Nystatin NYSTATIN REDPHARM DRUG, INC FDA Approved Nystatin is a polyene antifungal antibiotic obtained from Streptomyces nursei. Structural formula: Molecular formula : C 47 H 75 NO 17 Molecular weight : 926.09 g/mol Nystatin cream is for dermatologic use. Nystatin cream, USP for topical use, contains 100,000 USP nystatin units per gram. Inactive ingredients: aluminium hydroxide gel, ceteareth-15, mono- and di- glyceride, polyoxyl 8 stearate, propylene glycol, simethicone emulsion, sorbitol solution, titanium dioxide, white petrolatum, methylparaben and propylparaben. Image
Generic: NYSTATIN
Mfr: REDPHARM DRUG, INC FDA Rx Only
FunFoxMeds box
Substance Nystatin
Route
TOPICAL
Applications
ANDA212557

Drug Facts

Composition & Profile

Strengths
100000 unit/g 15 g 30 g
Quantities
01 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, 100,000 units per gram is a yellow to light green color cream available as follows: NDC 13668-595-01 15 g tube NDC 13668-595-02 30 g tube; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Nystatin Cream, USP 15 grams (Tube label) Nystatin Cream, USP 15 grams (Carton Label) Nystatin Cream, USP 30 grams (Tube Label) Nystatin Cream USP, 30 grams (Carton Label)

Package Descriptions
  • HOW SUPPLIED Nystatin Cream, USP, 100,000 units per gram is a yellow to light green color cream available as follows: NDC 13668-595-01 15 g tube NDC 13668-595-02 30 g tube
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Nystatin Cream, USP 15 grams (Tube label) Nystatin Cream, USP 15 grams (Carton Label) Nystatin Cream, USP 30 grams (Tube Label) Nystatin Cream USP, 30 grams (Carton Label)

Overview

Nystatin is a polyene antifungal antibiotic obtained from Streptomyces nursei. Structural formula: Molecular formula : C 47 H 75 NO 17 Molecular weight : 926.09 g/mol Nystatin cream is for dermatologic use. Nystatin cream, USP for topical use, contains 100,000 USP nystatin units per gram. Inactive ingredients: aluminium hydroxide gel, ceteareth-15, mono- and di- glyceride, polyoxyl 8 stearate, propylene glycol, simethicone emulsion, sorbitol solution, titanium dioxide, white petrolatum, methylparaben and propylparaben. Image

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 health is complete.

Warnings & Precautions
No warnings available yet.
Contraindications

Nystatin cream is contraindicated in patients with a history of hypersensitivity to any of their 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

STORAGE AND HANDLING Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. Avoid freezing. Manufactured by: TORRENT PHARMACEUTICALS LTD., Pithampur-454775, INDIA . Manufactured for: TORRENT PHARMA INC., Basking Ridge, NJ 07920 8088981 August 2022 Image


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