2121

FABIANA IMBRICATA

A, H

2122

FAGOPYRUM ESCULENTUM

A, H

2123

FAGUS GRANDIFOLIA

A, H

2124

FAGUS SYLVATICA

A, H

2125

FALLOPIA MULTIFLORA

A, H

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

- (FALLMUL) 'Warning: Fallopia multiflora may harm the liver in some people. Use under the supervision of a healthcare professional.'

2126

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%.

2127

FAST GREEN FCF

E

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

2128

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%.

2129

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%.

2130

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%.

2131

FENNEL BITTER SEED DRY

A, E, H

When used in oral medicines and the medicine is listed in the Register on or after 1 October 2017 the medicine must have the following statements on the medicine 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 used in oral medicines and the medicine is listed in the Register before 1 October 2017 the medicine requires the following statements on the medicine label if supplied after 1 April 2019:

- (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.'

2132

FENNEL LEAF

E

2133

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 medicine requires the following warning statement on the medicine 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 and the medicine is listed in the Register on or after 1 October 2017 the medicine must have the following statements on the medicine 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 used in oral medicines and the medicine is listed in the Register before 1 October 2017 the medicine requires the following statements on the medicine label if supplied after 1 April 2019:

- (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.'

2134

FENNEL SWEET SEED DRY

A, E, H

When used in oral medicines and the medicine is listed in the Register on or after 1 October 2017 the medicine must have the following statements on the medicine 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 used in oral medicines and the medicine is listed in the Register before 1 October 2017 the medicine requires the following statements on the medicine label if supplied after 1 April 2019:

- (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.'

2135

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%.

2136

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%.

2137

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 and the medicine is listed in the Register on or after 1 October 2017 the medicine must have the following statement on the medicine label:

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

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 and the medicine is listed in the Register before 1 October 2017 the medicine requires the following statement on the medicine label if supplied after 1 April 2019:

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

2138

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).

2139

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).

2140

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).

2141

FERRIC OXIDE

E

2142

FERRIC PHOSPHATE

H

Only for use as an active homoeopathic ingredient.

2143

FERRIC PYROPHOSPHATE

A, 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).

2144

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.

2145

FERROSOFERRIC PHOSPHATE

H

Only for use as an active homoeopathic ingredient.

2146

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 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).

2147

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).

2148

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).

2149

FERROUS IODIDE

H

Only for use as an active homoeopathic ingredient.

2150

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).

2151

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).

2152

FERROUS PICRATE

H

Only for use as an active homoeopathic ingredient.

2153

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).

2154

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).

2155

FERULA ASSA-FOETIDA

A, E, H

2156

FERULA FOETIDA

A, E, H

2157

FERULA GALBANIFLUA

A, E, H

2158

FERULA RUBRICAULIS

A, E, H

2159

FERULA SUMBUL

A, H

2160

FERULIC ACID

E

Only for use in topical medicines for dermal application.

2161

FESTUCA ELATIOR

A, H

2162

FEVERFEW HERB DRY

A, H

2163

FEVERFEW HERB POWDER

A, H

2164

FICUS CARICA

A, E, H

2165

FICUS PUMILA

A, H

2166

FIG

E

2167

FIG DRY

A, H

2168

FILIPENDULA ULMARIA

A, H

2169

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%.

2170

FIR NEEDLE OIL CANADIAN

A, E

2171

FIR NEEDLE OIL SIBERIAN

A, E

2172

FIRMIANA SIMPLEX

A, E, H

2173

FISH OIL - RICH IN OMEGA-3 ACIDS

A

Only for use in oral medicines.

2174

FLEMINGIA MACROPHYLLA

A, H

2175

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%.

2176

FLUORESCEIN SODIUM

E

2177

FOENICULUM VULGARE

A, E, H

When used in oral medicines and the medicine is listed in the Register on or after 1 October 2017 the medicine must have the following statements on the medicine 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 used in oral medicines and the medicine is listed in the Register before 1 October 2017 the medicine requires the following statements on the medicine label if supplied after 1 April 2019:

- (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 fitted on the container, and the medicine requires the following warning statement on the medicine label:

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

2178

FOLIC ACID

A

When for internal use, the maximum recommended daily dose must be no more than 500 micrograms of folic acid.

