MICONAZOLE NITRATE (ANTIFUNGAL LIQUID CONTINUOUS SPRAY) AEROSOL, SPRAY [HARMON STORE INC.]

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MICONAZOLE NITRATE (ANTIFUNGAL LIQUID CONTINUOUS SPRAY) AEROSOL, SPRAY [HARMON STORE INC.]
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NDC 63940-025-53
Set ID d8ae4426-3d1b-4e68-8bcc-b6a66244b2af
Category HUMAN OTC DRUG LABEL
Packager Harmon Store 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 (tinea pedis), ringworm (tinea corporis) and jock itch (tinea cruris)
    • relieves itching, burning and scaling
  • Warnings

    For external use only.

    Extremely flammable:

    Content under pressure. Keep away from fire, sparks and heated surfaces. Do not punchure or incinerate container. Exposure to temperatures above 120 oF may cause bursting. Intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal.

    Do not use

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

    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 and 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.

  • 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 condition persist, consult a doctor
    • this product is not effective on the scalp or nails
  • Other information

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

  • Inactive ingredients

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

  • Questions?

    Call 1-866-964-0939

  • Principal Display Panel

    Harmon FaceValues

    Continuous Spray!

    Anti-Fungal

    Miconazole Nitrate 2%

    Liquid Spray

    Relieves Burning,

    Itching and Scaling

    Helps Cure most Athlete's Foot Fungus

    NET WT 5.3OZ (150g)

    Harmon Antifungal Miconazole Liquid Continuous Spray.jpg

  • INGREDIENTS AND APPEARANCE
    MICONAZOLE NITRATE 
    antifungal liquid continuous spray aerosol, spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63940-025
    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:63940-025-53150 g in 1 CAN; Type 0: Not a Combination Product01/17/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C01/17/2012
    Labeler - Harmon Store Inc. (804085293)
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