Nystatin Ointment

Dosage Form: ointment
Nystatin Ointment USP

Rx only

Nystatin Ointment Description

Nystatin Ointment USP, for topical use only, contains 100,000 USP Nystatin Units per gram, in a polyethylene and mineral oil base. The structural formula is as follows:

Nystatin Ointment - 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 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 for Nystatin Ointment

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

Contraindications

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Should a reaction of hypersensitivity occur the drug should be immediately withdrawn and appropriate measures taken.

This preparation is not for ophthalmic use.

Adverse Reactions

Nystatin 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 Dosage and Administration

Nystatin Ointment 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.

How is Nystatin Ointment Supplied

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

NDC 0168-0007-15     15 gram tube

NDC 0168-0007-30     30 gram tube

Store at controlled room temperature 15°- 30°C (59°-86°F).

E. FOUGERA & CO.
A division of Nycomed US Inc.
Melville, New York 11747
I20715G
R3/08
#21

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 15 G CONTAINER

NDC 0168-0007-15

FOUGERA®

Nystatin Ointment USP

100,000 USP Nystatin Units Per Gram

For Topical Use Only.

Not for Ophthalmic Use.

Rx only

CONTAINS: 100,000 USP

Nystatin Units per gram,

in a polyethylene and

mineral oil base.

NET WT 15 grams

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 15 G CARTON

NDC 0168-0007-15

FOUGERA®    Rx only

Nystatin Ointment USP

100,000 USP Nystatin Units Per Gram

WARNING: Keep this and all

drugs out of reach of children.

For Topical Use Only.

Not for Ophthalmic Use.

NET WT 15 grams

NYSTATIN  nystatin  ointment

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0168-0007 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength nystatin (nystatin) nystatin 100000 [USP'U]  in 1 g

Inactive Ingredients Ingredient Name Strength Mineral Oil

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0168-0007-15 15 g In 1 TUBE None 2 0168-0007-30 30 g In 1 TUBE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA062124	09/23/1982

Labeler - E. FOUGERA & CO., A division of Nycomed US Inc. (043838424)

Registrant - Nycomed US Inc. (043838424)

Establishment
Name	Address	ID/FEI	Operations
Nycomed US Inc.		174491316	MANUFACTURE

Establishment
Name	Address	ID/FEI	Operations
Nycomed US Inc.		043838424	ANALYSIS

Revised: 11/2009E. FOUGERA & CO., A division of Nycomed US Inc.