Label: ISOPROPYL WINTER GREEN RUBBING ALCOHOL  - isopropyl alcohol liquid 

  • Label RSS
  • NDC Code(s): 76384-006-01
  • Packager: Worldwide Sales & Distribution Corp.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 08/11

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts Close
  • Active Ingredients


    Isopropyl Alcohol 50% Close
  • Purpose


    First aid antiseptic

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  • Uses

    First aid to help prevent risk of infection in

    • scrap
    • burns
    • minor cuts
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  • 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.

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  • 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
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  • Other information


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

    Green 3, Yellow 5, Methyl salicylate, Purified water

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  • Package Label
  • INGREDIENTS AND APPEARANCE
    ISOPROPYL WINTER GREEN RUBBING ALCOHOL  
    isopropyl alcohol liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:76384-006
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ISOPROPYL ALCOHOL (ISOPROPYL ALCOHOL) ISOPROPYL ALCOHOL 50 mL  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER 50 mL  in 100 mL
    FD&C BLUE NO. 1  
    METHYL SALICYLATE  
    FD&C YELLOW NO. 5  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:76384-006-01 355 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333A 08/15/2011
    Labeler - Worldwide Sales & Distribution Corp. (627014330)
    Establishment
    Name Address ID/FEI Business Operations
    Steller Mercantile Pvt. Ltd. 650493005 manufacture
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