Nystatin NYSTATIN MAYNE PHARMA INC. FDA Approved Nystatin is a polyene antifungal antibiotic obtained from Streptomyces noursei . The molecular formula for Nystatin is C 47 H 75 NO 17 . The molecular weight of Nystatin is 926.1. Structural formula: Nystatin topical powder is for dermatologic use. Nystatin topical powder contains 100,000 USP nystatin units per gram dispersed in talc. Chemical Structure
Generic: NYSTATIN
Mfr: MAYNE PHARMA INC. FDA Rx Only
FunFoxMeds bottle
Substance Nystatin
Route
TOPICAL
Applications
ANDA065203

Drug Facts

Composition & Profile

Strengths
100000 unit 15 g 30 g 60 g
Treats Conditions
Indications And Usage Nystatin Topical Powder Is Indicated In The Treatment Of Cutaneous Or Mucocutaneous Mycotic Infections Caused By Candida Albicans And Other Susceptible Candida Species Nystatin Topical Powder Is Not Indicated For Systemic Oral Intravaginal Or Ophthalmic Use

Identifiers & Packaging

Container Type BOTTLE
UPC
0368308152150
UNII
BDF1O1C72E
Packaging

HOW SUPPLIED Nystatin topical powder, USP is supplied as 100,000 units nystatin per gram in plastic squeeze bottles: 15g (NDC 68308-152-15) 30g (NDC 68308-152-30) 60g (NDC 68308-152-60) STORAGE Store at 20°C to 25°C (68°F to 77°F)[see USP Controlled Room Temperature]; avoid excessive heat (40°C/104°F). Keep tightly closed.; PRINCIPAL DISPLAY PANEL - 15 gram Bottle Label NDC 68308-152-15 Nystatin Topical Powder, USP 100,000 units per gram Rx Only 15 grams mayne pharma PRINCIPAL DISPLAY PANEL - 15 gram Bottle Label

Package Descriptions
  • HOW SUPPLIED Nystatin topical powder, USP is supplied as 100,000 units nystatin per gram in plastic squeeze bottles: 15g (NDC 68308-152-15) 30g (NDC 68308-152-30) 60g (NDC 68308-152-60) STORAGE Store at 20°C to 25°C (68°F to 77°F)[see USP Controlled Room Temperature]; avoid excessive heat (40°C/104°F). Keep tightly closed.
  • PRINCIPAL DISPLAY PANEL - 15 gram Bottle Label NDC 68308-152-15 Nystatin Topical Powder, USP 100,000 units per gram Rx Only 15 grams mayne pharma PRINCIPAL DISPLAY PANEL - 15 gram Bottle Label

Overview

Nystatin is a polyene antifungal antibiotic obtained from Streptomyces noursei . The molecular formula for Nystatin is C 47 H 75 NO 17 . The molecular weight of Nystatin is 926.1. Structural formula: Nystatin topical powder is for dermatologic use. Nystatin topical powder contains 100,000 USP nystatin units per gram dispersed in talc. Chemical Structure

Indications & Usage

Nystatin topical powder is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species. Nystatin topical powder is not indicated for systemic, oral, intravaginal or ophthalmic use.

Dosage & Administration

Very moist lesions are best treated with the topical dusting powder. Adults and Pediatric Patients (Neonates and Older) Apply to candidal lesions two or three times daily until healing is complete. For fungal infection of the feet caused by Candida species, the powder should be dusted on the feet, as well as, in all foot wear.

Warnings & Precautions
No warnings available yet.
Contraindications

Nystatin topical powder 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 topical powder 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°C to 25°C (68°F to 77°F)[see USP Controlled Room Temperature]; avoid excessive heat (40°C/104°F). Keep tightly closed.


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