Label: HAND SANITIZER FOAM- ethanol alcohol aerosol, foam

  • NDC Code(s): 83584-225-01, 83584-225-02, 83584-225-03
  • Packager: PurCel Labs LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 5, 2024

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  • Active Ingredient


    Ethyl Alcohol 70% 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 heat or flame.

  • Do not use


    • On children less than 2 months of age.
    • On open skin wounds.

  • WHEN USING


    When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

  • ASK DOCTOR


    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


    Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

  • Directions


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

  • Other information


    • Store below 110°F (43°C).
    • Avoid freezing and excessive heat above 104°F (40°C).
    • May discolor certain fabrics or surfaces.

  • Inactive ingredients


    Water, Peg-10 Dimethicone, Aloe Barbadensis Extract, Glycerin, Propylene Glycol, Peg-7 Glyceryl Cocoate,
    Tocopheryl Acetate.

  • PRINCIPAL DISPLAY PANEL

    83584-225-0183584-225-0283584-225-03

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER FOAM 
    ethanol alcohol aerosol, foam
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83584-225
    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
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83584-225-036 in 1 CARTON02/29/2024
    1NDC:83584-225-022 in 1 BOX
    1NDC:83584-225-011400 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00302/29/2024
    Labeler - PurCel Labs LLC (127672531)
    Registrant - PurCel Labs LLC (127672531)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhongshan Dermey Commodity Co.,Ltd550280464manufacture(83584-225)
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