Label: ALCOHOL HAND SANITIZER- alcohol solution

  • 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 April 27, 2020

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  • Active ingredient

    Ethyl Alcohol 80% v/v

  • Purpose

    Antiseptic

  • Uses

    Hand sanitizer to help reduce bacteria that potentially can cause disease.

    For use when soap and water are not available.

  • Warnings

    For external use only. Flammable. Keep away from source of heat, fire, or flame.

    Do not use in children less than 2 months of age. Do not use on open skin wounds.

    When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water

    Stop use and ask a doctor if irritation or redness develops and lasts.

    Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

  • Directions

    Place enough product in your palm to thoroughly cover your hands and rub hands together until dry.

    Children under 6 years should be supervised when using this product.

  • Other information

    Store at a temperature below 43C (110F).

    May discolor certain fabrics or surfaces.

  • Inactive ingredients

    Water, Hydroxypropylcellulose (naturally derived), Glycerin, Isopropyl Myristate, Lauryl Lactate, Cetyl Lactate.

  • PRINCIPAL DISPLAY PANEL

    container labelAlcohol

    Hand Sanitizer

    with

    Premium Skin Conditioners and Moisturizers

    Contains

    Ethyl Alcohol 80%

    PRD# 99000736

    Lot# 0040205

    Expiry 04/2022

    Net Contents: 4L

    GenesisHealth

  • INGREDIENTS AND APPEARANCE
    ALCOHOL HAND SANITIZER 
    alcohol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75784-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 L  in 100 L
    Inactive Ingredients
    Ingredient NameStrength
    LAURYL LACTATE (UNII: G5SU0BFK7O)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    CETYL LACTATE (UNII: A7EVH2RK4O)  
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75784-001-044 L in 1 BOTTLE; Type 0: Not a Combination Product04/23/2020
    2NDC:75784-001-011 L in 1 BOTTLE; Type 0: Not a Combination Product04/27/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E04/23/2020
    Labeler - Tri-State Media, LLC (005820446)
    Establishment
    NameAddressID/FEIBusiness Operations
    Genesis Chemical Canada251234027manufacture(75784-001)
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