Label: ISOPROPYL ALCOHOL 70 PERCENT WITH WINTERGREEN OIL- isopropyl alcohol liquid

  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated June 20, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Isopropyl Alcohol 70% by volume

  • Purpose

    First aid antiseptic

  • Use

    First aid to help prevent the risk of infection in.

    • minor cuts
    • scrapes
    • burns
  • Warnings

    For external use only.

    • Flammable, keep way from spark, heat and flame.
    • Use in well ventilated area, fumes may be harmful.
  • Ask a doctor before use for

    • deep wounds
    • animal bites
    • serious burns
  • When using this product

    • do not get into eyes or mucous membranes.
    • do not apply to irritated skin.
  • Stop use and ask a doctor if

    excessive irritation of the skin develops.

  • Keep out of reach of children.

    In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

  • Directions

    • apply freely and rub briskly with hands or towel.
  • Other Information

    • does not contain ethyl or grain alcohol and is not sold as a substitute for preparations containing the same.
    • Store at controlled room temperature
    • will produce serious gastric disturbances if taken internally.
  • Inactive Ingredient

    Methyl salicylate 0.5%

    FDC Blue #1

    FDC Yellow #5

    purified water

  • Good Neighbor Label

    GNPWinter.jpgPrincipal Display Panel NDC 46122-331-43 ISOPROPYL RUBBING ALCOHOL 70% With Wintergreen Oil Rubbing, Massage, Sponge Bath 16 fl oz (1 pt) 473 mL

  • Sunmark Label

    SM

  • INGREDIENTS AND APPEARANCE
    ISOPROPYL ALCOHOL 70 PERCENT WITH WINTERGREEN OIL 
    isopropyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0395-9121
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL700 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0395-9121-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/01/2016
    Labeler - Humco Holding Group, Inc. (825672884)
    Registrant - Humco Holding Group, Inc. (825672884)
    Establishment
    NameAddressID/FEIBusiness Operations
    Humco Holding Group, Inc.825672884analysis(0395-9121) , manufacture(0395-9121) , pack(0395-9121) , label(0395-9121)
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