Permissible ingredients and requirements

Column 1

Column 2

Column 3

Column 4

Item

Ingredient Name

Purpose

Specific requirements

2169

FABIANA IMBRICATA

A, H

2170

FAGOPYRUM ESCULENTUM

A, H

2171

FAGUS GRANDIFOLIA

A, H

2172

FAGUS SYLVATICA

A, H

2173

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%.

2174

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%.

2175

FAST GREEN FCF

E

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

2176

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%.

2177

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%.

2178

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%.

2179

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.'

2180

FENNEL LEAF

E

2181

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.'

2182

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.'

2183

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%.

2184

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%.

2185

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).

2186

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).

2187

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).

2188

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).

2189

FERRIC OXIDE

E

2190

FERRIC PHOSPHATE

H

Only for use as an active homoeopathic ingredient.

2191

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).

2192

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.

2193

FERROSOFERRIC PHOSPHATE

H

Only for use as an active homoeopathic ingredient.

2194

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).

2195

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).

2196

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).

2197

FERROUS IODIDE

H

Only for use as an active homoeopathic ingredient.

2198

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).

2199

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).

2200

FERROUS PICRATE

H

Only for use as an active homoeopathic ingredient.

2201

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).

2202

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).

2203

FERULA ASSA-FOETIDA

A, E, H

2204

FERULA FOETIDA

A, E, H

2205

FERULA GALBANIFLUA

A, E, H

2206

FERULA RUBRICAULIS

A, E, H

2207

FERULA SUMBUL

A, H

2208

FERULIC ACID

E

Only for use in topical medicines for dermal application.

2209

FESTUCA ELATIOR

A, H

2210

FEVERFEW HERB DRY

A, H

2211

FEVERFEW HERB POWDER

A, H

2212

FICUS CARICA

A, E, H

2213

FICUS PUMILA

A, H

2214

FIG

E

2215

FIG DRY

A, H

2216

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'.

2217

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%.

2218

FIR NEEDLE OIL CANADIAN

A, E

2219

FIR NEEDLE OIL SIBERIAN

A, E

2220

FIRMIANA SIMPLEX

A, E, H

2221

FISH OIL - RICH IN OMEGA-3 ACIDS

A

Only for use in oral medicines.

2222

FLEMINGIA MACROPHYLLA

A, H

2223

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%.

2224

FLUORESCEIN SODIUM

E

2225

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).

2226

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.

2227

FOOD ORANGE 6

E

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

2228

FOOD ORANGE 7

E

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

2229

FOOD RED 13

E

Permitted for use only as a colour for topical use.

2230

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%.

2231

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%.

2232

FORSYTHIA SUSPENSA

A, H

2233

FORTIFIED WINE

E

Ethanol is a mandatory component of fortified wine.

2234

FRACTIONATED COCONUT OIL

E

2235

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.

2236

FRAGARIA CHILOENSIS

A, E, H

2237

FRAGARIA VESCA

A, E, H

2238

FRAGARIA VIRGINIANA

A, E, H

2239

FRAGARIA X ANANASSA

A, E, H

2240

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'.

2241

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'.

2242

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'.

2243

FRAXINUS AMERICANA

A, H

2244

FRAXINUS CHINENSIS SUBSP. RHYNCHOPHYLLA

A, H

2245

FRAXINUS EXCELSIOR

A, H

2246

FRAXINUS ORNUS

A, H

2247

FRITILLARIA CIRRHOSA

A, H

2248

FRITILLARIA THUNBERGII

A, H

2249

FRITILLARIA VERTICILLATA

A, H

2250

FRUCTOOLIGOSACCHARIDES

A, E

2251

FRUCTOSE

A, E, H

2252

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.

2253

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%.

2254

FUMARIA OFFICINALIS

A, E, H

2255

FUMARIC ACID

E, H

Only for use as an active homoeopathic or excipient ingredient.

2256

FUMITORY HERB DRY

A, H

2257

FUMITORY HERB POWDER

A, H

2258

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%.

2259

FURFURAL

E

Permitted for use only in medicines containing 0.1% or less of furfural and 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 not be more than 5%.

If used in a fragrance the total fragrance concentration in a medicine must not be more than 1%.

2260

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%.

2261

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%.

2262

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%.

2263

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%.

2264

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.’

2265

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%.

2266

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%.

2267

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%.

