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Nystatin Ointment

Pronunciation

Dosage Form: ointment

Nystatin Ointment USP

For Dermatologic Use Only

Not For Ophthalmic Use

Rx Only

Nystatin Ointment 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:

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Molecular Weight 926.13

Molecular Formula C47H75NO17

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 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.

Indications and Usage for Nystatin Ointment

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Should a reaction of hypersensitivity occur, the drug should be immediately withdrawn and appropriate measures taken.

This preparation is not for ophthalmic use.

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.

Nystatin Ointment 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.

How is Nystatin Ointment 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

Bronx, NY 10457

Distributed By Perrigo

Allegan, MI 49010 • www.perrigo.com

Rev. 10/12

:2K800 RC J4

Principal Display Panel - 15 g Carton

Rx Only

NDC 45802-048-35

Nystatin Ointment USP

(100,000 USP Nystatin Units)

NET WT 15 g

Principal Display Panel - 15 g Tube

Rx Only

NDC 45802-048-35

Nystatin Ointment USP

(100,000 USP Nystatin Units)

NET WT 15 g

NYSTATIN 
Nystatin Ointment
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:45802-048
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
LIGHT MINERAL OIL  
PETROLATUM  
Packaging
# Item Code Package Description
1 NDC:45802-048-35 1 TUBE in 1 CARTON
1 15 g in 1 TUBE
2 NDC:45802-048-11 1 TUBE in 1 CARTON
2 30 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA062472 09/15/2006
Labeler - Perrigo New York Inc (078846912)
Revised: 08/2014
 
Perrigo New York Inc
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