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

Note: See sections 5 and 6.

Permissible ingredients and requirements

Column 1

Column 2

Column 3

Column 4

Item

Ingredient Name

Purpose

Specific requirements

2179

FABIANA IMBRICATA

A, H

 

2180

FAGOPYRUM ESCULENTUM

A, H

 

2181

FAGUS GRANDIFOLIA

A, H

 

2182

FAGUS SYLVATICA

A, H

 

2183

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%.

 

2184

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%.

 

2185

FAST GREEN FCF

E

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

 

2186

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%.

 

2187

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%.

 

2188

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%.

 

2189

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.'

 

2190

FENNEL LEAF

E

 

2191

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.'

 

2192

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.'

 

2193

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%.

 

2194

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%.

 

2195

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).

 

2196

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).

 

2197

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).

 

2198

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).

 

2199

FERRIC OXIDE

E

 

2200

FERRIC PHOSPHATE

H

Only for use as an active homoeopathic ingredient.

 

2201

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).

 

2202

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.

 

2203

FERROSOFERRIC PHOSPHATE

H

Only for use as an active homoeopathic ingredient.

 

2204

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).

 

2205

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).

 

2206

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).

 

2207

FERROUS IODIDE

H

Only for use as an active homoeopathic ingredient.

 

2208

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).

 

2209

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).

 

2210

FERROUS PICRATE

H

Only for use as an active homoeopathic ingredient.

 

2211

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).

 

2212

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).

 

2213

FERULA ASSA-FOETIDA

A, E, H

 

2214

FERULA FOETIDA

A, E, H

 

2215

FERULA GALBANIFLUA

A, E, H

 

2216

FERULA RUBRICAULIS

A, E, H

 

2217

FERULA SUMBUL

A, H

 

2218

FERULIC ACID

E

Only for use in topical medicines for dermal application.

 

2219

FESTUCA ELATIOR

A, H

 

2220

FEVERFEW HERB DRY

A, H

 

2221

FEVERFEW HERB POWDER

A, H

 

2222

FICUS CARICA

A, E, H

 

2223

FICUS PUMILA

A, H

 

2224

FIG

E

 

2225

FIG DRY

A, H

 

2226

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'.

 

2227

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%.

 

2228

FIR NEEDLE OIL CANADIAN

A, E

 

2229

FIR NEEDLE OIL SIBERIAN

A, E

 

2230

FIRMIANA SIMPLEX

A, E, H

 

2231

FISH OIL - RICH IN OMEGA-3 ACIDS

A

Only for use in oral medicines.

 

2232

FLEMINGIA MACROPHYLLA

A, H

 

2233

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%.

 

2234

FLUORESCEIN SODIUM

E

 

2235

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).

 

2236

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.

 

2237

FOOD ORANGE 6

E

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

 

2238

FOOD ORANGE 7

E

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

 

2239

FOOD RED 13

E

Permitted for use only as a colour for topical use.

 

2240

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%.

 

2241

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%.

 

2242

FORSYTHIA SUSPENSA

A, H

 

2243

FORTIFIED WINE

E

Ethanol is a mandatory component of fortified wine.

 

2244

FRACTIONATED COCONUT OIL

E

 

2245

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.

 

2246

FRAGARIA CHILOENSIS

A, E, H

 

2247

FRAGARIA VESCA

A, E, H

 

2248

FRAGARIA VIRGINIANA

A, E, H

 

2249

FRAGARIA X ANANASSA

A, E, H

 

2250

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'.

 

2251

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'.

 

2252

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'.

 

2253

FRAXINUS AMERICANA

A, H

 

2254

FRAXINUS CHINENSIS SUBSP. RHYNCHOPHYLLA

A, H

 

2255

FRAXINUS EXCELSIOR

A, H

 

2256

FRAXINUS ORNUS

A, H

 

2257

FRITILLARIA CIRRHOSA

A, H

 

2258

FRITILLARIA THUNBERGII

A, H

 

2259

FRITILLARIA VERTICILLATA

A, H

 

2260

FRUCTOOLIGOSACCHARIDES

A, E

 

2261

FRUCTOSE

A, E, H

 

2262

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.