When folic acid, folinic acid, levomefolate salts and/or their derivatives are used in combination, the medicine must provide no more than a total of 500 micrograms of folic acid, folinic acid, levomefolate salts and/or their derivatives in total per daily dose.

When used in preparations indicated for reducing the risk of having a child with spina bifida/neural tube defects: a) the maximum daily dose must provide 400 – 500 micrograms of folic acid; and b) the following statement must be included on the label:

- (NEUR) 'Warning: Do not exceed the stated dose except on medical advice. If you have had a baby with a neural tube defect/spina bifida - seek specific medical advice (or words to that effect)’.

2179

FOOD ORANGE 6

E

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

2180

FOOD ORANGE 7

E

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

2181

FOOD RED 13

E

Permitted for use only as a colour for topical use.

2182

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%.

2183

FORMIC ACID

H

Only for use as an active homoeopathic ingredient.

2184

FORSYTHIA SUSPENSA

A, H

2185

FORTIFIED WINE

E

Ethanol is a mandatory component of fortified wine.

When the concentration of ethanol in the medicine is more than 3%, the medicine requires the following warning statement on the medicine label:

- (ETHAN) 'Contains ethanol or contains alcohol'.

2186

FRACTIONATED COCONUT OIL

E

2187

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.

2188

FRAGARIA CHILOENSIS

A, E, H

2189

FRAGARIA VESCA

A, E, H

2190

FRAGARIA VIRGINIANA

A, E, H

2191

FRAGARIA X ANANASSA

A, E, H

2192

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'

- (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]'

- (S) 'If symptoms persist consult your healthcare practitioner [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)]'

- (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]'

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

2193

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'

- (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]'

- (S) 'If symptoms persist consult your healthcare practitioner [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)]'

- (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]'

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

2194

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'

- (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]'

- (S) 'If symptoms persist consult your healthcare practitioner [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)]'

- (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]'

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

2195

FRAXINUS AMERICANA

A, H

2196

FRAXINUS CHINENSIS SUBSP. RHYNCHOPHYLLA

A, H

2197

FRAXINUS EXCELSIOR

A, H

The components Nuzhenide and secoiridoid glucoside GL3 are only available when the plant part is seed.

2198

FRAXINUS ORNUS

A, H

2199

FRITILLARIA CIRRHOSA

A, H

2200

FRITILLARIA THUNDBERGII

A, H

2201

FRITILLARIA VERTICILLATA

A, H

2202

FRUCTOOLIGOSACCHARIDES

A, E

2203

FRUCTOSE

A, E, H

2204

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.

2205

FUMARIA OFFICINALIS

A, E, H

2206

FUMARIC ACID

E, H

Only for use as an active homoeopathic or excipient ingredient.

2207

FUMITORY HERB DRY

A, H

2208

FUMITORY HERB POWDER

A, H

2209

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%.

2210

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%.

2211

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%.

2212

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%.

2213

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%.

2214

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%.

2215

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%.

2216

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%.

2217

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%.

2218

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%.

2219

GALEGA OFFICINALIS

A, H

2220

GALEOPSIS SEGETUM

A, H

2221

GALIUM APARINE

A, H

2222

GALIUM ODORATUM

A, H

When used as an active ingredient coumarin is a mandatory component of Galium odoratum and the maximum daily dose of the medicine must contain no more than 0.001% of coumarin.

2223

GALIUM PALUSTRE

A, H

2224

GALIUM VERUM

A, H

2225

GALL STONE

H

Only for use as an active homoeopathic ingredient.

2226

GALPHIMIA GLAUCA

A, H

2227

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%.

2228

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%.

2229

GAMMA-CYCLODEXTRIN

E

2230

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%.

2231

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%.

2232

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%.

2233

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%.

2234

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%.