2268

GALEGA OFFICINALIS

A, H

2269

GALEOPSIS SEGETUM

A, H

2270

GALIUM APARINE

A, H

2271

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%.

2272

GALIUM PALUSTRE

A, H

2273

GALIUM VERUM

A, H

2274

GALL STONE

H

Only for use as an active homoeopathic ingredient.

2275

GALPHIMIA GLAUCA

A, H

2276

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%.

2277

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%.

2278

GAMMA-CYCLODEXTRIN

E

2279

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%.

2280

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%.

2281

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%.

2282

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%.

2283

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%.

2284

GAMMA-LINOLEIC ACID

E

Only for use in topical medicines for dermal application.

2285

GAMMA-LINOLENIC ACID

E

2286

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%.

2287

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%.

2288

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%.

2289

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%.

2290

GAMMA-TOCOPHEROL

E

2291

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%.

2292

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%.

2293

GANODERMA LUCIDUM

A, E, H

2294

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.

2295

GARCINIA QUAESITA

A, H

2296

GARDEN BEAN

E

2297

GARDENIA JASMINOIDES

A, E

2298

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%

2299

GARLIC BULB DRY

A, E, H

2300

GARLIC BULB FRESH

A, H

2301

GARLIC BULB POWDER

A, E, H

2302

GARLIC CLOVE POWDER

A, H

2303

GARLIC OIL

A, E, H

2304

GASTRODIA ELATA

A, H

2305

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'.

2306

GELATIN

A, E

2307

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.

2308

GELLAN GUM

E

2309

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%.

2310

GELSEMIUM POWDER

A, H

2311

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%.

2312

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%.

2313

GENTIAN DRY

A, H

2314

GENTIAN POWDER

A, H

2315

GENTIANA LUTEA

A, E, H

2316

GENTIANA MACROPHYLLA

A, H

2317

GENTIANA RHODANTHA

A, H

2318

GENTIANA SCABRA

A, H

2319

GENTIANELLA AMARELLA

A, H

2320

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%.

2321

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%.

2322

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%.

2323

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%.

2324

GERANIUM MACULATUM

A, E, H

2325

GERANIUM OIL

A, E, H

2326

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%.

2327

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%.

2328

GERANIUM ROBERTIANUM

A, E, H

2329

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%.

2330

GERANIUM SIBIRICUM

A, E, H

2331

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%.

2332

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%.

2333

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%.

2334

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%.

2335

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%.

2336

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%.

2337

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%.

2338

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%.

2339

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%.

2340

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%.

2341

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%.

2342

GEUM RIVALE

A, H

2343

GEUM URBANUM

A, H

2344

GHATTI GUM

A, E, H

2345

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.

2346

GINGER DRY

A, E, H

2347

GINGER OIL

A, E, H

2348

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%.

2349

GINGER POWDER

A, E, H

2350

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.

2351

GLACIAL ACETIC ACID

E, H

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

2352

GLECHOMA HEDERACEA

A, H

2353

GLECHOMA LONGITUBA

A, H

2354

GLEDITSIA AUSTRALIS

A, H

2355

GLEDITSIA SINENSIS

A, H

2356

GLEHNIA LITTORALIS

A, H

2357

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%.

2358

GLUCOMANNAN

E

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

2359

GLUCONOLACTONE

E

2360

GLUCOSAMINE HYDROCHLORIDE

A, E

2361

GLUCOSAMINE SULFATE

A

2362

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.’

2363

GLUCOSAMINE SULFATE SODIUM CHLORIDE

A

2364

GLUCOSE

A, E, H

2365

GLUCOSE GLUTAMATE

E

Only for use in topical medicines for dermal application.

2366

GLUCOSE MONOHYDRATE

A, E, H

2367

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%.

2368

GLUTAMIC ACID

A, E

Only for use in topical medicines for dermal application.

2369

GLUTAMIC ACID HYDROCHLORIDE

A, E, H

2370

GLUTAMINE

A, E, H

2371

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%.

2372

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).

2373

GLUTEN-FREE WHEAT STARCH

E

2374

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%.

2375

GLYCEROL

A, E

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

2376

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.

2377

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.

2378

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%.

2379

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%.

2380

GLYCERYL DIISOSTEARATE

E

For use in topical medicines for dermal application.

2381

GLYCERYL DILAURATE

E

Only for use in topical medicines for dermal application.

2382

GLYCERYL DIOLEATE

E

Only for use in topical medicines for dermal application.