 

2263

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%.

 

2264

FUMARIA OFFICINALIS

A, E, H

 

2265

FUMARIC ACID

E, H

Only for use as an active homoeopathic or excipient ingredient.

 

2266

FUMITORY HERB DRY

A, H

 

2267

FUMITORY HERB POWDER

A, H

 

2268

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%.

 

2269

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%.

 

2270

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%.

 

2271

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%.

 

2272

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%.

 

2273

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%.

 

2274

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%.

 

2275

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%.

 

2276

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%.

 

2277

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%.

 

2278

GALEGA OFFICINALIS

A, H

 

2279

GALEOPSIS SEGETUM

A, H

 

2280

GALIUM APARINE

A, H

 

2281

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%.

 

2282

GALIUM PALUSTRE

A, H

 

2283

GALIUM VERUM

A, H

 

2284

GALL STONE

H

Only for use as an active homoeopathic ingredient.

 

2285

GALPHIMIA GLAUCA

A, H

 

2286

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%.

 

2287

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%.

 

2288

GAMMA-CYCLODEXTRIN

E

 

2289

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%.

 

2290

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%.

 

2291

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%.

 

2292

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%.

 

2293

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%.

 

2294

GAMMA-LINOLEIC ACID

E

Only for use in topical medicines for dermal application.

 

2295

GAMMA-LINOLENIC ACID

E

 

2296

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%.

 

2297

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%.

 

2298

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%.

 

2299

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%.

 

2300

GAMMA-TOCOPHEROL

E

 

2301

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%.

 

2302

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%.

 

2303

GANODERMA LUCIDUM

A, E, H

 

2304

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.

 

2305

GARCINIA QUAESITA

A, H

 

2306

GARDEN BEAN

E

 

2307

GARDENIA JASMINOIDES

A, E

 

2308

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%

 

2309

GARLIC BULB DRY

A, E, H

 

2310

GARLIC BULB FRESH

A, H

 

2311

GARLIC BULB POWDER

A, E, H

 

2312

GARLIC CLOVE POWDER

A, H

 

2313

GARLIC OIL

A, E, H

 

2314

GASTRODIA ELATA

A, H

 

2315

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'.

 

2316

GELATIN

A, E

 

2317

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.

 

2318

GELLAN GUM

E

 

2319

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%.

 

2320

GELSEMIUM POWDER

A, H

 

2321

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%.

 

2322

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%.

 

2323

GENTIAN DRY

A, H

 

2324

GENTIAN POWDER

A, H

 

2325

GENTIANA LUTEA

A, E, H

 

2326

GENTIANA MACROPHYLLA

A, H

 

2327

GENTIANA RHODANTHA

A, H

 

2328

GENTIANA SCABRA

A, H

 

2329

GENTIANELLA AMARELLA

A, H

 

2330

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%.

 

2331

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%.

 

2332

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%.

 

2333

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%.

 

2334

GERANIUM MACULATUM

A, E, H

 

2335

GERANIUM OIL

A, E, H

 

2336

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%.

 

2337

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%.

 

2338

GERANIUM ROBERTIANUM

A, E, H

 

2339

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%.

 

2340

GERANIUM SIBIRICUM

A, E, H

 

2341

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%.

 

2342

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%.

 

2343

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%.

 

2344

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%.

 

2345

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%.

 

2346

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%.

 

2347

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%.

 

2348

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%.

 

2349

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%.

 

2350

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%.

 

2351

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%.

 

2352

GEUM RIVALE

A, H

 

2353

GEUM URBANUM

A, H

 

2354

GHATTI GUM

A, E, H

 

2355

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.

 

2356

GINGER DRY

A, E, H

 

2357

GINGER OIL

A, E, H

 

2358

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%.

