| 2. Qualitative and Quantitative Composition
Podophyllotoxin 1.5 mg/g (0.15% w/w).
The cream also contains the following excipients:
Methyl parahydroxybenzoate E218
Propyl parahydroxybenzoate E216
Sorbic acid
Stearyl alcohol
Cetyl alcohol
Butylhydroxyanisole (BHA) E320
For a full list of excipients, see section 6.1
4.4. Special Warnings and Precautions for Use
Avoid contact with eyes. Should the cream accidentally come into the eye, the eye should be thoroughly rinsed with water.
The hands should be thoroughly washed after each application. Prolonged contact with healthy skin must be avoided since cream contains an active pharmaceutical substance which could be harmful on healthy skin.
This cream contains:
· methyl and propyl parahydroxybenzoate which may cause allergic reactions (possibly delayed).
· sorbic acid, stearyl alcohol and cetyl alcohol which may cause local skin reactions, (e.g. contact dermatitis).
· butylhydroxyanisole which may cause local skin reactions (e.g.contact dermatitis), or irritation to the eyes and mucous membranes.
6.2 Not applicable.
6.4 This medicinal product does not require any special storage conditions
9. Date of first authorisation: 26th April 1999
Date of last renewal: 17th January 2010
10. 17th January 2010
|
