NYSTATIN- nystatin ointment 
Rebel Distributors Corp

----------

NYSTATIN OINTMENT USP

Rx only

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:

Structural Formula

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

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Should a reaction of hypersensitivity occur the drug should be immediately withdrawn and appropriate measures taken.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

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 SUPPLIED

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

NDC 42254-284-15 15 gram tube

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

E. FOUGERA & CO.
A division of Fougera Pharmaceuticals Inc.
Melville, New York 11747
I20715H
R08/11
#21

Repackaged by:
REBEL DISTRIBUTORS CORP.
Thousand Oaks, CA 91320

PRINCIPAL DISPLAY PANEL

Nystatin 100,000 Units/gm

NYSTATIN 
nystatin ointment
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42254-284(NDC:0168-0007)
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
nystatin (UNII: BDF1O1C72E) (nystatin - UNII:BDF1O1C72E) nystatin 100000 [USP'U]  in 1 g
Inactive Ingredients
Ingredient Name Strength
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
Mineral Oil (UNII: T5L8T28FGP)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:42254-284-15 15 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA062124 09/23/1982
Labeler - Rebel Distributors Corp (118802834)
Registrant - PSS World Medical, Inc. (101822862)
Establishment
Name Address ID/FEI Business Operations
PSS World Medical, Inc. 791528623 REPACK(42254-284)
Establishment
Name Address ID/FEI Business Operations
STAT RX USA LLC 786036330 REPACK(42254-284)
Establishment
Name Address ID/FEI Business Operations
Dispensing Solutions, Inc. 066070785 RELABEL(42254-284) , REPACK(42254-284)
Establishment
Name Address ID/FEI Business Operations
SCRIPT PAK 964420108 RELABEL(42254-284) , REPACK(42254-284)
Establishment
Name Address ID/FEI Business Operations
Keltman Pharmaceuticals, Inc. 362861077 REPACK(42254-284)
Establishment
Name Address ID/FEI Business Operations
Rebel Distirbutors Corp. 118802834 RELABEL(42254-284) , REPACK(42254-284)

Revised: 8/2012
Document Id: da4cd3fc-906d-4468-b7f9-c20f085c95ed
Set id: da4cd3fc-906d-4468-b7f9-c20f085c95ed
Version: 1
Effective Time: 20120828
 
Rebel Distributors Corp