 

2359

GINGER POWDER

A, E, H

 

2360

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.

 

2361

GLACIAL ACETIC ACID

E, H

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

 

2362

GLECHOMA HEDERACEA

A, H

 

2363

GLECHOMA LONGITUBA

A, H

 

2364

GLEDITSIA AUSTRALIS

A, H

 

2365

GLEDITSIA SINENSIS

A, H

 

2366

GLEHNIA LITTORALIS

A, H

 

2367

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%.

 

2368

GLUCOMANNAN

E

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

 

2369

GLUCONOLACTONE

E

 

2370

GLUCOSAMINE HYDROCHLORIDE

A, E

 

2371

GLUCOSAMINE SULFATE

A

 

2372

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.’

 

2373

GLUCOSAMINE SULFATE SODIUM CHLORIDE

A

 

2374

GLUCOSE

A, E, H

 

2375

GLUCOSE GLUTAMATE

E

Only for use in topical medicines for dermal application.

 

2376

GLUCOSE MONOHYDRATE

A, E, H

 

2377

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%.

 

2378

GLUTAMIC ACID

A, E

Only for use in topical medicines for dermal application.

 

2379

GLUTAMIC ACID HYDROCHLORIDE

A, E, H

 

2380

GLUTAMINE

A, E, H

 

2381

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%.

 

2382

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).

 

2383

GLUTEN-FREE WHEAT STARCH

E

 

2384

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%.

 

2385

GLYCEROL

A, E

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

 

2386

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.

 

2387

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.

 

2388

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%.

 

2389

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%.

 

2390

GLYCERYL DIISOSTEARATE

E

For use in topical medicines for dermal application.

 

2391

GLYCERYL DILAURATE

E

Only for use in topical medicines for dermal application.

 

2392

GLYCERYL DIOLEATE

E

Only for use in topical medicines for dermal application.

 

2393

GLYCERYL DISTEARATE

E

Only for use in topical medicines for dermal application.

 

2394

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%.

 

2395

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%.

 

2396

GLYCERYL LAURATE

E

Only for use in topical medicines for dermal application.

 

2397

GLYCERYL LINOLEATE

E

Only for use in topical medicines for dermal application.

 

2398

GLYCERYL LINOLENATE

E

Only for use in topical medicines for dermal application.

 

2399

GLYCERYL MONO AND DICAPRYLOCAPRATE

E

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

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

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

 

2400

GLYCERYL MONOOLEATE

E

 

2401

GLYCERYL MONOSTEARATE

E

 

2402

GLYCERYL MYRISTATE

E

Only for use in topical medicines for dermal application.

 

2403

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.

 

2404

GLYCERYL PALMITO-STEARATE

E

 

2405

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%.

 

2406

GLYCERYL POLYMETHACRYLATE

E

Only for use in topical medicines for dermal application.

 

2407

GLYCERYL RICINOLEATE

E

Only for use in topical medicines for dermal application.

 

2408

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.

 

2409

GLYCERYL SORBITAN OLEOSTEARATE

E

Only for use in topical medicines for dermal application.

 

2410

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.

 

2411

GLYCERYL STEARATE CITRATE

E

Only for use in topical medicines for dermal application.

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

 

2412

GLYCERYL TRIACETYL HYDROXYSTEARATE

E

Only for use in topical medicines for dermal application.

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

 

2413

GLYCERYL TRIACETYL RICINOLEATE

E

Only for use in topical medicines for dermal application.

 

2414

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%.

 

2415

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%.

 

2416

GLYCINE

A, E

 

2417

GLYCINE MAX

A, E, H

 

2418

GLYCOGEN

E

Only for use in topical medicines for dermal application.

 

2419

GLYCOL DISTEARATE

E

Only for use in topical medicines for dermal application.

 

2420

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.

 

2421

GLYCYRRHIZA GLABRA

A, E, H

 

2422

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%.

