CLOMAZOL Vaginal cream Ref.[50650] Active ingredients: Clotrimazole

Source: Medicines and Medical Devices Safety Authority (NZ)  Revision Year: 2022  Publisher: Multichem NZ Ltd, Private Bag 93527, Takapuna, AUCKLAND 0740 Telephone: (09) 478 3841

Product name and form

Clomazol 1% vaginal cream.

Clomazol 2% vaginal cream.

Pharmaceutical Form

Clomazol 1% vaginal cream is presented as a white smooth semi-solid cream.

Clomazol 2% vaginal cream is presented as a white smooth semi-solid cream.

Qualitative and quantitative composition

Clomazol 1% vaginal cream contains 10 mg/g (1% w/w) of clotrimazole in a cream base.

Clomazol 2% vaginal cream contains 20 mg/g (2% w/w) of clotrimazole in a cream base.

See section 6.1 for the full list of excipients.

Active Ingredient Description
Clotrimazole

Clotrimazole acts against fungi by inhibiting ergosterol synthesis. Inhibition of ergosterol synthesis leads to structural and functional impairment of the fungal cytoplasmic membrane. Clotrimazole has a broad antimycotic spectrum of action in vitro and in vivo, which includes dermatophytes, yeasts, moulds, etc.

List of Excipients

Clomazol 1% and 2% Vaginal Cream:

Benzyl alcohol
Cetomacrogol 1000
Cetostearyl alcohol
Dimeticone
Disodium edetate
Glyceryl monostearate
Liquid paraffin
Propylene glycol
Purified water
White soft paraffin

Pack sizes and marketing

Clomazol 1%: tube containing 35 g of vaginal cream, 10 mg clotrimazole per gram (1% w/w) packed in a carton with six single-use disposable applicators and patient instruction sheet.

Clomazol 2%: tube containing 20 g of vaginal cream, 20 mg clotrimazole per gram (2% w/w) packed in a carton with three single-use disposable applicators and patient instruction sheet.

Not all strengths may be marketed.

Marketing authorization holder

Multichem NZ Ltd, Private Bag 93527, Takapuna, AUCKLAND 0740
Telephone: (09) 478 3841

Marketing authorization dates and numbers

Date of first approval:

Clomazol 1% vaginal cream – 2/10/2003
Clomazol 2% vaginal cream – 19/06/2008

Drugs

Drug Countries
CLOMAZOL Brazil, Ecuador, New Zealand

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