Label: NYSTATIN- nystatin cream 

  • Label RSS
  • NDC Code(s): 51672-1289-1, 51672-1289-2
  • Packager: Taro Pharmaceuticals U.S.A., Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated 11/12

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  • SPL UNCLASSIFIED SECTION

    Rx only

    FOR TOPICAL USE ONLY • NOT FOR OPHTHALMIC USE

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  • DESCRIPTION

    Nystatin is a polyene antifungal antibiotic obtained from Streptomyces nursei.

    Structural formula:

    Chemical Structure

    C47H75NO17         Molecular Weight: 926.13

    Nystatin cream is for dermatologic use.

    Nystatin cream for topical use, contains 100,000 USP nystatin units per gram in an aqueous, perfumed cream base containing aluminum hydroxide gel, ceteareth-15, glyceryl monostearate, polyethylene glycol 400 monostearate, propylene glycol, purified water, simethicone emulsion, sorbitol solution, titanium dioxide, white petrolatum, with methylparaben and propylparaben as preservatives and, if necessary, sodium hydroxide for pH adjustment.

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  • CLINICAL PHARMACOLOGY

    Pharmacokinetics

    Nystatin is not absorbed from intact skin or mucous membrane.

    Microbiology

    Nystatin is an antibiotic which is both fungistatic and fungicidal in vitro against a wide variety of yeasts and yeast-like fungi, including Candida albicans, C. parapsilosis, C. tropicalis, C. guilliermondi, C. pseudotropicalis, C. krusei, Torulopsis glabrata, Tricophyton rubrum, T. mentagrophytes. Nystatin acts by binding to sterols in the cell membrane of susceptible species resulting in a change in membrane permeability and the subsequent leakage of intracellular components. On repeated subculturing with increasing levels of nystatin, Candida albicans does not develop resistance to nystatin. Generally, resistance to nystatin does not develop during therapy. However, other species of Candida (C. tropicalis, C. guilliermondi, C. krusei, and C. stellatoides) become quite resistant on treatment with nystatin and simultaneously become cross resistant to amphotericin as well. This resistance is lost when the antibiotic is removed. Nystatin exhibits no appreciable activity against bacteria, protozoa, or viruses.

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  • INDICATIONS AND USAGE

    Nystatin cream is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species.

    This cream is not indicated for systemic, oral, intravaginal or ophthalmic use.

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  • CONTRAINDICATIONS

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

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  • PRECAUTIONS

    General

    Nystatin cream should not be used for the treatment of systemic, oral, intravaginal or ophthalmic infections.

    If irritation or sensitization develops, treatment should be discontinued and appropriate measures taken as indicated. It is recommended that KOH smears, cultures, or other diagnostic methods be used to confirm the diagnosis of cutaneous or mucocutaneous candidiasis and to rule out infection caused by other pathogens.

    INFORMATION FOR THE PATIENT

    Patients using this medication should receive the following information and instructions:

    1. The patient should be instructed to use this medication as directed (including the replacement of missed doses). This medication is not for any disorder other than that for which it is prescribed.
    2. Even if symptomatic relief occurs within the first few days of treatment, the patient should be advised not to interrupt or discontinue therapy until the prescribed course of treatment is completed.
    3. If symptoms of irritation develop, the patient should be advised to notify the physician promptly.

    Laboratory Tests

    If there is a lack of therapeutic response, KOH smears, cultures, or other diagnostic methods should be repeated.

    Carcinogenesis, Mutagenesis, Impairment of Fertility

    No long-term animal studies have been performed to evaluate the carcinogenic potential of nystatin. No studies have been performed to determine the mutagenicity of nystatin or the effects on male or female fertility.

    Pregnancy

    Teratogenic Effects

    Category C

    Animal reproduction studies have not been conducted with any nystatin cream. It also is not known whether this cream can cause fetal harm when used by a pregnant woman or can affect reproductive capacity. Nystatin cream should be prescribed for a pregnant woman only if the potential benefit to the mother outweighs the potential risk to the fetus.

    Nursing Mothers

    It is not known whether nystatin is excreted in human milk. Caution should be exercised when nystatin is prescribed for a nursing woman.

    Pediatric Use

    Safety and effectiveness have been established in the pediatric population from birth to 16 years.

    (See DOSAGE AND ADMINISTRATION.)

    Geriatric Use

    Clinical studies with nystatin cream did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently than younger subjects. Other reported clinical experience has not identified differences in responses between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

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  • ADVERSE REACTIONS

    The frequency of adverse events reported in patients using nystatin cream is less than 0.1%. The more common events that were reported include allergic reactions, burning, itching, rash, eczema, and pain on application.

    (See PRECAUTIONS: General.)

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  • DOSAGE AND ADMINISTRATION

    Adults and Pediatric Patients (Neonates and Older)

    Apply liberally to affected areas twice daily or as indicated until healing is complete.

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  • HOW SUPPLIED

    Nystatin Cream USP is a smooth yellow to light green cream with a characteristic perfume odor.

    Nystatin Cream USP is supplied in 15 g (NDC 51672-1289-1) and 30 g (NDC 51672-1289-2) tubes providing 100,000 USP Nystatin Units per gram.

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

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  • SPL UNCLASSIFIED SECTION

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

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

    Revised: August, 2010

    PK-1161-4
    107

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  • PRINCIPAL DISPLAY PANEL - 30 g Tube Carton

    NDC 51672-1289-2

    30 g

    Nystatin
    Cream USP, 100,000 units per gram

    FOR EXTERNAL USE ONLY.
    NOT FOR OPHTHALMIC USE.

    Rx only

    Keep this and all medications out of the reach of children.

    TARO

    PRINCIPAL DISPLAY PANEL - 30 g Tube Carton
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  • INGREDIENTS AND APPEARANCE
    NYSTATIN 
    nystatin cream
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:51672-1289
    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
    petrolatum  
    glyceryl monostearate  
    ceteareth-15  
    water  
    propylene glycol  
    methylparaben  
    propylparaben  
    titanium dioxide  
    algeldrate  
    sorbitol  
    sodium hydroxide  
    Product Characteristics
    Color YELLOW (smooth yellow to light green) Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:51672-1289-1 1 in 1 CARTON
    1 15 g in 1 TUBE
    2 NDC:51672-1289-2 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 ANDA064022 01/28/1993
    Labeler - Taro Pharmaceuticals U.S.A., Inc. (145186370)
    Establishment
    Name Address ID/FEI Business Operations
    Taro Pharmaceuticals Inc. 206263295 MANUFACTURE(51672-1289)
    Establishment
    Name Address ID/FEI Business Operations
    Taro Pharmaceutical Industries Ltd. 600072078 MANUFACTURE(51672-1289)
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