Nystatin Ointment
FDA Label NDC 45802-048

For Dermatologic Use Only

Not For Ophthalmic Use

Rx Only

Nystatin Ointment USP for topical use only, contains 100,000 USP Nystatin units per gram, in an ointment base of light mineral oil and white petrolatum. The structural formula is as follows:

Structural Formula (Image 01)

Molecular Weight 926.13

Molecular Formula C₄₇H₇₅NO₁₇

Nystatin is an antifungal antibiotic which is both fungistatic and fungicidal in vitro against a wide variety of yeasts and yeast-like fungi. It probably acts by binding to sterols in the cell membrane of the fungus with a resultant change in membrane permeability allowing leakage of intracellular components. Nystatin is a polyene antibiotic that is obtained from Streptomyces noursei, and is the first well tolerated antifungal antibiotic of dependable efficacy for the treatment of cutaneous, oral and intestinal infections caused by Candida [Monilia]albicans and other Candida species. It exhibits no appreciable activity against bacteria.

Nystatin Ointment USP provides specific therapy for all localized forms of candidiasis. Symptomatic relief is rapid, often occurring within 24 to 72 hours after the initiation of treatment. Cure is effected both clinically and mycologically in most cases of localized candidiasis.

Nystatin Ointment USP is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida [Monilia]albicans and other Candida species.

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

Should a reaction of hypersensitivity occur, the drug should be immediately withdrawn and appropriate measures taken.

This preparation is not for ophthalmic use.

Nystatin Ointment USP is virtually non-toxic and nonsensitizing and is well tolerated by all age groups including debilitated infants, even on prolonged administration. If irritation on topical application should occur, discontinue medication.

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.

Nystatin Ointment USP (100,000 USP Nystatin Units per gram) is a yellow ointment available as follows:

15 g tube (NDC 45802-048-35)

30 g tube (NDC 45802-048-11)

Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature].

Manufactured By Perrigo

Bronx, NY 10457

Distributed By

Perrigo®

Allegan, MI 49010 • www.perrigo.com

Rev 08-15

: 2K800 RC JX1

Rx Only

Nystatin Ointment USP

(100,000 USP Nystatin Units)

NET WT 15 g