Other
Rx only
Nystatin
FDA Label NDC 54868-1425
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Physicians Total Care, Inc. for the product Nystatin (NDC 54868-1425). 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 other, description, clinical pharmacology, indications and usage, contraindications, precautions, adverse reactions, dosage and administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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 (Nystatin Ointment 01)
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Should a reaction of hypersensitivity occur the drug should be immediately withdrawn and appropriate measures taken.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 54868-1425-0 15 gram tube
NDC 54868-1425-1 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
I20715H
R08/11
#21
Additional barcode labeling by:
Physicians Total Care, Inc.
Tulsa, Oklahoma 74146
Package Label – Principal Display Panel
NDC 54868-1425-1
Rx only
NYSTATIN OINTMENT 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
Image Of Package Label (1425)
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