DIFFERIN Cream Ref.[6078] Active ingredients: Adapalene

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Galderma (UK) Limited, Meridien House, 69-71 Clarendon Road, Watford, Herts., WD17 1DS, UK

Product name and form

Differin 0.1% w/w Cream.

Pharmaceutical Form

Cream.

White shiny cream.

Qualitative and quantitative composition

Adapalene 0.1% w/w.

1g cream contains 1mg adapalene.

Excipients with known effect:

Methyl parahydroxybenzoate (E218)
Propyl parahydroxybenzoate (E216)

For the full list of excipients, see section 6.1.

Active Ingredient Description
Adapalene

Adapalene is a retinoid-like compound which in, in vivo and in vitro models of inflammation, has been demonstrated to possess anti-inflammatory properties. Mechanically, adapalene binds like tretinoin to specific retinoic acid nuclear receptors but, unlike tretinoin not to cytosolic receptor binding proteins. Adapalene is used in the treatment of acne and is also used (off-label) to treat keratosis pilaris as well as other skin conditions.

List of Excipients

Carbomer 934P
Macrogol-20 methyl glucose sesquistearate
Glycerol (E422)
Natural squalane
Methyl parahydroxybenzoate (E218)
Propyl parahydroxybenzoate (E216)
Disodium edetate
Methyl glucose sesquistearate
Phenoxyethanol
Cyclomethicone
Sodium hydroxide
Purified water

Pack sizes and marketing

Collapsible Aluminium tube coated internally with an epoxy-phenolic resin and fitted with a white Polypropylene screw cap. Pack sizes 5g (Sample Pack), 30g, 45g and 50g.

Not all pack sizes may be marketed.

Marketing authorization holder

Galderma (UK) Limited, Meridien House, 69-71 Clarendon Road, Watford, Herts., WD17 1DS, UK

Marketing authorization dates and numbers

PL 10590/0029

9 January 1998

Drugs

Drug Countries
DIFFERIN Austria, Brazil, Canada, Ecuador, Estonia, Finland, Hong Kong, Ireland, Japan, Lithuania, Netherlands, New Zealand, Poland, Singapore, Turkey, United Kingdom, United States, South Africa

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