TERBINAFINE MYLAN Cream Ref.[7467] Active ingredients: Terbinafine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Mylan, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom

Product name and form

Terbinafine 1% Cream.

Pharmaceutical Form

Cream.

White or almost white cream, with a slight almond odour.

Qualitative and quantitative composition

One gram of cream contains 10 mg terbinafine hydrochloride equivalent to 8.89 mg of terbinafine.

Excipients with known effect: Each gram of cream contains 10 mg benzyl alcohol, 40 mg cetostearyl alcohol and 40 mg cetyl alcohol.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Terbinafine

Terbinafine is an allylamine which has a broad spectrum of antifungal activity. Terbinafine acts by inhibition of squalene epoxidase in the fungal cell membrane. At low concentrations terbinafine is fungicidal against dermatophytes, moulds and certain dimorphic fungi. The activity versus yeasts is fungicidal or fungistatic depending on the species.

List of Excipients

Sodium hydroxide
Benzyl alcohol
Sorbitan monostearate
Cetyl palmitate
Cetyl alcohol
Cetostearyl alcohol
Polysorbate 60
Isopropyl myristate
Purified water

Pack sizes and marketing

Collapsible aluminium tube with a polyethylene screw cap in pack sizes of 7.5 g, 15 g or 30 g.

Not all pack sizes may be marketed.

Marketing authorization holder

Mylan, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom

Marketing authorization dates and numbers

PL 04569/0889

10/02/2010

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