ISOPROPYL RUBBING ALCOHOL (ISOPROPYL ALCOHOL) LIQUID [MAJOR PHARMACEUTICALS]

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ISOPROPYL RUBBING ALCOHOL (ISOPROPYL ALCOHOL) LIQUID [MAJOR PHARMACEUTICALS]
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NDC 0904-6045-16
Set ID fe4c5e74-7be6-4a5d-9a4c-ec3b281536a4
Category HUMAN OTC DRUG LABEL
Packager Major Pharmaceuticals
Generic Name
Product Class
Product Number
Application Number PART344
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  • Active ingredient (by volume)

    Isopropyl alcohol (70% conc.)

  • Purpose

    first aid antiseptic

  • Uses

    • first aid to help prevent the risk of infection in minor cuts, scrapes and burns
  • Warnings

    For external use only

    • flammable, keep away from fire or flame
    • if taken internally serious gastric disturbances will result

    Ask a doctor before use if you have

    • deep or puncture wounds, animal bites or serious burns

    When using this product

    • do not get into eyes
    • do not apply over large areas of the body
    • do not use longer than one week unless directed by a doctor

    Stop use and ask a doctor if

    • conditions persists or gets worse

    Keep out of reach of children

    In case of accidental ingestion seek professional assistance, or contact a poison control center right away

  • Directions

    • clean affected area
    • apply small amount of this product on the area 1-3 times daily
    • If bandaged, let dry first
    • may be covered with a sterile bandage
  • Other Information

    • store at room temperature
    • does not contain, nor is intended as a substitute for grain or ethyl alcohol
  • Inactive Ingredient

    purified water

  • Principal Display Panel

    70% Isopropyl Rubbing Alcohol

    First Aid Antiseptic

    Warning: Flammable, Keep away from fire or flame

    Distributed by: Major Pharmaceuticals

    31778 Enterprise Drive, Livonia, MI 48150 USA

    Questions or comments?

    Call 1-800-616-2471

    FL OZ (mL)

    TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY FOIL UNDER THE CAP IS BROKEN OR MISSING.

  • Package Label

    Isopropyl alcohol 70%

    Major 70% Isopropyl Alcohol

     
  • INGREDIENTS AND APPEARANCE
    ISOPROPYL RUBBING ALCOHOL 
    isopropyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-6045
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0904-6045-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/30/201412/30/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34411/30/201412/30/2021
    Labeler - Major Pharmaceuticals (191427277)
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