Permissible ingredients and requirements

Column 1

Column 2

Column 3

Column 4

2180

FABIANA IMBRICATA

A, H

2181

FAGOPYRUM ESCULENTUM

A, H

2182

FAGUS GRANDIFOLIA

A, H

2183

FAGUS SYLVATICA

A, H

2184

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%.

2185

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%.

2186

FAST GREEN FCF

E

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

2187

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%.

2188

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%.

2189

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%.

2190

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.'

2191

FENNEL LEAF

E

2192

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.'

2193

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.'

2194

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%.

2195

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%.

2196

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).

2197

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).

2198

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).

2199

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).

2200

FERRIC OXIDE

E

2201

FERRIC PHOSPHATE

H

Only for use as an active homoeopathic ingredient.

2202

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).

2203

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.

2204

FERROSOFERRIC PHOSPHATE

H

Only for use as an active homoeopathic ingredient.

2205

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).

2206

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).

2207

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).

2208

FERROUS IODIDE

H

Only for use as an active homoeopathic ingredient.

2209

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).

2210

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).

2211

FERROUS PICRATE

H

Only for use as an active homoeopathic ingredient.

2212

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).

2213

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).

2214

FERULA ASSA-FOETIDA

A, E, H

2215

FERULA FOETIDA

A, E, H

2216

FERULA GALBANIFLUA

A, E, H

2217

FERULA RUBRICAULIS

A, E, H

2218

FERULA SUMBUL

A, H

2219

FERULIC ACID

E

Only for use in topical medicines for dermal application.

2220

FESTUCA ELATIOR

A, H

2221

FEVERFEW HERB DRY

A, H

2222

FEVERFEW HERB POWDER

A, H

2223

FICUS CARICA

A, E, H

2224

FICUS PUMILA

A, H

2225

FIG

E

2226

FIG DRY

A, H

2227

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'.

2228

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%.

2229

FIR NEEDLE OIL CANADIAN

A, E

2230

FIR NEEDLE OIL SIBERIAN

A, E

2231

FIRMIANA SIMPLEX

A, E, H

2232

FISH OIL - RICH IN OMEGA-3 ACIDS

A

Only for use in oral medicines.

2233

FLEMINGIA MACROPHYLLA

A, H

2234

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%.

2235

FLUORESCEIN SODIUM

E

2236

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).

2237

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.

2238

FOOD ORANGE 6

E

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

2239

FOOD ORANGE 7

E

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

2240

FOOD RED 13

E

Permitted for use only as a colour for topical use.

2241

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%.

2242

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%.

2243

FORSYTHIA SUSPENSA

A, H

2244

FORTIFIED WINE

E

Ethanol is a mandatory component of fortified wine.

2245

FRACTIONATED COCONUT OIL

E

2246

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.

2247

FRAGARIA CHILOENSIS

A, E, H

2248

FRAGARIA VESCA

A, E, H

2249

FRAGARIA VIRGINIANA

A, E, H

2250

FRAGARIA X ANANASSA

A, E, H

2251

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'.

2252

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'.

2253

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'.

2254

FRAXINUS AMERICANA

A, H

2255

FRAXINUS CHINENSIS SUBSP. RHYNCHOPHYLLA

A, H

2256

FRAXINUS EXCELSIOR

A, H

2257

FRAXINUS ORNUS

A, H

2258

FRITILLARIA CIRRHOSA

A, H

2259

FRITILLARIA THUNBERGII

A, H

2260

FRITILLARIA VERTICILLATA

A, H

2261

FRUCTOOLIGOSACCHARIDES

A, E

2262

FRUCTOSE

A, E, H

2263

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.

2264

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%.

2265

FUMARIA OFFICINALIS

A, E, H

2266

FUMARIC ACID

E, H

Only for use as an active homoeopathic or excipient ingredient.

2267

FUMITORY HERB DRY

A, H

2268

FUMITORY HERB POWDER

A, H

2269

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%.

2270

FURFURAL

E

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

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

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

2271

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%.

2272

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%.

2273

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%.

2274

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%.

2275

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%.

2276

GALBANUM PHENOL

E

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

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

2277

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%.

2278

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%.

2279

GALEGA OFFICINALIS

A, H

2280

GALEOPSIS SEGETUM

A, H

2281

GALIUM APARINE

A, H

2282

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%.

2283

GALIUM PALUSTRE

A, H

2284

GALIUM VERUM

A, H

2285

GALL STONE

H

Only for use as an active homoeopathic ingredient.