2235

GAMMA-LINOLEIC ACID

E

Only for use in topical medicines for dermal application.

2236

GAMMA-LINOLENIC ACID

E

2237

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%.

2238

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%.

2239

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%.

2240

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%.

2241

GAMMA-TOCOPHEROL

E

2242

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%.

2243

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%.

2244

GANODERMA LUCIDUM

A, E, H

2245

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.

2246

GARCINIA QUAESITA

A, H

2247

GARDEN BEAN

E

2248

GARDENIA JASMINOIDES

A, E

2249

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%

2250

GARLIC BULB DRY

A, E, H

2251

GARLIC BULB FRESH

A, H

2252

GARLIC BULB POWDER

A, E, H

2253

GARLIC CLOVE POWDER

A, H

2254

GARLIC OIL

A, E, H

2255

GASTRODIA ELATA

A, H

2256

GAULTHERIA PROCUMBENS

A, E, H

Methyl salicylate is a mandatory component of Gaultheria procumbens and must be declared in the application.

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

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

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

2257

GELATIN

A, E

2258

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.

2259

GELLAN GUM

E

2260

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%.

2261

GELSEMIUM POWDER

A, H

2262

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%.

2263

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%.

2264

GENTIAN DRY

A, H

2265

GENTIAN POWDER

A, H

2266

GENTIANA LUTEA

A, E, H

2267

GENTIANA MACROPHYLLA

A, H

2268

GENTIANA RHODANTHA

A, H

2269

GENTIANA SCABRA

A, H

2270

GENTIANELLA AMARELLA

A, H

2271

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%.

2272

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%.

2273

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%.

2274

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%.

2275

GERANIUM MACULATUM

A, E, H

2276

GERANIUM OIL

A, E, H

2277

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%.

2278

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%.

2279

GERANIUM ROBERTIANUM

A, E, H

2280

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%.

2281

GERANIUM SIBIRICUM

A, E, H

2282

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%.

2283

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%.

2284

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%.

2285

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%.

2286

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%.

2287

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%.

2288

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%.

2289

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%.

2290

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%.

2291

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%.

2292

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%.

2293

GEUM RIVALE

A, H

2294

GEUM URBANUM

A, H

2295

GHATTI GUM

A, E, H

2296

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.

2297

GINGER DRY

A, E, H

2298

GINGER OIL

A, E, H

2299

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%.

2300

GINGER POWDER

A, E, H

2301

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.

2302

GLACIAL ACETIC ACID

E, H

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

2303

GLECHOMA HEDERACEA

A, H

2304

GLECHOMA LONGITUBA

A, H

2305

GLEDITSIA AUSTRALIS

A, H

2306

GLEDITSIA SINENSIS

A, H

2307

GLEHNIA LITTORALIS

A, H

2308

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%.

2309

GLUCOMANNAN

E

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

2310

GLUCONOLACTONE

E

2311

GLUCOSAMINE HYDROCHLORIDE

A, E

When derived from seafood, the medicine requires the following warning statement on the medicine label:

- (SFOOD) 'Derived from seafood'.

2312

GLUCOSAMINE SULFATE

A

When derived from seafood, the medicine requires the following warning statement on the medicine label:

- (SFOOD) 'Derived from seafood'.

2313

GLUCOSAMINE SULFATE POTASSIUM CHLORIDE

A

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

When derived from seafood, the medicine requires the following warning statement on the medicine label:

- (SFOOD) 'Derived from seafood'.

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

- (POTAS) ‘Contains [amount of potassium in milligrams] mg of potassium. 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.’

2314

GLUCOSAMINE SULFATE SODIUM CHLORIDE

A

When derived from seafood, the medicine requires the following warning statement on the medicine label:

- (SFOOD) 'Derived from seafood'.

2315

GLUCOSE

A, E, H

When the medicine is for oral ingestion and the total amount of all sugars (monosaccharides and disaccharides such as glucose, honey, invert sugar, lactose, maltose, and sucrose) is more than 100mg in the maximum daily dose, then the medicine requires the following warning statement on the medicine label:

- (SUGARS) ‘Contains [insert name of sugar]’ if medicine contains one sugar OR ‘Contains sugars' (or words to that effect) if medicine contains two or more sugars.

