Label: 91% ISOPROPYL ALCOHOL- 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 7, 2023

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

  • Active ingredient

    Isopropyl alcohol 91%

  • purpose

    First Aid Antiseptic

  • Uses

    First aid to help prevent the risk of infection in:

    • minor cuts
    • scrapes
    • burns
  • Warnings

    For external use only. If taken internally serious gastric disturbances will result.

    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 area 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 hep 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 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
  • Inactive ingredients

    water

  • SPL UNCLASSIFIED SECTION

    QC 100% Satisfaction Guaranteed

    Distributed by C.D.M.A., Inc.

    43157 W 9 Mile Rd

    Novi, MI 48375

    www.qualitychoice.com

    Questions: 800-935-2382

  • principal display panel

    QC

    Quality Choice

    91%

    Isopropyl

    Alcohol

    First Aid Antiseptic

    For Treatment of Minor Cuts and Scrapes

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

    CAUTION: Do not point at sel or others; product will squirt when squeezed

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

    16 FL OZ (473 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    91% ISOPROPYL ALCOHOL 
    isopropyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-804
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL91 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-804-45473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/07/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A02/07/2023
    Labeler - C.D.M.A. Inc (011920774)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(63868-804)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(63868-804)