Label: HAND SANITIZER- alcohol gel

  • NDC Code(s): 80711-002-01, 80711-002-02
  • Packager: IVM Especialidades Quimicas, S.A. de C.V.
  • 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 14, 2023

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  • Active Ingredient(s)

    Ethyl Alcohol 70% v/v. Purpose: Antiseptic

  • Purpose

    Antiseptic.

  • Use

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

  • Warnings

    For external use only. Flammable.

    Keep away from heat or flame.

  • Do not use

    • in children less than 2 months of age
    • on open skin wounds
  • When using this product

    Keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

  • Stop use and ask a doctor if

    irritation or rash occurs. These may be signs of a serious condition.

  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Place enough product on hands to cover all surfaces. Rub hands together until dry.
    • Supervise children under 6 years of age when using this product to avoid swallowing.
  • Other information

    • Store between 15-30°C (59-86 °F)
    • Avoid freezing and excessive heat above 40°C (104°F)
  • Inactive ingredients


    distilled water, glycerin, hydrogen peroxide, polyacrylic acid, triethanolamine.

  • Package Label - Principal Display Panel



    1000 mL NDC: 80711-002-01

    Hand Sanitizer_70_1000

  • PRINCIPAL DISPLAY PANEL



    5000 ml NDC:80711-002-02


    Hand Sanitizer_70_5000

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80711-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    WATER (UNII: 059QF0KO0R)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80711-002-011000 mL in 1 BOTTLE; Type 0: Not a Combination Product05/07/2021
    2NDC:80711-002-025000 mL in 1 BOTTLE; Type 0: Not a Combination Product05/07/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/07/2021
    Labeler - IVM Especialidades Quimicas, S.A. de C.V. (812761947)
    Establishment
    NameAddressID/FEIBusiness Operations
    IVM Especialidades Quimicas, S.A. de C.V.812761947manufacture(80711-002)
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