when abdominal pain, nausea or vomiting are present, or if you develop diarrhoea. If you are pregnant or breast feeding, seek the advice of a healthcare professional before taking this product [or words to that effect]'.

When promoted or marketed as a laxative, the medicine requires the following warning statement on the medicine label:

- (LAX1) 'Drink plenty of water [or words to that effect]'.

When not promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label:

- (LAX5) 'This product contains [name of the herb(s) or the chemical component(s)]'; and

- (LAX4) 'This product may have laxative effect'.

When used in oral medicines, if the maximum recommended daily dose contains less than 10 mg of hydroxyanthracene derivatives and is promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label:

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

- (LAX1) 'Drink plenty of water [or words to that effect]'; and

- (LAX2) 'Prolonged use may cause serious bowel problems'.

 

2243

FRANGULA PURSHIANA

A, H

When for oral use, hydroxyanthracene derivatives calculated as cascaroside A is a mandatory component of Frangula purshiana.

When used in oral medicines, if the maximum recommended daily dose contains more than 10 mg of hydroxyanthracene derivatives the medicine requires the following warning statements on the medicine label:

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

- (LAX2) 'Prolonged use may cause serious bowel problems'; and

- (LAX3) 'Do not use when abdominal pain, nausea or vomiting are present, or if you develop diarrhoea. If you are pregnant or breast feeding, seek the advice of a healthcare professional before taking this product' [or words to that effect].

When promoted or marketed as a laxative, the medicine requires the following warning statement on the medicine label:

- (LAX1) 'Drink plenty of water' [or words to that effect].

When not promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label:

- (LAX5) 'This product contains [name of the herb(s) or the chemical component(s)]'; and

- (LAX4) 'This product may have laxative effect'.

When used in oral medicines, if the maximum recommended daily dose contains less than 10 mg of hydroxyanthracene derivatives and is promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label:

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

- (LAX1) 'Drink plenty of water' [or words to that effect]; and

- (LAX2) 'Prolonged use may cause serious bowel problems'.

 

2244

FRAXINUS AMERICANA

A, H

 

2245

FRAXINUS CHINENSIS SUBSP. RHYNCHOPHYLLA

A, H

 

2246

FRAXINUS EXCELSIOR

A, H

 

2247

FRAXINUS ORNUS

A, H

 

2248

FRITILLARIA CIRRHOSA

A, H

 

2249

FRITILLARIA THUNBERGII

A, H

 

2250

FRITILLARIA VERTICILLATA

A, H

 

2251

FRUCTOOLIGOSACCHARIDES

A, E

 

2252

FRUCTOSE

A, E, H

 

2253

FUCUS VESICULOSUS

A, E, H

Iodine is a mandatory component of Fucus vesiculosus.

Only for external use when the concentration of available iodine in the medicine (excluding salts derivatives or iodophors) is 2.5% or less.

Only for internal use when the medicine contains less than 300 micrograms of iodine per maximum recommended daily dose.

 

2254

FULLY HYDROGENATED RAPESEED OIL

E

Fully hydrogenated rapeseed oil must only be used in topical medicines for dermal application.

The total concentration of fully hydrogenated rapeseed oil in the medicine must not be more than 5%.

 

2255

FUMARIA OFFICINALIS

A, E, H

 

2256

FUMARIC ACID

E, H

Only for use as an active homoeopathic or excipient ingredient.

 

2257

FUMITORY HERB DRY

A, H

 

2258

FUMITORY HERB POWDER

A, H

 

2259

FURAMINTON

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%.

 

2260

FURFURAL

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%.

 

2261

FURFURYL ACETATE

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%.

 

2262

FURFURYL 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%.

 

2263

FURFURYL MERCAPTAN

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%.

 

2264

FUSEL 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%.

 

2265

GALACTOOLIGOSACCHARIDES

A

Only to be used in a medicine where FrieslandCampina Ingredients B V (Client ID 79530), who applied to have the ingredient included in this Determination, is the sponsor of the medicine or has given written authorisation to the sponsor of a medicine to include the ingredient in the medicine. This paragraph ceases to be a requirement for this ingredient after 1 May 2025.

Lactose and glucose are mandatory components of galactooligosaccharides.

The route of administration for medicines that contain galactooligosaccharides must be limited to oral.

The maximum recommended daily dose of the medicine must not provide more than:

(a) 8 g of galactooligosaccharides to individuals aged 0 to 3 years (inclusive); and

(b) 16.2 g of galactooligosaccharides to individuals aged 4 years and older.

The following warning statement (or words to the same effect) is required on the medicine label:

(GOS) 'Not to be taken on the same day with other products containing galactooligosaccharides.’

 

 

2266

GALBANUM 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%.

 

2267

GALBANUM PHENOL

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%.

 

2268

GALBANUM RESIN

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%.

 

2269

GALBANUM RESINOID

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%.

 

2270

GALEGA OFFICINALIS

A, H

 

2271

GALEOPSIS SEGETUM

A, H

 

2272

GALIUM APARINE

A, H

 

2273

GALIUM ODORATUM

A, H

When used as an active ingredient coumarin is a mandatory component of Galium odoratum and the concentration of coumarin in the medicine must be no more than 0.001%.

 

2274

GALIUM PALUSTRE

A, H

 

2275

GALIUM VERUM

A, H

 

2276

GALL STONE

H

Only for use as an active homoeopathic ingredient.

 

2277

GALPHIMIA GLAUCA

A, H

 

2278

GAMMA-4-DIMETHYL-3-CYCLOHEXENE-1-PROPANOL

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%.

 

2279

GAMMA-BUTYROLACTONE

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%.

 

2280

GAMMA-CYCLODEXTRIN

E

 

2281

GAMMA-DECALACTONE

E

Permitted for use only:

(a) in topical medicines for dermal application; and

(b) in oral medicines in combination with other permitted ingredients as part of a flavour proprietary excipient formulation.

When used in a flavour, the total flavour proprietary excipient formulation in a medicine must be no more than 5%.

 

2282

GAMMA-DODECALACTONE

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%.

 

2283

GAMMA-HEPTALACTONE

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%.

 

2284

GAMMA-HEXALACTONE

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%.

 

2285

GAMMA-IONONE

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%.

 

2286

GAMMA-LINOLEIC ACID

E

Only for use in topical medicines for dermal application.

 

2287

GAMMA-LINOLENIC ACID

E

 

2288

GAMMA-N-METHYL IONONE

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%.

 

2289

GAMMA-NONALACTONE

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%.

 

2290

GAMMA-OCTALACTONE

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%.

 

2291

GAMMA-TERPINENE

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%.

 

2292

GAMMA-TOCOPHEROL

E

 

2293

GAMMA-UNDECALACTONE

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%.

 

2294

GAMMA-VALEROLACTONE

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%.

 

2295

GANODERMA LUCIDUM

A, E, H

 

2296

GARCINIA GUMMI-GUTTA

A

Only for use in oral medicines.

Must be obtained from the rind of the fruit only.

Must not contain any directions for use for children or pregnant or lactating women.

 

2297

GARCINIA QUAESITA

A, H

 

2298

GARDEN BEAN

E

 

2299

GARDENIA JASMINOIDES

A, E

 

2300

GARDENIA TAHITENSIS FLOWER EXTRACT

E

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

The concentration in the medicine must be no more than 0.002%

 

2301

GARLIC BULB DRY

A, E, H

 

2302

GARLIC BULB FRESH

A, H

 

2303

GARLIC BULB POWDER

A, E, H

 

2304

GARLIC CLOVE POWDER

A, H

 

2305

GARLIC OIL

A, E, H

 

2306

GASTRODIA ELATA

A, H

 

2307

GAULTHERIA PROCUMBENS

A, E, H

Methyl salicylate is a mandatory component of Gaultheria procumbens.

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'.

 

2308

GELATIN

A, E

 

2309

GELIDIUM AMANSII

A, H

Iodine is a mandatory component of Gelidium amansii.

Only for external use when the concentration of iodine in the medicine (excluding salts derivatives or iodophors) is 2.5% or less.

Only for internal use when the medicine contains less than 300 micrograms of iodine per maximum recommended daily dose.

 

2310

GELLAN GUM

E

 

2311

GELSEMIUM DRY

A, H

The concentration of Gelsemium dry in the medicine must be no more than 1mg/Kg or 1mg/L or 0.0001%.

