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NYSTATIN CREAM 100,000UNITS/GRAM 30 G

Generic: Nystatin

NDC:51672-1289-02

Manufacturer:Sun Pharmaceutical Industries, Inc.

Strength:100000 [USP'U]/g

Dosage Form:CREAM

Route:TOPICAL

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Drug Information

Identification

Generic Name

Nystatin

Brand Name

Nystatin

Labeler / Distributor

Sun Pharmaceutical Industries, Inc.

Product Type

HUMAN PRESCRIPTION DRUG

Administration

Dosage Form

CREAM

Route of Administration

TOPICAL

FDA Application Number

ANDA064022

Active Ingredients

Ingredient	Strength
NYSTATIN	100000 [USP'U]/g

Pharmacological Class

Polyene AntifungalPolyenes [CS]

Data sourced from openFDA / DailyMed. For full prescribing information, consult the drug label.

Wholesale compliance resources

DSCSA T2 documents DSCSA compliance resource hub

Drug Resources

Nystatin Drug Page NDC 51672-1289-02 Lookup

Clinical Drug Information

Indications & Usage

INDICATIONS AND USAGE Nystatin cream is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species. This cream is not indicated for systemic, oral, intravaginal or ophthalmic use.

Dosage & Administration

DOSAGE AND ADMINISTRATION Adults and Pediatric Patients (Neonates and Older) Apply liberally to affected areas twice daily or as indicated until healing is complete.

Adverse Reactions

ADVERSE REACTIONS The frequency of adverse events reported in patients using nystatin cream is less than 0.1%. The more common events that were reported include allergic reactions, burning, itching, rash, eczema, and pain on application. (See PRECAUTIONS: General .)

Information for Patients

INFORMATION FOR THE PATIENT Patients using this medication should receive the following information and instructions: The patient should be instructed to use this medication as directed (including the replacement of missed doses). This medication is not for any disorder other than that for which it is prescribed. Even if symptomatic relief occurs within the first few days of treatment, the patient should be advised not to interrupt or discontinue therapy until the prescribed course of treatment is completed. If symptoms of irritation develop, the patient should be advised to notify the physician promptly.

Clinical data sourced from openFDA drug labeling. For complete prescribing information, consult the full drug label.