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NYSTATIN Label and NYSTATIN General Information

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nystatin (Nystatin)  ointment 
[Actavis Mid Atlantic LLC]

DESCRIPTION

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

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 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.

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.

CONTRAINDICATIONS

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

PRECAUTIONS

Should a reaction of hypersensitivity occur the drug should be immediately withdrawn and appropriate measures taken.

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.

DOSAGE AND ADMINISTRATION

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

HOW SUPPLIED

Nystatin Ointment USP 100,000 units/g

15 g tube (0.53 oz)

30 g tube (1.1 oz)

Store at controlled room temperature 15°-30°C (59°-86°F). Do not freeze.

Manufactured by:

Actavis Mid Atlantic LLC

1877 Kawai Road

Lincolnton, NC 28092 USA

FORM NO. 0166

Rev. 1/06

VC2752

Nystatin (Nystatin)

PRODUCT INFO Product Code 0472-0166 Dosage Form OINTMENT Route Of Administration TOPICAL DEA Schedule

INGREDIENTS Name (Active Moiety) Type Strength nystatin (nystatin) Active 100000 UNITS  In 1 GRAM white petrolatum Inactive

IMPRINT INFORMATION Characteristic Appearance Characteristic Appearance Color Score Shape Symbol Imprint Code Coating Size

PACKAGING # NDC Package Description Multilevel Packaging 1 0472-0166-15 15 GRAM In 1 CARTON contains a TUBE 1 15 GRAM In 1 TUBE This package is contained within the CARTON (0472-0166-15) 2 0472-0166-30 30 GRAM In 1 CARTON contains a TUBE 2 30 GRAM In 1 TUBE This package is contained within the CARTON (0472-0166-30)

Revised: 01/2008Actavis Mid Atlantic LLC