Label: NYSTATIN- nystatin ointment

  • NDC Code(s): 45802-048-11, 45802-048-35
  • Packager: Perrigo New York Inc
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated 10/14

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    For Dermatologic Use Only

    Not For Ophthalmic Use

    Rx Only

    Close
  • DESCRIPTION

    Nystatin Ointment USP for topical use only, contains 100,000 USP Nystatin units per gram, in an ointment base of light mineral oil and white petrolatum. The structural formula is as follows:

    structural formula

    Molecular Weight 926.13

    Molecular Formula C47H75NO17

    Close
  • 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 Ointment USP 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.

    Close
  • 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.

    Close
  • CONTRAINDICATIONS

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

    Close
  • PRECAUTIONS

    Should a reaction of hypersensitivity occur, the drug should be immediately withdrawn and appropriate measures taken.

    This preparation is not for ophthalmic use.

    Close
  • ADVERSE REACTIONS

    Nystatin Ointment USP 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.

    Close
  • DOSAGE AND ADMINISTRATION

    Nystatin Ointment USP 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.

    Close
  • HOW SUPPLIED

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

    15 g tube (NDC 45802-048-35)

    30 g tube (NDC 45802-048-11)

    STORAGE

    Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature].

    Close
  • SPL UNCLASSIFIED SECTION

    Manufactured By Perrigo

    Bronx, NY 10457

    Distributed By Perrigo

    Allegan, MI 49010 • www.perrigo.com

    Rev. 10/12

    :2K800 RC J4

    Close
  • Principal Display Panel - 15 g Carton

    Rx Only

    NDC 45802-048-35

    Nystatin Ointment USP

    (100,000 USP Nystatin Units)

    NET WT 15 g

    Nystatin Ointment Carton Image
    Close
  • Principal Display Panel - 15 g Tube

    Rx Only

    NDC 45802-048-35

    Nystatin Ointment USP

    (100,000 USP Nystatin Units)

    NET WT 15 g

    Nystatin OIntment Tube
    Close
  • INGREDIENTS AND APPEARANCE
    NYSTATIN 
    nystatin ointment
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:45802-048
    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
    LIGHT MINERAL OIL  
    PETROLATUM  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:45802-048-35 1 in 1 CARTON
    1 15 g in 1 TUBE
    2 NDC:45802-048-11 1 in 1 CARTON
    2 30 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA062472 09/15/2006
    Labeler - Perrigo New York Inc (078846912)
    Close