NYSTATIN- nystatin cream 
E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.

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NYSTATIN CREAM USP

Rx only

DESCRIPTION

Nystatin Cream contains the antifungal antibiotic Nystatin at a concentration of 100,000 units per gram in an aqueous, vanishing cream base containing Polysorbate 60, Aluminum Hydroxide Compressed Gel, Titanium Dioxide, Glyceryl Monostearate, Polyethylene Glycol 400 Monostearate, Simethicone, Sorbic Acid, Propylene Glycol, Ethylenediamine, Polyoxyethylene Fatty Alcohol Ether, Sorbitol Solution, Methylparaben, Propylparaben, Hydrochloric Acid, White Petrolatum, and Purified Water.

ACTIONS

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

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

CONTRAINDICATIONS

Nystatin topical preparations are contraindicated in patients with a history of hypersensitivity to any of their components.

PRECAUTIONS

Should a reaction of hypersensitivity occur the drug should be immediately withdrawn and appropriate measures taken.

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 cream should be applied liberally to affected area twice daily or as indicated by a physician. The preparation does not stain skin or mucous membranes and provides a simple, convenient means of treatment.

HOW SUPPLIED

Nystatin Cream is available as follows:

NDC 0168-0054-15     15 gram tube
NDC 0168-0054-30     30 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

I25415F
R09/12
#61

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 30G CONTAINER

NDC 0168-0054-30

FOUGERA®

NYSTATIN CREAM USP

100,000 USP Nystatin Units Per Gram

For Topical Use Only.

Not for Ophthalmic Use.

Rx only

NET WT 30 grams

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 30G CONTAINER

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 30 G CARTON

NDC 0168-0054-30

Rx only

FOUGERA®

NYSTATIN CREAM 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 30 grams

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 30 G CARTON

NYSTATIN 
nystatin cream
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:0168-0054
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
nystatin (nystatin) nystatin100000 [USP'U]  in 1 g
Inactive Ingredients
Ingredient NameStrength
Polysorbate 60 
Algeldrate 
Titanium Dioxide 
Glyceryl Monostearate 
PEG-8 Stearate 
Silicon Dioxide 
Sorbic Acid 
Propylene Glycol 
Ethylenediamine 
Sorbitol 
Methylparaben 
Propylparaben 
Hydrochloric Acid 
Petrolatum 
Water 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0168-0054-151 in 1 CARTON
115 g in 1 TUBE
2NDC:0168-0054-301 in 1 CARTON
230 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA06212902/01/1979
Labeler - E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. (043838424)

Revised: 10/2013
Document Id: 2499741b-179c-48ec-aeac-f21704ef9e3b
Set id: c9e28323-21fa-4547-b70c-27dc13a5bd7e
Version: 5
Effective Time: 20131017
 
E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.