Nystatin

ADVERSE REACTIONS 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.

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

DESCRIPTION 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: Molecular Weight 926.13 Molecular Formula C 47 H 75 NO 17 structural formula

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.

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

CLINICAL PHARMACOLOGY 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.

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Nystatin Nystatin NYSTATIN NYSTATIN LIGHT MINERAL OIL PETROLATUM

ANDA062472

Nystatin

Nystatin

45802-048

HUMAN PRESCRIPTION DRUG

TOPICAL

Principal Display Panel Rx Only Nystatin Ointment USP (100,000 USP Nystatin Units) NET WT 30 g The following image is a placeholder representing the product identifier that is either affixed or imprinted on the drug package label during the packaging operation. carton serialization-template.jpg

For Dermatologic Use Only Not for Ophthalmic Use Rx Only

HOW SUPPLIED 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) STORAGE Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. Manufactured By Perrigo plc Bronx, NY 10457 Distributed By Padagis TM Allegan, MI 49010 www.padagis.com Rev 02-22 2K800 RC JX2

STORAGE Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. Manufactured By Perrigo plc Bronx, NY 10457 Distributed By Padagis TM Allegan, MI 49010 www.padagis.com Rev 02-22 2K800 RC JX2

PRECAUTIONS Should a reaction of hypersensitivity occur, the drug should be immediately withdrawn and appropriate measures taken. This preparation is not for ophthalmic use.