Label: NYSTATIN- nystatin ointment

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated 08/12

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  • SPL UNCLASSIFIED SECTION

    Rx only

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  • DESCRIPTION

    Nystatin Ointment USP, for topical use only, contains 100,000 USP Nystatin Units per gram, in a polyethylene and mineral oil base. The structural formula is as follows:

    Structural Formula
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  • 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 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.

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  • INDICATIONS AND USAGE

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

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  • CONTRAINDICATIONS

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

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  • PRECAUTIONS

    Should a reaction of hypersensitivity occur the drug should be immediately withdrawn and appropriate measures taken.

    This preparation is not for ophthalmic use.

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  • ADVERSE REACTIONS

    Nystatin 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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  • DOSAGE AND ADMINISTRATION

    Nystatin Ointment 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.

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  • HOW SUPPLIED

    Nystatin Ointment (100,000 USP Nystatin Units per gram) is a yellow ointment available as follows:

    NDC 42254-284-15 15 gram tube

    Store at controlled room temperature 15°- 30°C (59°-86°F).

    E. FOUGERA & CO.
    A division of Fougera Pharmaceuticals Inc.
    Melville, New York 11747
    I20715H
    R08/11
    #21

    Repackaged by:
    REBEL DISTRIBUTORS CORP.
    Thousand Oaks, CA 91320

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  • PRINCIPAL DISPLAY PANEL
  • INGREDIENTS AND APPEARANCE
    NYSTATIN 
    nystatin ointment
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:42254-284(NDC:0168-0007)
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    nystatin (nystatin) nystatin 100000 [USP'U]  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    HIGH DENSITY POLYETHYLENE  
    Mineral Oil  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:42254-284-15 15 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA062124 09/23/1982
    Labeler - Rebel Distributors Corp (118802834)
    Registrant - PSS World Medical, Inc. (101822862)
    Establishment
    Name Address ID/FEI Business Operations
    PSS World Medical, Inc. 791528623 REPACK(42254-284)
    Establishment
    Name Address ID/FEI Business Operations
    STAT RX USA LLC 786036330 REPACK(42254-284)
    Establishment
    Name Address ID/FEI Business Operations
    Dispensing Solutions, Inc. 066070785 RELABEL(42254-284), REPACK(42254-284)
    Establishment
    Name Address ID/FEI Business Operations
    SCRIPT PAK 964420108 RELABEL(42254-284), REPACK(42254-284)
    Establishment
    Name Address ID/FEI Business Operations
    Keltman Pharmaceuticals, Inc. 362861077 REPACK(42254-284)
    Establishment
    Name Address ID/FEI Business Operations
    Rebel Distirbutors Corp. 118802834 RELABEL(42254-284), REPACK(42254-284)
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