Label: HAND SANITIZER- alcohol gel

  • Category: HUMAN OTC DRUG LABEL

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 July 24, 2020

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  • Drug Facts

  • Active ingredient:

    Ethyl Alcohol 70%

    Purpose:

    Antimicrobial

  • Use:

    Hand Sanitizer to help reduce bacteria on the skin.

  • Warnings

    + Flammable --- Keep away from fire or flame.
    + For external use only.

    When using this product

     + do not use in or near the eyes. In case of contact, rinse eyes throughly with water.

    Stop use and ask a doctor

    + if irritation or rash appears and lasts.

    Keep out of reach of children.

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

  • Directions

    + Place product on hands.
    + Rub until dry.

  • Inactive ingredients:

    Water, Carbomer, Glycerin, T.E.A, Benzalkonium chloride, Fragrance ( Parfum ).

  • Other Information

    + Store below 110ºC ( 43ºF )
    + May discolor certain fabrics or surfaces.

  • Package Labeling: 236ml

    Label1

  • Package Labeling: 473ml

    Label2

  • Package Labeling: 1L

    Label3

  • Package Labeling: 3.78L

    Label4

  • Package Labeling: 1000L

    Label5

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79409-000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79409-000-01236 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2019
    2NDC:79409-000-02473 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2019
    3NDC:79409-000-031000 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2019
    4NDC:79409-000-043780 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2019
    5NDC:79409-000-051000000 mL in 1 TANK; Type 0: Not a Combination Product06/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/01/2019
    Labeler - Industrias Trevigo, S.A. de C.V. (589602580)
    Establishment
    NameAddressID/FEIBusiness Operations
    Industrias Trevigo, S.A. de C.V.589602580manufacture(79409-000) , label(79409-000) , pack(79409-000) , transfill(79409-000)
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