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 September 16, 2020

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  • DOSAGE & ADMINISTRATION

    clean affected area, apply a small amount of the this product to the affected area 1 to 3 times daily, bandage.

  • ACTIVE INGREDIENT

    Isopropyl Alcohol 91%

  • PURPOSE

    First Aid Antiseptic

  • ASK DOCTOR

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

  • WHEN USING

    do not get into eyes, do not inhale, do not apply over large area of body

  • STOP USE

    condition persists or gets worse

  • KEEP OUT OF REACH OF CHILDREN

    if swallowed, get medical help or contact a Poison Prevention Center immediately

  • OTHER SAFETY INFORMATION

    does not contain, nor is intended as a substitute for grain or ethyl alcohol

  • SPL UNCLASSIFIED SECTION

    fumes can be acutely irritating to the skin, eyes, and the respiratory system

  • INDICATIONS & USAGE

    First aid to help prevent the risk of infection in: minor cuts, scrapes, burns

  • INACTIVE INGREDIENT

    deionized water

  • WARNINGS

    for external use only. If taken internally serious gastric disturbances will result. Flammable. Keep away from heat, flame, electrical.

  • PRINCIPAL DISPLAY PANEL

    91% Isopropyl Alcohol

  • INGREDIENTS AND APPEARANCE
    91% ISOPROPYL ALCOHOL 
    isopropyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79590-003
    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:79590-003-00475 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/16/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/16/2020
    Labeler - MBS Medical Technologies (117581535)
    Registrant - MBS Medical Technologies (117581535)
    Establishment
    NameAddressID/FEIBusiness Operations
    MBS Medical Technologies117581535repack(79590-003) , relabel(79590-003) , manufacture(79590-003)
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