MICONAZOLE NITRATE (ANTI-FUNGAL POWDER MICONAZOLE NITRATE) POWDER [TOPCO ASSOCIATES LLC]

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MICONAZOLE NITRATE (ANTI-FUNGAL POWDER MICONAZOLE NITRATE) POWDER [TOPCO ASSOCIATES LLC]
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NDC 36800-071-25
Set ID 7ac90517-7d9b-4d94-b1c9-b424ad907a59
Category HUMAN OTC DRUG LABEL
Packager Topco Associates LLC
Generic Name
Product Class Azole Antifungal
Product Number
Application Number PART333C
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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, 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 1-888-423-0139

  • Principal Display Panel

    TopCare

    ANTIFUNGAL POWDER

    MiconasorbAF

    Miconazole Nitrate 2%

    • Cures and soothees most athlete's foot, jock itch & ringworm
    • Relieves chafing, itching, burning & scaling
    • Absorbs moisture

    COMPARE TO ZEASORB active ingredients

    NET WT 2.5 OZ (71g)

    Topcare Miconazorb AF Powder LABEL.jpg

  • INGREDIENTS AND APPEARANCE
    MICONAZOLE NITRATE 
    anti-fungal powder miconazole nitrate powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-071
    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)  
    TALC (UNII: 7SEV7J4R1U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-071-2571 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C04/01/2016
    Labeler - Topco Associates LLC (006935977)
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