CLARELUX Cutaneous foam Ref.[7162] Active ingredients: Clobetasol propionate

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Pierre Fabre Dermatologie, 45 Place Abel-Gance, 92100 Boulogne Cedex, France

Product name and form

CLARELUX 500 micrograms/g cutaneous foam in pressurised container.

Pharmaceutical Form

Cutaneous foam in pressurised container.

White foam that breaks down upon contact with skin.

Qualitative and quantitative composition

Active substance: Each gram of cutaneous foam contains 500 micrograms of clobetasol propionate. 500 micrograms of clobetasol propionate are equivalent to 440 micrograms of clobetasol.

Excipients with known effect: cetyl alcohol 11.5 mg/g, stearyl alcohol 5.2 mg/g and propylene glycol 20.9 mg/g.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Clobetasol propionate

Clobetasol propionate, like other topical corticosteroids, has anti-inflammatory, antipruritic, and vasoconstrictive properties. Corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid.

List of Excipients

Ethanol anhydrous
Purified water
Propylene glycol
Cetyl alcohol
Stearyl alcohol
Polysorbate 60
Citric acid anhydrous
Potassium citrate
Propellant: propane/n-butane/isobutane

Pack sizes and marketing

Pressurised aluminium container closed with an inverted valve, containing 50g or 100g of foam. The inside of the can is lined with a double coated, clear epoxy-phenolic lacquer. Each filled canister is fitted into a spout actuator with dust cap.

Not all pack sizes may be marketed.

Marketing authorization holder

Pierre Fabre Dermatologie, 45 Place Abel-Gance, 92100 Boulogne Cedex, France

Marketing authorization dates and numbers

PL 20693/0004

Date of first authorisation: 23/03/2005
Date of last renewal: 29/03/2012

Drugs

Drug Countries
CLARELUX Austria, Germany, Spain, France, Netherlands, Poland

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