Your browser does not support JavaScript! NYSTATIN OINTMENT [PERRIGO NEW YORK INC]
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NYSTATIN ointment
[Perrigo New York Inc]


Category DEA Schedule Marketing Status
HUMAN PRESCRIPTION DRUG LABEL Abbreviated New Drug Application
Drug Label Sections

For Dermatologic Use Only

Not For Ophthalmic Use

Rx Only

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:

structural formula

Molecular Weight 926.13

Molecular Formula C47H75NO17

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

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Should a reaction of hypersensitivity occur, the drug should be immediately withdrawn and appropriate measures taken.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

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 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

Nystatin Ointment Carton Image

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 OIntment Tube
NYSTATIN 
nystatin ointment
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:45802-048
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NYSTATIN (NYSTATIN) NYSTATIN100000 [USP'U]  in 1 g
Inactive Ingredients
Ingredient NameStrength
LIGHT MINERAL OIL 
PETROLATUM 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:45802-048-351 in 1 CARTON
115 g in 1 TUBE
2NDC:45802-048-111 in 1 CARTON
230 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA06247209/15/2006
Labeler - Perrigo New York Inc (078846912)

Revised: 8/2014
 
Perrigo New York Inc

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