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DALACIN CREAM Vaginal Cream (2021)

Active ingredients: Clindamycin

Product Name and Form

Dalacin Cream 2%.

Pharmaceutical form

Vaginal 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.

Excipients of known effect:

Dalacin Cream contains 160.5 mg cetostearyl alcohol in each 5 g applicator which is equivalent to 32.1 mg/g.

Dalacin Cream contains 250 mg propylene glycol in each 5 g applicator which is equivalent to 50 mg/g.

Dalacin Cream contains 50 mg benzyl alcohol in each 5 g applicator which is equivalent to 10 mg/g.

For the full list of excipients, see section 6.1.

Chemical substance
Description
Clindamycin

Clindamycin is a lincosamide antibiotic with a primarily bacteriostatic action against Gram-positive aerobes and a wide range of anaerobic bacteria. Lincosamides such as clindamycin bind to the 50S subunit of the bacterial ribosome and inhibit the early stages of protein synthesis.

List of excipients

Sorbitan stearate
Polysorbate 60
Propylene glycol (E1520)
Stearic acid
Cetostearyl alcohol
Cetyl palmitate
Liquid paraffin
Benzyl alcohol (E1519)
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

Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom

Date of first authorisation: 27 April 1993
Date of latest renewal 7th August 2009

Marketing authorization number:

PL 00057/0960