FUSIDIC ACID Cream Ref.[6873] Active ingredients: Fusidic acid

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Focus Pharmaceuticals Ltd, Capital House, 85 King William Street, London EC4N 7BL, United Kingdom

Product name and form

Fusidic acid 20 mg/g cream.

Pharmaceutical Form

Cream.

White, homogenous cream.

Qualitative and quantitative composition

Each gram contains 20 mg fusidic acid.

Excipient(s) with known effect: Butylhydroxyanisole 0.04 mg/gram, Cetyl alcohol 111.00 mg/gram and Potassium sorbate 2.70 mg/gram.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Fusidic acid

Fusidic acid belongs to a unique group of antibiotics, the fusidanes, which act to inhibit bacterial protein synthesis by blocking the lengthening of factor G. Fusidic acid is active against staphylococcus epidermidis and methicillin resistant staphylococci.

List of Excipients

Butylhydroxyanisole (E320)
Cetyl alcohol
Glycerol 85% (E422)
Liquid paraffin
Potassium sorbate (E202)
Polysorbate 60 (E435)
White soft paraffin
Hydrochloric acid for pH adjustment
Purified water

Pack sizes and marketing

Aluminium tube with HDPE screw cap.

Pack sizes: 15 gram and 30 gram.

Not all pack sizes may be marketed.

Marketing authorization holder

Focus Pharmaceuticals Ltd, Capital House, 85 King William Street, London EC4N 7BL, United Kingdom

Marketing authorization dates and numbers

PL 20046/0256

20/01/2012 / 01/12/2015

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