NYSTATIN CREAM [REBEL DISTRIBUTORS CORP]

NYSTATIN CREAM [REBEL DISTRIBUTORS CORP]
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NDC 21695-761-15, 21695-761-30
Set ID fb98a6b8-da0c-40f4-9e53-487b541865b5
Category HUMAN PRESCRIPTION DRUG LABEL
Packager Rebel Distributors Corp
Generic Name
Product Class
Product Number
Application Number ANDA064022
  • SPL UNCLASSIFIED SECTION

    Rx only

  • DESCRIPTION

    Nystatin Cream is for dermatologic use.

    Nystatin is a polyene antimycotic obtained from Streptomyces noursei. It is a yellow to light tan powder with a cereal-like odor, very soluble in water, and slightly to sparingly soluble in alcohol. Structural formula:

    Chemical Structure

    Nystatin Cream contains the antifungal antibiotic nystatin at a concentration of 100,000 USP Nystatin Units per gram in an aqueous, perfumed cream base containing purified water, propylene glycol, methylparaben, propylparaben, white petrolatum, glyceryl monostearate, polyethylene glycol 400 monostearate, ceteareth-15, medical antifoam AF emulsion, aluminum hydroxide gel, titanium dioxide, sorbitol solution, and, if necessary, sodium hydroxide for pH adjustment.

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

  • CONTRAINDICATIONS

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    Should a reaction of hypersensitivity occur the drug should be immediately withdrawn and appropriate measures taken.

    Nystatin Cream is not for ophthalmic use.

  • 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 Cream should be applied liberally to affected areas twice daily 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.

  • HOW SUPPLIED

    Nystatin Cream is a smooth yellow cream with a characteristic perfume odor.

    Nystatin Cream is supplied in 15g (NDC 21695-761-15) and 30g (NDC 21695-761-30) tubes providing 100,000 USP Nystatin Units per gram.

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

  • SPL UNCLASSIFIED SECTION

    Mfd. by: Taro Pharmaceuticals Inc.
    Brampton, Ontario, Canada L6T 1C1

    Dist. by: Taro Pharmaceuticals U.S.A., Inc.
    Hawthorne, NY 10532

    Repackaged by:

    Rebel Distributors Corp

    Thousand Oaks, CA 91320

  • Principal Display Panel

    Nystatin 100,000 Units

  • INGREDIENTS AND APPEARANCE
    NYSTATIN 
    nystatin cream
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:21695-761(NDC:51672-1289)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Nystatin (UNII: BDF1O1C72E) (Nystatin - UNII:BDF1O1C72E) Nystatin100000 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    propylene glycol (UNII: 6DC9Q167V3)  
    methylparaben (UNII: A2I8C7HI9T)  
    propylparaben (UNII: Z8IX2SC1OH)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    glyceryl monostearate (UNII: 230OU9XXE4)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    CETEARETH-12 (UNII: 7V4MR24V5P)  
    ALGELDRATE (UNII: 03J11K103C)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    SORBITOL (UNII: 506T60A25R)  
    sodium hydroxide (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21695-761-151 in 1 CARTON
    115 g in 1 TUBE
    2NDC:21695-761-301 in 1 CARTON
    230 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA06402201/29/1993
    Labeler - Rebel Distributors Corp (118802834)
    Establishment
    NameAddressID/FEIBusiness Operations
    Rebel Distributors Corp118802834RELABEL, REPACK

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