Nystatin NYSTATIN BRYANT RANCH PREPACK FDA Approved Nystatin is a polyene antifungal antibiotic drug obtained from Streptomyces nursei. Structural formula: Nystatin Ointment is for dermatologic use. Nystatin Ointment USP, for topical use only, contains 100,000 USP Nystatin Units per gram, in a white petrolatum and light mineral oil base.
Generic: NYSTATIN
Mfr: BRYANT RANCH PREPACK FDA Rx Only
FunFoxMeds box
Substance Nystatin
Route
TOPICAL
Applications
ANDA207767
Package NDC

Drug Facts

Composition & Profile

Strengths
30 g
Treats Conditions
Indications And Usage Nystatin Ointment Is Indicated In The Treatment Of Cutaneous Or Mucocutaneous Mycotic Infections Caused By Candida Albicans And Other Susceptible Candida Species Nystatin Ointment 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

HOW SUPPLIED Nystatin ointment (100,000 USP Nystatin Units per gram) is a yellow colored ointment is supplied in 30g tubes. NDC: 63629-2515-1: in tube of 30 gm; Nystatin 100,000u/g Oint, USP #30 Label

Package Descriptions
  • HOW SUPPLIED Nystatin ointment (100,000 USP Nystatin Units per gram) is a yellow colored ointment is supplied in 30g tubes. NDC: 63629-2515-1: in tube of 30 gm
  • Nystatin 100,000u/g Oint, USP #30 Label

Overview

Nystatin is a polyene antifungal antibiotic drug obtained from Streptomyces nursei. Structural formula: Nystatin Ointment is for dermatologic use. Nystatin Ointment USP, for topical use only, contains 100,000 USP Nystatin Units per gram, in a white petrolatum and light mineral oil base.

Indications & Usage

Nystatin Ointment is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species. Nystatin Ointment is not indicated for systemic, oral, intravaginal or ophthalmic use.

Dosage & Administration

NYSTATIN Ointment 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 Ointment 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 Ointment preparations 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 NYSTATIN Ointment: Store at room temperature. Call your doctor for medical advice about side effects. You may report side effects to Viona Pharmaceuticals Inc. at 1-888-304-5011 or FDA at 1-800-FDA-1088.


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