Description
Each gram of Nystatin Ointment USP contains 100,000 units of nystatin in a white petrolatum base.
Nystatin Ointment
FDA Label NDC 0472-0166
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Actavis Pharma, Inc. for the product Nystatin (NDC 0472-0166). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding description, clinical pharmacology, indications and usage, contraindications, precautions, adverse reactions, dosage and administration, how supplied, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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 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 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Should a reaction of hypersensitivity occur the drug should be immediately withdrawn and appropriate measures taken.
Adverse Reactions
Nystatin is virtually nontoxic 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 the affected areas twice a day or as indicated until healing is complete. The ointment does not stain the skin or mucous membranes and it provides a simple, convenient means of treatment.
How Supplied
Nystatin Ointment USP 100,000 units/g
15 g tube (0.53 oz)
30 g tube (1.1 oz)
Store at controlled room temperature 15°-30°C (59°-86°F). Do not freeze.
Manufactured by:
G&W Laboratories, Inc.
111 Coolidge Street
South Plainfield, NJ 07080 USA
Distributed by:
Actavis Pharma, Inc.
Parsippany, NJ 07054 USA
Revised – April 2017
I600-4780/4782A GW7210
Package Label.Principal Display Panel
Actavis
NDC 0472-0166-15
Nystatin Ointment USP 100,000 units per gram
Rx Only
For External Use Only
Not for Ophthalmic Use
15 g (0.53 oz)
* Please review the disclaimer below.
