Label: RUBBING ALCOHOL 50 PERCENT WITH WINTERGREEN- 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 February 22, 2018

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  • Active ingredient

    ISOPROPYL ALCOHOL 50%

  • Purpose

    FIRST AID ANTISEPTIC

  • Uses

    FIRST AID TO HELP PREVENT THE RISK IN:

    • MINOR CUTS
    • SCRAPES
    • BURNS

  • Keep Out of Reach of Children

    IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

    FOR RUBBING AND MASSAGING: CAUTION - DO NOT APPLY TO IRRITATED SKIN OR IF EXCESSIVE IRRITATION DEVELOPS. AVOID GETTING INTO THE EYES OR ON MUCOUS MEMBRANES.

  • WARNINGS

    For external use only.

    • FLAMMABLE, KEEP AWAY FROM FIRE OR FLAME, HEAT, SPARK, ELECTRICAL.
  • ASK DOCTOR

    ASK A DOCTOR BEFORE USE IF YOU HAVE

    • DEEP PUNCTURE WOUNDS SERIOUS BURNS
  • WHEN USING

    WHEN USING THIS PRODUCT

    • DO NOT GET INTO EYES
    • DO NOT APPLY OVER LARGE AREAS OF THE BODY.
    • DO NOT USE LONGER THAN 1 WEEK UNLESS DIRECTED BY A DOCTOR.
  • STOP USE

    STOP USE AND ASK A DOCTOR IF

    • CONDITION PERSISTS OR GET WORSE.
  • Directions

    • CLEAN THE AFFECTED AREA.
    • APPLY A SMALL AMOUNT OF THIS PRODUCT ON THE AREA 1 TO 3 TIMES DAILY
    • MAY BE COVERED WITH A STERILE BANDAGE
    • IF BANDAGED, LET DRY FIRST.
  • OTHER INFORMATION

    • DOES NOT CONTAIN, NOR IS INTENDED AS A SUBSTITUTE FOR GRAIN OR ETHYL ALCOHOL
    • WILL PRODUCE SERIOUS GASTRIC DISTURBANCES IF TAKEN INTERNALLY.
  • Inactive Ingredient

    BLUE 1, METHYL SALICYLATE, WATER, YELLOW 5

  • PRINCIPAL DISPLAY PANEL

    Rubbing Alcohol_50pct_Wintergreen_16oz

  • INGREDIENTS AND APPEARANCE
    RUBBING ALCOHOL  50 PERCENT WITH WINTERGREEN
    isopropyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71611-302
    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)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71611-302-12355 mL in 1 BOTTLE; Type 0: Not a Combination Product02/22/2018
    2NDC:71611-302-16475 mL in 1 BOTTLE; Type 0: Not a Combination Product02/22/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A02/22/2018
    Labeler - MY Sales LLC dba Click Products LLC (080766174)
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