 

2423

GLYCYRRHIZA URALENSIS

A, E, H

 

2424

GLYCYRRHIZINIC ACID

E

 

2425

GNAPHALIUM AFFINE

A, H

 

2426

GNAPHALIUM POLYCEPHALUM

A, H

 

2427

GNAPHALIUM ULIGINOSUM

A, H

 

2428

GOAT

H

Only for use as an active homoeopathic ingredient.

 

2429

GOAT MILK

E

 

2430

GOLD

E, H

Only for use as an active homoeopathic or excipient ingredient.

 

2431

GOLD CHLORIDE

H

Only for use as an active homoeopathic ingredient.

 

2432

GOLDEN ROD HERB DRY

A, E, H

 

2433

GOLDEN SEAL ROOT DRY

A, H

 

2434

GOLDEN SEAL ROOT POWDER

A, H

 

2435

GOLDEN SYRUP

E

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

 

2436

GOMPHRENA GLOBOSA

A, H

 

2437

GOOSEBERRY

E

 

2438

GOSSYPIUM HERBACEUM

A, E, H

 

2439

GRAPE

E

 

2440

GRAPE SEED OIL

E

 

2441

GRAPE WINE RED

E

Ethanol is a mandatory component of grape wine red.

 

2442

GRAPE WINE SHERRY

E

Ethanol is a mandatory component of grape wine sherry.

 

2443

GRAPE WINE WHITE

E

Ethanol is a mandatory component of grape wine white.

 

2444

GRAPEFRUIT

E

 

2445

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%.

 

2446

GRAPEFRUIT OIL COLDPRESSED

A, E, H

 

2447

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%.

 

2448

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%.

 

2449

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%.

 

2450

GRAPHITE

H

Only for use as an active homoeopathic ingredient.

 

2451

GRATIOLA LINIFOLIA

A, H

 

2452

GREATER NETTLE HERB DRY

A, H

 

2453

GREATER NETTLE HERB POWDER

A, H

 

2454

GREATER NETTLE ROOT DRY

A, H

 

2455

GREATER NETTLE ROOT POWDER

A, H

 

2456

GREEN LIPPED MUSSEL

A

The following warning statement is required on the medicine label:

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

 

2457

GREEN LIPPED MUSSEL DRIED

A

The following warning statement is required on the medicine label:

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

 

2458

GREEN LIPPED MUSSEL OIL

A

The following warning statement is required on the medicine label:

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

 

2459

GREEN S

E

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

 

2460

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.'

 

2461

GRINDELIA CAMPORUM

A, H

 

2462

GRINDELIA ROBUSTA

A, H

 

2463

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%.

 

2464

GROUND IVY HERB DRY

A, H

 

2465

GROUND IVY HERB POWDER

A, H

 

2466

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%.

 

2467

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%.

 

2468

GUAIACUM OFFICINALE

A, E, H

 

2469

GUAIACUM RESIN

A, E, H

 

2470

GUAIACUM SANCTUM

A, H

 

2471

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%.

 

2472

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%.

 

2473

GUANINE

E

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

 

2474

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.

 

2475

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).

 

2476

GUAR GUM

A, E, H

 

2477

GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE

E

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

 

2478

GUAREA RUSBYI

A, H

 

2479

GUAVA

E

 

2480

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%.

 

2481

GYMNADENIA NIGRA

A

 

2482

GYMNEMA SYLVESTRE

A, H

 

2483

GYMNOCLADUS DIOICA

A, H

 

2484

GYNOSTEMMA PENTAPHYLLUM

A

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

 

2485

HAHNEMANN'S SOLUBLE MERCURY

H

Only for use as an active homoeopathic ingredient.

 

2486

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.’

