DALACIN T Topical solution Ref.[6727] Active ingredients: Clindamycin

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2017  Publisher: Pfizer Limited, Ramsgate Road, Sandwich Kent, CT13 9NJ, United Kingdom

Product name and form

Dalacin T Topical Solution.

Pharmaceutical Form

Topical solution.

Clear colourless aqueous solution.

Qualitative and quantitative composition

One ml of Dalacin T Topical Solution contains the equivalent of 10 mg Clindamycin.

Excipients with known effect: Propylene glycol 50 mg/ml.

For the 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

Isopropyl alcohol
Propylene glycol
Purified water
Hydrochloric acid (10%)
Sodium hydroxide (10%)

Pack sizes and marketing

Bottle: White high density polyethylene bottle containing 30 ml, 50 ml or 60 ml.

Cap: Prolypropylene, linerless screw caps or Polypropylene screw caps lined with laminated films consisting of polyethylene, polyvinylidene chloride (PVdc) and polyethylene.

Applicator: Low-density polyethylene applicator made by Dab-O-Matic.

Not all pack sizes may be marketed.

Marketing authorization holder

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

Marketing authorization dates and numbers

PL 00057/0962

Date of first authorisation: 18th January 1988
Date of latest renewal of authorisation: 7th August 2009

Drugs

Drug Countries
DALACIN T Estonia, Hong Kong, Ireland, Japan, Mexico, Netherlands, Poland, Singapore, United Kingdom, South Africa

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