Nystatin NYSTATIN BRYANT RANCH PREPACK FDA Approved Nystatin Ointment USP for topical use only, contains 100,000 USP Nystatin units per gram, in an ointment base of light mineral oil and white petrolatum. The structural formula is as follows: Molecular Weight 926.13 Molecular Formula C 47 H 75 NO 17
Generic: NYSTATIN
Mfr: BRYANT RANCH PREPACK FDA Rx Only
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Substance Nystatin
Route
TOPICAL
Applications
ANDA062472

Drug Facts

Composition & Profile

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

Identifiers & Packaging

Container Type UNKNOWN
UNII
BDF1O1C72E
Packaging

HOW SUPPLIED Nystatin Ointment USP (100,000 USP Nystatin Units per gram) is a yellow ointment available as follows: NDC 72162-2333-2: 15 g in a TUBE NDC 72162-2333-3: 30 g in a TUBE STORAGE Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504; Nystatin Ointment USP (100,000 USP Nystatin Units) Extended Label Label extended label

Package Descriptions
  • HOW SUPPLIED Nystatin Ointment USP (100,000 USP Nystatin Units per gram) is a yellow ointment available as follows: NDC 72162-2333-2: 15 g in a TUBE NDC 72162-2333-3: 30 g in a TUBE STORAGE Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504
  • Nystatin Ointment USP (100,000 USP Nystatin Units) Extended Label Label extended label

Overview

Nystatin Ointment USP for topical use only, contains 100,000 USP Nystatin units per gram, in an ointment base of light mineral oil and white petrolatum. The structural formula is as follows: Molecular Weight 926.13 Molecular Formula C 47 H 75 NO 17

Indications & Usage

Nystatin Ointment USP is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida [Monilia] albicans and other Candida species.

Dosage & Administration

Nystatin Ointment USP should be applied liberally to affected areas twice a day or as indicated until healing is complete. Nystatin cream is usually preferred to nystatin ointment in candidiasis involving intertriginous areas; very moist lesions, however, are best treated with nystatin topical powder. This preparation does not stain skin or mucous membranes and provides a simple, convenient means of treatment.

Warnings & Precautions
No warnings available yet.
Contraindications

Nystatin Ointment USP is contraindicated in patients with a history of hypersensitivity to any of its components.

Adverse Reactions

Nystatin Ointment USP is virtually non-toxic and nonsensitizing and is well tolerated by all age groups including debilitated infants, even on prolonged administration. If irritation on topical application should occur, discontinue medication.


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