 

2487

HAMAMELIS LEAF DRY

A, H

 

2488

HAMAMELIS LEAF POWDER

A, H

 

2489

HAMAMELIS VIRGINIANA

A, E, H

 

2490

HAMAMELIS WATER

A, E, H

 

2491

HANDROANTHUS HEPTAPHYLLUS

A, H

 

2492

HANDROANTHUS IMPETIGINOSUS

A, E, H

 

2493

HARD FAT

E

 

2494

HARD PARAFFIN

E

 

2495

HARICOT BEAN

E

 

2496

HARPAGOPHYTUM PROCUMBENS

A, E, H

 

2497

HARUNGANA MADAGASCARIENSIS

A, H

 

2498

HAZEL NUT

E

 

2499

HAZEL NUT OIL

E

 

2500

HEAVY KAOLIN

E

 

2501

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.

 

2502

HECTORITE

E

Only for use in topical medicines for dermal application.

 

2503

HEDEOMA PULEGIOIDES

A

 

2504

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%.

 

2505

HEDTA

E

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

 

2506

HEKLA LAVA

H

Only for use as an active homoeopathic ingredient.

 

2507

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%.

 

2508

HELIANTHEMUM NUMMULARIUM

A, H

 

2509

HELIANTHUS ANNUUS

A, E, H

 

2510

HELIANTHUS TUBEROSUS

A, H

 

2511

HELICHRYSUM ANGUSTIFOLIUM

A, E, H

 

2512

HELICHRYSUM ARENARIUM

A, H

 

2513

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%.

 

2514

HELLEBORUS NIGER

A, H

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

 

2515

HELLEBORUS VIRIDIS

A, H

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

 

2516

HELONIAS RHIZOME DRY

A, H

 

2517

HELONIAS RHIZOME POWDER

A, H

 

2518

HEMIDESMUS INDICUS

A, E, H

 

2519

HEMP SEED OIL

A, E

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

Cannabidiol and tetrahydrocannabinols are mandatory components of hemp seed oil.

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

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

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

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

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

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

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

 

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%.

 

2675

HYPERICUM ASCYRON

A, H

 

2676

HYPERICUM JAPONICUM

A, H

 

2677

HYPERICUM PERFORATUM

A, E, H

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

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

 

2678

HYPROLOSE

E

 

2679

HYPROMELLOSE

E

 

2680

HYPROMELLOSE PHTHALATE

E

 

2681

HYPTIS SUAVEOLENS

A, H

 

2682

HYSSOPUS OFFICINALIS

A, E, H

 

2683

IBERIS AMARA

A, H

 

2684

ICHTHAMMOL

H

Only for use as an active homoeopathic ingredient. 

 

2685

ILEX AQUIFOLIUM

A, H

 

2686

ILEX CHINENSIS

A, H

 

2687

ILEX PARAGUARIENSIS

A, E, H

Caffeine is a mandatory component of Ilex paraguariensis.

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

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

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

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

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

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

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

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

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

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

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

 

2688

ILEX ROTUNDA

A, H

 

2689

ILEX VERTICILLATA

A, H

 

2690

ILLICIUM VERUM

A, H

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

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

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

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

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

 

2691

IMIDUREA

E

Only for use in topical medicines for dermal application.

 

2692

IMMORTELLE

E

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

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

 

2693

IMMORTELLE OIL

E

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

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

 

2694

IMPATIENS

E

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

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

 

2695

IMPATIENS BALSAMINA

A, H

 

2696

IMPATIENS GLANDULIFERA

A, H

 

2697

IMPERATA CYLINDRICA

A, E, H

 

2698

INDIGO CARMINE

E

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

 

2699

INDIGO CARMINE ALUMINIUM LAKE

E

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

 

2700

INDIGOFERA TINCTORIA

A, H

 

2701

INDISAN

E

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

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

 

2702

INDOLE

E, H

Only for use as an active homoeopathic or excipient ingredient.

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

 

2703

INDOLENE

E

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

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

 

2704

INDUSTRIAL METHYLATED SPIRIT

E

 

2705

INOSITOL

A, E

 

2706

INULA BRITANNICA

A, H

 

2707

INULA HELENIUM

A, E, H

 

2708

INULA RACEMOSA

A, H

 

2709

INULIN

A, E

 

2710

INULIN LAURYL CARBAMATE

E

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

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

 

2711

INVERT SUGAR

E

 

2712

INVERT SYRUP

E

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

 

2713

IODINE

H

Only for use as an active homoeopathic ingredient.