If one of the sugars is lactose then the medicine also requires the following warning statement on the medicine label:

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

2316

GLUCOSE GLUTAMATE

E

Only for use in topical medicines for dermal application.

2317

GLUCOSE MONOHYDRATE

A, E, H

When the medicine is for oral ingestion and the total amount of all sugars (monosaccharides and disaccharides such as glucose monohydrate, honey, invert sugar, lactose, maltose, and sucrose) is more than 100mg in the maximum daily dose, then the medicine requires the following warning statement on the medicine label:

- (SUGARS) ‘Contains [insert name of sugar]’ if medicine contains one sugar OR ‘Contains sugars' (or words to that effect) if medicine contains two or more sugars.

If one of the sugars is lactose then the medicine also requires the following warning statement on the medicine label:

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

2318

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%.

2319

GLUTAMIC ACID

A, E

Only for use in topical medicines for dermal application.

2320

GLUTAMIC ACID HYDROCHLORIDE

A, E, H

2321

GLUTAMINE

A, E, H

2322

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%.

2323

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).

2324

GLUTEN-FREE WHEAT STARCH

E

2325

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%.

2326

GLYCEROL

A, E

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

2327

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.

2328

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%.

2329

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%.

2330

GLYCERYL DIISOSTEARATE

E

For use in topical medicines for dermal application.

2331

GLYCERYL DILAURATE

E

Only for use in topical medicines for dermal application.

2332

GLYCERYL DIOLEATE

E

Only for use in topical medicines for dermal application.

2333

GLYCERYL DISTEARATE

E

Only for use in topical medicines for dermal application.

2334

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%.

2335

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%.

2336

GLYCERYL LAURATE

E

Only for use in topical medicines for dermal application.

2337

GLYCERYL LINOLEATE

E

Only for use in topical medicines for dermal application.

2338

GLYCERYL LINOLENATE

E

Only for use in topical medicines for dermal application.

2339

GLYCERYL MONOOLEATE

E

2340

GLYCERYL MONOSTEARATE

E

2341

GLYCERYL MYRISTATE

E

Only for use in topical medicines for dermal application.

2342

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.

2343

GLYCERYL PALMITO-STEARATE

E

2344

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%.

2345

GLYCERYL POLYMETHACRYLATE

E

Only for use in topical medicines for dermal application.

2346

GLYCERYL RICINOLEATE

E

Only for use in topical medicines for dermal application.

2347

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.

2348

GLYCERYL SORBITAN OLEOSTEARATE

E

Only for use in topical medicines for dermal application.

2349

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.

2350

GLYCERYL STEARATE CITRATE

E

Only for use in topical medicines for dermal application.

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

2351

GLYCERYL TRIACETYL HYDROXYSTEARATE

E

Only for use in topical medicines for dermal application.

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

2352

GLYCERYL TRIACETYL RICINOLEATE

E

Only for use in topical medicines for dermal application.

2353

GLYCERYL TRINITRATE

H

Only for use as an active homoeopathic ingredient.

2354

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%.

2355

GLYCINE

A, E

2356

GLYCINE MAX

A, E, H

2357

GLYCOGEN

E

Only for use in topical medicines for dermal application.

2358

GLYCOL DISTEARATE

E

Only for use in topical medicines for dermal application.

2359

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.

2360

GLYCYRRHIZA GLABRA

A, E, H

2361

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%.

2362

GLYCYRRHIZA URALENSIS

A, E, H

2363

GLYCYRRHIZINIC ACID

E

2364

GNAPHALIUM AFFINE

A, H

2365

GNAPHALIUM POLYCEPHALUM

A, H

2366

GNAPHALIUM ULIGINOSUM

A, H

2367

GOAT

H

Only for use as an active homoeopathic ingredient.

