Nystatin NYSTATIN BRYANT RANCH PREPACK FDA Approved 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
Generic: NYSTATIN
Mfr: BRYANT RANCH PREPACK FDA Rx Only
FunFoxMeds box
Substance Nystatin
Route
TOPICAL
Applications
ANDA062225
Package NDC

Drug Facts

Composition & Profile

Strengths
30 g
Treats Conditions
Indications And 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

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UNII
BDF1O1C72E
Packaging

HOW SUPPLIED Nystatin Cream USP (100,000 USP Nystatin Units per gram) is a yellow cream available as follows: NDC: 71335-2830-1: 30 g in a TUBE STORAGE Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504; Nystatin 100,000 unit/gram Cream #15 Label

Package Descriptions
  • HOW SUPPLIED Nystatin Cream USP (100,000 USP Nystatin Units per gram) is a yellow cream available as follows: NDC: 71335-2830-1: 30 g in a TUBE STORAGE Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504
  • Nystatin 100,000 unit/gram Cream #15 Label

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 ).


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