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Drug Product Composition: Flurandrenolone

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USFDA APPLICATION NUMBER - 13790 / DOSAGE - LOTION;TOPICAL - 0.05%

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

Inactive Ingredients

Ingredient Name
Artesa Labs, LLC
Cintex Services, LLC
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)