MICONAZOLE NITRATE (ANTIFUNGAL MICONAZOLE LIQUID CONTINUOUS SPRAY) AEROSOL, SPRAY [PREMIER BRANDS OF AMERICA INC.]

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  • MICONAZOLE NITRATE (ANTIFUNGAL MICONAZOLE LIQUID CONTINUOUS SPRAY) AEROSOL, SPRAY [PREMIER BRANDS OF AMERICA INC.]

MICONAZOLE NITRATE (ANTIFUNGAL MICONAZOLE LIQUID CONTINUOUS SPRAY) AEROSOL, SPRAY [PREMIER BRANDS OF AMERICA INC.]
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NDC 56104-141-53
Set ID 53b664cb-33e1-43f5-a7f0-6005b3528d12
Category HUMAN OTC DRUG LABEL
Packager Premier Brands of America Inc.
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.

    When using this product

    • avoid contact with the 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

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

    ​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) 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 ​

    Medicated

    Antifungal

    Continuous Liquid Spray

    Miconazole Nitrate 2%

     Sprays At Any Angle!

    • Cures and prevents most Athletes Foot
    • Relieves itching and burning

    NET WT 5.3 FL OZ (150g)

    PB Antifngl Mic Contin LiqSpry label.jpg

  • INGREDIENTS AND APPEARANCE
    MICONAZOLE NITRATE 
    antifungal miconazole liquid continuous spray aerosol, spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56104-141
    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:56104-141-53150 g in 1 CANISTER; Type 0: Not a Combination Product01/01/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C01/01/2013
    Labeler - Premier Brands of America Inc. (117557458)
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