MICONAZOLE NITRATE (ATHLETES FOOT POWDER SPRAY TALC FREE) AEROSOL, POWDER [CHAIN DRUG MARKETING ASSOCIATION]

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MICONAZOLE NITRATE (ATHLETES FOOT POWDER SPRAY TALC FREE) AEROSOL, POWDER [CHAIN DRUG MARKETING ASSOCIATION]
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NDC 63868-180-46
Set ID edc2da26-ae46-4175-86ed-83e1a65f6d14
Category HUMAN OTC DRUG LABEL
Packager Chain Drug Marketing Association
Generic Name
Product Class Azole Antifungal
Product Number
Application Number PART333C
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  • Active ingredient

    Miconazole nitrate 2%

  • Purpose

    Antifungal

  • Uses

    • cures most athlete's foot (linea pedis), ringworm (linea corporis) and jock itch (linea cruris)
    • relieves symptoms of athlete's foot, including itching burning and cracking
  • WARNINGS

    For external use only.

    Flammable:

    Do not use while smoking or near heat or flame. Do not puncture or incinerate. Contents under pressure. Do not store at temperature above 120ºF

    When using this product

    • do not get into eyes or mouth
    • use only as directed

    Intentional misuse by deliberately concentrating and inhaling contents cans be harmful or fatal.

    Stop use and ask a doctor if

    • irritation occurs
    • no improvement within 4 weeks for athlete's foot and ringworm; 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

    • wash affected area and dry thoroughly
    • shake can well and spray a thin layer over affected area twice daily (morning and night)
    • 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
    • use daily for 4 weeks for athlete's foot and ringworm; use daily for 2 weeks for jock itch, if conditions persist, consult a doctor
    • this product is not effective on the scalp or nails
    • in case clogging, clear nozzle under running water
  • Other information

    store between 20º and 30ºC (68ºF and 86º)

  • Inactive ingredients

    SD alcohol 40-B(10%w/w), isobutane (propellant), stearalkonium hectorite, talc

  • Questions?

    call 1-866-964-0939

  • Principal Display Panel

    Quality Choice

    Talc- Free

    Athlete's Foot

    Antifungal Powder Spray

    Miconazole Nitrate 2%

    • Cures Most Athlete's Foot
    • Relieves Itching, Cracking, and Burning

    NET WT 4.6 OZ (130 g)

    Quality Choice_Anti-Fungal Miconazole Powder Spray_50-031QC-01.jpg

  • INGREDIENTS AND APPEARANCE
    MICONAZOLE NITRATE 
    athletes foot powder spray talc free aerosol, powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-180
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE2.6 g  in 130 g
    Inactive Ingredients
    Ingredient NameStrength
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    ISOBUTANE (UNII: BXR49TP611)  
    KAOLIN (UNII: 24H4NWX5CO)  
    ALCOHOL (UNII: 3K9958V90M)  
    ZEA MAYS SUBSP. MAYS WHOLE (UNII: 1G5HNE09V8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-180-46130 g in 1 CAN; Type 0: Not a Combination Product12/19/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C12/19/2017
    Labeler - Chain Drug Marketing Association (011920774)
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