Label: 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 91%

  • Purpose

    First aid antiseptic

  • Use

    helps prevent the rist 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

    for deep or puncture wounds, animal bites or serious burns

  • When using this product

    • do not get into eyes
    • do not inhale
    • do not apply over large areas of the body
    • do not use longer than 1 week
  • Stop use and ask a doctor if

    condition persists or gets worse

  • Keep out of reach of children

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

  • Caution

    Fumes can be acutely irritating to skin, eyes and the respiratory system.  Do not apply to irritated skin or if excessive irritation develops.  Avoid getting into the eyes or on mucous membranes.  Avoid inhaling this product.

  • 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 ingredients

    water

  • SPL UNCLASSIFIED SECTION

    DIST. BY TOPCO ASSOC LLC  ELK GROOVE VILLAGE,  IL 60077

    QUESTIONS? 1-888-423-0139 topcare@topcare.com   www.topcarebrands.com

    804.003/804AA

  • principal display panel

    TopCare

    health

    91%

    Isopropyl

    Alcohol

    FIRST AID ANTISEPTIC

    Helps Prevent 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 whe squeezed.

    Visit here for more information:

    http://topbrands.com

    16 FL OZ (1 PT) 473 mL

    image description

  • INGREDIENTS AND APPEARANCE
    ISOPROPYL ALCOHOL 
    isopropyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-804
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL.91 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-804-43.473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/15/1991
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/15/1991
    Labeler - TopCo Assoc LLC (006935977)
    Registrant - Vi-Jon Inc, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, Inc, LLC790752542manufacture(36800-804)