Label: NYSTATIN ointment

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

Drug Label Information

Updated August 5, 2020

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

  • SPL UNCLASSIFIED SECTION

    For Dermatologic Use Only

    Not For Ophthalmic Use

    Rx Only

  • 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

  • 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.

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    Should a reaction of hypersensitivity occur, the drug should be immediately withdrawn and appropriate measures taken.

    This preparation is not for ophthalmic use.

  • 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.

  • 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.

  • HOW SUPPLIED

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

    15 g tube (NDC 68788-9516-1)

    30 g tube (NDC 68788-9516-3)

    STORAGE

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

    Manufactured By Perrigo

    Bronx, NY 10457

    Distributed By

    Perrigo®

    Allegan, MI 49010 • www.perrigo.com

    Rev 08-15

    : 2K800 RC JX1

    Relabeled By: Preferred Pharmaceuticals Inc.

  • Principal Display Panel

    Rx Only

    Nystatin Ointment USP

    (100,000 USP Nystatin Units)

    NET WT 15 g

    Nystatin Ointment USP (100,000 USP Nystatin Units
  • INGREDIENTS AND APPEARANCE
    NYSTATIN 
    nystatin ointment
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:68788-9516(NDC:45802-048)
    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
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68788-9516-11 in 1 CARTON02/10/2014
    115 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:68788-9516-31 in 1 CARTON02/10/2014
    230 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA06247202/10/2014
    Labeler - Preferred Pharmaceuticals, Inc. (791119022)
    Registrant - Preferred Pharmaceuticals, Inc. (791119022)
    Establishment
    NameAddressID/FEIBusiness Operations
    Preferred Pharmaceuticals, Inc.791119022RELABEL(68788-9516)