Nystatin NYSTATIN PROFICIENT RX LP FDA Approved Each gram of Nystatin Ointment USP contains 100,000 units of nystatin in a white petrolatum base.
Generic: NYSTATIN
Mfr: PROFICIENT RX LP FDA Rx Only
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Substance Nystatin
Route
TOPICAL
Applications
ANDA062840
Package NDC

Drug Facts

Composition & Profile

Strengths
100000 unit/g 15 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
All Product Codes
UPC
0363187464158
UNII
BDF1O1C72E
Packaging

HOW SUPPLIED Nystatin Ointment USP 100,000 units/g 15 g tube (0 . 53 oz) Store at controlled room temperature 15°-30°C (59°-86°F). Do not freeze. Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA FORM NO. 0166 Rev. 10/19 VC2752 Relabeled By: Proficient Rx LP Thousand Oaks, CA 91320; Package/Label Display Panel 63187-464-15

Package Descriptions
  • HOW SUPPLIED Nystatin Ointment USP 100,000 units/g 15 g tube (0 . 53 oz) Store at controlled room temperature 15°-30°C (59°-86°F). Do not freeze. Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA FORM NO. 0166 Rev. 10/19 VC2752 Relabeled By: Proficient Rx LP Thousand Oaks, CA 91320
  • Package/Label Display Panel 63187-464-15

Overview

Each gram of Nystatin Ointment USP contains 100,000 units of nystatin in a white petrolatum base.

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 the affected areas twice a day or as indicated until healing is complete. The ointment does not stain the skin or mucous membranes and it 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 is virtually nontoxic 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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