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Setid B7d605cf Bf84 461b 939b 1f773a4cba65 Applno 21794 Form Gel Topical Dosage 5 - Drug Product Composition: Dapsone

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USFDA APPLICATION NUMBER - 21794 / DOSAGE - GEL;TOPICAL - 5%

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DAPSONE(UNII: 8W5C518302)
(DAPSONE - UNII:8W5C518302)
DAPSONE50mg in 1

Inactive Ingredients

Ingredient Name
Allergan, Inc.
Encube Ethicals Private Limited
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)(4Q93RCW27E) 
CARBOMER HOMOPOLYMER TYPE C(4Q93RCW27E) 
DIETHYLENE GLYCOL MONOETHYL ETHER(A1A1I8X02B)
METHYLPARABEN(A2I8C7HI9T)
SODIUM HYDROXIDE(55X04QC32I)
WATER(059QF0KO0R)