NYSTATIN NYSTATIN DIRECT RX FDA Approved Nystatin is a polyene antifungal antibiotic obtained from Streptomyces nursei. Structural formula: [Chemical Structure] C47H75NO17 Molecular Weight: 926.13 Nystatin cream is for dermatologic use. Nystatin cream for topical use, contains 100,000 USP nystatin units per gram in an aqueous, perfumed cream base containing aluminum hydroxide gel, ceteareth-15, glyceryl monostearate, polyethylene glycol 400 monostearate, propylene glycol, purified water, simethicone emulsion, sorbitol solution, titanium dioxide, white petrolatum, with methylparaben and propylparaben as preservatives and, if necessary, sodium hydroxide for pH adjustment.
Generic: NYSTATIN
Mfr: DIRECT RX FDA Rx Only
FunFoxMeds box
Substance Nystatin
Route
ORAL TOPICAL
Applications
ANDA064022
Package NDC

Drug Facts

Composition & Profile

Strengths
15 g 30 g
Treats Conditions
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
Pill Appearance
Color: yellow

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UNII
BDF1O1C72E
Packaging

Nystatin Cream USP is a smooth yellow to light green cream with a characteristic perfume odor. Nystatin Cream USP is supplied in 15 g and 30 g ) tubes providing 100,000 USP Nystatin Units per gram. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Avoid freezing.; 278

Package Descriptions
  • Nystatin Cream USP is a smooth yellow to light green cream with a characteristic perfume odor. Nystatin Cream USP is supplied in 15 g and 30 g ) tubes providing 100,000 USP Nystatin Units per gram. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Avoid freezing.
  • 278

Overview

Nystatin is a polyene antifungal antibiotic obtained from Streptomyces nursei. Structural formula: [Chemical Structure] C47H75NO17 Molecular Weight: 926.13 Nystatin cream is for dermatologic use. Nystatin cream for topical use, contains 100,000 USP nystatin units per gram in an aqueous, perfumed cream base containing aluminum hydroxide gel, ceteareth-15, glyceryl monostearate, polyethylene glycol 400 monostearate, propylene glycol, purified water, simethicone emulsion, sorbitol solution, titanium dioxide, white petrolatum, with methylparaben and propylparaben as preservatives and, if necessary, sodium hydroxide for pH adjustment.

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.)


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