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

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

 

2714

IODOPROPYNYL BUTYLCARBAMATE

E

For use as an excipient ingredient in topical medicines only.

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

 

2715

IONONE

E

Permitted for use only:

(a) in topical medicines for dermal application; and

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

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

 

2716

IOPAMIDOL

E

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

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

 

2717

IPECACUANHA DRY

A, H

Emetine is a mandatory component of Ipecacuanha Dry.

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

 

2718

IPECACUANHA POWDER

A, H

Emetine is a mandatory component of Ipecacuanha Powder.

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

 

2719

IPECACUANHA PREPARED

A, H

Emetine is a mandatory component of Ipecacuanha Prepared.

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

 

2720

IPECACUANHA ROOT LIQUID EXTRACT

A, H

Emetine is a mandatory component of Ipecacuanha root liquid extract.

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

 

2721

IPOMOEA BATATAS

A, H

 

2722

IPOMOEA JALAPA

A, H

 

2723

IRIDOPHYCUS FLACCIDUM

A, H

Iodine is a mandatory component of Iridophycus flaccidum.

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

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

 

2724

IRIS DOMESTICA

A, H

 

2725

IRIS FLORENTINA

A, H

 

2726

IRIS GERMANICA

A, H

 

2727

IRIS PALLIDA

A, H

 

2728

IRIS TENAX

H

 

2729

IRIS VERSICOLOR

A, H

 

2730

IRON

A, H

Only for use in oral medicines.

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

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

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

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

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

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

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

 

2731

IRON (II) BISGLYCINE SULFATE TRIHYDRATE

A

Only for use in oral medicines.

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

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

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

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

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

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

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

 

2732

IRON (II) GLYCINATE

A

Only for use in oral medicines.

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

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

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

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

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

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

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

 

2733

IRON (III) GLYCINATE

A

Only for use in oral medicines.

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

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

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

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

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

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

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

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

 

2734

IRON AMINO ACID CHELATE

A, H

Only for use in oral medicines.

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

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

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

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

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

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

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

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

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

 

2735

IRON OXIDE BLACK

E

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

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

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

 

2736

IRON OXIDE RED

E

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

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

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

 

2737

IRON OXIDE YELLOW

E

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

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

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

 

2738

IRON PHOSPHATE

A, E, H

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

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

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

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

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

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

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

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

 

2739

IRONE

E

 

2740

IRVINGIA GABONENSIS SEED TRIGLYCERIDES

E

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

The concentration must be no more than 0.375%.

 

2741

ISATIS TINCTORIA

A, H

 

2742

ISOAMBRETTOLIDE

E

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

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

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

 

2743

ISOAMYL 2-METHYLBUTYRATE

E

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

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

 

2744

ISOAMYL ACETATE

E

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

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

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

 

2745

ISOAMYL ALCOHOL

E

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

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

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

 

2746

ISOAMYL BENZOATE

E

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

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

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

 

2747

ISOAMYL BUTYRATE

E

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

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

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

 

2748

ISOAMYL CAPRYLATE

E

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

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

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

 

2749

ISOAMYL CINNAMATE

E

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

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

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

 

2750

ISOAMYL CITRONELLYL KETONE

E

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

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

 

2751

ISOAMYL FORMATE

E

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

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

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

 

2752

ISOAMYL HEXANOATE

E

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

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

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

 

2753

ISOAMYL ISOBUTYRATE

E

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

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

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

 

2754

ISOAMYL ISOVALERATE

E

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

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

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

 

2755

ISOAMYL LAURATE

E

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

The concentration must be no more than 12%.