 

2312

GELSEMIUM POWDER

A, H

 

2313

GELSEMIUM SEMPERVIRENS

A, H

The concentration of equivalent dry Gelsemium sempervirens in the product must be no more than 1mg/Kg or 1mg/L or 0.0001%.

 

2314

GENET 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%.

 

2315

GENTIAN DRY

A, H

 

2316

GENTIAN POWDER

A, H

 

2317

GENTIANA LUTEA

A, E, H

 

2318

GENTIANA MACROPHYLLA

A, H

 

2319

GENTIANA RHODANTHA

A, H

 

2320

GENTIANA SCABRA

A, H

 

2321

GENTIANELLA AMARELLA

A, H

 

2322

GERANIAL

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%.

 

2323

GERANIC ACID

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%.

 

2324

GERANIOL

E

Permitted for use only:

(a) in topical medicines for dermal application; and

(b) in oral medicines in combination with other permitted ingredients as part of a flavour proprietary excipient formulation.

When used in a flavour, the total flavour proprietary excipient formulation in a medicine must be no more than 5%.

 

2325

GERANIUM

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%.

 

2326

GERANIUM MACULATUM

A, E, H

 

2327

GERANIUM OIL

A, E, H

 

2328

GERANIUM OIL SAPONIFIED

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%.

 

2329

GERANIUM OIL TERPENELESS

E

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

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

 

2330

GERANIUM ROBERTIANUM

A, E, H

 

2331

GERANIUM ROSE 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%.

 

2332

GERANIUM SIBIRICUM

A, E, H

 

2333

GERANYL ACETATE

E

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

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

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

 

2334

GERANYL ACETONE

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%.

 

2335

GERANYL BUTYRATE

E

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

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

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

 

2336

GERANYL CROTONATE

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%.

 

2337

GERANYL ETHYL ETHER

E

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

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

 

2338

GERANYL FORMATE

E

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

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

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

 

2339

GERANYL 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%.

 

2340

GERANYL ISOVALERATE

E

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

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

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

 

2341

GERANYL NITRILE

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%.

 

2342

GERANYL PROPIONATE

E

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

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

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

 

2343

GERANYL TIGLATE

E

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

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

 

2344

GEUM RIVALE

A, H

 

2345

GEUM URBANUM

A, H

 

2346

GHATTI GUM

A, E, H

 

2347

GIGARTINA MAMILLOSA

A, H

Iodine is a mandatory component of Gigartina mamillosa.

Only for external use when the concentration of iodine in the medicine (excluding salts derivatives or iodophors) is 2.5% or less.

Only for internal use when the medicine contains less than 300 micrograms of iodine per maximum recommended daily dose.

 

2348

GINGER DRY

A, E, H

 

2349

GINGER OIL

A, E, H

 

2350

GINGER 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 the medicine must be no more than 5%.

 

2351

GINGER POWDER

A, E, H

 

2352

GINKGO BILOBA

A, E, H

The Ginkgo biloba leaf extract used in the manufacture of this medicine must comply with the requirement of Identification Test B of the monograph Powdered Ginkgo Extract in the United States Pharmacopeia 32 - National Formulary 27 (USP32-NF27), as in force or existing from time to time. This condition does not apply to powdered or dried leaf.

 

2353

GLACIAL ACETIC ACID

E, H

The concentration in the medicine must be no more than 1.5%.

 

2354

GLECHOMA HEDERACEA

A, H

 

2355

GLECHOMA LONGITUBA

A, H

 

2356

GLEDITSIA AUSTRALIS

A, H

 

2357

GLEDITSIA SINENSIS

A, H

 

2358

GLEHNIA LITTORALIS

A, H

 

2359

GLORIOSA SUPERBA

A, H

Colchicine is a mandatory component of Gloriosa superba and must be declared in the application.

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

 

2360

GLUCOMANNAN

E

Only for use when the dosage form is other than tablet.

 

2361

GLUCONOLACTONE

E

 

2362

GLUCOSAMINE HYDROCHLORIDE

A, E

 

2363

GLUCOSAMINE SULFATE

A

 

2364

GLUCOSAMINE SULFATE POTASSIUM CHLORIDE

A

Potassium chloride is a mandatory component of glucosamine sulfate potassium chloride.

When for oral use, the medicine requires the following warning statement on the medicine label:

- (POTAS1) ‘If you have kidney disease or are taking heart or blood pressure medicines - consult your doctor or pharmacist before use. Keep out of reach of children.’

 

2365

GLUCOSAMINE SULFATE SODIUM CHLORIDE

A

 

2366

GLUCOSE

A, E, H

 

2367

GLUCOSE GLUTAMATE

E

Only for use in topical medicines for dermal application.

 

2368

GLUCOSE MONOHYDRATE

A, E, H

 

2369

GLUCOSYLRUTIN

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%.

 

2370

GLUTAMIC ACID

A, E

Only for use in topical medicines for dermal application.

 

2371

GLUTAMIC ACID HYDROCHLORIDE

A, E, H

 

2372

GLUTAMINE

A, E, H

 

2373

GLUTARAL

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%.

 

2374

GLUTATHIONE

A, E

When used as an active ingredient, glutathione can only be used in medicines with an oral route of administration and must be indicated for use in adults only and not in pregnant or lactating women.

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)

- (ADULT) 'Adults only' (or words to that effect).

 

2375

GLUTEN-FREE WHEAT STARCH

E

 

2376

GLYCERETH-26

E

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

The concentration in the medicine must be no more than 7%.

 

2377

GLYCEROL

A, E

When used as an active ingredient, it is only for use in topical medicines for dermal application.

 

2378

GLYCEROL ESTER OF PARTIALLY HYDROGENATED GUM ROSIN

E

Only for use when the dosage form is 'chewing gum'.

Must comply with:

a) the Glycerol Ester of Partially Hydrogenated Gum Rosin monograph in the Food Chemicals Codex published by the United States Pharmacopeial Convention, as in force or existing from time to time; and

b) the requirements for residual solvents and catalysts in the British Pharmacopoeia or the United States Pharmacopeia-National Formulary, as in force or existing from time to time.

 

2379

GLYCEROL ESTER OF PARTIALLY HYDROGENATED WOOD ROSIN

E

Glycerol ester of partially hydrogenated wood rosin must only be included in medicines when in combination with other permitted ingredients as a proprietary excipient formulation in medicines with a dermal route of administration for topical application.

 

2380

GLYCERYL BEHENATE

E

Behenic acid is a mandatory component of glyceryl behenate.

When for oral ingestion, the maximum recommended daily dose must not provide more than 383.5 milligrams of behenic acid.

In medicines for topical use, the concentration of glyceryl behenate must be no more than 5%.

 

2381

GLYCERYL CAPRYLATE

E

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

The concentration in the medicine must be no more than 1%.

 

2382

GLYCERYL DIISOSTEARATE

E

For use in topical medicines for dermal application.

 

2383

GLYCERYL DILAURATE

E

Only for use in topical medicines for dermal application.

 

2384

GLYCERYL DIOLEATE

E

Only for use in topical medicines for dermal application.

 

2385

GLYCERYL DISTEARATE

E

Only for use in topical medicines for dermal application.

 

2386

GLYCERYL GLUCOSIDE

E

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

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

 

2387

GLYCERYL ISOSTEARATE

E

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

The concentration in the medicine must be no more than 5.5%.

 

2388

GLYCERYL LAURATE

E

Only for use in topical medicines for dermal application.

 

2389

GLYCERYL LINOLEATE

E

Only for use in topical medicines for dermal application.

 

2390

GLYCERYL LINOLENATE

E

Only for use in topical medicines for dermal application.

 

2391

GLYCERYL MONO AND DICAPRYLOCAPRATE

E

Only permitted for use in medicines limited to oral routes of administration, or when in combination with other permitted ingredients as a fragrance proprietary excipient formulation.

The maximum recommended oral daily dose of the medicine must not provide more than 8 mg of glyceryl mono and dicaprylocaprate.

The total concentration of fragrance proprietary excipient formulations containing glyceryl mono and dicaprylocaprate must not be more than 1% of the total medicine.

 

2392

GLYCERYL MONOOLEATE

E

 

2393

GLYCERYL MONOSTEARATE

E

 

2394

GLYCERYL MYRISTATE

E

Only for use in topical medicines for dermal application.

