Label: ISOPROPYL WINTER GREEN 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 August 25, 2011

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  • SPL UNCLASSIFIED SECTION

    Drug Facts
  • Active Ingredients


    Isopropyl Alcohol 50%
  • Purpose


    First aid antiseptic

  • Uses

    First aid to help prevent risk of infection in

    • scrap
    • burns
    • minor cuts
  • Warnings

    For external use only

    • Flammable keep away from fire and flames

    Consult a doctor before use if you have animal bites or serious burns, deep or punctured wounds

    When using this product

    • do not let it get into your eyes
    • do not apply over large areas of the body
    • do not use longer than a week unless directed by the doctor
    • do not use other than as directed

    Stop use and ask a doctor if condition persists or worsens

    Keep out of reach of children. In case of an accidental ingestion, seek professional assistance or contact a poison control center immediately.

  • Directions


    • clean affected area
    • apply a small amount of this product on the affected area 1-3 times a day
    • may be covered with a sterile bandage but let dry before using bandage
  • Other information


    • Store at controlled room temperature
    • Not intended as substitute for grain or ethyl alcohol
    • Will produce serious gastric disturbance if taken internally
  • Inactive ingredient

    Green 3, Yellow 5, Methyl salicylate, Purified water

  • Package Label

    Container Label

  • INGREDIENTS AND APPEARANCE
    ISOPROPYL WINTER GREEN RUBBING ALCOHOL  
    isopropyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76384-006
    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
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76384-006-01355 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/15/2011
    Labeler - Worldwide Sales & Distribution Corp. (627014330)
    Establishment
    NameAddressID/FEIBusiness Operations
    Steller Mercantile Pvt. Ltd.650493005manufacture
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