Label: A 50% ISOPROPYL RUBBING ALCOHOL- isopropyl alcohol liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 December 28, 2015

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  • Drug Facts

  • Active ingredients (by volume):

    Isopropyl alcohol (50% conc.)

  • Purpose

    first aid antiseptic

  • KEEP OUT OF REACH OF CHILDREN

    Keep this drug out of the reach of children
    • Incase of an accidental ingestion, seek professional assistance or contact a doctor immediately

  • INDICATIONS & USAGE

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

  • WARNINGS

    Warnings
    • For external use only; flammable, keep away from fire or flame, heat, spark, electrical, etc.

    Ask a doctor before use if you have
    • Deep punctured 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 using this product if
    • Condition persists or gets worse

  • DOSAGE & ADMINISTRATION

    Directions
    • Clean affected area
    • Apply small amount of this product on the area 1-3 times daily
    • You can cover it with a sterile bandage
    • If bandaged, let dry first

  • INACTIVE INGREDIENT

    Inactive Ingredient Water(Aqua)

  • STORAGE AND HANDLING

    Other information
    • Store at room temperature
    • Does not contain, nor is intended as a substitute for grain or ethyl alcohol. Will produce serious gastric disturbances if taken internally

  • SPL UNCLASSIFIED SECTION

    FIRST AID ANTISEPTIC

    For Rubbing & Massaging

    Use only in a well ventilated area

    Fumes may be harmful

    WARNING FLAMMABLE
    Keep away from fire or flame!

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

    Distributed By:
    JMD ALL STAR IMPEX INC.,
    Edison, NJ - 08817

    DESIGNED IN THE USA

  • Packaging

    ispa

  • INGREDIENTS AND APPEARANCE
    A  50% ISOPROPYL RUBBING ALCOHOL
    isopropyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69859-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL50 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69859-003-55355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/18/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A12/18/2015
    Labeler - JT Cosmetics and Chemicals (650884849)
    Establishment
    NameAddressID/FEIBusiness Operations
    JT Cosmetics and Chemicals650884849manufacture(69859-003)
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