Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Nystatin Ointment, USP (100,000 USP Nystatin Units per gram) is a light yellow to yellow ointment available as follows: NDC 0713-0686-15 15 gram tube NDC 0713-0686-31 30 gram tube Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Distributed by: Cosette Pharmaceuticals, Inc. South Plainfield, NJ 07080 8-0686CPLNC3 Rev.03/2022 VC7623; PRINCIPAL DISPLAY PANEL NDC 0713-0686-15 Nystatin Ointment, USP 100,000 USP Nystatin Units Per Gram 15 g Rx only FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC USE. Cosette Pharmaceuticals, Inc. NDC 0713-0686-31 Nystatin Ointment, USP 100,000 USP Nystatin Units Per Gram 30 g Rx only FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC USE. Cosette Pharmaceuticals, Inc. 15gm-carton 30gm-carton
- HOW SUPPLIED Nystatin Ointment, USP (100,000 USP Nystatin Units per gram) is a light yellow to yellow ointment available as follows: NDC 0713-0686-15 15 gram tube NDC 0713-0686-31 30 gram tube Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Distributed by: Cosette Pharmaceuticals, Inc. South Plainfield, NJ 07080 8-0686CPLNC3 Rev.03/2022 VC7623
- PRINCIPAL DISPLAY PANEL NDC 0713-0686-15 Nystatin Ointment, USP 100,000 USP Nystatin Units Per Gram 15 g Rx only FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC USE. Cosette Pharmaceuticals, Inc. NDC 0713-0686-31 Nystatin Ointment, USP 100,000 USP Nystatin Units Per Gram 30 g Rx only FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC USE. Cosette Pharmaceuticals, Inc. 15gm-carton 30gm-carton
Overview
Nystatin Ointment, USP is for dermatologic use. Nystatin Ointment, USP for topical use only, contains 100,000 USP nystatin units per gram, in a white petrolatum base. Nystatin is a polyene antifungal antibiotic drug obtained from Streptomyces nursei . The structural formula is as follows: Molecular Weight 926.13 Molecular Formula C 47 H 75 NO 17 image description
Indications & Usage
Nystatin Ointment, USP is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candidaspecies. Nystatin Ointment, USP is not indicated for systemic, oral, intravaginal or ophthalmic use.
Dosage & Administration
Nystatin Ointment 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 Ointment is contraindicated in patients with a history of hypersensitivity to any of their components.
Adverse Reactions
The frequency of adverse events reported in patients using Nystatin Ointment preparations 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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