DAKTARIN Cream Ref.[6991] Active ingredients: Miconazole

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2016  Publisher: McNeil Products Limited, Foundation Park, Roxborough Way, Maidenhead, Berkshire, SL6 3UG, United Kingdom

Product name and form

Daktarin 2% Cream.

Pharmaceutical Form

Cream.

White homogeneous cream.

Qualitative and quantitative composition

Miconazole nitrate 2% w/w.

Excipients: Benzoic acid, Butylated hydroxyanisole.

For a full list of excipients, see Section 6.1.

Active Ingredient Description
Miconazole

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

Aluminium tube inner lined with heat polymerised epoxy-phenol resin with a white polypropylene cap containing 15g, 30g or 70g of cream, or aluminium tube inner lined with heat polymerised epoxy-phenol resin with a high density polyethylene cap containing 5g of cream.

Not all pack sizes may be marketed.

Marketing authorization holder

McNeil Products Limited, Foundation Park, Roxborough Way, Maidenhead, Berkshire, SL6 3UG, United Kingdom

Marketing authorization dates and numbers

PL 15513/0307

01/04/2009

Drugs

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

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