Label: NYSTATIN ointment

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

Drug Label Information

Updated February 1, 2020

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  • SPL UNCLASSIFIED SECTION

    Rx Only

  • DESCRIPTION

    Each gram of Nystatin Ointment USP contains 100,000 units of nystatin in a white petrolatum base.

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

  • CONTRAINDICATIONS

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    Should a reaction of hypersensitivity occur the drug should be immediately withdrawn and appropriate measures taken.

  • 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 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.

  • HOW SUPPLIED

    Nystatin Ointment USP 100,000 units/g

    15 g tube (0.53 oz)

    Store at controlled room temperature 15°-30°C (59°-86°F). Do not freeze.

    Manufactured by:

    Actavis Mid Atlantic LLC

    1877 Kawai Road

    Lincolnton, NC 28092 USA

    FORM NO. 0166

    Rev. 1/06

    VC2752

    Relabeled By:

    Proficient Rx LP

    Thousand Oaks, CA 91320

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    41a98c36-figure-01
  • Package/Label Display Panel

    63187-464-15
  • INGREDIENTS AND APPEARANCE
    NYSTATIN 
    nystatin ointment
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:63187-464(NDC:0472-0166)
    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
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63187-464-151 in 1 CARTON01/01/2019
    115 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA06284009/03/2002
    Labeler - Proficient Rx LP (079196022)
    Establishment
    NameAddressID/FEIBusiness Operations
    Proficient Rx LP079196022REPACK(63187-464) , RELABEL(63187-464)