Label: NYSTATIN cream

  • NDC Code(s): 0472-0163-15, 0472-0163-30
  • Packager: Actavis Pharma, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated April 30, 2017

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    Should a reaction of hypersensitivity occur the drug should be immediately withdrawn and appropriate measures taken.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

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Actavis

    NDC 0472-0163-15

    Nystatin Cream USP 100,000 unit per gram

    Rx Only

    For External Use Only
    Not for Ophthalmic Use

    15 g (0.53 oz)

    15g
  • INGREDIENTS AND APPEARANCE
    NYSTATIN 
    nystatin cream
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0472-0163
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NYSTATIN (UNII: BDF1O1C72E) (NYSTATIN - UNII:BDF1O1C72E) NYSTATIN100000 [USP'U]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0472-0163-151 in 1 CARTON07/21/201005/31/2020
    115 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:0472-0163-301 in 1 CARTON07/21/201001/30/2021
    230 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA06294907/21/201001/30/2021
    Labeler - Actavis Pharma, Inc. (119723554)