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

  • NDC Code(s): 49348-175-38
  • Packager: Strategic Sourcing Services LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 19, 2023

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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

    bitrex

    purified water

  • Principal Display Panel

    SM70W.jpgNDC 49348-175-38

    isopropyl

    rubbing

    alcohol

    70% USP

    Wintergreen

    16 FL OZ (1 PT) 473 mL

    Principal Display Panel NDC 49348-175-38 isopropyl rubbing alcohol 70% USP Wintergreen 16 FL OZ (1 PT) 473 mL

  • INGREDIENTS AND APPEARANCE
    SUNMARK ISOPROPYL ALCOHOL 70 PERCENT WITH WINTERGREEN OIL 
    isopropyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49348-175
    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:49348-175-38473 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 DrugM00301/01/2016
    Labeler - Strategic Sourcing Services LLC (116956644)
    Registrant - Pharma Nobis, LLC (118564114)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharma Nobis, LLC118564114analysis(49348-175) , manufacture(49348-175) , pack(49348-175) , label(49348-175)
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