EPIDUO Gel Ref.[50792] Active ingredients: Adapalene Benzoyl peroxide

Source: Medicines and Medical Devices Safety Authority (NZ)  Revision Year: 2019  Publisher: Healthcare Logistics, 58 Richard Pearce Drive, Airport Oaks, AUCKLAND, Telephone (09) 9185100

Product name and form

Epiduo topical gel.

Pharmaceutical Form

Epiduo is a white to very pale yellow opaque gel containing in each 1 g of gel, adapalene 1 mg (0.1%) and benzoyl peroxide 25 mg (2.5%).

Qualitative and quantitative composition

Adapalene 0.1% / benzoyl peroxide 2.5% gel.

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.

Benzoyl peroxide

Benzoyl peroxide is a highly lipophilic, oxidising agent with keratolytic and bacteriocidal effects. The effectiveness of benzoyl peroxide in the treatment of acne vulgaris is primarily attributable to its antibacterial activity, especially with respect to Propionibacterium acnes. Benzoyl peroxide is also believed to be effective in the treatment of acne on account of its anti-inflammatory and mild keratolytic properties.

List of Excipients

Disodium edetate
Docusate sodium
Glycerin
Poloxamer
Propylene glycol (E1520)
Simulgel 600PHA (copolymer of acrylamide and sodium acryloyldimethyltaurate,
isohexadecane, polysorbate 80, sorbitan oleate)
Purified water

Pack sizes and marketing

2 g, 5 g, 15 g, 30 g, 45 g, 60 g and 90g HDPE tubes closed with a white polypropylene screw-cap.

15 g, 30 g, 45 g and 60 g PP bottles with pump, closed with a PP cap.

Not all pack sizes may be marketed.

Marketing authorization holder

Healthcare Logistics, 58 Richard Pearce Drive, Airport Oaks, AUCKLAND, Telephone (09) 9185100

Marketing authorization dates and numbers

7 April 2011

Drugs

Drug Countries
EPIDUO Austria, Australia, Brazil, Cyprus, Ecuador, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Japan, Lithuania, Malta, New Zealand, Poland, Romania, Singapore, Tunisia, United Kingdom, United States

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