Label: EO HAND SANITIZER PEPPERMINT- alcohol spray

  • NDC Code(s): 54748-102-01, 54748-102-02, 54748-102-05
  • Packager: Small World Trading Company
  • 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 May 15, 2017

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active Ingredient:

    Ethanol 62%

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  • PURPOSE

    Purpose:

    Antiseptic

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  • 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.

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  • INDICATIONS & USAGE

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

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  • 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.
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  • DOSAGE & ADMINISTRATION

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

    • Do not use other than directed.

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  • INACTIVE INGREDIENT

    Inactive Ingredients:

    Purified Water, Organic Mentha Piperita (Peppermint) Oil, Organic Thymus Vulgaris (Thyme) Leaf Extract, Vegetable Glycerin, Tocopherol

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  • Other Information:

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

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  • SPL UNCLASSIFIED SECTION

    ESSENTIAL OILS

    ORGANIC HAND SANITIZER

    peppermint SPRAY

    SYNTHETIC FRAGRANCE FREE

    EO® PRODUCTS
    SMALL WORLD TRADING CO.
    CA 94901 MADE IN THE USA
    FROM DOMESTIC AND GLOBALLY SOURCED INGREDIENTS
    800-570-3775
    eoproducts.com
    CERTIFIED ORGANIC BY CCOF
    99.9% EFFECTIVE AGAINST MOST COMMON GERMS

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  • Packaging
  • INGREDIENTS AND APPEARANCE
    EO HAND SANITIZER  PEPPERMINT
    alcohol spray
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:54748-102
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 62 mL  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    THYMUS VULGARIS LEAF (UNII: GRX3499643)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54748-102-01 10 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 01/15/2013
    2 NDC:54748-102-02 60 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 01/15/2013
    3 NDC:54748-102-05 59 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 05/02/2017
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333A 01/15/2013
    Labeler - Small World Trading Company (786611210)
    Establishment
    Name Address ID/FEI Business Operations
    Small World Trading Company 786611210 manufacture(54748-102)
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