ADVERSE REACTIONS SECTION.

ADVERSE REACTIONS. Nystatin is virtually nontoxic 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.

CLINICAL PHARMACOLOGY SECTION.

CLINICAL PHARMACOLOGY. Nystatin is an antifungal antibiotic which is both fungistatic and fungicidal in vitro, against wide variety of yeasts and yeast-like fungi. It probably acts by binding to sterols in the cell membrane of the fungus with resultant change in membrane permeability allowing leakage of intracellular components. Nystatin is polyene antibiotic of undetermined structural formula 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 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.

CONTRAINDICATIONS SECTION.

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

DESCRIPTION SECTION.

DESCRIPTION. Each gram of Nystatin Ointment USP contains 100,000 units of nystatin in white petrolatum base.

DOSAGE & ADMINISTRATION SECTION.

DOSAGE AND ADMINISTRATION. Nystatin Ointment USP should be applied liberally to the affected areas twice day or as indicated until healing is complete. The ointment does not stain the skin or mucous membranes and it provides simple, convenient means of treatment.

HOW SUPPLIED SECTION.

HOW SUPPLIED. Nystatin Ointment USP 100,000 units/g15 tube (0.53 oz)30 tube (1.1 oz)Store at controlled room temperature 15-30C (59-86F). Do not freeze.Distributed by:Actavis Pharma, Inc.Parsippany, NJ 07054 USARev. 10/20193701600-478 GW7351.

INDICATIONS & USAGE SECTION.

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL. ActavisNDC 0472-0166-15Nystatin Ointment USP 100,000 units per gramRx OnlyFor External Use OnlyNot for Ophthalmic Use15 (0.53 oz). 1.

PRECAUTIONS SECTION.

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 Should reaction of hypersensitivity occur the drug should be immediately withdrawn and appropriate measures taken.