SKINOREN Cream

Active ingredients: Azelaic acid

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 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
Austria, Cyprus, France, Hong Kong, Ireland, Lithuania, Singapore, United Kingdom