Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Nystatin Cream, USP is a smooth yellow cream. Nystatin Cream, USP is supplied in 15 g (NDC 0713-0678-15) and 30 g (NDC 0713-0678-31) tubes providing 100,000 USP Nystatin units per gram. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Avoid freezing. Distributed by: Cosette Pharmaceuticals, Inc. South Plainfield, NJ 07080 Rev. 03/2022 8-0678CPLNC2 VC7625; PRINCIPAL DISPLAY PANEL NDC 0713-0678-15 Nystatin Cream, USP 15 g Rx only FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. Cosette Pharmaceuticals, Inc. NDC 0713-0678-31 Nystatin Cream, USP 30 g Rx only FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. Cosette Pharmaceuticals, Inc. image description image description image description image description
- HOW SUPPLIED Nystatin Cream, USP is a smooth yellow cream. Nystatin Cream, USP is supplied in 15 g (NDC 0713-0678-15) and 30 g (NDC 0713-0678-31) tubes providing 100,000 USP Nystatin units per gram. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Avoid freezing. Distributed by: Cosette Pharmaceuticals, Inc. South Plainfield, NJ 07080 Rev. 03/2022 8-0678CPLNC2 VC7625
- PRINCIPAL DISPLAY PANEL NDC 0713-0678-15 Nystatin Cream, USP 15 g Rx only FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. Cosette Pharmaceuticals, Inc. NDC 0713-0678-31 Nystatin Cream, USP 30 g Rx only FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. Cosette Pharmaceuticals, Inc. image description image description image description image description
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, USP is for dermatologic use. Nystatin cream for topical use, contains 100,000 USP nystatin units per gram in a cream base containing aluminum hydroxide gel, ceteareth-15, glyceryl monostearate, polyethylene glycol 400 monostearate, propylene glycol, purified water, simethicone emulsion, sorbitol solution, titanium dioxide, white petrolatum, methylparaben, propylparaben, and sodium hydroxide. image description
Indications & Usage
Nystatin Cream, USP 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 . ) To report SUSPECTED ADVERSE REACTIONS, contact Cosette Pharmaceuticals, Inc. at 1-800-922-1038 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
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