 

2756

ISOAMYL METHOXYCINNAMATE

A

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

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

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

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

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

 

2757

ISOAMYL PHENYLACETATE

E

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

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

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

 

2758

ISOAMYL PHENYLETHYL ETHER

E

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

The total fragrance proprietary excipient formulation in a medicine must be no more than 1%.

 

2759

ISOAMYL PROPIONATE

E

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

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

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

 

2760

ISOAMYL SALICYLATE

E

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

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

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

 

2761

ISOBERGAMIATE

E

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

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

 

2762

ISOBORNEOL

E

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

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

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

 

2763

ISOBORNYL ACETATE

E

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

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

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

 

2764

ISOBORNYL CYCLOHEXANOL

E

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

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

 

2765

ISOBUTANE

E

Only for use in topical medicines for dermal application.

 

2766

ISOBUTYL ACETATE

E

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

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

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

 

2767

ISOBUTYL ALCOHOL

E

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

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

 

2768

ISOBUTYL BENZOATE

E

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

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

 

2769

ISOBUTYL BENZYL CARBINOL

E

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

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

 

2770

ISOBUTYL BUTYRATE

E

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

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

 

2771

ISOBUTYL CAPROATE

E

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

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

 

2772

ISOBUTYL CINNAMATE

E

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

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

 

2773

ISOBUTYL FORMATE

E

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

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

 

2774

ISOBUTYL HYDROXYBENZOATE

E

Only for use in topical medicines for dermal application.

 

2775

ISOBUTYL ISOBUTYRATE

E

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

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

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

 

2776

ISOBUTYL ISOVALERATE

E

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

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

 

2777

ISOBUTYL PHENYLACETATE

E

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

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

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

 

2778

ISOBUTYL PROPIONATE

E

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

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

 

2779

ISOBUTYL QUINOLINE

E

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

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

 

2780

ISOBUTYL SALICYLATE

E

Only for use in topical medicines for dermal application.

 

2781

ISOBUTYLENE/ISOPRENE COPOLYMER

E

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

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

 

2782

ISOBUTYRALDEHYDE

E

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

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

 

2783

ISOBUTYRIC ACID

E

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

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

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

 

2784

ISOCETYL ALCOHOL

E

Only for use in topical medicines for dermal application.

 

2785

ISOCETYL LINOLEOYL STEARATE

E

Only for use in topical medicines for dermal application.

 

2786

ISOCETYL STEARATE

E

Only for use in topical medicines for dermal application.

 

2787

ISOCETYL STEAROYL STEARATE

E

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

The concentration must be no more than 10%.

 

2788

ISOCYCLOCITRAL

E

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

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

 

2789

ISODECYL ISONONANOATE

E

Only for use in topical medicines for dermal application.

 

2790

ISODECYL NEOPENTANOATE

E

Only for use in topical medicines for dermal application.

 

2791

ISODECYL OLEATE

E

Only for use in topical medicines for dermal application.

 

2792

ISODECYL SALICYLATE

E

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

The concentration must be no more than 2%.

 

2793

ISODODECANE

E

Only for use in topical medicines for dermal application.

 

2794

ISOEICOSANE

E

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

The concentration must be no more than 2%.

 

2795

ISOEUGENOL

E

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

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

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

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

 

2796

ISOEUGENYL ACETATE

E

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

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

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

 

2797

ISOEUGENYL BENZYL ETHER

E

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

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

 

2798

ISOHEXADECANE

E

Only for use in topical medicines for dermal application.

 

2799

ISOJASMONE

E

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

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

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

 

2800

ISOLEUCINE

A, E

 

2801

ISOMALT

E

 

2802

ISOMENTHONE

E

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

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

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

 

2803

ISOMETHYLIONONE

E

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

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

 

2804

ISONONYL ACETATE

E

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

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

 

2805

ISONONYL ISONONANOATE

E

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

The concentration must be no more than 15%.

 

2806

ISOPENTANE

E

For dental use only.

The concentration must be no more than 2%.

 

2807

ISOPENTANOIC ACID