Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Nystatin Cream USP is a light yellow to yellow cream that is supplied in: 15 gram tube NDC 0316-0221-15 30 gram tube NDC 0316-0221-30 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Avoid freezing. Manufactured and Distributed by: Crown Laboratories, Inc., Johnson City, TN 37604 Printed in USA P9526.00; 15 gram tube NDC 0316-0221-15 Rx Only Nystatin Cream, USP 100,000 units per gram WARNING: Keep out of reach of children. For external use only. Not for ophthalmic use. 15 grams Each gram contains: 100,000 USP Nystatin Units in an aqueous, cream base consisting of purified water, emulsifying wax, mineral oil, propylene glycol, sorbitol solution, cetyl palmitate, sorbic acid and potassium sorbate. TO OPEN: Use cap to puncture seal. IMPORTANT: Do not use if seal has been punctured or is not visible. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Avoid freezing. Usual Dosage: Apply liberally to affected area twice daily. See package insert for full prescribing information. See crimp of tube for Lot Number and Expiration Date. Manufactured and Distributed by: Crown Laboratories, Inc., Johnson City, TN 37604 P9503.01 p950301; 15 gram carton NDC 0316-0221-15 Rx Only Nystatin Cream, USP 100,000 units per gram WARNING: Keep out of reach of children. For external use only. Not for ophthalmic use. 15 grams Each gram contains: 100,000 USP Nystatin Units in an aqueous, cream base consisting of purified water, emulsifying wax, mineral oil, propylene glycol, sorbitol solution, cetyl palmitate, sorbic acid and potassium sorbate. Directions for puncturing tube seal: Remove cap. Turn cap upside down and place puncture tip onto tube seal. Push cap down until seal is punctured. Screw cap back on to close. IMPORTANT: Do not use if seal has been punctured or is not visible. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Avoid freezing. Usual Dosage: Apply liberally to affected area twice daily. See package insert for full prescribing information. See end of carton for Lot Number and Expiration Date. Manufactured and Distributed by: Crown Laboratories, Inc., Johnson City, TN 37604 P9515.00 nystatin_15g_carton
- HOW SUPPLIED Nystatin Cream USP is a light yellow to yellow cream that is supplied in: 15 gram tube NDC 0316-0221-15 30 gram tube NDC 0316-0221-30 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Avoid freezing. Manufactured and Distributed by: Crown Laboratories, Inc., Johnson City, TN 37604 Printed in USA P9526.00
- 15 gram tube NDC 0316-0221-15 Rx Only Nystatin Cream, USP 100,000 units per gram WARNING: Keep out of reach of children. For external use only. Not for ophthalmic use. 15 grams Each gram contains: 100,000 USP Nystatin Units in an aqueous, cream base consisting of purified water, emulsifying wax, mineral oil, propylene glycol, sorbitol solution, cetyl palmitate, sorbic acid and potassium sorbate. TO OPEN: Use cap to puncture seal. IMPORTANT: Do not use if seal has been punctured or is not visible. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Avoid freezing. Usual Dosage: Apply liberally to affected area twice daily. See package insert for full prescribing information. See crimp of tube for Lot Number and Expiration Date. Manufactured and Distributed by: Crown Laboratories, Inc., Johnson City, TN 37604 P9503.01 p950301
- 15 gram carton NDC 0316-0221-15 Rx Only Nystatin Cream, USP 100,000 units per gram WARNING: Keep out of reach of children. For external use only. Not for ophthalmic use. 15 grams Each gram contains: 100,000 USP Nystatin Units in an aqueous, cream base consisting of purified water, emulsifying wax, mineral oil, propylene glycol, sorbitol solution, cetyl palmitate, sorbic acid and potassium sorbate. Directions for puncturing tube seal: Remove cap. Turn cap upside down and place puncture tip onto tube seal. Push cap down until seal is punctured. Screw cap back on to close. IMPORTANT: Do not use if seal has been punctured or is not visible. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Avoid freezing. Usual Dosage: Apply liberally to affected area twice daily. See package insert for full prescribing information. See end of carton for Lot Number and Expiration Date. Manufactured and Distributed by: Crown Laboratories, Inc., Johnson City, TN 37604 P9515.00 nystatin_15g_carton
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. Each gram contains 100,000 USP Nystatin Units in an aqueous, cream base consisting of purified water, emulsifying wax, mineral oil, propylene glycol, sorbitol solution, cetyl palmitate, sorbic acid and potassium sorbate. nystatin_structure
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 .) To report SUSPECTED ADVERSE REACTIONS, contact Crown Laboratories, Inc. at 1-423-926-4413 or FDA at 1-800-FDA-1088 or https://www.fda.gov/Safety/MedWatch/
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