BENZAC AC Gel Ref.[27768] Active ingredients: Benzoyl peroxide

Source: Medicines and Medical Devices Safety Authority (NZ)  Revision Year: 2018  Publisher: Sponsor and distributor in New Zealand: Healthcare Logistics, 58 Richard Pearse Drive, Airport Oaks, Auckland, New Zealand, Ph (09) 918 5100, Fax (09) 918 5101 For: Galderma Australia Pty Ltd, Suite 4, ...

Product name and form

BENZAC AC Gel.

Pharmaceutical Form

BENZAC AC Gel contains benzoyl peroxide 25mg/g or 50mg/g or 100mg/g in a white to off-white smooth gel.

Qualitative and quantitative composition

Benzoyl peroxide 25 mg/g, 50mg/g and 100 mg/g.

Active Ingredient Description
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

Docusate sodium, disodium edetate, poloxamer 182, carbomer 940, propylene glycol, acrylates copolymer, glycerol, purified water, citric acid and/or sodium hydroxide.

Pack sizes and marketing

50g plastic tube contained in a carton for each strength.

Marketing authorization holder

Sponsor and distributor in New Zealand: Healthcare Logistics, 58 Richard Pearse Drive, Airport Oaks, Auckland, New Zealand, Ph (09) 918 5100, Fax (09) 918 5101

For: Galderma Australia Pty Ltd, Suite 4, 13B Narabang Way, Belrose NSW 2085, Australia

Marketing authorization dates and numbers

6 June 1996

Drugs

Drug Countries
BENZAC Canada, Ecuador, Spain, Hong Kong, Israel, Netherlands, New Zealand, Turkey, South Africa

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