Label: EO HAND SANITIZER LAVENDER- alcohol spray 

  • NDC Code(s): 54748-101-01, 54748-101-02
  • Packager: Small World Trading Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 12/12

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

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  • INDICATIONS & USAGE

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

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  • WARNINGS

    Warnings:

    For external use only
    Flammable
    Keep away from fire/flame
    Do not use this product in or near eyes. If contact occurs, rinse thoroughly with water
    keep out of reach of children
    Children under 6 years of age should be supervised when using this product
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  • DOSAGE & ADMINISTRATION

    Directions:

    Spray onto palm, Rub hands together.

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  • INACTIVE INGREDIENT

    Inactive Ingredients:

    Purified Water, Organic Lavendula Angustifolia (Lavender) Essential Oil, Organic Echinacea Angustifolia Leaf Extract, Vegetable Glycerin, Tocopherol (Vitamin E).

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  • STORAGE AND HANDLING


    Other Information:

    Do not store above 104°F / 40°C, May discolor some fabrics.
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  • INGREDIENTS AND APPEARANCE
    EO HAND SANITIZER  LAVENDER
    alcohol spray
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:54748-101
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ALCOHOL (ALCOHOL) ALCOHOL 62 mL  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    LAVENDER OIL  
    ECHINACEA ANGUSTIFOLIA LEAF  
    GLYCERIN  
    .ALPHA.-TOCOPHEROL  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54748-101-01 10 mL in 1 BOTTLE, SPRAY
    2 NDC:54748-101-02 60 mL in 1 BOTTLE, SPRAY
    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(54748-101)
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