Label: HAND-I-SAN- isopropyl alcohol hand sanitizer liquid

  • NDC Code(s): 86161-210-01, 86161-210-02, 86161-210-03, 86161-210-04, view more
    86161-210-05
  • Packager: ZECO, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 18, 2024

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  • Active Ingredient

    Isopropyl Alcohol 75% v/v

  • Purpose

    Antiseptic

    Non-Sterile, Hand-Rub Solution

  • Uses

    Hand Sanitizer to help reduce bacteria that can potentially cause disease. For use when soap and water are not available.

  • Warnings

    For external use only.

    Flammable.  Keep away from heat, sparks, flames, or hot surfaces.

    Do not smoke while applying this product.

    Ground/bond container and receiving equipment.

    Use explosion-proof electrical/ventilating/lighting equipment.

    Take precautionary measures against static discharge.

    Vapors may cause drowsiness or dizziness.

  • Do not use

    on children less than 2 months of age.

    open skin wounds.

  • WHEN USING

    When using this product, keep out of eyes, ears, and mouth. If swallowed, get medical help or contact a Poison Control Center immediately.  In case of eye contact immediately flush eyes thoroughly with water.

  • STOP USE

    Stop using and ask a doctor if irritation or rash appears and lasts. These may be a sign of a serious condition.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • Directions

    • Put enough product in palm to cover hands, and rub together briskly until dry.
    • Children under 6 years of age should be supervised when using this product.
  • Other information

    • Store between 15 ​°C to 30 ​°C (59 ​°F to 86 ​°F)
    • Avoid freezing and excessive heat above 40 ​°C (104 ​°F), sparks, open flames, and hot surfaces. 
  • Inactive ingredients

    Glycerin, Hydrogen Peroxide, Purified Water USP

  • SPL UNCLASSIFIED SECTION

    IN CASE OF EMERGENCY:  CALL CHEMTREC: 1-800-424-9300

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    HAND-I-SAN 
    isopropyl alcohol hand sanitizer liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:86161-210
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL75 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL
    HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 mL  in 100 mL
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:86161-210-013785.41 mL in 1 JUG; Type 0: Not a Combination Product03/15/2024
    2NDC:86161-210-0218927.05 mL in 1 PAIL; Type 0: Not a Combination Product03/15/2024
    3NDC:86161-210-03208197.64 mL in 1 DRUM; Type 0: Not a Combination Product03/15/2024
    4NDC:86161-210-041040987.75 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product03/15/2024
    5NDC:86161-210-051249185.3 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product03/15/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00303/15/2024
    Labeler - ZECO, LLC (118545809)
    Establishment
    NameAddressID/FEIBusiness Operations
    ZECO, LLC119173569manufacture(86161-210) , pack(86161-210) , label(86161-210)
    Establishment
    NameAddressID/FEIBusiness Operations
    ZECO, LLC118545809manufacture(86161-210) , pack(86161-210) , label(86161-210)
    Establishment
    NameAddressID/FEIBusiness Operations
    ZECO, LLC119124232manufacture(86161-210) , pack(86161-210) , label(86161-210)
    Establishment
    NameAddressID/FEIBusiness Operations
    ZECO, LLC119124226manufacture(86161-210) , pack(86161-210) , label(86161-210)
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