Label: DESENEX- miconazole nitrate powder

  • NDC Code(s): 0316-0225-15, 0316-0225-30
  • Packager: Crown Laboratories
  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 February 21, 2022

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  • Active ingredient

    Miconazole nitrate 2%

  • Purpose

    Antifungal

  • Uses

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

    For external use only · Avoid contact with eyes.

    Do Not Use

    • for nail or scalp infections

    When using this product

    • do not get into the eyes

    Stop use and ask a doctor if

    • irritation occurs or gets worse
    • no improvement within 4 weeks

    Keep out of reach of children.

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

  • Directions

    • adults and children 2 years and older
    • wash the affected area with soap and water and dry thoroughly 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
  • Other information

    • Store at 20 o - 25 oC (68 o - 77 oF) [see USP Controlled Room Temperature].
    • See container bottom for lot number and expiration date
  • Inactive ingredients

    Aldioxa, Chloroxylenol, Croscarmellose Sodium, Fragrance, Imidazolidinyl Urea, Magnesium Stearate, Microcrystalline Cellulose, Sodium Acrylates Crosspolymer-2

  • Questions or comments?

    call 1-833-279-6522

  • Principal Display

    NDC 0316-0225-30

    New & Improved

    Desenex®

    Miconazole Nitrate 2% Antifungal Treatment

    PRESCRIPTION STRENGTH

    TRIPLE ACTION POWDER

    Absorbs Wetness

    Repels Moisture

    Relieves Itching & Burning

    Cures Most Athlete's Foot

    NET WT. 3 oz (85 g)

    PRODUCT PACKAGED BY WEIGHT NOT VOLUME

    ©2020 Crown Laboratories, Inc.

    Distributed by: Crown Laboratories, Inc. Johnson City, TN 37604

    DESENEX is a registered trademark of Crown Laboratories, Inc.

    P11528.01

    desenex

  • INGREDIENTS AND APPEARANCE
    DESENEX 
    miconazole nitrate powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0316-0225
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE20 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    CHLOROXYLENOL (UNII: 0F32U78V2Q)  
    IMIDUREA (UNII: M629807ATL)  
    ALDIOXA (UNII: 8T66I31YNK)  
    SODIUM ACRYLATES CROSSPOLYMER-2 (UNII: D3HPR4WW6F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0316-0225-1543 g in 1 CONTAINER; Type 0: Not a Combination Product12/01/2018
    2NDC:0316-0225-3085 g in 1 CONTAINER; Type 0: Not a Combination Product12/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C08/03/2009
    Labeler - Crown Laboratories (079035945)
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