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Drug Product Composition: Sulconazole Nitrate

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USFDA APPLICATION NUMBER - 18737 / DOSAGE - CREAM;TOPICAL - 1%

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SULCONAZOLE NITRATE(UNII: 1T89100D5U)
(SULCONAZOLE - UNII:5D9HAA5Q5S)
SULCONAZOLE NITRATE10mg in 1

Inactive Ingredients

Ingredient Name
Sun Pharmaceutical Industries, Inc.
ASCORBYL PALMITATE(QN83US2B0N)
CETYL ALCOHOL(936JST6JCN)
GLYCERYL MONOSTEARATE(230OU9XXE4)
ISOPROPYL MYRISTATE(0RE8K4LNJS)
NITRIC ACID(411VRN1TV4)
PEG-100 STEARATE(YD01N1999R)
POLYSORBATE 60(CAL22UVI4M)
PROPYLENE GLYCOL(6DC9Q167V3)
SODIUM HYDROXIDE(55X04QC32I)
SORBITAN MONOSTEARATE(NVZ4I0H58X)
STEARYL ALCOHOL(2KR89I4H1Y)
WATER(059QF0KO0R)