Nystatin NYSTATIN MACLEODS PHARMACEUTICALS LIMITED FDA Approved Nystatin is a polyene antifungal antibiotic obtained from Streptomyces nursei . Nystatin cream is for dermatologic use. Nystatin cream for topical use, contains 100,000 USP Nystatin Units in an aqueous cream base containing aluminium hydroxide, ceteareth-15, polyethylene glycol monostearate, glycerol monostearate, propylene glycol, purified water, simethicone emulsion, non-crystallizing sorbitol solution, titanium dioxide, white petrolatum with methyl paraben and propyl paraben as preservatives. 555
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Substance Nystatin
Route
TOPICAL
Applications
ANDA213566

Drug Facts

Composition & Profile

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

Identifiers & Packaging

Container Type BOX
UNII
BDF1O1C72E
Packaging

HOW SUPPLIED Nystatin Cream USP is a yellow to light green cream. It is supplied as: 15 gram Tube NDC 33342-469-15 30 gram Tube NDC 33342-469-30 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Avoid freezing. Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540 Manufacturer: Macleods Pharmaceuticals Limited At Oxalis Labs Baddi, Himachal Pradesh, INDIA Rev. 08/2021; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Nystatin Cream USP, 100000 units per gram Pack Count: 15 gms Tube NDC: 33342-469-15 Nystatin Cream USP, 100000 units/gram Pack Count: 15 gms carton NDC: 33342-469-15 Nystatin Cream USP, 100000 units per gram Pack Count: 30 gms Tube NDC: 33342-469-30 Nystatin Cream USP, 100000 units/gram Pack Count: 30 gms carton NDC: 33342-469-30 1 2 3 4

Package Descriptions
  • HOW SUPPLIED Nystatin Cream USP is a yellow to light green cream. It is supplied as: 15 gram Tube NDC 33342-469-15 30 gram Tube NDC 33342-469-30 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Avoid freezing. Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540 Manufacturer: Macleods Pharmaceuticals Limited At Oxalis Labs Baddi, Himachal Pradesh, INDIA Rev. 08/2021
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Nystatin Cream USP, 100000 units per gram Pack Count: 15 gms Tube NDC: 33342-469-15 Nystatin Cream USP, 100000 units/gram Pack Count: 15 gms carton NDC: 33342-469-15 Nystatin Cream USP, 100000 units per gram Pack Count: 30 gms Tube NDC: 33342-469-30 Nystatin Cream USP, 100000 units/gram Pack Count: 30 gms carton NDC: 33342-469-30 1 2 3 4

Overview

Nystatin is a polyene antifungal antibiotic obtained from Streptomyces nursei . Nystatin cream is for dermatologic use. Nystatin cream for topical use, contains 100,000 USP Nystatin Units in an aqueous cream base containing aluminium hydroxide, ceteareth-15, polyethylene glycol monostearate, glycerol monostearate, propylene glycol, purified water, simethicone emulsion, non-crystallizing sorbitol solution, titanium dioxide, white petrolatum with methyl paraben and propyl paraben as preservatives. 555

Indications & Usage

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

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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