Label: ANTI- FUNGAL MICONAZOLE NITRATE- miconazole nitrate powder

  • NDC Code(s): 56104-253-01
  • Packager: Premier Brands of America Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 January 25, 2023

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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 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 & 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, and change shoes and 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 ingredient

    allantoin, chloroxylenol, fragrance, imidazolidinyl urea, microcrystalline cellulose, tricalicum phosphate, zea mays (corn) starch

  • Questions?

    call 1-866-964-0939

  • Principal Display Panel

    CORE VALUES

    Absorbs Moisture

    Miconazorb AF

    ANTI-FUNGAL POWDER

    Miconazole Nitrate 2%

    Cures Most:

    • Athlete's foot
    • Jock itch
    • Ringworm

    Relieves itching, burning, scaling and chafing

    Talc-Free

    NET WT 2.5 OZ (71 g)

    image 1

  • INGREDIENTS AND APPEARANCE
    ANTI- FUNGAL MICONAZOLE NITRATE 
    miconazole nitrate powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56104-253
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE1.42 g  in 71 g
    Inactive Ingredients
    Ingredient NameStrength
    ALLANTOIN (UNII: 344S277G0Z)  
    CHLOROXYLENOL (UNII: 0F32U78V2Q)  
    IMIDUREA (UNII: M629807ATL)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    TRICALCIUM PHOSPHATE (UNII: K4C08XP666)  
    ZEA MAYS SUBSP. MAYS WHOLE (UNII: 1G5HNE09V8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:56104-253-0171 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/05/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C04/11/2022
    Labeler - Premier Brands of America Inc. (117557458)
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