Nystatin NYSTATIN SUN PHARMACEUTICAL INDUSTRIES, INC. FDA Approved Nystatin is a polyene antifungal antibiotic obtained from Streptomyces nursei . Structural formula: 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. Chemical Structure
FunFoxMeds box
Substance Nystatin
Route
TOPICAL
Applications
ANDA064022

Drug Facts

Composition & Profile

Strengths
15 g 30 g
Quantities
2 count
Treats Conditions
Indications And 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
Pill Appearance
Color: yellow

Identifiers & Packaging

Container Type BOX
UNII
BDF1O1C72E
Packaging

HOW SUPPLIED Nystatin Cream USP is a smooth yellow to light green cream with a characteristic perfume odor. Nystatin Cream USP is supplied in 15 g (NDC 51672-1289-1) and 30 g (NDC 51672-1289-2) 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.; PRINCIPAL DISPLAY PANEL - 30 g Tube Carton NDC 51672-1289-2 30 g Nystatin Cream USP, 100,000 units per gram FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. Rx only Keep this and all medications out of the reach of children. TARO PRINCIPAL DISPLAY PANEL - 30 g Tube Carton

Package Descriptions
  • HOW SUPPLIED Nystatin Cream USP is a smooth yellow to light green cream with a characteristic perfume odor. Nystatin Cream USP is supplied in 15 g (NDC 51672-1289-1) and 30 g (NDC 51672-1289-2) 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.
  • PRINCIPAL DISPLAY PANEL - 30 g Tube Carton NDC 51672-1289-2 30 g Nystatin Cream USP, 100,000 units per gram FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. Rx only Keep this and all medications out of the reach of children. TARO PRINCIPAL DISPLAY PANEL - 30 g Tube Carton

Overview

Nystatin is a polyene antifungal antibiotic obtained from Streptomyces nursei . Structural formula: 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. Chemical 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 .)

Storage & Handling

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Avoid freezing.


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