MICONAZOLE NITRATE (MICONAZORB AF POWDER) POWDER [PREMIER BRANDS OF AMERICA INC.]

MICONAZOLE NITRATE (MICONAZORB AF POWDER) POWDER [PREMIER BRANDS OF AMERICA INC.]
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NDC 56104-020-25
Set ID df110dec-4a50-433a-99ba-4b53bf6a0133
Category HUMAN OTC DRUG LABEL
Packager Premier Brands of America Inc.
Generic Name
Product Class Azole Antifungal
Product Number
Application Number PART333C
  • 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. Do not use on children under 2 years of age unless directed by a doctor.

  • ​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, 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 ingredients

    aldioxa, chloroxylenol, fragrance, imidurea, powdered cellulose, talc

  • ​ ​Questions?

    call 1-866-964-0939

  • Principal Display Panel

    Premier

    Miconazorb ​AF

    Miconazole Nitrate 2%

    Anti-fungal Powder

    Cures and soothes most athlete's foot, jock itch and ringworm

    • Absorbs moisture
    • Soothes chafing, itching and burning

    NET WT 2.5 OZ (71g)

    PB Miconazorb Anti-Fungal Powder Talc-01.jpg

  • INGREDIENTS AND APPEARANCE
    MICONAZOLE NITRATE 
    miconazorb af powder powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56104-020
    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
    ALDIOXA (UNII: 8T66I31YNK)  
    CHLOROXYLENOL (UNII: 0F32U78V2Q)  
    IMIDUREA (UNII: M629807ATL)  
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:56104-020-2571 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/01/201312/31/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C01/01/201312/31/2021
    Labeler - Premier Brands of America Inc. (117557458)

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