Indications
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.
Contraindications
Nystatin topical powder is contraindicated in patients with a history of hypersensitivity to any of its components.
Pregnancy and breastfeeding
Pregnancy Teratogenic Effects Category C Animal reproduction studies have not been conducted with any nystatin topical preparation. It also is not known whether these preparations can cause fetal harm when used by a pregnant woman or can affect reproductive capacity. Nystatin topical powder should be prescribed for a pregnant woman only if the potential benefit to the mother outweighs the potential risk to the fetus.
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 .)
Composition
- Active ingredients
- NYSTATIN 100,000 UNITS/GM
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application ANDA210532.