2368

GOAT MILK

E

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

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

2369

GOLD

E, H

Only for use as an active homoeopathic or excipient ingredient.

2370

GOLD CHLORIDE

H

Only for use as an active homoeopathic ingredient.

2371

GOLDEN ROD HERB DRY

A, E, H

2372

GOLDEN SEAL ROOT DRY

A, H

2373

GOLDEN SEAL ROOT POWDER

A, H

2374

GOLDEN SYRUP

E

Sucrose is a mandatory component of Golden syrup when the route of administration of the medicine is oral or sublingual.

When the medicine is for oral ingestion and the total amount of all sugars (monosaccharides and disaccharides such as glucose, honey, invert sugar, lactose, maltose, and sucrose) is more than 100mg in the maximum daily dose, then the medicine requires the following warning statement on the medicine label:

- (SUGARS) ‘Contains [insert name of sugar]’ if medicine contains one sugar OR ‘Contains sugars' (or words to that effect) if medicine contains two or more sugars.

If one of the sugars is lactose then the medicine also requires the following warning statement on the medicine label:

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

2375

GOMPHRENA GLOBOSA

A, H

2376

GOOSEBERRY

E

2377

GOSSYPIUM HERBACEUM

A, E, H

2378

GRAPE

E

2379

GRAPE SEED OIL

E

2380

GRAPE WINE RED

E

Ethanol is a mandatory component of Grape wine red.

When the concentration of ethanol in the medicine is more than 3%, the medicine requires the following warning statement on the medicine label:

- (ETHAN) ‘Contains ethanol’ or ‘contains alcohol’

2381

GRAPE WINE SHERRY

E

Ethanol is a mandatory component of Grape wine sherry.

When the concentration of ethanol in the medicine is more than 3%, the medicine requires the following warning statement on the medicine label:

- (ETHAN) ‘Contains ethanol’ or ‘contains alcohol’

2382

GRAPE WINE WHITE

E

Ethanol is a mandatory component of Grape wine white.

When the concentration of ethanol in the medicine is more than 3%, the medicine requires the following warning statement on the medicine label:

- (ETHAN) ‘Contains ethanol’ or ‘contains alcohol’

2383

GRAPEFRUIT

E

2384

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%.

2385

GRAPEFRUIT OIL COLDPRESSED

A, E, H

2386

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%.

2387

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%.

2388

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%.

2389

GRAPHITE

H

Only for use as an active homoeopathic ingredient.

2390

GRATIOLA LINIFOLIA

A, H

2391

GREATER NETTLE HERB DRY

A, H

2392

GREATER NETTLE HERB POWDER

A, H

2393

GREATER NETTLE ROOT DRY

A, H

2394

GREATER NETTLE ROOT POWDER

A, H

2395

GREEN LIPPED MUSSEL

A

2396

GREEN LIPPED MUSSEL DRIED

A

2397

GREEN LIPPED MUSSEL OIL

A

2398

GREEN S

E

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

2399

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.'

2400

GRINDELIA CAMPORUM

A, H

2401

GRINDELIA ROBUSTA

A, H

2402

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%.

2403

GROUND IVY HERB DRY

A, H

2404

GROUND IVY HERB POWDER

A, H

2405

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%.

2406

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%.

2407

GUAIACUM OFFICINALE

A, E, H

2408

GUAIACUM RESIN

A, E, H

2409

GUAIACUM SANCTUM

A, H

2410

GUAIACWOOD 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 than 1%.

2411

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%.

2412

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%.

2413

GUANINE

E

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

2414

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.

2415

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).

2416

GUAR GUM

A, E, H

2417

GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE

E

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

2418

GUAREA RUSBYI

A, H

2419

GUAVA

E

2420

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%.

2421

GYMNADENIA NIGRA

A

2422

GYMNEMA SYLVESTRE

A, H

2423

GYMNOCLADUS DIOICA

A, H

2424

GYNOSTEMMA PENTAPHYLLUM

A

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

2425

GYNURA JAPONICA

A, H

2426

HAHNEMANN'S SOLUBLE MERCURY

H

Only for use as an active homoeopathic ingredient.

