Nystatin Ointment Usp

Nystatin Ointment Usp
SPL v5
SPL
SPL Set ID d7d04c02-d07d-4382-8f93-5c0c3e68790c
Route
TOPICAL
Published
Effective Date 2022-10-01
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Nystatin (100000 [USP'U])
Inactive Ingredients
Petrolatum

Identifiers & Packaging

Marketing Status
ANDA Active Since 2002-09-03

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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