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Drug Product Composition: Ketoconazole

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$ API Ref.Price (USD/KG) : 82Xls

USFDA APPLICATION NUMBER - 21946 / DOSAGE - GEL;TOPICAL - 2%

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
KETOCONAZOLE(UNII: R9400W927I)
(KETOCONAZOLE - UNII:R9400W927I)
KETOCONAZOLE20mg in 1

Inactive Ingredients

Ingredient Name
Aqua Pharmaceuticals
ALCOHOL(3K9958V90M)
ASCORBIC ACID(PQ6CK8PD0R)
BUTYLATED HYDROXYTOLUENE(1P9D0Z171K)
CITRIC ACID MONOHYDRATE(2968PHW8QP)
D&C YELLOW NO. 10(35SW5USQ3G)
FD&C YELLOW NO. 6(H77VEI93A8)
GLYCERIN(PDC6A3C0OX)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(RFW2ET671P)
POLYETHYLENE GLYCOL 400(B697894SGQ)
PPG-15 STEARYL ETHER(1II18XLS1L)
PROPYLENE GLYCOL(6DC9Q167V3)