Label: EO HAND SANITIZER UNSCENTED- alcohol gel

  • NDC Code(s): 54748-203-04, 54748-203-07
  • Packager: EO Products, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 10, 2024

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  • ACTIVE INGREDIENT

    Active Ingredient:

    Ethanol 62%

  • PURPOSE

    Purpose:

    Antiseptic

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact the Poison Control center right away.

  • INDICATIONS & USAGE

    Uses: •For hand  washing to decrease bacteria on skin.

    •Recommended for repeated use 

  • WARNINGS


    Warnings:

    • Flammable, Keep away from fire/flame
    • For external use only
    • Do not use in eyes. If contact occurs, flush thoroughly with water.
    • Stop use and contact a doctor if redness and irritation develops and persists for more than 72 hours.
  • DOSAGE & ADMINISTRATION

    Directions: • Wet hands thoroughly with product and allow to dry without wiping

    • Do not use other than directed.

  • INACTIVE INGREDIENT

    Inactive Ingredients: Purified Water, Vegetable Glycerin, Organic Simmondsia Chinensis (Jojoba) Seed Oil, Carbomer, Dimethicone, Aminomethyl Propanol.

  • STORAGE AND HANDLING

    Other Information: • Store below 104°F (40°C)

    • May discolor certain fabrics.

  • SPL UNCLASSIFIED SECTION

    ESSENTIAL OILS

    99.9% EFFECTIVE AGAINST MOST COMMON GERMS

  • Packaging

    Drug Label

  • INGREDIENTS AND APPEARANCE
    EO HAND SANITIZER  UNSCENTED
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54748-203
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    JOJOBA OIL (UNII: 724GKU717M)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    DIMETHICONE, UNSPECIFIED (UNII: 92RU3N3Y1O)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54748-203-04960 mL in 1 BOTTLE; Type 0: Not a Combination Product01/15/201312/31/2016
    2NDC:54748-203-07946 mL in 1 BOTTLE; Type 0: Not a Combination Product05/19/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)01/15/2013
    Labeler - EO Products, LLC (786611210)
    Establishment
    NameAddressID/FEIBusiness Operations
    EO Products, LLC786611210manufacture(54748-203)
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