 

2395

GLYCERYL OLEATE CITRATE

E

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

The concentration in the medicine must be no more than 4% of the formulation.

 

2396

GLYCERYL PALMITO-STEARATE

E

 

2397

GLYCERYL POLYACRYLATE

E

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

The concentration in the medicine must be no more than 0.15%.

 

2398

GLYCERYL POLYMETHACRYLATE

E

Only for use in topical medicines for dermal application.

 

2399

GLYCERYL RICINOLEATE

E

Only for use in topical medicines for dermal application.

 

2400

GLYCERYL ROSINATE

E

Only for use when the dosage form is 'chewing gum'.

Must comply with:

a) the Glycerol Ester of Gum Rosin monograph in the Food Chemicals Codex published by the United States Pharmacopeial Convention, as in force or existing from time to time; and

b) the requirements for residual solvents and catalysts in the British Pharmacopoeia or the United States Pharmacopeia National Formulary, as in force or existing from time to time.

 

2401

GLYCERYL SORBITAN OLEOSTEARATE

E

Only for use in topical medicines for dermal application.

 

2402

GLYCERYL STARCH

E

Only for use in topical medicines for dermal application.

The concentration in the medicine must be no more than 4%.

The residual levels of epichlorohydrin are to be kept below the level of detection.

 

2403

GLYCERYL STEARATE CITRATE

E

Only for use in topical medicines for dermal application.

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

 

2404

GLYCERYL TRIACETYL HYDROXYSTEARATE

E

Only for use in topical medicines for dermal application.

The concentration in the medicine must be no more than 6%.

 

2405

GLYCERYL TRIACETYL RICINOLEATE

E

Only for use in topical medicines for dermal application.

 

2406

GLYCERYL TRINITRATE

H

Only for use as an active homoeopathic ingredient.

The total concentration of glyceryl trinitrate in the medicine must not be more than 100 micrograms/kg or 100 micrograms/L or 0.00001%.

 

2407

GLYCERYL UNDECYLENATE

E

Only for use in topical medicines for dermal application and not to be included in medicines intended for use in the eye or on damaged skin. The concentration of glyceryl undecylenate in a medicine must be no more than 3%.

 

2408

GLYCINE

A, E

 

2409

GLYCINE MAX

A, E, H

 

2410

GLYCOGEN

E

Only for use in topical medicines for dermal application.

 

2411

GLYCOL DISTEARATE

E

Only for use in topical medicines for dermal application.

 

2412

GLYCOLIC ACID

E

Only for use in topical medicines for dermal application.

Sponsors should consider the impact of excipients on the sensitivity of the skin to sunlight and should ensure the finished product is safe for its intended purpose.

When present as an excipient in sunscreens, the concentration in the medicine must be no more than 5%.

When used as an excipient ingredient in other medicines the concentration in the medicine must be no more than 20%.

If the concentration is more than 5% but no more than 20%, the pH of the medicine must be 3.5 or greater.

 

2413

GLYCYRRHIZA GLABRA

A, E, H

 

2414

GLYCYRRHIZA SPECIES

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%.

 

2415

GLYCYRRHIZA URALENSIS

A, E, H

 

2416

GLYCYRRHIZINIC ACID

E

 

2417

GNAPHALIUM AFFINE

A, H

 

2418

GNAPHALIUM POLYCEPHALUM

A, H

 

2419

GNAPHALIUM ULIGINOSUM

A, H

 

2420

GOAT

H

Only for use as an active homoeopathic ingredient.

 

2421

GOAT MILK

E

 

2422

GOLD

E, H

Only for use as an active homoeopathic or excipient ingredient.

 

2423

GOLD CHLORIDE

H

Only for use as an active homoeopathic ingredient.

 

2424

GOLDEN ROD HERB DRY

A, E, H

 

2425

GOLDEN SEAL ROOT DRY

A, H

 

2426

GOLDEN SEAL ROOT POWDER

A, H

 

2427

GOLDEN SYRUP

E

When the route of administration of the medicine is oral or sublingual, sucrose is a mandatory component of golden syrup.

 

2428

GOMPHRENA GLOBOSA

A, H

 

2429

GOSSYPIUM HERBACEUM

A, E, H

 

2430

GRAPE

E

 

2431

GRAPE SEED OIL

E

 

2432

GRAPE WINE RED

E

Ethanol is a mandatory component of grape wine red.

 

2433

GRAPE WINE SHERRY

E

Ethanol is a mandatory component of grape wine sherry.

 

2434

GRAPE WINE WHITE

E

Ethanol is a mandatory component of grape wine white.

 

2435

GRAPEFRUIT

E

 

2436

GRAPEFRUIT 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%.

 

2437

GRAPEFRUIT OIL COLDPRESSED

A, E, H

 

2438

GRAPEFRUIT OIL 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%.

 

2439

GRAPEFRUIT OIL TERPENELESS

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%.

 

2440

GRAPEFRUIT OIL TERPENES AND TERPENOIDS

E

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

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

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

 

2441

GRAPHITE

H

Only for use as an active homoeopathic ingredient.

 

2442

GRATIOLA LINIFOLIA

A, H

 

2443

GREATER NETTLE HERB DRY

A, H

 

2444

GREATER NETTLE HERB POWDER

A, H

 

2445

GREATER NETTLE ROOT DRY

A, H

 

2446

GREATER NETTLE ROOT POWDER

A, H

 

2447

GREEN LIPPED MUSSEL

A

The following warning statement is required on the medicine label:

- (MOLLUSC) ‘Contains mollusc’ or ’Contains mollusc products’.

 

2448

GREEN LIPPED MUSSEL DRIED

A

The following warning statement is required on the medicine label:

- (MOLLUSC) ‘Contains mollusc’ or ’Contains mollusc products’.

 

2449

GREEN LIPPED MUSSEL OIL

A

The following warning statement is required on the medicine label:

- (MOLLUSC) ‘Contains mollusc’ or ’Contains mollusc products’.

 

2450

GREEN S

E

Only for use as a colour in topical and oral medicines.

 

2451

GRIFOLA FRONDOSA

A

When the route of administration is oral or sublingual, the medicine requires the following warning statement on the medicine label:                                                                                                                                                      

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

 

2452

GRINDELIA CAMPORUM

A, H

 

2453

GRINDELIA ROBUSTA

A, H

 

2454

GRISALVA

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%.

 

2455

GROUND IVY HERB DRY

A, H

 

2456

GROUND IVY HERB POWDER

A, H

 

2457

GUAIAC WOOD 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%.

 

2458

GUAIACOL

E

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

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

 

2459

GUAIACUM OFFICINALE

A, E, H

 

2460

GUAIACUM RESIN

A, E, H

 

2461

GUAIACUM SANCTUM

A, H

 

2462

GUAIENE

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%.

 

2463

GUAIYL 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%.

 

2464

GUANINE

E

Only for use as an excipient in topical medicines for dermal application.

 

2465

GUANOSINE

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 must be no more than 0.01% in the medicine.

 

2466

GUAR GALACTOMANNAN

A

When for oral use:

(a) the maximum daily dose must provide no more than 25 g of guar galactomannan;

(b) the medicine requires the following dosage instructions:

- (FIBRE) 'The dose of fibre should be increased gradually. Fluid intake should be increased with an increasing dose of fibre.' (or words to that effect)

(c) when the dosage form is a powder preparation, the medicine requires the following dosage instructions:

- (DNTPOW) 'Do not take powder alone. Mix with food or fluid.' (or words to that effect).

 

2467

GUAR GUM

A, E, H

 

2468

GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE

E

Only for use as an excipient in topical medicines for dermal application.

 

2469

GUAREA RUSBYI

A, H

 

2470

GUAVA

E

 

2471

GURJUN BALSAM

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%.

 

2472

GYMNADENIA NIGRA

A

 

2473

GYMNEMA SYLVESTRE

A, H

 

2474

GYMNOCLADUS DIOICA

A, H

 

2475

GYNOSTEMMA PENTAPHYLLUM

A

The herbal substance must be derived from the aerial parts of the vine only (stem, leaves, fruit).

 

2476

HAHNEMANN'S SOLUBLE MERCURY

H

Only for use as an active homoeopathic ingredient.

 

2477

HALIBUT-LIVER OIL

A, E

Colecalciferol and Vitamin A are mandatory components of Halibut-liver oil.

