MICONAZOLE NITRATE (ANTIFUNGAL LIQUID CONTINUOUS SPRAY) AEROSOL, SPRAY [CHAIN DRUG CONSORTIUM, LLC]

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MICONAZOLE NITRATE (ANTIFUNGAL LIQUID CONTINUOUS SPRAY) AEROSOL, SPRAY [CHAIN DRUG CONSORTIUM, LLC]
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NDC 68016-516-00
Set ID 7f6912a6-a576-4138-bd78-a075a7d24036
Category HUMAN OTC DRUG LABEL
Packager Chain Drug Consortium, LLC
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.

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

    When using this product

    • avoid contact with the eyes or mouth
    • use only as directed

    Stop use and ask a doctor if

    • no improvement within 4 weeks for athlete's foot and ringworm; 2 weeks for jock itch
    • irritation occurs

    Do not use

    on children under 2 years of age unless directed by a doctor.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • wash affected area and dry thoroughly
    • shake can well and spray a thin layer 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, consult a doctor
    • this product is not effective on the scalp or nails
  • Other information

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

  • Inactive ingredients

    acetone, ethoxyglycol, propylene glycol, SD alcohol 40-B (74%w/w), tocopheryl acetate

  • Questions?

    call 1-866-964-0939

  • Principal Display Panel

    Premier Value

    Medicated

    Antifungal Liquid Continuous Spray

    Miconazole Nitrate 2%

    • Cures most athlete's foot
    • Relief from burning & itching

    Net WT 5.3 OZ (150 g)

    PV Antifngl Mic Nitrate LiqSpry-3.jpg

  • INGREDIENTS AND APPEARANCE
    MICONAZOLE NITRATE 
    antifungal liquid continuous spray aerosol, spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-516
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE3 g  in 150 g
    Inactive Ingredients
    Ingredient NameStrength
    ACETONE (UNII: 1364PS73AF)  
    DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALCOHOL (UNII: 3K9958V90M)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68016-516-00150 g in 1 CAN; Type 0: Not a Combination Product01/05/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C01/05/2010
    Labeler - Chain Drug Consortium, LLC (101668460)
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