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Skinoren Cream (2011)

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 a full list of excipients, see Section 6.1.

Chemical substance
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
  • Arlatone 983S (polyoxyethylene fatty acid ester)
  • Cutina CBS (mixture of mono-diglycerides, fatty alcohols, triglycerides and wax esters)
  • Cetearyl octanoate
  • Propylene glycol
  • Glycerol 85% (E422)
  • Benzoic acid (E210)
  • Purified water

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
Authorization dates

Intendis GmbH
Max-Dohrn-Strasse 10
D-10589
Berlin
Germany

Date of first authorisation: 12 December 1989

Date of latest renewal: 24 November 2005

Marketing authorization number:

PL 28428/0005