Nystatin by REMEDYREPACK INC. NYSTATIN cream

Nystatin by

Drug Labeling and Warnings

Nystatin by is a Prescription medication manufactured, distributed, or labeled by REMEDYREPACK INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

(100,000 units/g)

Rx Only

DESCRIPTION

EACH GRAM OF NYSTATIN CREAM USP CONTAINS: 100,000 units in an aqueous cream base of aluminum hydroxide gel, cetearyl alcohol (and) ceteareth-20, citric acid, glyceryl stearate, methylparaben, polyoxyl 40 stearate, propylene glycol, propylparaben, purified water, sodium citrate, sorbic acid, sorbitol solution, titanium dioxide and white petrolatum.

CLINICAL PHARMACOLOGY

Nystatin is an antifungal antibiotic which is both fungistatic and fungicidal in vitro against a wide variety of yeasts and yeast-like fungi. It probably acts by binding to sterols in the cell membrane of the fungus with a resultant change in membrane permeability allowing leakage of intracellular components. Nystatin is a polyene antibiotic of undetermined structural formula that is obtained from Streptomyces noursei, and is the first well tolerated antifungal antibiotic of dependable efficacy for the treatment of cutaneous, oral and intestinal infections caused by Candida (Monilia) albicans and other Candida species. It exhibits no appreciable activity against bacteria.

Nystatin provides specific therapy for all localized forms of candidiasis. Symptomatic relief is rapid, often occurring within 24 to 72 hours after the initiation of treatment. Cure is effected both clinically and mycologically in most cases of localized candidiasis.

INDICATIONS AND USAGE

Nystatin Cream USP is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida (Monilia) albicans and other Candida species.

CONTRAINDICATIONS

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

PRECAUTIONS

Should a reaction of hypersensitivity occur the drug should be immediately withdrawn and appropriate measures taken.

This preparation is not for ophthalmic use.

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.

DOSAGE AND ADMINISTRATION

Nystatin Cream USP should be applied liberally to the 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.

The cream does not stain the skin or mucous membranes and it provides a simple, convenient means of treatment.

HOW SUPPLIED

Nystatin Cream USP 100,000 units/g

15 g tube (0 .53 oz)

30 g tube (1 .1 oz)

Store at controlled room temperature 15°-30°C (59°-86°F). Avoid exposure to excessive heat, 40°C (104°F).

Manufactured by:

G&W Laboratories, Inc.
111 Coolidge Street
South Plainfield, NJ 07080 USA

Distributed by:
Actavis Pharma, Inc.
Parsippany, NJ 07054 USA

Revised – April 2017

I600-4830/4835A GW7211

PRINCIPAL DISPLAY PANEL

DRUG: Nystatin

GENERIC: Nystatin

DOSAGE: CREAM

ADMINSTRATION: TOPICAL

NDC: 70518-1305-0

PACKAGING: 30 g in 1 TUBE

OUTER PACKAGING: 1 in 1 CARTON

ACTIVE INGREDIENT(S):

• NYSTATIN 100000[USP'U] in 1g

INACTIVE INGREDIENT(S):

• ALUMINUM HYDROXIDE
• SODIUM CITRATE
• SORBIC ACID
• SORBITOL
• PETROLATUM
• TITANIUM DIOXIDE
• WATER
• CETOSTEARYL ALCOHOL
• CITRIC ACID MONOHYDRATE
• GLYCERYL MONOSTEARATE
• METHYLPARABEN
• POLYOXYL 40 STEARATE
• PROPYLENE GLYCOL
• PROPYLPARABEN

INGREDIENTS AND APPEARANCE

NYSTATIN 
nystatin cream

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 70518-1305(NDC:0472-0163)
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
NYSTATIN (UNII: BDF1O1C72E) (NYSTATIN - UNII:BDF1O1C72E)	NYSTATIN	100000 [USP'U]  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SORBIC ACID (UNII: X045WJ989B)
SORBITOL (UNII: 506T60A25R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
PETROLATUM (UNII: 4T6H12BN9U)
METHYLPARABEN (UNII: A2I8C7HI9T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70518-1305-0	1 in 1 CARTON	07/16/2018
1		30 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA062949	07/16/2018

Labeler - REMEDYREPACK INC. (829572556)