Nystatin Ointment Usp
d7d04c02-d07d-4382-8f93-5c0c3e68790c
34391-3
HUMAN PRESCRIPTION DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Rx Only
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.
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.
Contraindications
Nystatin Ointment USP is contraindicated in patients with a history of hypersensitivity to any of its components.
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.
How Supplied
Nystatin Ointment USP 100,000 units/g 15 g tube (0 . 53 oz) Store at controlled room temperature 15°-30°C (59°-86°F). Do not freeze. Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA FORM NO. 0166 Rev. 10/19 VC2752 Relabeled By: Proficient Rx LP Thousand Oaks, CA 91320
Medication Information
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.
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.
Contraindications
Nystatin Ointment USP is contraindicated in patients with a history of hypersensitivity to any of its components.
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.
How Supplied
Nystatin Ointment USP 100,000 units/g
15 g tube (0.53 oz)
Store at controlled room temperature 15°-30°C (59°-86°F). Do not freeze.
Distributed by:
Actavis Pharma, Inc.
Parsippany, NJ 07054 USA
FORM NO. 0166
Rev. 10/19
VC2752
Relabeled By:
Proficient Rx LP
Thousand Oaks, CA 91320
Description
Each gram of Nystatin Ointment USP contains 100,000 units of nystatin in a white petrolatum base.
Section 42229-5
Rx Only
Precautions
Should a reaction of hypersensitivity occur the drug should be immediately withdrawn and appropriate measures taken.
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.
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Structured Label Content
Section 42229-5 (42229-5)
Rx Only
Description (DESCRIPTION)
Each gram of Nystatin Ointment USP contains 100,000 units of nystatin in a white petrolatum base.
Precautions (PRECAUTIONS)
Should a reaction of hypersensitivity occur the drug should be immediately withdrawn and appropriate measures taken.
How Supplied (HOW SUPPLIED)
Nystatin Ointment USP 100,000 units/g
15 g tube (0.53 oz)
Store at controlled room temperature 15°-30°C (59°-86°F). Do not freeze.
Distributed by:
Actavis Pharma, Inc.
Parsippany, NJ 07054 USA
FORM NO. 0166
Rev. 10/19
VC2752
Relabeled By:
Proficient Rx LP
Thousand Oaks, CA 91320
Adverse Reactions (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.
Contraindications (CONTRAINDICATIONS)
Nystatin Ointment USP is contraindicated in patients with a history of hypersensitivity to any of its components.
Clinical Pharmacology (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 (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.
Dosage and Administration (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.
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Source: dailymed · Ingested: 2026-02-15T11:37:22.567076 · Updated: 2026-03-14T21:49:49.570057