Nystatin

INDICATIONS AND USAGE Nystatin Ointment, USP is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candidaspecies. Nystatin Ointment, USP is not indicated for systemic, oral, intravaginal or ophthalmic use.

DOSAGE AND ADMINISTRATION Nystatin Ointment USP should be applied liberally to affected areas twice a day or as indicated until healing is complete. Nystatin cream is usually preferred to nystatin ointment in candidiasis involving intertriginous areas; very moist lesions, however, are best treated with nystatin topical powder. This preparation does not stain skin or mucous membranes and provides a simple, convenient means of treatment.

CONTRAINDICATIONS Nystatin ointment, USP is contraindicated in patients with a history of hypersensitivity to any of its components.

ADVERSE REACTIONS The frequency of adverse events reported in patients using Nystatin Ointment preparations 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.) To report SUSPECTED ADVERSE REACTIONS, contact Macleods Pharma USA, Inc., at 1-888-943-3210 or 1-855-926-338 or FDA at 1-800-FDA-1088 ( www.fda.gov/medwatch ).

DESCRIPTION Nystatin Ointment, USP is for dermatologic use. Nystatin Ointment, USP for topical use only, contains 100,000 USP nystatin units per gram, in a white petrolatum base. Nystatin is a polyene antifungal antibiotic drug obtained from Streptomyces nursei . The structural formula is as follows: Molecular Weight 926.13 Molecular Formula C 47 H 75 NO 17 image description

HOW SUPPLIED Nystatin ointment USP, 100,000 units per gram is a pale yellow to yellow color ointment available as follows: NDC 13668-534-01 15 gram tube NDC 13668-534-02 30 gram tube STORAGE Store at 20° to 25°C (68° to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. Manufactured by: Torrent Pharmaceuticals LTD., Pithampur-454775, INDIA . Manufactured for: Torrent Pharma INC., Basking Ridge, NJ 07920 8102492 Revised: March 2026 Image