SPL Set ID: 1034d417-493a-443a-a62e-30786f673ee3

1 drug(s) with this SPL Set ID

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Nystatin and Triamcinolone Acetonide NYSTATIN AND TRIAMCINOLONE ACETONIDE
ALEMBIC PHARMACEUTICALS INC. FDA Rx Only

Nystatin and triamcinolone acetonide cream, USP for dermatologic use contain the antifungal agent nystatin and the synthetic corticosteroid triamcinolone acetonide. Nystatin is a polyene antimycotic obtained from Streptomyces noursei . It is a yellow to light tan powder with a cereal-like odor, practically insoluble or insoluble in water and in alcohol. Structural formula: C 47 H 75 NO 17 MW = 926.23 Triamcinolone acetonide is designated chemically as pregna-1,4-diene-3,20-dione, 9-fluoro-11,21-dihydroxy-16,17- [(1-methylethylidene)bis(oxy)]-, (11β,16α)-9-fluoro-11b,16a,17,21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17- acetal with acetone. The white to cream crystalline powder has a slight odor, is practically insoluble in water, and very soluble in alcohol. Structural formula: C 24 H 31 FO 6 MW = 434.51 Nystatin and triamcinolone acetonide cream, USP is a soft, smooth cream having a light yellow to buff color. Each gram contains 100,000 USP nystatin units and 1 mg triamcinolone acetonide USP in a cream base of polysorbate-60, aluminum hydroxide gel, titanium dioxide, mono-and di-glycerides, polyoxyl 8 stearate, simethicone emulsion, sorbic acid, propylene glycol, white petrolatum, polyoxyl 20- cetostearyl ether, methylparaben, propylparaben, noncrystallizing sorbitol solution and purified water. Image Image

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