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
  • 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 22, 2021

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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 (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 not finalpart333A01/15/2013
    Labeler - EO Products, LLC (786611210)
    Establishment
    NameAddressID/FEIBusiness Operations
    EO Products, LLC786611210manufacture(54748-203)
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