2427

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.’

2428

HAMAMELIS LEAF DRY

A, H

2429

HAMAMELIS LEAF POWDER

A, H

2430

HAMAMELIS VIRGINIANA

A, E, H

2431

HAMAMELIS WATER

A, E, H

2432

HANDROANTHUS HEPTAPHYLLUS

A, H

2433

HANDROANTHUS IMPETIGINOSUS

A, E, H

2434

HARD FAT

E

2435

HARD PARAFFIN

E

2436

HARICOT BEAN

E

2437

HARPAGOPHYTUM PROCUMBENS

A, E, H

2438

HARUNGANA MADAGASCARIENSIS

A, H

2439

HAZEL NUT

E

2440

HAZEL NUT OIL

E

2441

HEAVY KAOLIN

E

2442

HEAVY MAGNESIUM OXIDE

A, E, H

2443

HECTORITE

E

Only for use in topical medicines for dermal application.

2444

HEDEOMA PULEGIOIDES

A

2445

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%.

2446

HEDTA

E

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

2447

HEKLA LAVA

H

Only for use as an active homoeopathic ingredient.

2448

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%.

2449

HELIANTHEMUM NUMMULARIUM

A, H

2450

HELIANTHUS ANNUUS

A, E, H

2451

HELIANTHUS TUBEROSUS

A, H

2452

HELICHRYSUM ANGUSTIFOLIUM

A, E, H

2453

HELICHRYSUM ARENARIUM

A, H

2454

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%.

2455

HELLEBORUS NIGER

A, H

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

2456

HELLEBORUS VIRIDIS

A, H

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

2457

HELONIAS RHIZOME DRY

A, H

2458

HELONIAS RHIZOME POWDER

A, H

2459

HEMIDESMUS INDICUS

A, E, H

2460

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%.

2461

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%.

2462

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%.

2463

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%.

2464

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%.

2465

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%.

2466

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%.

2467

HERACLEUM HEMSLEYANUM

A, H

2468

HERNIARIA GLABRA

A, H

2469

HESPERIDIN

A, E

2470

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%.

2471

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%.

2472

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%.

2473

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%.

2474

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.

2475

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%.

2476

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%.

2477

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 %.

2478

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%.

2479

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%.

2480

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%.

2481

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%.

2482

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%.

2483

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%.

2484

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%.

2485

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%.

2486

HEXYL LAURATE

E

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

2487

HEXYL NICOTINATE

E

2488

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%.

2489

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%.

2490

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%.

2491

HEXYLENE GLYCOL

E

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

2492

HIBISCUS ESCULENTUS

A, H

2493

HIBISCUS MUTABILIS

A, H

2494

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%.

2495

HIBISCUS SABDARIFFA

A, E, H

2496

HIERACIUM PILOSELLA

A, H

2497

HIGH AMYLOSE MAIZE STARCH

A, E, H

2498

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.

2499

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%.

2500

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.

2501

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.'

2502

HIMATANTHUS LANCIFOLIUS

A, E, H

2503

HIPPOPHAE RHAMNOIDES

A, E, H

2504

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%.

2505

HISTAMINE DIHYDROCHLORIDE

H

Only for use as an active homoeopathic ingredient. 

2506

HISTIDINE

A

2507

HISTIDINE HYDROCHLORIDE

A, E, H

2508

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%.

2509

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%.

2510

HOLCUS LANATUS

A, H

2511

HOLY THISTLE HERB DRY

A, H

2512

HOLY THISTLE HERB POWDER

A, H

2513

HOMALOMENA OCCULTA

A, H

2514

HOMOSALATE

A, E

Only for use as an active ingredient in sunscreens.

In other products, 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 homosalate in the medicine must be no more than 15%.

2515

HONEY

A, E

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

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

When the medicine is for oral ingestion and the total amount of all sugars (monosaccharides and disaccharides such as glucose, honey, invert sugar, lactose, maltose, and sucrose) is more than 100mg in the maximum daily dose, then the medicine requires the following warning statement on the medicine label:

- (SUGARS) ‘Contains [insert name of sugar]’ if medicine contains one sugar OR ‘Contains sugars' (or words to that effect) if medicine contains two or more sugars.

