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 May 19, 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
    • scarapes
    • 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 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 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 eyes or on mucous membranes.  Avoid inhaling this product.

  • Directions

    • clean the affected area
    • apply a small amount of the is 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 reactions

    Manufactured for Big Lots By: Vi-Jon, LLC

    8515 Page Avenue  St. Louis, MO 63114

    864.003/864AC

  • principal display panel

    SOUND

    BODY

    FIRST AID

    ANTISPETIC

    50%

    Isopropyl

    Alcohol

    First Aid Antispetic

    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.

    32 FL OZ (1 QT) 946 mL

    image description

  • INGREDIENTS AND APPEARANCE
    50% RUBBING 
    isopropyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11344-003
    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:11344-003-43473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/08/2014
    2NDC:11344-003-45946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/08/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/08/2014
    Labeler - Sound Body (150931459)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(11344-003)