When for internal use, the maximum recommended daily dose must be no more than 25 micrograms of Vitamin D.

When for use in topical medicines, the concentration of Vitamin A in the medicine must be no more than 1%.

When for internal use, the maximum daily dose must be no more than 3000 micrograms of Retinol Equivalents.

When preparations for internal use in adults contain more than 33 micrograms of retinol equivalents per dosage unit in divided preparations or per gram of an undivided preparation, the medicine requires the following warning statements on the medicine label:

- (VITA2) ‘WARNING: If you are pregnant - or considering becoming pregnant - do not take Vitamin A supplements without consulting your doctor or pharmacist [or words to that effect].’ NOTE: Position this warning at the beginning of the directions for use.

- (VITA4) ‘WARNING - When taken in excess of 3000 micrograms retinol equivalents - Vitamin A can cause birth defects.’ NOTE: Position this warning at the beginning of the directions for use.

- (VITA3) ‘The recommended daily amount of Vitamin A from all sources is 700 micrograms retinol equivalents for women and 900 micrograms retinol equivalents for men.’

 

2478

HAMAMELIS LEAF DRY

A, H

 

2479

HAMAMELIS LEAF POWDER

A, H

 

2480

HAMAMELIS VIRGINIANA

A, E, H

 

2481

HAMAMELIS WATER

A, E, H

 

2482

HANDROANTHUS HEPTAPHYLLUS

A, H

 

2483

HANDROANTHUS IMPETIGINOSUS

A, E, H

 

2484

HARD FAT

E

 

2485

HARD PARAFFIN

E

 

2486

HARICOT BEAN

E

 

2487

HARPAGOPHYTUM PROCUMBENS

A, E, H

 

2488

HARUNGANA MADAGASCARIENSIS

A, H

 

2489

HAZEL NUT

E

 

2490

HAZEL NUT OIL

E

 

2491

HEAVY KAOLIN

E

 

2492

HEAVY MAGNESIUM OXIDE

A, E, H

Magnesium is a mandatory component of heavy magnesium oxide.

When used in a medicine:

(a) with an oral route of administration;

(b) not indicated for laxative (or related) use; and

(c) where the maximum recommended daily dose for:

(i) children aged between 1 and 3 years (inclusive) provides 65 mg or more total magnesium from inorganic magnesium salts;

(ii) children aged between 4 and 8 years (inclusive) provides 110 mg or more total magnesium from inorganic magnesium salts; or

(iii) individuals aged 9 years or older provides 350 mg or more total magnesium from inorganic magnesium salts;

the following warning statement is required on the medicine label:

- (LAX6) 'Contains magnesium, which may have a laxative effect or cause diarrhoea' (or words to that effect).

When the route of administration is oral, the medicine must not be directed for use in infants younger than 12 months of age.

 

2493

HECTORITE

E

Only for use in topical medicines for dermal application.

 

2494

HEDEOMA PULEGIOIDES

A

 

2495

HEDERA HELIX

A, H

Emetine is a mandatory component of Hedera helix.

The concentration of emetine in the medicine must be no more than 0.2%.

 

2496

HEDTA

E

Only for use as an excipient in topical medicines for dermal application.

 

2497

HEKLA LAVA

H

Only for use as an active homoeopathic ingredient.

 

2498

HELESTRALIS

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%.

 

2499

HELIANTHEMUM NUMMULARIUM

A, H

 

2500

HELIANTHUS ANNUUS

A, E, H

 

2501

HELIANTHUS TUBEROSUS

A, H

 

2502

HELICHRYSUM ANGUSTIFOLIUM

A, E, H

 

2503

HELICHRYSUM ARENARIUM

A, H

 

2504

HELIOTROPYL 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%.

 

2505

HELLEBORUS NIGER

A, H

The maximum recommended daily dose must be no more than 1mg of the equivalent dry herbal material.

 

2506

HELLEBORUS VIRIDIS

A, H

The maximum recommended daily dose must be no more than 1mg of the equivalent dry herbal material.

 

2507

HELONIAS RHIZOME DRY

A, H

 

2508

HELONIAS RHIZOME POWDER

A, H

 

2509

HEMIDESMUS INDICUS

A, E, H

 

2510

HEMP SEED OIL

A, E

Only to be used in a medicine where Elixinol Wellness (Byron Bay) Pty Ltd (Client ID 78778), who applied to have the ingredient included in this Determination, is the sponsor of the medicine or has given written authorisation to the sponsor of a medicine to include the ingredient in the medicine. This paragraph ceases to be a requirement for this ingredient after 13 December 2024.

Cannabidiol and tetrahydrocannabinols are mandatory components of hemp seed oil.

The total concentration of cannabidiol in the medicine must not be more than 75 mg/kg.

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

The route of administration for medicines that contain hemp seed oil must be limited to oral.

The maximum recommended daily dose of the medicine must not provide more than 36 g of hemp seed oil.

The following warning statements (or words to that effect) are required on the medicine label:

- ‘Not for use in children under 2 years of age’; and

- ‘Not to be taken on the same day with other products containing hemp seed oil, including food sources’.

 

2511

HEPTANAL

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%.

 

2512

HEPTANAL DIMETHYL ACETAL

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%.

 

2513

HEPTANOIC ACID

E

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

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

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

 

2514

HEPTENAL

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%.

 

2515

HEPTYL ACETATE

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%.

 

2516

HEPTYL BUTYRATE

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%.

 

2517

HEPTYL UNDECYLENATE

E

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

The concentration of the medicine must be no more than 25%.

 

2518

HERACLEUM HEMSLEYANUM

A, H

 

2519

HERNIARIA GLABRA

A, H

 

2520

HESPERIDIN

A, E

 

2521

HESPEROCYPARIS MACROCARPA

A, H

 

2522

HESPEROYUCCA WHIPPLEI

A, H

 

2523

HEX-3-ENYL 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%.

 

2524

HEXAHYDRO-4,7-METHANOINDEN-6-YL PIVALATE

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%.

 

2525

HEXAMETHYLINDANOPYRAN

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%.

 

2526

HEXAN-1-OL

E

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

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

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

 

2527

HEXANE

E

The concentration of the medicine must be no more than 0.029%.

When used for a route of administration other than topical, the residual solvent limit for Hexane is 2.9 mg per recommended daily dose.

 

2528

HEXANOATE

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%.

 

2529

HEXANOIC ACID

E

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

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

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

 

2530

HEXASODIUM FYTATE

E

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

The concentration of Hexasodium fytate in the medicine must be no more than 1.0 %.

 

2531

HEXENAL

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%.

 

2532

HEXYL 2-METHYLBUTYRATE

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%.

 

2533

HEXYL ACETATE

E

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

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

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

 

2534

HEXYL BUTYRATE

E

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

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

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

 

2535

HEXYL CAPROATE

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%.

 

2536

HEXYL FORMATE

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%.

 

2537

HEXYL ISOBUTYRATE

E

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

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

 

2538

HEXYL ISOVALERATE

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%.

 

2539

HEXYL LAURATE

E

Only for use as an excipient in topical medicines for dermal application.

 

2540

HEXYL NICOTINATE

E

 

2541

HEXYL PROPIONATE

E

Only for use in medicines in combination with other permitted ingredients as a flavour proprietary excipient formulation.

The total flavour proprietary excipient formulation in a medicine must not be more than 5%.

 

2542

HEXYL SALICYLATE

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%.

 

2543

HEXYL TIGLATE

E

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

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

 

2544

HEXYLDECANOL

E

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

The concentration of the medicine must be no more than 3%.

 

2545

HEXYLENE GLYCOL

E

Only for use as an excipient in topical medicines for dermal application.

 

2546

HEXYLRESORCINOL

A

Permitted for use only in medicated throat lozenges.

The medicine of must not contain more than 2.5 mg of hexylresorcinol per lozenge.

The maximum recommended daily dose of the medicine must not provide more than 30mg of hexylresorcinol.

The medicine label must specify that the medicine is only to be used for 7 days (or less).

The following warning statement must be included on the medicine label:

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

 

2547

HIBISCUS ESCULENTUS

A, H

 

2548

HIBISCUS MUTABILIS

A, H

 

2549

HIBISCUS ROSA-SINENSIS

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%.

