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Dalacin Cream 2% (2012)

Product Name and Form

Dalacin Cream 2%.

Pharmaceutical form

Cream.

White, semi-solid.

Qualitative and Quantitative Composition

Each gram of cream contains clindamycin phosphate equivalent to 20 mg or 2.0% w/w clindamycin. Each applicator full of 5 grams of vaginal cream contains approximately 100 mg of clindamycin phosphate.

For Excipients, see section 6.1

List of excipients

Sorbitan stearate
Polysorbate 60
Propylene glycol
Stearic acid
Cetostearyl alcohol
Cetyl palmitate
Liquid paraffin
Benzyl alcohol
Water

Pack sizes and Marketing

Laminate tube (consisting of LMDPE and aluminium foil) with polypropylene cap containing 7.8 g, 20 g or 40 g cream, packed in cardboard carton, together with a leaflet.

Not all pack sizes may be marketed.

Marketing authorization holder
Authorization dates

Pharmacia Limited
Ramsgate Road
Sandwich Kent
CT13 9NJ
United Kingdom

Date of first authorisation: 27 April 1993 / Renewal 21st May 2001/ 7th August 2009

Marketing authorization number:

PL 0032/0176