If one of the sugars is lactose then the medicine also requires the following warning statement on the medicine label:

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

2516

HONEY BEE

H

Only for use as an active homoeopathic ingredient.

2517

HONEY EXTRACT

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 of the medicine must be no more than 1%.

2518

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%.

2519

HOP STROBILE DRY

A, H

2520

HOP STROBILE POWDER

A, H

2521

HOPS OIL

A, E, H

2522

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.

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

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

2523

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.

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

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

2524

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%.

2525

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).

2526

HOTTONIA PALUSTRIS

A, H

2527

HOUTTUYNIA CORDATA

A, H

2528

HOVENIA DULCIS

A, H

2529

HUMULUS LUPULUS

A, E, H

2530

HYALURONIC ACID

E

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

2531

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.

2532

HYDRANGEA ARBORESCENS

A, H

2533

HYDRANGEA PANICULATA

A, H

2534

HYDRASTIS CANADENSIS

A, E, H

2535

HYDRATED SILICA

E

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

2536

HYDROCHLORIC ACID

E

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

2537

HYDROCOTYLE UMBELLATA

A, H

2538

HYDROFLUORIC ACID

H

Only for use as an active homoeopathic ingredient. 

2539

HYDROGEN CYANIDE

H

Only for use as an active homoeopathic ingredient. 

2540

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.

2541

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%.

2542

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%.

2543

HYDROGENATED CASTOR OIL

E

2544

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%.

2545

HYDROGENATED COCONUT OIL

E

2546

HYDROGENATED COTTONSEED OIL

E

2547

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.

2548

HYDROGENATED ETHYLENE/PROPYLENE/STYRENE COPOLYMER

E

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

2549

HYDROGENATED LANOLIN

E

2550

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%.

2551

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%.

2552

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%.

2553

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%.

2554

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.

2555

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.

2556

HYDROGENATED POLYISOBUTENE

E

Only for use in topical medicines for dermal application.

2557

HYDROGENATED SOYA OIL

E

2558

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%.

2559

HYDROGENATED VEGETABLE OIL

E

2560

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%.

2561

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%

2562

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%

2563

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%.

2564

HYDROLYSED COLLAGEN

E

2565

HYDROLYSED ELASTIN

E

Only for use in topical medicines for dermal application.

2566

HYDROLYSED GELATIN

A, E

2567

HYDROLYSED GLYCOSAMINOGLYCANS

E

Only for use in topical medicines for dermal application.

2568

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%.

2569

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%.

2570

HYDROLYSED MAIZE STARCH

E

2571

HYDROLYSED MILK PROTEIN

E

2572

HYDROLYSED RICE

A, E, H

2573

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%.

2574

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%.

2575

HYDROLYSED VEGETABLE PROTEIN

E

2576

HYDROLYSED WHEAT PROTEIN

E

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

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

2577

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%.

2578

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%.

2579

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%.

2580

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.

2581

HYDROXOCOBALAMIN

A

2582

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%.

2583

HYDROXYAPATITE

A, E

2584

HYDROXYCITRATE COMPLEX

A

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

2585

HYDROXYCITRIC ACID

A

2586

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%.

2587

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%.

2588

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%.

2589

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%.

2590

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%.

2591

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%.

2592

HYDROXYLATED LANOLIN

E

2593

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%.

2594

HYDROXYLYSINE

A, E

2595

HYDROXYMETHYLCELLULOSE

E

2596

HYDROXYOCTACOSANYL HYDROXYSTEARATE

E

Only for use in topical medicines for dermal application.

2597

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%.

2598

HYDROXYPROLINE

A, E

2599

HYDROXYPROPYL DISTARCH PHOSPHATE

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 4%.

2600

HYDROXYPROPYL STARCH

E

2601

HYDROXYPROPYLBETADEX