Label: DESENEX- miconazole nitrate powder

  • NDC Code(s): 0316-0225-01, 0316-0225-02
  • Packager: Crown Laboratories
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 10, 2023

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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
  • Warnings

    For external use only.

    Avoid contact with eyes.

    Do not use

    on children under 2 years of age unless directed by a doctor.

    If irritation occurs or if there is no improvement within 4 weeks, discontinue use and consult a doctor.

    Keep out of reach of children.

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

  • Directions

    Wash the affected area and dry thoroughly. Apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor. Supervise children in the use of this product. Pay special attention to spaces between the toes; wear well fitting, ventilated shoes, and change shoes and socks at least once daily. Use daily for 4 weeks. If condition persists longer,
    consult a doctor. This product is not effective on the scalp or nails.

  • Other information

    • store at 20 o - 25 oC (68 o - 77 oF) [see USP Controlled Room Temperature].
  • Inactive ingredients

    1,2-Hexanediol, Aloe Barbadensis Leaf Juice Powder, Beta-Glucan, Caprylyl Glycol, Fragrance, Glycerin, Potassium Sorbate, Sodium Benzoate, Tapioca Starch, Tricalcium Phosphate, Water, Zea Mays (Corn) Starch

  • Questions?

    call 1-833-279-6522

  • Principal Display

    New & Improved

    Desenex®

    Antifungal Foot Powder

    with 2% Miconazole Nitrate

    PRESCRIPTION STRENGTH

    Cures Most Athlete's Foot

    Triple Action Powder

    Relieves Itching, Burning, and Scaling

    Attacks and Absorbs Moisture

    All Day Odor Control

    NET WT. 1.5 oz [43g]

    PRODUCT PACKAGED BY WEIGHT NOT VOLUME

    ©2023 Crown Laboratories, Inc.

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

    DESENEX is a registered trademark of Crown Laboratories, Inc.

    P12319.00

    Desenex Bottle Label

  • 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
    STARCH, TAPIOCA (UNII: 24SC3U704I)  
    TRICALCIUM PHOSPHATE (UNII: K4C08XP666)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    WATER (UNII: 059QF0KO0R)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    YEAST .BETA.-D-GLUCAN (UNII: 44FQ49X6UN)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0316-0225-0143 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/19/2023
    2NDC:0316-0225-0285 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/19/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00510/19/2023
    Labeler - Crown Laboratories (079035945)
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