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Xolegel (Ketoconazole Topical) - Description

 


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XOLEGELTM (KETOCONAZOLE, USP) GEL, 2%
Rx ONLY
FOR TOPICAL USE ONLY.
NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL USE.

DESCRIPTION

XOLEGEL Gel contains the antifungal agent ketoconazole USP at 2% in a topical anhydrous gel vehicle.

Chemically ketoconazole is (±)- cis -1-Acetyl-4-[p-[[2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]piperazine, with a molecular weight of 531.43.

Each gram contains: 20 mg ketoconazole USP, 34% dehydrated alcohol USP, ascorbic acid USP, butylated hydroxytoluene NF, citric acid monohydrate USP, glycerin USP, hydroxypropyl cellulose NF, polyethylene glycol 400 NF, PPG-15 stearyl ether, propylene glycol USP, FD&C yellow No. 6, D&C yellow No. 10

XOLEGEL Gel is a smooth, translucent to clear, amber gel.

Page last updated: 2006-10-08

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