Nystatin NYSTATIN ACTAVIS PHARMA, INC. FDA Approved Each gram of nystatin ointment, USP contains 100,000 units of nystatin in a white petrolatum base.
Generic: NYSTATIN
Mfr: ACTAVIS PHARMA, INC. FDA Rx Only
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Substance Nystatin
Route
TOPICAL
Applications
ANDA062840

Drug Facts

Composition & Profile

Strengths
100000 unit/g 15 g 30 g
Quantities
15 count
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 units/g is available as follows: 15 g tube (0 . 53 oz) NDC 0472-0166-15 30 g tube (1 . 1 oz) NDC 0472-0166-30 Store at controlled room temperature 15° to 30°C (59° to 86°F). Do not freeze. Manufactured In Croatia By: Pliva Hrvatska d.o.o. Zagreb, Croatia Manufactured For: Teva Pharmaceuticals Parsippany, NJ 07054 Rev. A 10/2023; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 0472-0166-15 Nystatin Ointment, USP 100,000 units per gram Rx only For External Use Only - Not for Ophthalmic Use 15 g (0.53 oz) 15 g (0.53 oz)

Package Descriptions
  • HOW SUPPLIED Nystatin ointment, USP 100,000 units/g is available as follows: 15 g tube (0 . 53 oz) NDC 0472-0166-15 30 g tube (1 . 1 oz) NDC 0472-0166-30 Store at controlled room temperature 15° to 30°C (59° to 86°F). Do not freeze. Manufactured In Croatia By: Pliva Hrvatska d.o.o. Zagreb, Croatia Manufactured For: Teva Pharmaceuticals Parsippany, NJ 07054 Rev. A 10/2023
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 0472-0166-15 Nystatin Ointment, USP 100,000 units per gram Rx only For External Use Only - Not for Ophthalmic Use 15 g (0.53 oz) 15 g (0.53 oz)

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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