 

2550

HIBISCUS SABDARIFFA

A, E, H

 

2551

HIERACIUM PILOSELLA

A, H

 

2552

HIGH AMYLOSE MAIZE STARCH

A, E, H

 

2553

HIGH CHROMIUM YEAST

A, E

Chromium is a mandatory component of high chromium yeast.

The maximum recommended daily dose must not provide more than 50 micrograms of chromium from organic chromium sources.

High chromium yeast is considered to be an organic form of chromium.

 

2554

HIGH FRUCTOSE MAIZE SYRUP

E

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

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

 

2555

HIGH MOLYBDENUM YEAST

A, E

Molybdenum is a mandatory component of high molybdenum yeast.

The maximum daily dose of molybdenum from high molybdenum yeast must be no more than 62.5 micrograms.

 

2556

HIGH SELENIUM YEAST

A

When for oral or sublingual use, selenium is a mandatory component of high selenium yeast.

Oral medicines must contain no more than 150 micrograms of selenium per maximum recommended daily dose.

When for oral use, the medicine requires the following warning statement on the medicine label:

- (SELE) 'This medicine contains selenium which is toxic in high doses. A daily dose of 150 micrograms for adults of selenium from dietary supplements should not be exceeded.'

 

2557

HIMATANTHUS LANCIFOLIUS

A, E, H

 

2558

HIPPOPHAE RHAMNOIDES

A, E, H

 

2559

HIRSCHFELDIA INCANA

A, H

Allyl isothiocyanate is a mandatory component of Hirschfeldia incana when the plant part is seed.

The concentration of allyl isothiocyanate from all ingredients in the product must be no more than 10 mg/kg or 10 mg/L or 0.001%.

 

2560

HISTAMINE DIHYDROCHLORIDE

H

Only for use as an active homoeopathic ingredient. 

 

2561

HISTIDINE

A

 

2562

HISTIDINE HYDROCHLORIDE

A, E, H

 

2563

HO LEAF 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%.

 

2564

HO WOOD 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%.

 

2565

HOLCUS LANATUS

A, H

 

2566

HOLY THISTLE HERB DRY

A, H

 

2567

HOLY THISTLE HERB POWDER

A, H

 

2568

HOMALOMENA OCCULTA

A, H

 

2569

HOMOSALATE

A, E

For use as an active ingredient only in sunscreens for dermal application.

For use as an excipient only in topical medicines for dermal application.

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

The concentration in the medicine must not be more than 15%.

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).

 

2570

HONEY

A, E

When the route of administration is oral, the following warning statement is required on the medicine label:

- (BABY2) 'Not suitable for infants under the age of twelve months' (or words to that effect).

 

2571

HONEY BEE

H

Only for use as an active homoeopathic ingredient.

 

2572

HONEY EXTRACT

E

Honey extract must not be included in medicines intended for use in the eye.

The concentration of honey extract in the medicine must not be more than 1%.

 

2573

HONEY POWDER

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%.

 

2574

HOP STROBILE DRY

A, H

 

2575

HOP STROBILE POWDER

A, H

 

2576

HOPS OIL

A, E, H

 

2577

HORDEUM DISTICHON

A, E, H

Gluten is a mandatory component when the plant part is seed, and must be declared in the application when the route of administration is other than topical and mucosal.

 

2578

HORDEUM VULGARE

A, E, H

Gluten is a mandatory component when the plant part is seed, and must be declared in the application when the route of administration is other than topical and mucosal.

 

2579

HOREHOUND 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%.

 

2580

HOTTONIA PALUSTRIS

A, H

 

2581

HOUTTUYNIA CORDATA

A, H

 

2582

HOVENIA DULCIS

A, H

 

2583

HUMULUS LUPULUS

A, E, H

 

2584

HYALURONIC ACID

E

Only for use as an excipient in topical medicines for dermal application.

 

2585

HYDNOCARPUS CASTANEUS

A, H

When the medicine is for other than topical use and the plant part is seed, the maximum recommended daily dose must be no more than 1mg of the equivalent dry seed.

 

2586

HYDRANGEA ARBORESCENS

A, H

 

2587

HYDRANGEA PANICULATA

A, H

 

2588

HYDRASTIS CANADENSIS

A, E, H

 

2589

HYDRATED SILICA

E

Only for use when the route of administration is other than inhalation.

 

2590

HYDROCHLORIC ACID

E

The concentration of the medicine must be no more than 0.5%.

 

2591

HYDROCOTYLE UMBELLATA

A, H

 

2592

HYDROGEN CYANIDE

H

Only for use as an active homoeopathic ingredient. 

 

2593

HYDROGEN PEROXIDE

A, E

When used as the active ingredient, it is only for use in topical medicines for dermal application.

The concentration of hydrogen peroxide in the medicine must be no more than 3%.

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.

 

2594

HYDROGENATED BUTYLENE/ETHYLENE/STYRENE COPOLYMER

E

Only for use in topical medicines for dermal application.

The combined concentration of hydrogenated butylene/ethylene/stryene copolymer and hydrogenated ethylene/propylene/styrene copolymer in the medicine must be no more than 9%.

 

2595

HYDROGENATED C6-14 OLEFIN POLYMERS

E

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

The concentration in the medicine must be no more than 7%.

 

2596

HYDROGENATED CASTOR OIL

E

 

2597

HYDROGENATED COCO-GLYCERIDES

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 be no more than 3%.

 

2598

HYDROGENATED COCONUT OIL

E

 

2599

HYDROGENATED COTTONSEED OIL

E

 

2600

HYDROGENATED DIMER DILINOLEYL/DIMETHYLCARBONATE 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 be no more than 4% in the product.

 

2601

HYDROGENATED ETHYLENE/PROPYLENE/STYRENE COPOLYMER

E

The combined concentration of hydrogenated ethylene/propylene/styrene copolymer must be no more than 9%.

 

2602

HYDROGENATED LANOLIN

E

 

2603

HYDROGENATED LECITHIN

E

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

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

 

2604

HYDROGENATED PALM GLYCERIDES

E

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

The concentration in the medicine must be no more than 1.6%.

 

2605

HYDROGENATED PALM GLYCERIDES CITRATE

E

Only for use in topical medicines for dermal application and not to be included in medicines for use in the eye or on damaged skin.

The concentration in the medicine must be no more than 0.01%.

 

2606

HYDROGENATED PALM KERNEL OIL

E

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

The concentration in the medicine must be no more than 1.2%.

 

2607

HYDROGENATED PALM OIL

E

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

The concentration in the medicine must be no more than 2%.

Polycyclic aromatic hydrocarbons must be kept below the level of detection.

 

2608

HYDROGENATED POLYDECENE

E

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

 

2609

HYDROGENATED POLYDEXTROSE

A

Only permitted for use in medicines:

(a) limited to oral routes of administration; and

(b) when the maximum recommended daily dose does not provide more than 15 g of hydrogenated polydextrose.

 

2610

HYDROGENATED POLYISOBUTENE

E

Only for use in topical medicines for dermal application.

 

2611

HYDROGENATED SOYA OIL

E

 

2612

HYDROGENATED TALLOW GLYCERIDE

E

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

The concentration in the medicine must be no more than 3%.

 

2613

HYDROGENATED VEGETABLE OIL

E

 

2614

HYDROLIAC

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%.

 

2615

HYDROLYSED ADANSONIA DIGITATA LEAF POLYSACCHARIDES

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 be no more than 0.01%

 

2616

HYDROLYSED ALGIN

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 be no more than 0.02%

 

2617

HYDROLYSED CEREAL SOLIDS

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%.

 

2618

HYDROLYSED CHICKEN CARTILAGE EXTRACT

A

Only to be used in a medicine where BioCell Technology LLC (Client ID 70666), who applied to have the ingredient included in this Determination, is the sponsor of the medicine or has given written authorisation to the sponsor of a medicine to include the ingredient in the medicine.  This paragraph ceases to be a requirement for this ingredient after 25 October 2023.

The route of administration for medicines that contain hydrolysed chicken cartilage extract must be limited to oral.

The maximum recommended daily dose of the medicine must not provide more than 2000 mg hydrolysed chicken cartilage extract.

The following warning statements (or words to the same effect) are required on the medicine label:

- (ADULT) 'Adults only’.

 

2619

HYDROLYSED COLLAGEN

A, E

 

2620

HYDROLYSED ELASTIN

E

Only for use in topical medicines for dermal application.