2383

GLYCERYL DISTEARATE

E

Only for use in topical medicines for dermal application.

2384

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%.

2385

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%.

2386

GLYCERYL LAURATE

E

Only for use in topical medicines for dermal application.

2387

GLYCERYL LINOLEATE

E

Only for use in topical medicines for dermal application.

2388

GLYCERYL LINOLENATE

E

Only for use in topical medicines for dermal application.

2389

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.

2390

GLYCERYL MONOOLEATE

E

2391

GLYCERYL MONOSTEARATE

E

2392

GLYCERYL MYRISTATE

E

Only for use in topical medicines for dermal application.

2393

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.

2394

GLYCERYL PALMITO-STEARATE

E

2395

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%.

2396

GLYCERYL POLYMETHACRYLATE

E

Only for use in topical medicines for dermal application.

2397

GLYCERYL RICINOLEATE

E

Only for use in topical medicines for dermal application.

2398

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.

2399

GLYCERYL SORBITAN OLEOSTEARATE

E

Only for use in topical medicines for dermal application.

2400

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.

2401

GLYCERYL STEARATE CITRATE

E

Only for use in topical medicines for dermal application.

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

2402

GLYCERYL TRIACETYL HYDROXYSTEARATE

E

Only for use in topical medicines for dermal application.

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

2403

GLYCERYL TRIACETYL RICINOLEATE

E

Only for use in topical medicines for dermal application.

2404

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%.

2405

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%.

2406

GLYCINE

A, E

2407

GLYCINE MAX

A, E, H

2408

GLYCOGEN

E

Only for use in topical medicines for dermal application.

2409

GLYCOL DISTEARATE

E

Only for use in topical medicines for dermal application.

2410

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.

2411

GLYCYRRHIZA GLABRA

A, E, H

2412

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%.

2413

GLYCYRRHIZA URALENSIS

A, E, H

2414

GLYCYRRHIZINIC ACID

E

2415

GNAPHALIUM AFFINE

A, H

2416

GNAPHALIUM POLYCEPHALUM

A, H

2417

GNAPHALIUM ULIGINOSUM

A, H

2418

GOAT

H

Only for use as an active homoeopathic ingredient.

2419

GOAT MILK

E

2420

GOLD

E, H

Only for use as an active homoeopathic or excipient ingredient.

2421

GOLD CHLORIDE

H

Only for use as an active homoeopathic ingredient.

2422

GOLDEN ROD HERB DRY

A, E, H

2423

GOLDEN SEAL ROOT DRY

A, H

2424

GOLDEN SEAL ROOT POWDER

A, H

2425

GOLDEN SYRUP

E

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

2426

GOMPHRENA GLOBOSA

A, H

2427

GOSSYPIUM HERBACEUM

A, E, H

2428

GRAPE

E

2429

GRAPE SEED OIL

E

2430

GRAPE WINE RED

E

Ethanol is a mandatory component of grape wine red.

2431

GRAPE WINE SHERRY

E

Ethanol is a mandatory component of grape wine sherry.

2432

GRAPE WINE WHITE

E

Ethanol is a mandatory component of grape wine white.

2433

GRAPEFRUIT

E

2434

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%.

2435

GRAPEFRUIT OIL COLDPRESSED

A, E, H

2436

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%.

2437

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%.

2438

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%.

2439

GRAPHITE

H

Only for use as an active homoeopathic ingredient.

2440

GRATIOLA LINIFOLIA

A, H

2441

GREATER NETTLE HERB DRY

A, H

2442

GREATER NETTLE HERB POWDER

A, H

2443

GREATER NETTLE ROOT DRY

A, H

2444

GREATER NETTLE ROOT POWDER

A, H

2445

GREEN LIPPED MUSSEL

A

The following warning statement is required on the medicine label:

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

2446

GREEN LIPPED MUSSEL DRIED

A

The following warning statement is required on the medicine label:

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

2447

GREEN LIPPED MUSSEL OIL

A

The following warning statement is required on the medicine label:

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

2448

GREEN S

E

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

2449

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.'

2450

GRINDELIA CAMPORUM

A, H

2451

GRINDELIA ROBUSTA

A, H

2452

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%.

2453

GROUND IVY HERB DRY

A, H

2454

GROUND IVY HERB POWDER

A, H

2455

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%.

2456

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%.

2457

GUAIACUM OFFICINALE

A, E, H

2458

GUAIACUM RESIN

A, E, H

2459

GUAIACUM SANCTUM

A, H

2460

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%.

