Label: ANTI-FUNGAL POWDER MICONAZOLE NITRATE- miconazole nitrate powder

  • NDC Code(s): 56104-500-00
  • Packager: Premier Brands of America Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 26, 2024

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  • Active ingredient

    Miconazole nitrate 2%

  • Purpose

    Antifungal

  • Uses

    for the cure of most athlete's foot, jock itch and ringworm

  • Warnings

    For external use only.

    Do not use

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

    When using this product

    avoid contact with the eyes

    Stop and ask a doctor if

    irritation occurs or there is no improvement within 4 weeks for athlete's foot and ringworm, or 2 weeks for jock itch.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • clean the affected area and dry thoroughly
    • apply a thin layer of product over affected area twice daily (morning and night) or as directed by a doctor
    • supervise children in the use of this product
    • for athlete’s foot: pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, & change shoes & socks at least once daily
    • for athlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks
    • if conditions persist longer, consult a doctor
    • this product is not effective on the scalp or nails
  • Other information

    • store between 59º - 86ºF
    • lightly shake bottle to loosen settled powder
  • Inactive ingredients

    allantoin, chloroxylenol, fragrance, imidazolidinyl urea, micocrystalline cellulose, tricalcium phosphate, zea mays (corn) starch

  • Questions?

    call 1-866-964-0939

  • Principal Display Panel

    EndZone

    ANTIFUNGAL

    POWDER

    MICONAZOLE NITRATE 2%/ANTIFUNGAL

    CURES MOST ATHLETE'S FOOT,

    JOCK ITCH & RINGWORM

    Absorbs Moisture

    Relieves itching, Burning,

    Scaling & Chafing

    Talc-Free

    NET WT. 2.5 OZ. (71 g)

    Image 1

  • INGREDIENTS AND APPEARANCE
    ANTI-FUNGAL POWDER MICONAZOLE NITRATE 
    miconazole nitrate powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56104-500
    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
    ALDIOXA (UNII: 8T66I31YNK)  
    CHLOROXYLENOL (UNII: 0F32U78V2Q)  
    IMIDUREA (UNII: M629807ATL)  
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:56104-500-0071 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/12/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00509/12/2023
    Labeler - Premier Brands of America Inc. (117557458)
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