Label: DESENEX- miconazole nitrate powder

  • NDC Code(s): 0067-0949-15, 0067-0949-30
  • Packager: Novartis Consumer Health, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 12/12

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

  • Active ingredient

    Miconazole nitrate 2%

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  • Purpose

    Antifungal

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  • Uses

    • cures most athlete’s foot (tinea pedis)
    • relieves itching, burning, cracking and discomfort associated with athlete’s foot
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  • Warnings

    For external use only

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  • Do Not Use

    • in the eyes
    • for nail or scalp infections
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  • When using this product

    • do not get into the eyes
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  • Stop use and ask a doctor if

    • irritation occurs or gets worse.
    • no improvement within 4 weeks
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  • Keep Out of Reach of Children

    If swallowed, get medical help or contact a poison control center right away.

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  • Directions

    • adults and children 2 years and older
    • wash the affected area with soap and water and dry completely before applying
    • apply a thin layer over affected area twice a day (morning and night) or as directed by a doctor
    • supervise children in the use of this product
    • pay special attention to the spaces between the toes. Wear well-fitting, ventilated shoes, and change shoes and socks at least once a day
    • use every day for 4 weeks
    • children under 2 years of age: ask a doctor
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  • Other information

    • store at controlled room temperature 20-25C (68-77F)
    • See container bottom for lot number and expiration date
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  • Inactive ingredients

    corn starch, fragrance, talc

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  • Questions or comments?

    call 1-800-452-0051

    Distributed by:  

    Novartis Consumer Health, Inc.

    Parsippany, NJ 07054-0622

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  • Principal Display Panel

    NDC 0067-0949-30

    2% Miconazole Nitrate, Antifungal

    Desenex®

    Powder

    Absorbs Wetness

    Cures Most Athlete’s Foot

    Relieves Itching & Burning

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  • Principal Display
  • INGREDIENTS AND APPEARANCE
    DESENEX 
    miconazole nitrate powder
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0067-0949
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MICONAZOLE NITRATE (MICONAZOLE) MICONAZOLE NITRATE 2 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    STARCH, CORN  
    TALC  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0067-0949-15 43 g in 1 CONTAINER
    2 NDC:0067-0949-30 85 g in 1 CONTAINER
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333C 08/03/2009
    Labeler - Novartis Consumer Health, Inc. (879821635)
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