2461

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%.

2462

GUANINE

E

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

2463

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.

2464

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).

2465

GUAR GUM

A, E, H

2466

GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE

E

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

2467

GUAREA RUSBYI

A, H

2468

GUAVA

E

2469

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%.

2470

GYMNADENIA NIGRA

A

2471

GYMNEMA SYLVESTRE

A, H

2472

GYMNOCLADUS DIOICA

A, H

2473

GYNOSTEMMA PENTAPHYLLUM

A

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

2474

HAHNEMANN'S SOLUBLE MERCURY

H

Only for use as an active homoeopathic ingredient.

2475

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.’

2476

HAMAMELIS LEAF DRY

A, H

2477

HAMAMELIS LEAF POWDER

A, H

2478

HAMAMELIS VIRGINIANA

A, E, H

2479

HAMAMELIS WATER

A, E, H

2480

HANDROANTHUS HEPTAPHYLLUS

A, H

2481

HANDROANTHUS IMPETIGINOSUS

A, E, H

2482

HARD FAT

E

2483

HARD PARAFFIN

E

2484

HARICOT BEAN

E

2485

HARPAGOPHYTUM PROCUMBENS

A, E, H

2486

HARUNGANA MADAGASCARIENSIS

A, H

2487

HAZEL NUT

E

2488

HAZEL NUT OIL

E

2489

HEAVY KAOLIN

E

2490

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.

2491

HECTORITE

E

Only for use in topical medicines for dermal application.

2492

HEDEOMA PULEGIOIDES

A

2493

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%.

2494

HEDTA

E

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

2495

HEKLA LAVA

H

Only for use as an active homoeopathic ingredient.

2496

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%.

2497

HELIANTHEMUM NUMMULARIUM

A, H

2498

HELIANTHUS ANNUUS

A, E, H

2499

HELIANTHUS TUBEROSUS

A, H

2500

HELICHRYSUM ANGUSTIFOLIUM

A, E, H

2501

HELICHRYSUM ARENARIUM

A, H

2502

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%.

2503

HELLEBORUS NIGER

A, H

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

2504

HELLEBORUS VIRIDIS

A, H

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

2505

HELONIAS RHIZOME DRY

A, H

2506

HELONIAS RHIZOME POWDER

A, H

2507

HEMIDESMUS INDICUS

A, E, H

2508

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 hemp seed oil must not be more than 75 mg/kg.

The total concentration of tetrahydrocannabinols in hemp seed oil 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’.

2509

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%.

2510

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%.

2511

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%.

2512

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%.

2513

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%.

2514

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%.

2515

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%.

2516

HERACLEUM HEMSLEYANUM

A, H

2517

HERNIARIA GLABRA

A, H

2518

HESPERIDIN

A, E

2519

HESPEROCYPARIS MACROCARPA

A, H

2520

HESPEROYUCCA WHIPPLEI

A, H

2521

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%.

2522

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%.

2523

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%.

2524

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%.

2525

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.

2526

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%.

2527

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%.

2528

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 %.

2529

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%.

2530

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%.

2531

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%.

2532

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%.

2533

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%.

2534

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%.

2535

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%.

2536

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%.

2537

HEXYL LAURATE

E

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

2538

HEXYL NICOTINATE

E

2539

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%.

2540

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%.

2541

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%.

2542

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%.

2543

HEXYLENE GLYCOL

E

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

2544

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).

2545

HIBISCUS ESCULENTUS

A, H

2546

HIBISCUS MUTABILIS

A, H

2547

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%.

2548

HIBISCUS SABDARIFFA

A, E, H

2549

HIERACIUM PILOSELLA

A, H

2550

HIGH AMYLOSE MAIZE STARCH

A, E, H

2551

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.

2552

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%.

2553

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.

2554

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.'

2555

HIMATANTHUS LANCIFOLIUS

A, E, H

2556

HIPPOPHAE RHAMNOIDES

A, E, H

2557

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%.

2558

HISTAMINE DIHYDROCHLORIDE

H

Only for use as an active homoeopathic ingredient. 

2559

HISTIDINE

A

2560

HISTIDINE HYDROCHLORIDE

A, E, H

2561

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%.

2562

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%.

2563

HOLCUS LANATUS

A, H

2564

HOLY THISTLE HERB DRY

A, H

2565

HOLY THISTLE HERB POWDER

A, H

2566

HOMALOMENA OCCULTA

A, H

2567

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).

