STIEPROX Shampoo Ref.[6919] Active ingredients: Ciclopirox olamine

Source: Health Products Regulatory Authority (IE)  Revision Year: 2015  Publisher: GlaxoSmithKline (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24

Product name and form

Stieprox 15 mg/g Shampoo.

Pharmaceutical Form

Shampoo.

Clear, straw to light-orange coloured, viscous shampoo.

Qualitative and quantitative composition

Each gram of shampoo contains 15mg/g ciclopirox olamine.

Excipients with known effect: Contains dipropylene glycol.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Ciclopirox olamine

Ciclopirox is a hydroxypyridone antifungal agent which is active in vitro inhibiting the growth of various fungal species including the yeast Malassezia furfur (formerly known as Pityrosporum ovale or Pityrosporum orbiculare).
List of Excipients

Sodium lauryl ether sulphate 70%
Cocamidopropyl betaine
Disodium phosphate dodecahydrate
Citric acid monohydrate (for pH-adjustment)
Coconut diethanolamide
Hexylene glycol
Oleyl alcohol
Polysorbate 80
Polyquaternium 10
Fruitier timotei AF17050
Sodium hydroxide (for pH-adjustment)
Purified Water

Pack sizes and marketing

High density polyethylene bottles fitted with polypropylene screw caps containing 20 ml or 100 ml shampoo.

Not all pack sizes may be marketed.

Marketing authorization holder

GlaxoSmithKline (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24

Marketing authorization dates and numbers

PA1077/130/001

Date of first authorisation: 5th October 2001
Date of last renewal: 5th October 2006

Drugs

Drug Countries
STIEPROX Austria, Ireland, Lithuania, Poland
 
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