ISOPROPYL WINTER GREEN RUBBING ALCOHOL (ISOPROPYL ALCOHOL) LIQUID [WORLDWIDE SALES & DISTRIBUTION CORP.]

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ISOPROPYL WINTER GREEN RUBBING ALCOHOL (ISOPROPYL ALCOHOL) LIQUID [WORLDWIDE SALES & DISTRIBUTION CORP.]
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NDC 76384-006-01
Set ID e895b887-f365-408d-8904-f98e78fe8e14
Category HUMAN OTC DRUG LABEL
Packager Worldwide Sales & Distribution Corp.
Generic Name
Product Class
Product Number
Application Number PART333A
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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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