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Drug Product Composition: Flurandrenolone

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USFDA APPLICATION NUMBER - 13790 / DOSAGE - LOTION;TOPICAL - 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Flurandrenolide(UNII: 8EUL29XUQT)
(Flurandrenolide - UNII:8EUL29XUQT)
Flurandrenolide0.5mg in 1

Inactive Ingredients

Ingredient Name
Taro Pharmaceuticals U.S.A., Inc.
Benzyl Alcohol(LKG8494WBH)
Cetyl Alcohol(936JST6JCN)
Glycerin(PDC6A3C0OX)
Glyceryl Monostearate(230OU9XXE4)
Menthol, Unspecified Form(L7T10EIP3A)
Mineral oil(T5L8T28FGP)
Polyoxyl 40 stearate(13A4J4NH9I)
Stearic Acid(4ELV7Z65AP)
Water(059QF0KO0R)