MICONAZOLE NITRATE (ANTI-FUNGAL POWDER MICONAZOLE NITRATE TALC FREE) POWDER [CARDINAL HEALTH]

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MICONAZOLE NITRATE (ANTI-FUNGAL POWDER MICONAZOLE NITRATE TALC FREE) POWDER [CARDINAL HEALTH]
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NDC 70000-0323-1
Set ID e754d590-0a92-4605-89a3-e698b8906672
Category HUMAN OTC DRUG LABEL
Packager Cardinal Health
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 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

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

  • Questions?

    call 1-866-964-0939

  • Principal Display Panel

    LEADER

    Moisture Absorbing

    Antifungal Powder

    Miconzole Nitrate 2% | Antfungal

    Cures Most Athlete's Foot, Jock Itch, and Ringworm

    Relieves Chafing, Itching, Burning, and Scaling

    Absorbs Moisture

    Talc - Free

    2.5 OZ (71 g)

    Leader_Antifungal Miconazorb Powder Talc-Free_50-081LD_51-081LD.jpg

  • INGREDIENTS AND APPEARANCE
    MICONAZOLE NITRATE 
    anti-fungal powder miconazole nitrate talc free powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0323
    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:70000-0323-171 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product10/20/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C10/20/2017
    Labeler - Cardinal Health (063997360)
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