Label: 50% RUBBING- 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 March 22, 2021

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

  • Active ingredient

    Isopropyl alcohol 50%

  • Purpose

    First aid antiseptic

  • Use

    helps prevent the risk of infection in:

    • minor cuts
    • scrapes
    • burns
  • Warnings

    For external use only

  • Flammable

    keep away from fire or flame, heat spark, electrical

  • Ask a doctor before use

    If you have deep or puncture wounds, animal bites or serious burns

  • 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 and ask a doctor

    if condition persists or gets worse

  • keep out of children

    If swallowed, get medical help or contact a Poison Control Center right away.

  • For Rubbing & Massaging

    Caution - do not apply to irritated skin or if excessive irritation develops.  Avoid getting into the eyes or on mucous membranes.

  • Directions

    • clean the affected area
    • apply a small amount of this product on the affected 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 distrubances if taken internally
  • Inactive ingredient

    water

  • adverse reaction

    DIST. BY TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007

    1-888-423-0139  topcare@topco.com   www.topcarebrands.com

    864.003/864AA/AC

  • principal display panel

    TopCare

    health

    50%

    Isopropyl

    Alcohol

    FIRST AID ANTISEPTIC

    Helps Preven the Risk of Infection in:

    • Minor Cuts
    • Minor Scrapes
    • Minor Burns

    OUR PHARMACISTS RECOMMEND

    WARNING FLAMMABLE: Keep away from heat, spark, electrical fire or flame

    Use only in a well-ventilated area: fumes can be harmful.

    CAUTION: Do not point at self or others, product will squirt when squeezed

    Visit here for more information:

    http://topbrnds.com

    16 FL OZ (1 PT) 473 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    50% RUBBING 
    isopropyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-864
    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
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-864-43473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/03/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/03/2017
    Labeler - TopCo Associates (006935977)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(36800-864)