Label: ISOPROPYL ALCOHOL 70 PERCENT WITH WINTERGREEN OIL- 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 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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