Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Nystatin Cream USP is yellow to light green smooth cream and supplied as follows: Tube of 15 g NDC 59651-907-14 Tube of 30 g NDC 59651-907-30 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Avoid freezing. Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 032, India Issued: May 2024; PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 15 g Tube Label NDC 59651-907-14 Rx only Nystatin Cream, USP 100,000 units per gram FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. AUROBINDO Keep this and all medications out of the reach of children. 15 g PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 15 g Tube Label; PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 15 g Tube Carton Label NDC 59651-907-14 Rx only Nystatin Cream, USP 100,000 units per gram FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. Keep this and all medications out of the reach of children. AUROBINDO 15 g PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 15 g Tube Carton Label
- HOW SUPPLIED Nystatin Cream USP is yellow to light green smooth cream and supplied as follows: Tube of 15 g NDC 59651-907-14 Tube of 30 g NDC 59651-907-30 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Avoid freezing. Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 032, India Issued: May 2024
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 15 g Tube Label NDC 59651-907-14 Rx only Nystatin Cream, USP 100,000 units per gram FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. AUROBINDO Keep this and all medications out of the reach of children. 15 g PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 15 g Tube Label
- PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 15 g Tube Carton Label NDC 59651-907-14 Rx only Nystatin Cream, USP 100,000 units per gram FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. Keep this and all medications out of the reach of children. AUROBINDO 15 g PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 15 g Tube Carton Label
Overview
Nystatin is a polyene antifungal antibiotic obtained from Streptomyces nursei . Structural formula: C 47 H 75 NO 17 Molecular Weight: 926.13 Nystatin cream is for dermatologic use. Nystatin cream for topical use, contains 100,000 USP nystatin units per gram in an aqueous, cream base containing aluminum hydroxide gel, ceteareth-15, mono and diglycerides, polyoxyl 8 stearate, propylene glycol, purified water, simethicone emulsion, sorbitol solution, titanium dioxide, white petrolatum, with methylparaben and propylparaben as preservatives. str
Indications & 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
Adults and Pediatric Patients (Neonates and Older) Apply liberally to affected areas twice daily or as indicated until healing is complete.
Warnings & Precautions
No warnings available yet.
Contraindications
Nystatin cream is contraindicated in patients with a history of hypersensitivity to any of its components.
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 .)
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