TINADERM Cream Ref.[50294] Active ingredients: Tolnaftate

Source: Health Products Regulatory Authority (IE)  Revision Year: 2015  Publisher: Bayer Limited, The Atrium, Blackthorn Road, Dublin 18, Ireland

Product name and form

Tinaderm Cream 1% w/w.

Pharmaceutical Form

Cream.

A smooth homogeneous white cream.

Qualitative and quantitative composition

Tolnaftate 1.0% w/w.

Excipients: Also includes Chlorocresol 0.1%w/w, cetostearyl alcohol 7.2% w/w and Butylated hydroxytoluene (E321) 0.002% w/w.

For a full list of excipients, see section 6.1.

Active Ingredient Description
Tolnaftate
List of Excipients

Chlorocresol
Sodium Dihydrogen Phosphate Dihydrate
White Soft Paraffin
Macrogol cetostearyl Ether
Cetostearyl Alcohol
Paraffin Liquid
Butylhydroxytoluene (E321)
Phosphoric acid
Sodium Hydroxide
Purified Water

Pack sizes and marketing

Epoxy lined aluminium tubes with polyethylene caps containing 15 g.

Marketing authorization holder

Bayer Limited, The Atrium, Blackthorn Road, Dublin 18, Ireland

Marketing authorization dates and numbers

PA1410/080/001

Date of first authorisation: 19 July 1983
Date of last renewal: 21 April 2007

Drugs

Drug Countries
TINADERM Australia, South Africa
 
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