2286

GALPHIMIA GLAUCA

A, H

2287

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%.

2288

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%.

2289

GAMMA-CYCLODEXTRIN

E

2290

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%.

2291

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%.

2292

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%.

2293

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%.

2294

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%.

2295

GAMMA-LINOLEIC ACID

E

Only for use in topical medicines for dermal application.

2296

GAMMA-LINOLENIC ACID

E

2297

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%.

2298

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%.

2299

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%.

2300

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%.

2301

GAMMA-TOCOPHEROL

E

2302

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%.

2303

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%.

2304

GANODERMA LUCIDUM

A, E, H

2305

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.

2306

GARCINIA QUAESITA

A, H

2307

GARDEN BEAN

E

2308

GARDENIA JASMINOIDES

A, E

2309

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%

2310

GARLIC BULB DRY

A, E, H

2311

GARLIC BULB FRESH

A, H

2312

GARLIC BULB POWDER

A, E, H

2313

GARLIC CLOVE POWDER

A, H

2314

GARLIC OIL

A, E, H

2315

GASTRODIA ELATA

A, H

2316

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'.

2317

GELATIN

A, E

2318

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.

2319

GELLAN GUM

E

2320

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%.

2321

GELSEMIUM POWDER

A, H

2322

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%.

2323

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%.

2324

GENTIAN DRY

A, H

2325

GENTIAN POWDER

A, H

2326

GENTIANA LUTEA

A, E, H

2327

GENTIANA MACROPHYLLA

A, H

2328

GENTIANA RHODANTHA

A, H

2329

GENTIANA SCABRA

A, H

2330

GENTIANELLA AMARELLA

A, H

2331

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%.

2332

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%.

2333

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%.

2334

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%.

2335

GERANIUM MACULATUM

A, E, H

2336

GERANIUM OIL

A, E, H

2337

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%.

2338

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%.

2339

GERANIUM ROBERTIANUM

A, E, H

2340

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%.

2341

GERANIUM SIBIRICUM

A, E, H

2342

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%.

2343

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%.

2344

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%.

2345

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%.

2346

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%.

2347

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%.

2348

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%.

2349

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%.

2350

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%.

2351

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%.

2352

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%.

2353

GEUM RIVALE

A, H

2354

GEUM URBANUM

A, H

2355

GHATTI GUM

A, E, H

2356

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.

2357

GINGER DRY

A, E, H

2358

GINGER OIL

A, E, H

2359

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%.

2360

GINGER POWDER

A, E, H

2361

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.

2362

GLACIAL ACETIC ACID

E, H

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

2363

GLECHOMA HEDERACEA

A, H

2364

GLECHOMA LONGITUBA

A, H

2365

GLEDITSIA AUSTRALIS

A, H

2366

GLEDITSIA SINENSIS

A, H

2367

GLEHNIA LITTORALIS

A, H

2368

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%.

2369

GLUCOMANNAN

E

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

2370

GLUCONOLACTONE

E

2371

GLUCOSAMINE HYDROCHLORIDE

A, E

2372

GLUCOSAMINE SULFATE

A

2373

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.’

2374

GLUCOSAMINE SULFATE SODIUM CHLORIDE

A

2375

GLUCOSE

A, E, H

2376

GLUCOSE GLUTAMATE

E

Only for use in topical medicines for dermal application.

2377

GLUCOSE MONOHYDRATE

A, E, H

2378

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%.

2379

GLUTAMIC ACID

A, E

Only for use in topical medicines for dermal application.

2380

GLUTAMIC ACID HYDROCHLORIDE

A, E, H

2381

GLUTAMINE

A, E, H

2382

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%.

2383

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).

2384

GLUTEN-FREE WHEAT STARCH

E

2385

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%.

2386

GLYCEROL

A, E

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

2387

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.

2388

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.

2389

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%.

2390

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%.

2391

GLYCERYL DIISOSTEARATE

E

For use in topical medicines for dermal application.

2392

GLYCERYL DILAURATE

E

Only for use in topical medicines for dermal application.

2393

GLYCERYL DIOLEATE

E

Only for use in topical medicines for dermal application.

2394

GLYCERYL DISTEARATE

E

Only for use in topical medicines for dermal application.

2395

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%.

2396

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%.

2397

GLYCERYL LAURATE

E

Only for use in topical medicines for dermal application.

2398

GLYCERYL LINOLEATE

E

Only for use in topical medicines for dermal application.

2399

GLYCERYL LINOLENATE

E

Only for use in topical medicines for dermal application.

