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 January 23, 2021

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  • Active Ingredient

    Isopropyl Alcohol 91%...................................................First aid antiseptic

  • Uses

    helps prevent risk of infection from:

    • minor cuts
    • burns
    • lacerations
    • burns
  • Warnings

    For External use only. Internal ingestion will result in gastric problems.

  • Flammable

    • keep away from fire, flame, spark, heat, electric
  • Ask a doctor before use

    for deep lacerations, puncture wounds, animal bites, or any serious burns

  • When using this product

    • avoid from contact with eyes
    • do not apply over large areas of body
    • do not use longer than 1 week unless instructed by a physician
  • 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 immediately.

  • Caution

    Fumes created by Isopropyl Alcohol can be irritating to skin, eyes, or respiratory system. Do not apply if irritation is present on skin or continued irritation develops. Avoid from applying to eyes or mucous membranes. Do not inhale this product.

  • Directions

    • clean the affected area
    • apply a small amount of product on the area 1 to 3 times each day
    • may be covered with a sterile
    • bandage following application
    • let dry prior to being bandaged
  • Other Information

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

    water

  • PRINCIPAL DISPLAY PANEL

    75396-071-18 LABEL PANEL

    -18 LABEL

    75396-071-20 LABEL PANEL

    -20 LABEL

    75396-071-21 LABEL PANEL

    -21 PANEL

  • INGREDIENTS AND APPEARANCE
    ISOPROPYL ALCOHOL 
    isopropyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75396-071
    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:75396-071-183785 mL in 1 JUG; Type 0: Not a Combination Product07/18/2020
    2NDC:75396-071-20473 mL in 1 BOTTLE; Type 0: Not a Combination Product12/12/2020
    3NDC:75396-071-21946 mL in 1 BOTTLE; Type 0: Not a Combination Product01/18/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/17/2020
    Labeler - BuckAirways Inc. (117488255)
    Registrant - BuckAirways Inc. (117488255)
    Establishment
    NameAddressID/FEIBusiness Operations
    BuckAirways Inc.117488255manufacture(75396-071)
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