Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Nystatin Cream USP (100,000 USP Nystatin Units per gram) is a yellow cream available as follows: 15 g tube (NDC 45802- 059 -35) 30 g tube (NDC 45802- 059 -11) STORAGE Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature].; Principal Display Panel NDC 45802- 059 -11 Rx Only Nystatin Cream USP (100,000 USP Nystatin Units) NET WT 30 g The following image is a placeholder representing the product identifier that is either affixed or imprinted on the drug package label during the packaging operation. A white Nystatin Cream USP package with blue and black text serialization-template.jpg
- HOW SUPPLIED Nystatin Cream USP (100,000 USP Nystatin Units per gram) is a yellow cream available as follows: 15 g tube (NDC 45802- 059 -35) 30 g tube (NDC 45802- 059 -11) STORAGE Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature].
- Principal Display Panel NDC 45802- 059 -11 Rx Only Nystatin Cream USP (100,000 USP Nystatin Units) NET WT 30 g The following image is a placeholder representing the product identifier that is either affixed or imprinted on the drug package label during the packaging operation. A white Nystatin Cream USP package with blue and black text serialization-template.jpg
Overview
Nystatin is a polyene antifungal antibiotic obtained from Streptomyces noursei . The molecular formula is C 47 H 75 NO 17 , and the molecular weight is 926.13. Structural formula: Nystatin Cream USP is for dermatologic use. Nystatin Cream USP for topical use, contains 100,000 USP nystatin units per gram. Inactive ingredients: emulsifying wax, glycerin, isopropyl myristate, lactic acid, purified water, sodium hydroxide, and sorbic acid. chemical structure
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. Nystatin Cream USP is not indicated for systemic, oral, intravaginal or ophthalmic use.
Dosage & Administration
Very moist lesions are best treated with nystatin topical dusting powder. 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 USP 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 USP 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 ).
Storage & Handling
STORAGE Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature].
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