2400

GLYCERYL MONO AND DICAPRYLOCAPRATE

E

Only permitted for use in medicines limited to oral routes of administration.

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

2401

GLYCERYL MONOOLEATE

E

2402

GLYCERYL MONOSTEARATE

E

2403

GLYCERYL MYRISTATE

E

Only for use in topical medicines for dermal application.

2404

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.

2405

GLYCERYL PALMITO-STEARATE

E

2406

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%.

2407

GLYCERYL POLYMETHACRYLATE

E

Only for use in topical medicines for dermal application.

2408

GLYCERYL RICINOLEATE

E

Only for use in topical medicines for dermal application.

2409

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.

2410

GLYCERYL SORBITAN OLEOSTEARATE

E

Only for use in topical medicines for dermal application.

2411

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.

2412

GLYCERYL STEARATE CITRATE

E

Only for use in topical medicines for dermal application.

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

2413

GLYCERYL TRIACETYL HYDROXYSTEARATE

E

Only for use in topical medicines for dermal application.

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

2414

GLYCERYL TRIACETYL RICINOLEATE

E

Only for use in topical medicines for dermal application.

2415

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%.

2416

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%.

2417

GLYCINE

A, E

2418

GLYCINE MAX

A, E, H

2419

GLYCOGEN

E

Only for use in topical medicines for dermal application.

2420

GLYCOL DISTEARATE

E

Only for use in topical medicines for dermal application.

2421

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.

2422

GLYCYRRHIZA GLABRA

A, E, H

2423

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%.

2424

GLYCYRRHIZA URALENSIS

A, E, H

2425

GLYCYRRHIZINIC ACID

E

2426

GNAPHALIUM AFFINE

A, H

2427

GNAPHALIUM POLYCEPHALUM

A, H

2428

GNAPHALIUM ULIGINOSUM

A, H

2429

GOAT

H

Only for use as an active homoeopathic ingredient.

2430

GOAT MILK

E

2431

GOLD

E, H

Only for use as an active homoeopathic or excipient ingredient.

2432

GOLD CHLORIDE

H

Only for use as an active homoeopathic ingredient.

2433

GOLDEN ROD HERB DRY

A, E, H

2434

GOLDEN SEAL ROOT DRY

A, H

2435

GOLDEN SEAL ROOT POWDER

A, H

2436

GOLDEN SYRUP

E

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

2437

GOMPHRENA GLOBOSA

A, H

2438

GOOSEBERRY

E

2439

GOSSYPIUM HERBACEUM

A, E, H

2440

GRAPE

E

2441

GRAPE SEED OIL

E

2442

GRAPE WINE RED

E

Ethanol is a mandatory component of grape wine red.

2443

GRAPE WINE SHERRY

E

Ethanol is a mandatory component of grape wine sherry.

2444

GRAPE WINE WHITE

E

Ethanol is a mandatory component of grape wine white.

2445

GRAPEFRUIT

E

2446

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%.

2447

GRAPEFRUIT OIL COLDPRESSED

A, E, H

2448

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%.

2449

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%.

2450

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%.

2451

GRAPHITE

H

Only for use as an active homoeopathic ingredient.

2452

GRATIOLA LINIFOLIA

A, H

2453

GREATER NETTLE HERB DRY

A, H

2454

GREATER NETTLE HERB POWDER

A, H

2455

GREATER NETTLE ROOT DRY

A, H

2456

GREATER NETTLE ROOT POWDER

A, H

2457

GREEN LIPPED MUSSEL

A

The requirement specified in paragraph (a) below applies to a medicine that contains the ingredient that is:

- listed in the Register on or after 1 March 2022; or

- released for supply on or after 1 March 2023.

(a) The following warning statement is required on the medicine label:

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

2458

GREEN LIPPED MUSSEL DRIED

A

The requirement specified in paragraph (a) below applies to a medicine that contains the ingredient that is:

- listed in the Register on or after 1 March 2022; or

- released for supply on or after 1 March 2023.

(a) The following warning statement is required on the medicine label:

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

2459

GREEN LIPPED MUSSEL OIL

A

The requirement specified in paragraph (a) below applies to a medicine that contains the ingredient that is:

- listed in the Register on or after 1 March 2022; or

- released for supply on or after 1 March 2023.

(a) The following warning statement is required on the medicine label:

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

2460

GREEN S

E

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

2461

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.'

2462

GRINDELIA CAMPORUM

A, H

2463

GRINDELIA ROBUSTA

A, H

2464

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%.