2568

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).

2569

HONEY BEE

H

Only for use as an active homoeopathic ingredient.

2570

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%.

2571

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%.

2572

HOP STROBILE DRY

A, H

2573

HOP STROBILE POWDER

A, H

2574

HOPS OIL

A, E, H

2575

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.

2576

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.

2577

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%.

2578

HOTTONIA PALUSTRIS

A, H

2579

HOUTTUYNIA CORDATA

A, H

2580

HOVENIA DULCIS

A, H

2581

HUMULUS LUPULUS

A, E, H

2582

HYALURONIC ACID

E

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

2583

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.

2584

HYDRANGEA ARBORESCENS

A, H

2585

HYDRANGEA PANICULATA

A, H

2586

HYDRASTIS CANADENSIS

A, E, H

2587

HYDRATED SILICA

E

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

2588

HYDROCHLORIC ACID

E

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

2589

HYDROCOTYLE UMBELLATA

A, H

2590

HYDROGEN CYANIDE

H

Only for use as an active homoeopathic ingredient. 

2591

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.

2592

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%.

2593

HYDROGENATED C6-14 OLEFIN POLYMERS

E

Only permitted for use in solid or semi-solid medicines for dermal application or in topical medicines for dermal application:

(a) containing 25% or less of hydrocarbons, liquid; or

(b) when packed in pressurised spray packs; or

(c) when packed in containers with a capacity of 2 millilitres or less.

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

The concentration in the medicine must not be more than 7%.

2594

HYDROGENATED CASTOR OIL

E

2595

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%.

2596

HYDROGENATED COCONUT OIL

E

2597

HYDROGENATED COTTONSEED OIL

E

2598

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.

2599

HYDROGENATED ETHYLENE/PROPYLENE/STYRENE COPOLYMER

E

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

2600

HYDROGENATED LANOLIN

E

2601

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%.

2602

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%.

2603

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%.

2604

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%.

2605

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.

2606

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.

2607

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.

2608

HYDROGENATED POLYISOBUTENE

E

Only for use in topical medicines for dermal application.

2609

HYDROGENATED SOYA OIL

E

2610

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%.

2611

HYDROGENATED VEGETABLE OIL

E

2612

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%.

2613

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%

2614

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%

2615

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%.

2616

HYDROLYSED CHICKEN CARTILAGE EXTRACT

A

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

- (ADULT) 'Adults only’.

2617

HYDROLYSED COLLAGEN

A, E

2618

HYDROLYSED ELASTIN

E

Only for use in topical medicines for dermal application.

2619

HYDROLYSED GELATIN

A, E

2620

HYDROLYSED GLYCOSAMINOGLYCANS

E

Only for use in topical medicines for dermal application.

2621

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%.

2622

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%.

2623

HYDROLYSED MAIZE STARCH

E

2624

HYDROLYSED MILK PROTEIN

E

2625

HYDROLYSED RICE

A, E, H

2626

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%.

2627

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%.

2628

HYDROLYSED VEGETABLE PROTEIN

E

2629

HYDROLYSED WHEAT PROTEIN

E

Gluten is a mandatory component of hydrolysed wheat protein.

2630

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%.

2631

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%.

2632

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%.

2633

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.

2634

HYDROXOCOBALAMIN

A

2635

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%.

2636

HYDROXYAPATITE

A, E

2637

HYDROXYCITRATE COMPLEX

A

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

2638

HYDROXYCITRIC ACID

A

2639

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%.

2640

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%.

2641

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%.

2642

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%.

2643

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%.

2644

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%.

2645

HYDROXYLATED LANOLIN

E

2646

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%.

2647

HYDROXYLYSINE

A, E

2648

HYDROXYMETHYLCELLULOSE

E

2649

HYDROXYOCTACOSANYL HYDROXYSTEARATE

E

Only for use in topical medicines for dermal application.

2650

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%.

2651

HYDROXYPROLINE

A, E

2652

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.

2653

HYDROXYPROPYL STARCH

E

2654

HYDROXYPROPYLBETADEX

E

Only for use in topical medicines for dermal application.

2655

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%.

2656

HYETELLOSE

E

2657

HYLOCEREUS LEMAIREI

E

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

2658

HYLOCEREUS UNDATUS

A, H

2659

HYMETELLOSE

E

2660

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%.

2661

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%.