 

2621

HYDROLYSED GELATIN

A, E

 

2622

HYDROLYSED GLYCOSAMINOGLYCANS

E

Only for use in topical medicines for dermal application.

 

2623

HYDROLYSED JOJOBA ESTERS

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 be no more than 5%.

 

2624

HYDROLYSED KERATIN

E

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

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

 

2625

HYDROLYSED MAIZE STARCH

E

 

2626

HYDROLYSED MILK PROTEIN

E

 

2627

HYDROLYSED RICE

A, E, H

 

2628

HYDROLYSED RICE PROTEIN

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 be no more than 0.125%.

 

2629

HYDROLYSED SOY PROTEIN

E

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

The concentration in the medicine must be no more than 0.5%.

 

2630

HYDROLYSED VEGETABLE PROTEIN

E

 

2631

HYDROLYSED WHEAT PROTEIN

E

Gluten is a mandatory component of hydrolysed wheat protein.

 

2632

HYDROLYSED WHEAT PROTEIN/PVP CROSSPOLYMER

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 be no more than 1.2%.

 

2633

HYDROLYSED YEAST PROTEIN

E

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

The concentration in the medicine must be no more than 0.3%.

 

2634

HYDROQUINONE DIMETHYL ETHER

E

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

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

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

 

2635

HYDROUS 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.

 

2636

HYDROXOCOBALAMIN

A

 

2637

HYDROXYACETOPHENONE

E

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

The concentration in the medicine must be no more than 1%.

 

2638

HYDROXYAPATITE

A, E

 

2639

HYDROXYCITRATE COMPLEX

A

Hydroxycitrate complex must contain one or more of the three salts (calcium, sodium or potassium hydroxycitrate) of hydroxycitric acid.

 

2640

HYDROXYCITRIC ACID

A

 

2641

HYDROXYCITRONELLAL

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%.

 

2642

HYDROXYCITRONELLAL DIMETHYL ACETAL

E

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

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

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

 

2643

HYDROXYCITRONELLAL-METHYLANTHRANILATE

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%.

 

2644

HYDROXYCITRONELLOL

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%.

 

2645

HYDROXYETHYL CETEARAMIDOPROPYLDIMONIUM CHLORIDE

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 be no more than 0.1%.

 

2646

HYDROXYETHYL UREA

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 must be no more than 1%.

 

2647

HYDROXYLATED LANOLIN

E

 

2648

HYDROXYLATED MILK GLYCERIDES

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 must be no more than 0.1%.

 

2649

HYDROXYLYSINE

A, E

 

2650

HYDROXYMETHYLCELLULOSE

E

 

2651

HYDROXYOCTACOSANYL HYDROXYSTEARATE

E

Only for use in topical medicines for dermal application.

 

2652

HYDROXYPALMITOYL SPHINGANINE

E

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

The concentration must be no more than 0.1%.

 

2653

HYDROXYPROLINE

A, E

 

2654

HYDROXYPROPYL DISTARCH PHOSPHATE

E

Only permitted for:

- use in topical medicines for dermal application; and

- medicines for internal use.

When for use in topical medicines for dermal application:

- not to be included medicines intended for use in the eye or damaged skin; and

- the concentration of hydroxypropyl distarch phosphate in the medicine must be no more than 4%.

When for internal use, the maximum recommended daily dose must not contain more than 240mg of hydroxypropyl distarch phosphate.

 

2655

HYDROXYPROPYL STARCH

E

 

2656

HYDROXYPROPYLBETADEX

E

Only for use in topical medicines for dermal application.

 

2657

HYDROXYSTEARIC ACID

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 must be no more than 9%.

 

2658

HYETELLOSE

E

 

2659

HYLOCEREUS LEMAIREI

E

Permitted for use only as a colour for oral and topical use.

 

2660

HYLOCEREUS UNDATUS

A, H

 

2661

HYMETELLOSE

E

 

2662

HYOSCYAMUS LEAF DRY

A, H

Alkaloids calculated as hyoscyamine and hyoscine are mandatory components of Hyoscamus leaf dry.

The concentration of alkaloids calculated as hyoscyamine in the medicine must be no more than 300 micrograms/Kg or 300 micrograms/L or 0.00003%.

The concentration of hyoscine in the medicine must be no more than than 300 micrograms/kg or 300 micrograms/L or 0.00003%.

 

2663

HYOSCYAMUS LEAF POWDER

A, H

Alkaloids calculated as hyoscyamine and hyoscine are mandatory components of Hyoscamus leaf powder.

The concentration of alkaloids calculated as hyoscyamine in the medicine must be no more than 300 micrograms/Kg or 300 micrograms/L or 0.00003%.

The concentration of hyoscine in the medicine must be no more than 300 micrograms/kg or 300 micrograms/L or 0.00003%.

 

2664

HYOSCYAMUS NIGER

A, H

Alkaloids calculated as hyoscyamine and hyoscine are mandatory components of Hyoscyamus niger.

The concentration of hyoscyamine in the medicine must be no more than 3 micrograms/kg or 3 micrograms/L or 0.3%.

The concentration of hyoscine in the medicine must be no more than 300 micrograms/kg or 300 micrograms/L or 0.00003%.

 

2665

HYPERICUM ASCYRON

A, H

 

2666

HYPERICUM JAPONICUM

A, H

 

2667

HYPERICUM PERFORATUM

A, E, H

When used for oral ingestion, the medicine requires the following warning statement on the medicine label:

- (STJOHN) 'St John's Wort affects the way many prescription medicines work - including oral contraceptives. Consult your doctor.'

 

2668

HYPROLOSE

E

 

2669

HYPROMELLOSE

E

 

2670

HYPROMELLOSE PHTHALATE

E

 

2671

HYPTIS SUAVEOLENS

A, H

 

2672

HYSSOPUS OFFICINALIS

A, E, H

 

2673

IBERIS AMARA

A, H

 

2674

ICHTHAMMOL

H

Only for use as an active homoeopathic ingredient.  

 

2675

ILEX AQUIFOLIUM

A, H

 

2676

ILEX CHINENSIS

A, H

 

2677

ILEX PARAGUARIENSIS

A, E, H

Caffeine is a mandatory component of Ilex paraguariensis.

When the medicine is packaged for supply as a divided preparation and is for internal use or oral application, the medicine must not contain a concentration of total caffeine greater than 33%.

When for internal use or oral application, the maximum recommended daily dose of the medicine must provide no more than 400 mg of total caffeine.

When the medicine is packaged for supply as an undivided preparation and is for internal use or oral application, the medicine must not contain a concentration of total caffeine greater than 1%.

When the medicine is for internal use or oral application, a maximum recommended dose of the medicine must not provide more than 100 mg of total caffeine within a 3 hour period.

When the maximum recommended daily dose of the medicine provides greater than 10 mg of total caffeine and the medicine is for internal use or oral application, the following warning statements are required on the label:

- (ADULT) 'Adults only' (or words to that effect).

- (CAFF) 'Contains [state quantity per dosage unit or per mL or per gram of product] total caffeine [per dosage unit or per mL or per gram]. A cup of instant coffee contains approximately 80mg of caffeine.'

- (CAFFPREG) ‘Caffeine intake more than 200 mg per day is not recommended during pregnancy or breastfeeding.’

When the maximum recommended daily dose of the medicine provides greater than 80 mg of total caffeine and the medicines is for internal use or oral application, the following warning statements are required on the label:

- (CAFFLMT) 'Limit the use of caffeine-containing products (including tea and coffee) when taking this product.'

- (CAFFCYP) ‘Caffeine interacts with enzyme CYP1A2 in the liver. Consult your health professional before taking with other medicines’ (or words to that effect).

 

2678

ILEX ROTUNDA

A, H

 

2679

ILEX VERTICILLATA

A, H

 

2680

ILLICIUM VERUM

A, H

When the plant preparation is oil or distillate, and the concentration of Illicium verum oil or distillate in the preparation is greater than 50%:

(a) the nominal capacity of the container must not be more than 50 millilitres;

(b) a restricted flow insert must be fitted on the container; and

(c) the following warning statement is required on the label:

- (CHILD) 'Keep out of reach of children' (or words to that effect).

 

2681

IMIDUREA

E

Only for use in topical medicines for dermal application.

