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 May 18, 2018

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  • Active ingredient (BY VOLUME)

    ISOPROPYL ALCOHOL (70% CONCENTRATE)

  • Purpose

    FIRST AID ANTISEPTIC

  • Uses

    FIRST AID TO HELP THE RISK OF INFECTION IN MINOR CUTS AND SCRAPES.

  • Keep Out of Reach of Children

    IN CASE OF INGESTION, GET MEDICAL HELP OR CONTACT A POSON CONTROL CENTER (1-800-222-1222) IMMEDIATELY.

  • WARNINGS

    For external use only.

    • FLAMMABLE, KEEP AWAY FROM FIRE AND FLAME
    • IF TAKEN NTERNALLY SERIOUS GASTRIC DISTURBANCES WILL RESULT
  • ASK DOCTOR

    ASK A DOCTOR BEFORE USE IF YOU HAVE

    • DEEP OR PUNCTURE WOUNDS, ANIMAL BITES OR 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 ONE WEEK UNLESS DIRECTED BY A DOCTOR
  • STOP USE

    STOP USE AND ASK A DOCTOR IF

    • CONDITION PERSISTS OR GET WORSE.
  • Directions

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

  • OTHER INFORMATION

    • STORE AT ROOM TEMPERATURE
    • DOES NOT CONTAIN, NOR IS INTENDED AS A SUBSTITUTE FOR GRAIN OR ETHYL ALCOHOL
  • Inactive Ingredient

    BLUE 1, METHYL SALICYLATE, WATER, YELLOW 5

  • PRINCIPAL DISPLAY PANEL

    Amoray_50pct_Green

  • INGREDIENTS AND APPEARANCE
    RUBBING ALCOHOL  50 PERCENT WITH WINTERGREEN
    isopropyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51628-1014
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL70 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:51628-1014-1355 mL in 1 BOTTLE; Type 0: Not a Combination Product12/03/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A12/03/2014
    Labeler - MY IMPORT USA INC (195767988)
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