2465

GROUND IVY HERB DRY

A, H

2466

GROUND IVY HERB POWDER

A, H

2467

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%.

2468

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%.

2469

GUAIACUM OFFICINALE

A, E, H

2470

GUAIACUM RESIN

A, E, H

2471

GUAIACUM SANCTUM

A, H

2472

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%.

2473

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%.

2474

GUANINE

E

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

2475

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.

2476

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).

2477

GUAR GUM

A, E, H

2478

GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE

E

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

2479

GUAREA RUSBYI

A, H

2480

GUAVA

E

2481

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%.

2482

GYMNADENIA NIGRA

A

2483

GYMNEMA SYLVESTRE

A, H

2484

GYMNOCLADUS DIOICA

A, H

2485

GYNOSTEMMA PENTAPHYLLUM

A

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

2486

HAHNEMANN'S SOLUBLE MERCURY

H

Only for use as an active homoeopathic ingredient.

2487

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.’

2488

HAMAMELIS LEAF DRY

A, H

2489

HAMAMELIS LEAF POWDER

A, H

2490

HAMAMELIS VIRGINIANA

A, E, H

2491

HAMAMELIS WATER

A, E, H

2492

HANDROANTHUS HEPTAPHYLLUS

A, H

2493

HANDROANTHUS IMPETIGINOSUS

A, E, H

2494

HARD FAT

E

2495

HARD PARAFFIN

E

2496

HARICOT BEAN

E

2497

HARPAGOPHYTUM PROCUMBENS

A, E, H

2498

HARUNGANA MADAGASCARIENSIS

A, H

2499

HAZEL NUT

E

2500

HAZEL NUT OIL

E

2501

HEAVY KAOLIN

E

2502

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.

2503

HECTORITE

E

Only for use in topical medicines for dermal application.

2504

HEDEOMA PULEGIOIDES

A

2505

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%.

2506

HEDTA

E

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

2507

HEKLA LAVA

H

Only for use as an active homoeopathic ingredient.

2508

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%.

2509

HELIANTHEMUM NUMMULARIUM

A, H

2510

HELIANTHUS ANNUUS

A, E, H

2511

HELIANTHUS TUBEROSUS

A, H

2512

HELICHRYSUM ANGUSTIFOLIUM

A, E, H

2513

HELICHRYSUM ARENARIUM

A, H

2514

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%.

2515

HELLEBORUS NIGER

A, H

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

2516

HELLEBORUS VIRIDIS

A, H

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

2517

HELONIAS RHIZOME DRY

A, H

2518

HELONIAS RHIZOME POWDER

A, H

2519

HEMIDESMUS INDICUS

A, E, H

2520

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%.

2521

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%.

2522

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%.

2523

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%.

2524

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%.

2525

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%.

2526

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%.

2527

HERACLEUM HEMSLEYANUM

A, H

2528

HERNIARIA GLABRA

A, H

2529

HESPERIDIN

A, E

2530

HESPEROCYPARIS MACROCARPA

A, H

2531

HESPEROYUCCA WHIPPLEI

A, H

2532

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%.

2533

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%.

2534

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%.

2535

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%.

2536

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.

2537

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%.

2538

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%.

2539

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 %.

2540

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%.

2541

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%.

2542

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%.

2543

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%.

2544

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%.

2545

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%.

2546

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%.

2547

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%.

2548

HEXYL LAURATE

E

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

2549

HEXYL NICOTINATE

E

2550

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%.

2551

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%.

2552

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%.

2553

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%.

2554

HEXYLENE GLYCOL

E

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

2555

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).

2556

HIBISCUS ESCULENTUS

A, H

2557

HIBISCUS MUTABILIS

A, H

2558

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%.

2559

HIBISCUS SABDARIFFA

A, E, H

2560

HIERACIUM PILOSELLA

A, H

2561

HIGH AMYLOSE MAIZE STARCH

A, E, H

2562

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.

2563

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%.

2564

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.

2565

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.'

2566

HIMATANTHUS LANCIFOLIUS

A, E, H

2567

HIPPOPHAE RHAMNOIDES

A, E, H

2568

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%.

2569

HISTAMINE DIHYDROCHLORIDE

H

Only for use as an active homoeopathic ingredient. 

2570

HISTIDINE

A

2571

HISTIDINE HYDROCHLORIDE

A, E, H

2572

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%.

2573

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%.

