SPC, UK: SKINOREN Cream (2019)

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.

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
Authorization dates

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

Date of first authorisation: 12 December 1989

Date of latest renewal: 24 November 2005

Marketing authorization number:

PL 00043/0236