 

2682

IMMORTELLE

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%.

 

2683

IMMORTELLE 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%.

 

2684

IMPATIENS

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%.

 

2685

IMPATIENS BALSAMINA

A, H

 

2686

IMPATIENS GLANDULIFERA

A, H

 

2687

IMPERATA CYLINDRICA

A, E, H

 

2688

INDIGO CARMINE

E

Permitted for use only as a colour in medicines limited to topical and oral routes of administration.

 

2689

INDIGO CARMINE ALUMINIUM LAKE

E

Permitted for use only as a colour in medicines limited to topical and oral routes of administration.

 

2690

INDIGOFERA TINCTORIA

A, H

 

2691

INDISAN

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%.

 

2692

INDOLE

E, H

Only for use as an active homoeopathic or excipient ingredient.

The maximum recommended daily dose must contain no more than 75 mg indole.

 

2693

INDOLENE

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%.

 

2694

INDUSTRIAL METHYLATED SPIRIT

E

 

2695

INOSITOL

A, E

 

2696

INULA BRITANNICA

A, H

 

2697

INULA HELENIUM

A, E, H

 

2698

INULA RACEMOSA

A, H

 

2699

INULIN

A, E

 

2700

INULIN LAURYL CARBAMATE

E

Only for use in topical medicines for dermal application and not to be included in medicines for use in the eye or on damaged skin.

The concentration in the medicine must be no more than 1.2%.

 

2701

INVERT SUGAR

E

 

2702

INVERT SYRUP

E

When the route of administration is oral or sublingual, glucose is a mandatory component of Invert syrup.

 

2703

IODINE

H

Only for use as an active homoeopathic ingredient.

Only for external use when the concentration of iodine in the medicine (excluding salts derivatives or iodophors) is 2.5% or less.

Only for internal use when the medicine contains less than 300 micrograms of iodine per maximum recommended daily dose.

 

2704

IODOPROPYNYL BUTYLCARBAMATE

E

For use as an excipient ingredient in topical medicines only.

The concentration in aqueous medicines must be no more than 10%.

 

2705

IONONE

E

Permitted for use only:

(a) in topical medicines for dermal application; and

(b) in oral medicines in combination with other permitted ingredients as part of a flavour proprietary excipient formulation.

When used in a flavour, the total flavour proprietary excipient formulation in a medicine must be no more than 5%.

 

2706

IOPAMIDOL

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%.

 

2707

IPECACUANHA DRY

A, H

Emetine is a mandatory component of Ipecacuanha Dry.

The concentration of emetine in the medicine must be no more than 0.2%.

 

2708

IPECACUANHA POWDER

A, H

Emetine is a mandatory component of Ipecacuanha Powder.

The concentration of emetine in the medicine must be no more than 0.2%.

 

2709

IPECACUANHA PREPARED

A, H

Emetine is a mandatory component of Ipecacuanha Prepared.

The concentration of emetine in the medicine must be no more than 0.2%.

 

2710

IPECACUANHA ROOT LIQUID EXTRACT

A, H

Emetine is a mandatory component of Ipecacuanha root liquid extract.

The concentration of emetine in the medicine must be no more than 0.2%.

 

2711

IPOMOEA BATATAS

A, H

 

2712

IPOMOEA JALAPA

A, H

 

2713

IRIDOPHYCUS FLACCIDUM

A, H

Iodine is a mandatory component of Iridophycus flaccidum.

Only for external use when the concentration of iodine in the medicine (excluding salts derivatives or iodophors) is more than 2.5%.

Only for internal use when the medicine contains less than 300 micrograms of iodine per maximum recommended daily dose.

 

2714

IRIS DOMESTICA

A, H

 

2715

IRIS FLORENTINA

A, H

 

2716

IRIS GERMANICA

A, H

 

2717

IRIS PALLIDA

A, H

 

2718

IRIS TENAX

H

 

2719

IRIS VERSICOLOR

A, H

 

2720

IRON

A, H

Only for use in oral medicines.

When used as an active ingredient, the medicine must contain a daily dose of no more than 24 mg of iron.

If the divided dosage form contains more than 5 mg of iron per dosage unit (excluding up to 10 mg of iron oxide when used as an excipient), the primary pack must contain no more than 750 mg of iron.

In undivided preparations, the primary pack must contain no more than 750 mg of iron (excluding iron oxides when present as an excipient at a quantity of no more than 1%).

Divided preparations with a dose of more than 5mg of elemental iron per dosage unit and more than 250 mg of elemental iron in the total contents of the container are required to have a child resistant closure.

Undivided preparations containing more than 250 mg of elemental iron in the total contents of the container are required to have a child resistant closure.

When for internal use except for iron-containing multivitamin/mineral products indicated for general nutritional support that do not make specific iron-deficiency related claims, the following warning statement is required on the label:

- (IRONDEF) 'Not for the treatment of iron deficiency conditions' (or words to that effect).

 

2721

IRON (II) BISGLYCINE SULFATE TRIHYDRATE

A

Only for use in oral medicines.

Iron is a mandatory component of iron (II) bisglycine sulfate trihydrate.

When for internal use, the medicine must contain a daily dose of no more than 24 mg of iron.

If the divided dosage form contains more than 5 mg of iron per dosage unit (excluding up to 10 mg of iron oxide when used as an excipient), the primary pack must contain no more than 750 mg of iron.

In undivided preparations, the primary pack must contain no more than 750 mg of iron (excluding iron oxides when present as an excipient at a quantity of no more than 1%).

Divided preparations with a dose of more than 5 mg of elemental iron per dosage unit and more than 250 mg of elemental iron in the total contents of the container are required to have a child resistant closure.

When for internal use except for iron-containing multivitamin/mineral products indicated for general nutritional support that do not make specific iron-deficiency related claims, the following warning statement is required on the label:

- (IRONDEF) 'Not for the treatment of iron deficiency conditions' (or words to that effect).

 

2722

IRON (II) GLYCINATE

A

Only for use in oral medicines.

Iron is a mandatory component of iron (II) glycinate.

When for internal use, the medicine must contain a daily dose of no more than 24 mg of iron.

If the divided dosage form contains more than 5 mg of iron per dosage unit (excluding up to 10 mg of iron oxide when used as an excipient), the primary pack must contain no more than 750 mg of iron.

In undivided preparations, the primary pack must contain no more than 750 mg of iron (excluding iron oxides when present as an excipient at a quantity of no more than 1%).

Divided preparations with a dose of more than 5 mg of elemental iron per dosage unit and more than 250 mg of elemental iron in the total contents of the container are required to have a child resistant closure.

When for internal use except for iron-containing multivitamin/mineral products indicated for general nutritional support that do not make specific iron-deficiency related claims, the following warning statement is required on the label:

- (IRONDEF) 'Not for the treatment of iron deficiency conditions' (or words to that effect).

 

2723

IRON (III) GLYCINATE

A

Only for use in oral medicines.

Iron is a mandatory component of iron (III) glycinate.

When for internal use, the medicine must contain a daily dose of no more than 24 mg of iron.

If the divided dosage form contains more than 5 mg of iron per dosage unit (excluding up to 10 mg of iron oxide when used as an excipient), the primary pack must contain no more than 750 mg of iron.

In undivided preparations, the primary pack must contain no more than 750 mg of iron (excluding iron oxides when present as an excipient at a quantity of no more than 1%).

Divided preparations with a dose of more than 5 mg of elemental iron per dosage unit and more than 250 mg of elemental iron in the total contents of the container are required to have a child resistant closure.

Undivided preparations containing more than 250 mg of elemental iron in the total contents of the container are required to have a child resistant closure.

When for internal use except for iron-containing multivitamin/mineral products indicated for general nutritional support that do not make specific iron-deficiency related claims, the following warning statement is required on the label:

- (IRONDEF) 'Not for the treatment of iron deficiency conditions' (or words to that effect).

 

2724

IRON AMINO ACID CHELATE

A, H

Only for use in oral medicines.

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

The concentration of iron in iron amino acid chelate must be no more than 25%.

When for internal use, the medicine must contain a daily dose of no more than 24 mg of iron.

If the divided dosage form contains more than 5 mg of iron per dosage unit (excluding up to 10 mg of iron oxide when used as an excipient), the primary pack must contain no more than 750 mg of iron.

