Label: EO HAND SANITIZER SWEET ORANGE- alcohol spray

  • NDC Code(s): 54748-103-02, 54748-103-05, 54748-103-09
  • 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 19, 2021

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  • Active Ingredients:

    Organic Ethanol 62%

  • Purpose:

    Antiseptic

  • Uses:

    • For hand washing to decrease bacteria on skin
    • Recommended for repeated use

  • 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 ask a doctor if redness and irritation develop and persists for more than 72 hours.
  • 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.
  • Directions:

    • Wet hands thoroughly with product and allow to dry without wiping.
    • Do not use other than intended.

  • Other Information:

    • Store below 104°F (40°C).
    • May discolor certain fabrics.

  • Inactive Ingredients:

    Purified Water, Organic Lavandula Angustifolia (Lavender) Oil, Organic Citrus Aurantium Dulcis (Orange) Peel Oil, Organic Citrus Medica Limonum (Lemon) Peel Oil, Vegetable Glycerin, Tocopherol

  • SPL UNCLASSIFIED SECTION

    ESSENTIAL OILS

    USDA ORGANIC

    HAND sanitizer SPRAY

    sweet orange

    99.9% EFFECTIVE AGAINST MOST COMMON GERMS

    made with moisturizing ingredients

    SYNTHETIC FRAGRANCE FREE

    TRICLOSAN FREE • BENZALKONIUM CHLORIDE FREE

    MADE WITH ORGANIC INGREDIENTS • PHTHALATE FREE

    EO® PRODUCTS

    SMALL WORLD TRADING CO. SAN RAFAEL, CA 94901

    MADE IN THE USA FROM DOMESTIC AND GLOBALLY SOURCED INGREDIENTS

    800-570-3775 eoproducts.com

    CERTIFIED ORGANIC BY CCOF

  • Packaging

    EOrange59

  • INGREDIENTS AND APPEARANCE
    EO HAND SANITIZER  SWEET ORANGE
    alcohol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54748-103
    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)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    LEMON OIL (UNII: I9GRO824LL)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54748-103-0260 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product01/15/201311/30/2016
    2NDC:54748-103-0559 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product05/02/2017
    3NDC:54748-103-096 in 1 BOX08/13/2018
    3NDC:54748-103-0559 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    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(54748-103)
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