Drug Catalog - Product Detail
NYSTATIN W/TRIAMCINOLONE CREAM 100MU/GM 60GM
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 68462-0314-65 | GLENMARK PHARMACEUTICALS | 60 | 100000-0.1UNIT/GM-% | CREAM |
PACKAGE FILES
Generic Name
NYSTATIN AND TRIAMCINOLONE ACETONIDE
Substance Name
NYSTATIN
Product Type
HUMAN PRESCRIPTION DRUG
Route
TOPICAL
Application Number
ANDA208136
Description
DESCRIPTION Nystatin and Triamcinolone Acetonide Cream, USP for dermatologic use contains the antifungal agent nystatin, USP and the synthetic corticosteroid triamcinolone acetonide, USP. Nystatin, USP is a polyene antimycotic obtained from Streptomyces noursei . It is a yellow to light tan, hygroscopic powder, having a bitter taste and an odor suggestive of cereals. It is freely soluble in dimethylformamide and dimethyl sulfoxide; slightly to sparingly soluble in methanol, n-propyl alcohol, and n-butyl alcohol; practically insoluble in water and alcohol; insoluble in chloroform and ether. Structural formula: C 47 H 75 NO 17 ; MW = 926.11 g/mol Triamcinolone acetonide, USP 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-11β,16α,17,21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16, 17-acetal with acetone. The white to cream colored, crystalline powder, having not more than a slight odor, is practically insoluble in water, sparingly soluble in dehydrated alcohol, in chloroform and in methanol. Structural formula: C 24 H 31 FO 6 ; MW = 434.50 g/mol Nystatin and Triamcinolone Acetonide Cream, USP is a soft, smooth yellow color cream. Each gram provides 100,000 USP Nystatin units and 1 mg Triamcinolone Acetonide, USP in a cream base with dried aluminum hydroxide gel, glyceryl monostearate, methylparaben, polyethylene glycol 400 monostearate, polyoxyl 20 cetostearyl ether, polysorbate-60, propylene glycol, propylparaben, purified water, simethicone emulsion, sorbic acid, sorbitol, titanium dioxide, and white petrolatum. nystatin-image triamcinolone-structure
How Supplied
HOW SUPPLIED Nystatin and Triamcinolone Acetonide Cream, USP is supplied as follows: NDC 68462-314-17 15g tube (1 tube per carton) NDC 68462-314-35 30g tube (1 tube per carton) NDC 68462-314-65 60g tube (1 tube per carton) STORAGE Store at 20°C to 25°C (68°F to 77°F); [see USP Controlled Room Temperature]. Avoid freezing.
Indications & Usage
INDICATIONS AND USAGE Nystatin and triamcinolone acetonide cream is indicated for the treatment of cutaneous candidiasis; it has been demonstrated that the nystatin-steroid combination provides greater benefit than the nystatin component alone during the first few days of treatment.
Dosage and Administration
DOSAGE AND ADMINISTRATION Nystatin and triamcinolone acetonide cream is usually applied to the affected areas twice daily in the morning and evening by gently and thoroughly massaging the preparation into the skin. The cream should be discontinued if symptoms persist after 25 days of therapy (see PRECAUTIONS, Laboratory Tests ). Nystatin and triamcinolone acetonide cream should not be used with occlusive dressings.