Nystatin Topical Powder
Nystatin Topical Powder is an FDA drug label for the active ingredient NYSTATIN TOPICAL POWDER manufactured by Epic Pharma, LLC administered by TOPICAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20230810.
- Generic name
- NYSTATIN TOPICAL POWDER
- Manufacturer
- Epic Pharma, LLC
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- TOPICAL
- Dosage form
- N/A
- NDC
- 42806-185
- Application
- ANDA210532
- Label effective
- 20230810
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 & 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.
Contraindications
CONTRAINDICATIONS Nystatin topical powder is contraindicated in patients with a history of hypersensitivity to any of its components.
Warnings
Not available.
Adverse Reactions
ADVERSE REACTIONS The frequency of adverse events reported in patients using nystatin topical powder is less than 0.1%. The more common events that were reported include allergic reactions, burning, itching, rash, eczema, and pain on application. (See PRECAUTIONS, General .)