ZORAC Gel Ref.[8690] Active ingredients: Tazarotene

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Allergan Pharmaceuticals Ireland, Castlebar Road, Westport, County Mayo, Ireland

Product name and form

ZORAC 0.05%, gel.

Pharmaceutical Form

Gel.

Colourless to light yellow, translucent to homogeneous cloudy gel.

Qualitative and quantitative composition

Active substance: Tazarotene 0.05g.

Excipients with known effect:

Butylhydroxyanisole: 0.05g

Butylhydroxytoluene: 0.05g

For 100g of gel.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Tazarotene

Tazarotene, a member of the acetylenic class of retinoids, is a prodrug which is converted to its active free form, tazarotenic acid, by de-esterification in the skin area. Tazarotenic acid is the only known metabolite of tazarotene to have retinoid activity.

List of Excipients

Benzyl alcohol
Macrogol 400
Hexylene glycol
Carbomer 974P
Trometamol
Poloxamer 407
Polysorbate 40
Ascorbic acid
Butylhydroxyanisole (E320)
Butylhydroxytoluene (E321)
Disodium edetate
Purified water

Pack sizes and marketing

10g, 15g, 30g, 50g, 60g and 100g in tube (aluminium, internally lacquered epoxyphenolic) with white polypropylene cap.

Not all pack sizes may be marketed.

Marketing authorization holder

Allergan Pharmaceuticals Ireland, Castlebar Road, Westport, County Mayo, Ireland

Marketing authorization dates and numbers

PL 41443/0003

30th July 1997 / 3rd December 2006

Drugs

Drug Countries
ZORAC Spain, New Zealand, Poland

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