NYSTATIN NYSTATIN AUROBINDO PHARMA LIMITED FDA Approved Nystatin is a polyene antifungal antibiotic obtained from Streptomyces nursei . Structural formula: C 47 H 75 NO 17 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, cream base containing aluminum hydroxide gel, ceteareth-15, mono and diglycerides, polyoxyl 8 stearate, propylene glycol, purified water, simethicone emulsion, sorbitol solution, titanium dioxide, white petrolatum, with methylparaben and propylparaben as preservatives. str
Generic: NYSTATIN
FunFoxMeds box
Substance Nystatin
Route
TOPICAL
Applications
ANDA219527

Drug Facts

Composition & Profile

Strengths
15 g 30 g
Quantities
500 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 yellow to light green smooth cream and supplied as follows: Tube of 15 g NDC 59651-907-14 Tube of 30 g NDC 59651-907-30 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Avoid freezing. Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 032, India Issued: May 2024; PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 15 g Tube Label NDC 59651-907-14 Rx only Nystatin Cream, USP 100,000 units per gram FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. AUROBINDO Keep this and all medications out of the reach of children. 15 g PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 15 g Tube Label; PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 15 g Tube Carton Label NDC 59651-907-14 Rx only Nystatin Cream, USP 100,000 units per gram FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. Keep this and all medications out of the reach of children. AUROBINDO 15 g PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 15 g Tube Carton Label

Package Descriptions
  • HOW SUPPLIED Nystatin Cream USP is yellow to light green smooth cream and supplied as follows: Tube of 15 g NDC 59651-907-14 Tube of 30 g NDC 59651-907-30 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Avoid freezing. Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Manufactured by: Aurobindo Pharma Limited Hyderabad-500 032, India Issued: May 2024
  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 15 g Tube Label NDC 59651-907-14 Rx only Nystatin Cream, USP 100,000 units per gram FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. AUROBINDO Keep this and all medications out of the reach of children. 15 g PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 15 g Tube Label
  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 15 g Tube Carton Label NDC 59651-907-14 Rx only Nystatin Cream, USP 100,000 units per gram FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. Keep this and all medications out of the reach of children. AUROBINDO 15 g PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 15 g Tube Carton Label

Overview

Nystatin is a polyene antifungal antibiotic obtained from Streptomyces nursei . Structural formula: C 47 H 75 NO 17 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, cream base containing aluminum hydroxide gel, ceteareth-15, mono and diglycerides, polyoxyl 8 stearate, propylene glycol, purified water, simethicone emulsion, sorbitol solution, titanium dioxide, white petrolatum, with methylparaben and propylparaben as preservatives. str

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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