FLAMAZINE Cream Ref.[9584] Active ingredients: Silver sulfadiazine

Source: Medicines and Medical Devices Safety Authority (NZ)  Revision Year: 2019  Publisher: Smith & Nephew Ltd, Unit A, 36 Hillside Road, Wairau Valley, Auckland 0627, New Zealand

Product name and form

FLAMAZINE CREAM 1.0% w/w.

Pharmaceutical Form

Cream.

White to off-white, oil in water, sterile homogeneous cream.

Qualitative and quantitative composition

Contains Silver sulfadiazine 1% w/w.

Excipients: Contains 4% cetyl alchol and 7% w/w propylene glycol.

For the full list excipients, see section 6.1

Active Ingredient Description
Silver sulfadiazine

Silver sulfadiazine is a sulfonamide and has broad antimicrobial activity against both Gram-positive and Gram-negative organisms including Pseudomonas aeruginosa, some yeasts and fungi. Silver sulfadiazine acts on the cell membrane and cell wall.

List of Excipients

Polysorbate 60
Polysorbate 80
Glycerol monostearate
Cetyl alcohol
Liquid paraffin
Propylene glycol
Purified water

Pack sizes and marketing

20g*, 50g or 80g* pre-printed cylindrical polyethylene tubes fitted with polypropylene caps.

250g* or 500g black polypropylene jar fitted with a black polyethylene or polypropylene lid.

All tubes and jars are tamper-evident.

* Pack sizes not marketed.

Marketing authorization holder

Smith & Nephew Ltd, Unit A, 36 Hillside Road, Wairau Valley, Auckland 0627, New Zealand

Marketing authorization dates and numbers

Date of publication in the New Zealand Gazette of consent to distribute the medicine: 29 October 2009

Drugs

Drug Countries
FLAMAZINE Australia, Canada, Hong Kong, Ireland, New Zealand, Singapore, United Kingdom, South Africa

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