Label: GNP ISOPROPYL ALCOHOL 50 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 January 1, 2016

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

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Isopropyl Alcohol 50% 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 #4

    bitrex

    purified water

  • Principal Display Panel

    NDC 46122-333-43
    ISOPROPYL
    RUBBING
    ALCOHOL 50%
    With Wintergreen Oil
    First Aid Antiseptic
    16 fl oz (1 pt) 473 mL

    Principal Display Panel NDC 46122-333-43 ISOPROPYL RUBBING ALCOHOL 50% With Wintergreen Oil First Aid Antiseptic 16 fl oz (1 pt) 473 mL

  • INGREDIENTS AND APPEARANCE
    GNP ISOPROPYL ALCOHOL 50 PERCENT WITH WINTERGREEN OIL 
    isopropyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46122-333
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL500 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)  
    DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:46122-333-43473 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 - Amerisource Bergen (007914906)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!