Drug Catalog - Product Detail
NYSTATIN TOPICAL POWDER PWD 100MU 60GM
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 68308-0152-60 | MAYNE PHARMA | 60 | 100000UNIT/GM | NA |
PACKAGE FILES
Generic Name
NYSTATIN
Substance Name
NYSTATIN
Product Type
HUMAN PRESCRIPTION DRUG
Route
TOPICAL
Application Number
ANDA065203
Description
DESCRIPTION Nystatin is a polyene antifungal antibiotic obtained from Streptomyces noursei . The molecular formula for Nystatin is C 47 H 75 NO 17 . The molecular weight of Nystatin is 926.1. Structural formula: Nystatin topical powder is for dermatologic use. Nystatin topical powder contains 100,000 USP nystatin units per gram dispersed in talc. Chemical Structure
How Supplied
HOW SUPPLIED Nystatin topical powder, USP is supplied as 100,000 units nystatin per gram in plastic squeeze bottles: 15g (NDC 68308-152-15) 30g (NDC 68308-152-30) 60g (NDC 68308-152-60) STORAGE Store at 20°C to 25°C (68°F to 77°F)[see USP Controlled Room Temperature]; avoid excessive heat (40°C/104°F). Keep tightly closed.
Indications & Usage
INDICATIONS AND USAGE Nystatin topical powder is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species. Nystatin topical powder is not indicated for systemic, oral, intravaginal or ophthalmic use.
Dosage and Administration
DOSAGE AND ADMINISTRATION Very moist lesions are best treated with the topical dusting powder. Adults and Pediatric Patients (Neonates and Older) Apply to candidal lesions two or three times daily until healing is complete. For fungal infection of the feet caused by Candida species, the powder should be dusted on the feet, as well as, in all foot wear.