Label: BORTONS ETHYL RUBBING ALCOHOL- alcohol liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated May 14, 2010

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active Ingredients                        Purpose

    Ethyl Alcohol 82 percent            Antiseptic

  • PURPOSE

    Uses

    First aid to help reduce the risk of infection in minor cuts, scrapes, and burns.

  • WARNINGS

    Warnings

    Flammable. Keep away from fire or flame. For external use only. Do not use in the eyes or apply over large areas of the body. In case of deep or puncture wounds, animal bites, or serious burns, consult a doctor. Stop use and consult a doctor if the condition persists or gets worse. Do not use longer than 1 week unless directed by a doctor. Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    Clean the affected area. Apply a small amount of this product on the area 1 ti 3 times daily. May be covered with a sterile bandage.

  • INACTIVE INGREDIENT

    Inactive Ingredients

    Camphor, Water

  • STORAGE AND HANDLING

    Other Information

    For your protection, this bottle has an imprinted seal around the cap. Do not use if tamper evident seal is missing, tampered, broken, or destroyed.

  • DESCRIPTION

    Distributed by/Distribuido por

    J-MARK International Inc.

    0819-03925

    Panama



    Made In/Hecho en Panama

    Expiration Date/Fecha de Expiracion 12/20/15

  • PRINCIPAL DISPLAY PANEL

    Borton's ETHYL RUBBING ALCOHOL 82 percent By Volume FIRST AID ANTISEPTIC Net Contents 16 fl oz (473 ml)

  • CONTROLLED SUBSTANCE

    FrontLabel

  • PRINCIPAL DISPLAY PANEL

    BackLabel
  • INGREDIENTS AND APPEARANCE
    BORTONS ETHYL RUBBING ALCOHOL 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50790-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL82 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50790-100-16473 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33304/30/2010
    Labeler - J-Mark International Inc. (853770001)
    Registrant - J-Mark International Inc. (853770001)
    Establishment
    NameAddressID/FEIBusiness Operations
    J-Mark International Inc. 853770001manufacture
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