Label: ISOPROPYL ALCOHOL 99% 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 November 23, 2021

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  • Active Ingredient(s)

    Isopropyl Alcohol 99% v/v. Purpose: Antiseptic

  • Purpose Section

    first aid antiseptic, isopropyl alcohol

  • Indications and usage section

    first aid to help prevent the risk of infection in minor cuts, scrapes and burns

  • Warnings Section

    For external use only. Flammable. Keep away from heat or flame

  • Ask a doctor before use if you have

    deep puncture wounds, animal bites or serious burns

  • When using this product

    do not get into eyes, do not apply over large areas of the body, do not use longer than one week unless directed by a doctor

  • Stop using this product if

    condition persists or gets worse

  • Keep this and all drugs our of the reach of children

    In case of accidentail ingestion, seek professional assistance or contact a Poison Control Center (1-800-222-1222) immediately

  • Directions

    clean effected area. apply small amount of this product on the area 1 - 3 times daily, may be covered with a sterile bandage, if bandaged, let dry first

  • Other information

    store at room temperature. does not contain, nor is intended as a substitute for grain or ethyl alcohol. will produce serious gastric disturbances if taken internally

  • Inactive Ingredients

    purified water

  • Package Label - Principal Display Panel

    236 ml NDC 80668-414-05
    236 ml - IPA

    946.4 ml NDC 80668-414-06
    946.4 ml - IPA

    18927 ml NDC 80668-414-01
    ipa-5g

    3785 ml NDC 80668-414-02
    ipa-128

    1892 ml NDC 80668-414-03
    ipa-64

    IPA-16473.2ml NDC 80668-414-04

  • INGREDIENTS AND APPEARANCE
    ISOPROPYL ALCOHOL 99% 
    isopropyl alcohol 99% liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80668-414
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL99 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 1 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80668-414-0118927 mL in 1 PAIL; Type 0: Not a Combination Product03/20/2020
    2NDC:80668-414-023785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/20/2020
    3NDC:80668-414-031892 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/20/2020
    4NDC:80668-414-04473.2 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/20/2020
    5NDC:80668-414-06946.4 mL in 1 JUG; Type 0: Not a Combination Product03/20/2020
    6NDC:80668-414-05236 mL in 1 BOTTLE; Type 0: Not a Combination Product03/20/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/20/2020
    Labeler - UBQ Industries, LLC (069021187)
    Establishment
    NameAddressID/FEIBusiness Operations
    UBQ Industries, LLC069021187repack(80668-414) , manufacture(80668-414) , relabel(80668-414)
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