2574

HOLCUS LANATUS

A, H

2575

HOLY THISTLE HERB DRY

A, H

2576

HOLY THISTLE HERB POWDER

A, H

2577

HOMALOMENA OCCULTA

A, H

2578

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).

2579

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).

2580

HONEY BEE

H

Only for use as an active homoeopathic ingredient.

2581

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%.

2582

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%.

2583

HOP STROBILE DRY

A, H

2584

HOP STROBILE POWDER

A, H

2585

HOPS OIL

A, E, H

2586

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.

2587

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.

2588

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%.

2589

HORSE RADISH

E, H

Volatile oil components (of Armoracia rusticana) is a mandatory component of Horse radish.

The maximum recommended daily dose must be no more than 20 mg of volatile oil components (of Armoracia rusticana).

2590

HOTTONIA PALUSTRIS

A, H

2591

HOUTTUYNIA CORDATA

A, H

2592

HOVENIA DULCIS

A, H

2593

HUMULUS LUPULUS

A, E, H

2594

HYALURONIC ACID

E

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

2595

HYDNOCARPUS ANTHELMINTICA

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.

2596

HYDRANGEA ARBORESCENS

A, H

2597

HYDRANGEA PANICULATA

A, H

2598

HYDRASTIS CANADENSIS

A, E, H

2599

HYDRATED SILICA

E

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

2600

HYDROCHLORIC ACID

E

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

2601

HYDROCOTYLE UMBELLATA

A, H

2602

HYDROGEN CYANIDE

H

Only for use as an active homoeopathic ingredient. 

2603

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.

2604

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%.

2605

HYDROGENATED C6-14 OLEFIN POLYMERS

E

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

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

2606

HYDROGENATED CASTOR OIL

E

2607

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%.

2608

HYDROGENATED COCONUT OIL

E

2609

HYDROGENATED COTTONSEED OIL

E

2610

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.

2611

HYDROGENATED ETHYLENE/PROPYLENE/STYRENE COPOLYMER

E

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

2612

HYDROGENATED LANOLIN

E

2613

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%.

2614

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%.

2615

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%.

2616

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%.

2617

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.

2618

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.

2619

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.

2620

HYDROGENATED POLYISOBUTENE

E

Only for use in topical medicines for dermal application.

2621

HYDROGENATED SOYA OIL

E

2622

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%.

2623

HYDROGENATED VEGETABLE OIL

E

2624

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%.

2625

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%

2626

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%

2627

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%.

2628

HYDROLYSED CHICKEN CARTILAGE EXTRACT

A

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

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

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

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

- (ADULT) 'Adults only’.

2629

HYDROLYSED COLLAGEN

A, E

2630

HYDROLYSED ELASTIN

E

Only for use in topical medicines for dermal application.

2631

HYDROLYSED GELATIN

A, E

2632

HYDROLYSED GLYCOSAMINOGLYCANS

E

Only for use in topical medicines for dermal application.

2633

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%.

2634

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%.

2635

HYDROLYSED MAIZE STARCH

E

2636

HYDROLYSED MILK PROTEIN

E

2637

HYDROLYSED RICE

A, E, H

2638

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%.

2639

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%.

2640

HYDROLYSED VEGETABLE PROTEIN

E

2641

HYDROLYSED WHEAT PROTEIN

E

Gluten is a mandatory component of hydrolysed wheat protein.

2642

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%.

2643

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%.

2644

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%.

2645

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.

2646

HYDROXOCOBALAMIN

A

2647

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%.

2648

HYDROXYAPATITE

A, E

2649

HYDROXYCITRATE COMPLEX

A

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

2650

HYDROXYCITRIC ACID

A

2651

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%.

2652

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%.

2653

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%.

2654

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%.

2655

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%.

2656

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%.

2657

HYDROXYLATED LANOLIN

E

2658

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%.

2659

HYDROXYLYSINE

A, E

2660

HYDROXYMETHYLCELLULOSE

E

2661

HYDROXYOCTACOSANYL HYDROXYSTEARATE

E

Only for use in topical medicines for dermal application.

2662

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%.

2663

HYDROXYPROLINE

A, E

2664

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.

2665

HYDROXYPROPYL STARCH

E

2666

HYDROXYPROPYLBETADEX

E

Only for use in topical medicines for dermal application.

2667

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%.

2668

HYETELLOSE

E

2669

HYLOCEREUS LEMAIREI

E

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

2670

HYLOCEREUS UNDATUS

A, H

2671

HYMETELLOSE

E

2672

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%.

2673

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%.

2674

HYOSCYAMUS NIGER

A, H

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

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

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