Label: EO HAND SANITIZER LAVENDER- alcohol gel

  • NDC Code(s): 54748-201-02, 54748-201-03, 54748-201-04
  • 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 April 20, 2016

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

    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, Vegetable Glycerin, EO Essential Oil Blend [ Organic Lavandula Hybrida Angustifolia (Lavender) Oil, Lavandula Hybrida Oil, Organic Simmondsia Chinensis (Jojoba) Seed Oil, Carbomer, Dimethicone, Aminomethyl Propanol.

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  • STORAGE AND HANDLING

    Other Information
    • Store at room temperature 200-250 C(660F - 770F)
    • May discolour certain fabrics
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  • INGREDIENTS AND APPEARANCE
    EO HAND SANITIZER  LAVENDER
    alcohol gel
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:54748-201
    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)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    LAVANDIN OIL (UNII: 9RES347CKG)  
    JOJOBA OIL (UNII: 724GKU717M)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54748-201-02 60 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/15/2013
    2 NDC:54748-201-03 240 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/15/2013
    3 NDC:54748-201-04 960 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/15/2013
    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(54748-201)
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