In undivided preparations, the primary pack must contain no more than 750 mg of iron (excluding iron oxides when present as an excipient at a quantity of no more than 1%).

Divided preparations with a dose of more than 5 mg of elemental iron per dosage unit and more than 250 mg of elemental iron in the total contents of the container are required to have a child resistant closure.

Undivided preparations containing more than 250 mg of elemental iron in the total contents of the container are required to have a child resistant closure.

When for internal use except for iron-containing multivitamin/mineral products indicated for general nutritional support that do not make specific iron-deficiency related claims, the following warning statement is required on the label:

- (IRONDEF) 'Not for the treatment of iron deficiency conditions' (or words to that effect).

 

2725

IRON OXIDE BLACK

E

Permitted for use only as a colour in medicines limited to topical and oral routes of administration.

When used in undivided preparations for internal use and the concentration of iron oxide in the medicine is more than 1%, it is considered part of the total iron content.

When used in divided preparations for internal use, the concentration in the medicine must be no more than 10 mg per dosage unit.

 

2726

IRON OXIDE RED

E

Permitted for use only as a colour in medicines limited to topical and oral routes of administration.

When used in undivided preparations for internal use and the concentration of iron oxide in the medicine is more than 1%, it is considered part of the total iron content.

When used in divided preparations for internal use, the concentration in the medicine must be no more than 10 mg per dosage unit.

 

2727

IRON OXIDE YELLOW

E

Permitted for use only as a colour in medicines limited to topical and oral routes of administration.

When used in undivided preparations for internal use and the concentration of iron oxide in the medicine is more than 1%, it is considered part of the total iron content.

When used in divided preparations for internal use, the concentration in the medicine must be no more than 10 mg per dosage unit.

 

2728

IRON PHOSPHATE

A, E, H

When used internally, iron is a mandatory component of iron phosphate and must be declared.

When for internal use, the medicine must contain a daily dose of no more than 24 mg of iron.

If the divided dosage form contains more than 5 mg of iron per dosage unit (excluding up to 10 mg of iron oxide when used as an excipient), the primary pack must contain no more than 750 mg of iron.

In undivided preparations, the primary pack must contain no more than 750 mg of iron (excluding iron oxides when present as an excipient at a quantity of no more than 1%).

Divided preparations with a dose of more than 5 mg of elemental iron per dosage unit and more than 250 mg of elemental iron in the total contents of the container are required to have a child resistant closure.

Undivided preparations containing more than 250 mg of elemental iron in the total contents of the container are required to have a child resistant closure.

When for internal use except for iron-containing multivitamin/mineral products indicated for general nutritional support that do not make specific iron-deficiency related claims, the following warning statement is required on the label:

- (IRONDEF) 'Not for the treatment of iron deficiency conditions' (or words to that effect).

 

2729

IRONE

E

 

2730

IRVINGIA GABONENSIS SEED TRIGLYCERIDES

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 must be no more than 0.375%.

 

2731

ISATIS TINCTORIA

A, H

 

2732

ISOAMBRETTOLIDE

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%.

 

2733

ISOAMYL 2-METHYLBUTYRATE

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%.

 

2734

ISOAMYL ACETATE

E

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

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

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

 

2735

ISOAMYL 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%.

 

2736

ISOAMYL BENZOATE

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%.

 

2737

ISOAMYL BUTYRATE

E

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

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

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

 

2738

ISOAMYL CAPRYLATE

E

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

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

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

 

2739

ISOAMYL CINNAMATE

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%.

 

2740

ISOAMYL CITRONELLYL KETONE

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%.

 

2741

ISOAMYL FORMATE

E

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

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

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

 

2742

ISOAMYL HEXANOATE

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%.

 

2743

ISOAMYL 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%.

 

2744

ISOAMYL ISOVALERATE

E

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

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

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

 

2745

ISOAMYL LAURATE

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 must be no more than 12%.

 

2746

ISOAMYL METHOXYCINNAMATE

A

Only for use as an active ingredient in sunscreens for dermal application and not to be included in medicines intended for use in the eye.

The concentration in the medicine must not be more than 10%.

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

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

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

 

2747

ISOAMYL PHENYLACETATE

E

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

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

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

 

2748

ISOAMYL PHENYLETHYL ETHER

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%.

 

2749

ISOAMYL PROPIONATE

E

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

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

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

 

2750

ISOAMYL SALICYLATE

E

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

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

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

 

2751

ISOBERGAMIATE

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%.

 

2752

ISOBORNEOL

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%.

 

2753

ISOBORNYL ACETATE

E

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

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

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

 

2754

ISOBORNYL CYCLOHEXANOL

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%.

 

2755

ISOBUTANE

E

Only for use in topical medicines for dermal application.

 

2756

ISOBUTYL ACETATE

E

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

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

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

 

2757

ISOBUTYL ALCOHOL

E

The residual solvent limit for Isobutyl alcohol is 50mg per recommended daily dose.

The concentration of isobutyl alcohol must be no more than 0.5% of the formulation.

 

2758

ISOBUTYL BENZOATE

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%.

 

2759

ISOBUTYL BENZYL CARBINOL

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%.

 

2760

ISOBUTYL BUTYRATE

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%.

 

2761

ISOBUTYL CAPROATE

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%.

 

2762

ISOBUTYL CINNAMATE

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%.

 

2763

ISOBUTYL FORMATE

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%.

 

2764

ISOBUTYL HYDROXYBENZOATE

E

Only for use in topical medicines for dermal application.

 

2765

ISOBUTYL 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%.

 

2766

ISOBUTYL ISOVALERATE

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%.

 

2767

ISOBUTYL PHENYLACETATE

E

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

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

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

 

2768

ISOBUTYL PROPIONATE

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%.

 

2769

ISOBUTYL QUINOLINE

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%.

 

2770

ISOBUTYL SALICYLATE

E

Only for use in topical medicines for dermal application.

 

2771

ISOBUTYLENE/ISOPRENE COPOLYMER

E

Only for oral use when the dosage form is chewing gum.

The concentration must be consistent with best practice for the production of gum delivery systems.

 

2772

ISOBUTYRALDEHYDE

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%.

 

2773

ISOBUTYRIC ACID

E

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

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

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

 

2774

ISOCETYL ALCOHOL

E

Only for use in topical medicines for dermal application.

 

2775

ISOCETYL LINOLEOYL STEARATE

E

Only for use in topical medicines for dermal application.

 

2776

ISOCETYL STEARATE

E

Only for use in topical medicines for dermal application.

 

2777

ISOCETYL STEAROYL STEARATE

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 must be no more than 10%.

 

2778

ISOCYCLOCITRAL

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%.

 

2779

ISODECYL ISONONANOATE

E

Only for use in topical medicines for dermal application.

 

2780

ISODECYL NEOPENTANOATE

E

Only for use in topical medicines for dermal application.

 

2781

ISODECYL OLEATE

E

Only for use in topical medicines for dermal application.

 

2782

ISODECYL SALICYLATE

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 must be no more than 2%.

 

2783

ISODODECANE

E

Only for use in topical medicines for dermal application.

 

2784

ISOEICOSANE

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 must be no more than 2%.

 

2785

ISOEUGENOL

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%.

When the medicine is for dermal use, the total concentration of isoeugenol in the medicine must not be more than 0.02%.

 

2786

ISOEUGENYL ACETATE

E

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

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

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

 

2787

ISOEUGENYL BENZYL ETHER

E

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

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

 

2788

ISOHEXADECANE

E

Only for use in topical medicines for dermal application.

 

2789

ISOJASMONE

E

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

The total flavour proprietary excipient formulation in a medicine must not be more than 5%.

The total fragrance proprietary excipient formulation in a medicine must not be more 1%.

 

2790

ISOLEUCINE

A, E

 

2791

ISOMALT

E

 

2792

ISOMENTHONE

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%.

 

2793

ISOMETHYLIONONE

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%.

 

2794

ISONONYL ACETATE

E

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

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

 

2795

ISONONYL ISONONANOATE

E

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

The concentration must be no more than 15%.

 

2796

ISOPENTANE

E

For dental use only.

The concentration must be no more than 2%.

 

2797

ISOPENTANOIC ACID

E

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

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

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

 

2798

ISOPHORONE

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%.

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

 

2799

ISOPHYTOL

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%.

 

2800

ISOPROPYL 2-METHYLBUTYRATE

E

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