[E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.]
|Category||DEA Schedule||Marketing Status|
|HUMAN PRESCRIPTION DRUG LABEL||Abbreviated New Drug Application|
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.
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.
Nystatin topical preparations are indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida [Monilia] albicans and other Candida species.
Nystatin topical preparations are contraindicated in patients with a history of hypersensitivity to any of their components.
Should a reaction of hypersensitivity occur the drug should be immediately withdrawn and appropriate measures taken.
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.
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
Melville, New York 11747
PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 30G CONTAINER
NYSTATIN CREAM USP
100,000 USP Nystatin Units Per Gram
For Topical Use Only.
Not for Ophthalmic Use.
NET WT 30 grams
|Labeler - E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. (043838424)|