GYNO-DAKTARIN Vaginal cream Ref.[6992] Active ingredients: Miconazole

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Janssen-Cilag Ltd, 50-100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4EG, UK

Product name and form

Gyno-Daktarin 20mg/g vaginal cream.

Pharmaceutical Form

Vaginal cream.

The cream is white and homogeneous.

Qualitative and quantitative composition

Miconazole nitrate 2% w/w.

(Each gram of cream contains 20mg miconazole nitrate)

Excipients: Each gram of cream contains 2mg benzoic acid and 5 micrograms of butylated hydroxyanisole.

For a full list of excipients, see section 6.1.

Active Ingredient Description

Miconazole possesses an antifungal activity against the common dermatophytes and yeasts as well as an antibacterial activity against certain gram-positive bacilli and cocci. Its activity is based on the inhibition of the ergosterol biosynthesis in fungi and the change in the composition of the lipid components in the membrane, resulting in fungal cell necrosis.

List of Excipients

PEG-6, PEG-32 and glycol stearate
Oleoyl macroglycerides
Liquid paraffin
Benzoic acid (E210)
Butylated hydroxyanisole (E320)
Purified water

Pack sizes and marketing

Tube containing 15 g, 40 g or 78 g of cream.

The aluminium tube inner is lined with heat polymerised epoxy-phenol resin with a white polypropylene cap.

The cream is supplied with disposable cardboard vaginal applicators.

* Not all pack sizes are marketed.

Marketing authorization holder

Janssen-Cilag Ltd, 50-100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4EG, UK

Marketing authorization dates and numbers

PL 00242/0015

12 December 2008


Drug Countries
DAKTARIN Austria, Australia, Brazil, Cyprus, Germany, Estonia, Spain, Finland, France, Ireland, Israel, Lithuania, Malta, Mexico, Netherlands, New Zealand, Poland, Singapore, Tunisia, United Kingdom, South Africa
GYNO-DAKTARIN Cyprus, Finland, Ireland, Mexico, Netherlands, United Kingdom, South Africa

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