Drug Catalog - Product Detail
NYSTATIN W/TRIAMCINOLONE 100MU/GM CRM 30GM
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 45802-0880-94 | PADAGIS | 30 | 100000-0.1UNIT/GM-% | CREAM |
PACKAGE FILES
Generic Name
NYSTATIN, TRIAMCINOLONE ACETONIDE
Substance Name
NYSTATIN
Product Type
HUMAN PRESCRIPTION DRUG
Route
TOPICAL
Application Number
ANDA208479
Description
DESCRIPTION: Nystatin and Triamcinolone Acetonide Cream for dermatologic use contains 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, very slightly soluble in water, and slightly to sparingly soluble in alcohol. Structural formula: C 47 H 75 N0 17 MW = 926.13 Triamcinolone acetonide is designated chemically as 9-fluoro-11ß, 16ɑ, 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 F0 6 MW = 434.50 Nystatin and Triamcinolone Acetonide Cream is a soft, smooth cream having a light yellow to buff color. Each gram provides 100,000 USP Nystatin units and 1 mg Triamcinolone Acetonide in a cream base with aluminum hydroxide, cetearyl alcohol and ceteareth 20, glyceryl monostearate, methylparaben, polyethylene glycol monostearate, polysorbate 60, propylene glycol, propylparaben, purified water, simethicone emulsion, sodium hydroxide, sorbic acid, sorbitol, titanium dioxide, and white petrolatum. structural formula 1.jpg structural formula 2.jpg
How Supplied
HOW SUPPLIED: Nystatin and Triamcinolone Acetonide Cream is supplied in 15 g (NDC 45802-880-14), 30 g (NDC 45802-880-94) and 60 g (NDC 45802-880-96) tubes. STORAGE: Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Avoid freezing. Manufactured by Padagis ® Yeruham, Israel www.padagis.com Rev 03-23 7M900 RC PH3
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.