ENSTILAR Foam Ref.[50952] Active ingredients: Betamethasone Calcipotriol

Source: FDA, National Drug Code (US)  Revision Year: 2021 

Product description

Enstilar Foam contains calcipotriene hydrate and betamethasone dipropionate. It is for topical use only.

Calcipotriene Hydrate

Calcipotriene hydrate is a synthetic vitamin D analog and has the chemical name 9,10-secochola-5,7,10(19),22-tetraene-1,3,24-triol,24-cyclo-propyl-,monohydrate, (1α,3β,5Z,7E,22E,24S) with the empirical formula C27H40O3∙H2O), a molecular weight of 430.6, and the following structural formula (calcipotriene hydrate is a white to almost white, crystalline compound):

Betamethasone Dipropionate

Betamethasone dipropionate is a synthetic corticosteroid and has the chemical name pregna-1,4-diene-3,20-dione-9-fluoro-11-hydroxy-16-methyl-17,21-bis(1-oxypropoxy)-(11β,16β), with the empirical formula C28H37FO7, a molecular weight of 504.6, and the following structural formula (betamethasone dipropionate is a white to almost white, crystalline powder):

Enstilar Foam

Each gram of Enstilar Foam contains 50 mcg of calcipotriene (equivalent to 52.2 mcg of calcipotriene hydrate) and 0.643 mg of betamethasone dipropionate (equivalent to 0.5 mg of betamethasone) in a base of white petrolatum, polyoxypropylene stearyl ether, mineral oil, all-rac-alpha-tocopherol, and butylhydroxytoluene. Enstilar Foam is a white to off-white opalescent liquid in a pressurized aluminum spray can with a continuous valve and actuator. The propellants used in Enstilar Foam are dimethyl ether and butane. At administration, the product is a white to off-white foam after evaporation of the propellants. Enstilar Foam has the appearance of a non-expanding foam that gradually collapses after spraying.

Dosage Forms and Strengths

Enstilar Foam: 0.005%/0.064% - each gram contains 50 mcg calcipotriene and 0.643 mg of betamethasone dipropionate in a white to off-white opalescent liquid in a pressurized aluminum spray can with a continuous valve and actuator. At administration the product is a white to off-white foam after evaporation of the propellants.

How Supplied

Enstilar (calcipotriene and betamethasone dipropionate) Foam, 0.005%/0.064% is a white to off-white opalescent liquid in a pressurized aluminum spray can with a continuous valve and actuator. At administration, the product is a white to off-white foam after evaporation of the propellants. It is available as:

  • 60 gram can (NDC 50222-302-60)
  • 120 gram (2 cans of 60 gram) (NDC 50222-302-66)

Manufactured by: LEO Laboratories Ltd., 285 Cashel Road, Dublin 12, Ireland

Distributed by: LEO Pharma Inc., Madison, NJ 07940, USA

Drugs

Drug Countries
ENSTILAR Austria, Australia, Canada, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Israel, Lithuania, Malta, Netherlands, New Zealand, Poland, United Kingdom, United States

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