ZINDACLIN Gel Ref.[27720] Active ingredients: Clindamycin

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2014  Publisher: Crawford Healthcare Ltd, Kind Edward Court, Kind Edward Road, Knutsford, Cheshire, WA16 0BE, United Kingdom

Product name and form

Zindaclin 1% Gel.

Pharmaceutical Form

Gel.

A white translucent gel.

Qualitative and quantitative composition

1g of gel contains 10mg clindamycin (1% w/w) equivalent to 11.88 mg clindamycin phosphate. Zindaclin 1% Gel also contains 40% w/w propylene glycol.

For a full list of excipients, see section 6.1.

Active Ingredient 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

Propylene glycol
Purified water
Ethanol 96%
Zinc acetate dihydrate
Hydroxyethylcellulose
Sodium hydroxide 30% (w/w)

Pack sizes and marketing

Zindaclin is packaged in 15g, 30g, 60g laminate tubes with a high-density polyethylene inner layer and a peelable membrane laminate seal covering the orifice. The tube is fitted with a white opaque polypropylene screw cap.

Not all pack sizes may be marketed.

Marketing authorization holder

Crawford Healthcare Ltd, Kind Edward Court, Kind Edward Road, Knutsford, Cheshire, WA16 0BE, United Kingdom

Marketing authorization dates and numbers

PA 1098/001/001

Date of first authorisation: 22 November 2002
Date of last renewal: 16 August 2006

Drugs

Drug Countries
ZINDACLIN Austria, Spain, Hong Kong, Ireland, Israel, Singapore, Turkey, United Kingdom

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