Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Nystatin Cream, USP is a smooth yellow cream. Nystatin Cream, USP is supplied in 30 g (NDC 71205-723-30) 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. Manufactured by: Cosette Pharmaceuticals, Inc. 111 Coolidge Street South Plainfield, NJ 07080 Relabeled by: Proficient Rx LP Thousand Oaks, CA 91320 Iss. 08/2019 8-0678CP1; PRINCIPAL DISPLAY PANEL NDC 71205-723-30 Nystatin Cream, USP 30 g Rx only FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. 71205-723-30
- HOW SUPPLIED Nystatin Cream, USP is a smooth yellow cream. Nystatin Cream, USP is supplied in 30 g (NDC 71205-723-30) 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. Manufactured by: Cosette Pharmaceuticals, Inc. 111 Coolidge Street South Plainfield, NJ 07080 Relabeled by: Proficient Rx LP Thousand Oaks, CA 91320 Iss. 08/2019 8-0678CP1
- PRINCIPAL DISPLAY PANEL NDC 71205-723-30 Nystatin Cream, USP 30 g Rx only FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. 71205-723-30
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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