DESENEX (MICONAZOLE NITRATE) POWDER [CROWN LABORATORIES]

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DESENEX (MICONAZOLE NITRATE) POWDER [CROWN LABORATORIES]
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NDC 0316-0225-15, 0316-0225-30
Set ID 7c4a483e-199a-7ee1-e053-2a91aa0a3dec
Category HUMAN OTC DRUG LABEL
Packager Crown Laboratories
Generic Name
Product Class Azole Antifungal
Product Number
Application Number PART333C
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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)  
    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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