SKINOREN Cream Ref.[6345] Active ingredients: Azelaic acid

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: LEO Laboratories Limited, Horizon, Honey Lane, Hurley, Maidenhead, Berkshire, SL6 6RJ, UK

Product name and form

Skinoren 20% Cream.

Pharmaceutical Form

Cream.

White, opaque cream.

Qualitative and quantitative composition

1 g of Skinoren Cream contains 200 mg (20% w/w) azelaic acid.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Azelaic acid

Azelaic Acid is a naturally occurring dicarboxylic acid. Azelaic acid possesses antibacterial, keratolytic, comedolytic, and anti-oxidant activity. Azelaic acid is bactericidal against Proprionibacterium acnes and Staphylococcus epidermidis due to its inhibitory effect on the synthesis of microbial cellular proteins.

List of Excipients

Benzoic acid (E210)
Cetearyl octanoate
Glycerol 85%
Glyceryl stearate + cetearyl alcohol + cetyl palmitate + cocoglycerides (CUTINA CBS)
Propylene glycol
Purified water
Stearoyl macrogolglycerides

Pack sizes and marketing

Tubes containing 20, 30 or 50 g. Not all pack sizes are marketed.

Aluminium tube with internal epoxide coating and polyethylene screw cap.

Marketing authorization holder

LEO Laboratories Limited, Horizon, Honey Lane, Hurley, Maidenhead, Berkshire, SL6 6RJ, UK

Marketing authorization dates and numbers

PL 00043/0236

Date of first authorisation: 12 December 1989
Date of latest renewal: 24 November 2005

Drugs

Drug Countries
SKINOREN Austria, Cyprus, Estonia, Finland, France, Hong Kong, Croatia, Ireland, Lithuania, New Zealand, Poland, Romania, Singapore, Turkey, United Kingdom, South Africa

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