Label: 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 September 1, 2009

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  • SPL UNCLASSIFIED SECTION

    Drug Facts
  • Active Ingredients


    Isopropyl Alcohol  (50% conc.)
  • Purpose


    Topical antimicrobial

  • Uses


    • to decrease germs in minor cuts and scrapes.
    • helps relieve minor muscular aches due to exertion.
  • Warnings

    For external use only

    • flammable, keep away from fire and flame
    • will produce serious gastric disturbances if taken internally

    Ask a doctor before use if you have deep puncture wounds or serious burns

    When using this product

    • do not get into eyes or mucous membranes
    • use only in a well-ventilated area

    Stop use and ask a doctor if condition persists or gets worse.

    Keep out of reach of children. In case of an accidental ingestion, contact a Poison Control Center immediately.

  • Directions


    • apply to skin directly or with clean gauze, cotton or swab.
    • for rubbing, apply liberally and rub with hands.
  • Other information


    • does not contain, nor is intended as a substitute for grain or ethyl alcohol.
    • keep bottle tightly closed.
  • Inactive ingredient

    purified water

  • Package Label

    Container Label

  • INGREDIENTS AND APPEARANCE
    ISOPROPYL RUBBING ALCOHOL 
    isopropyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:34954-010
    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) 50 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:34954-010-01355 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33309/01/2009
    Labeler - KIM CHEMICALS LTD. (650470164)
    Establishment
    NameAddressID/FEIBusiness Operations
    KIM CHEMICALS LTD.650470164manufacture
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