NYSTATIN OINTMENT [PHYSICIANS TOTAL CARE, INC.]

NYSTATIN OINTMENT [PHYSICIANS TOTAL CARE, INC.]
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NDC 54868-1425-0, 54868-1425-1
Set ID db8e62a1-9a5e-49d1-8c6b-64a3e083487c
Category HUMAN PRESCRIPTION DRUG LABEL
Packager Physicians Total Care, Inc.
Generic Name
Product Class
Product Number
Application Number ANDA062124
  • SPL UNCLASSIFIED SECTION

    Rx only

  • 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
  • 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.

  • 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.

  • CONTRAINDICATIONS

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    Should a reaction of hypersensitivity occur the drug should be immediately withdrawn and appropriate measures taken.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

  • 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.

  • HOW SUPPLIED

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

    NDC 54868-1425-0 15 gram tube

    NDC 54868-1425-1 30 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

    Additional barcode labeling by:

    Physicians Total Care, Inc.

    Tulsa, Oklahoma 74146

  • PACKAGE LABEL – PRINCIPAL DISPLAY PANEL

    NDC 54868-1425-1

    Rx only

    NYSTATIN OINTMENT USP

    100,000 USP Nystatin Units Per Gram

    WARNING: Keep this and all

    drugs out of reach of children.

    For Topical Use Only.

    Not for Ophthalmic Use.

    NET WT 30 grams

    image of package label
  • INGREDIENTS AND APPEARANCE
    NYSTATIN 
    nystatin ointment
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:54868-1425(NDC:0168-0007)
    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
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    Mineral Oil (UNII: T5L8T28FGP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54868-1425-11 in 1 CARTON
    130 g in 1 TUBE
    2NDC:54868-1425-01 in 1 CARTON
    215 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA06212404/11/2007
    Labeler - Physicians Total Care, Inc. (194123980)
    Establishment
    NameAddressID/FEIBusiness Operations
    Physicians Total Care, Inc.194123980relabel(54868-1425)