Label: JURLIQUE MOISTURIZING HAND SANITIZER- alcohol lotion

  • Category: HUMAN OTC DRUG LABEL

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 January 12, 2011

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Alcohol, 62 %

  • Purpose

    Antiseptic Hand Sanitizer

  • Use

    for hand sanitizing to decrease bacteria on the skin

  • Warnings

    • For external use only
    • Flammable, keep away from fire or flame

    When using this product

    • Avoid contact with eyes. In case of eye contact, flush with water
    • Stop use and ask a doctor if rash or irritation develops and lasts

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

  • Directions

    • Apply to one palm and rub hands together
    • Distribute over hands and fingers until dry
  • Other information

    • Store below 30°C
    • You may report a serious adverse reaction to Report Reaction, LLC PO Box 22, Plainsboro, NJ 08536-022
  • Inactive ingredients

    Water, Carthamus Tinctorious (Safflower) Oleosomes, Ammonium Acryloyldimethyltaurate/VP Copolymer, Mentha Piperita (Peppermint) Leaf Extract, Equisetum Arvense Extract, Lavandula Angustifolia (Lavender) Flower Extract, Melissa Officinalis Leaf Extract, Origanum Majorana Leaf Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Salvia Officinalis (Sage) Leaf Extract, Urtica Dioica (Nettle) Extract, Hamamelis Virginiana (Witch Hazel) Extract, Achillea Millefolium Extract, Calendula Officinalis Flower Extract, SD Alcohol 40-A, Glycerin, Prostanthera Rotundifolia Leaf Extract, Citric Acid, Potassium Sorbate, Sodium Benzoate, Fragrance

  • SPL UNCLASSIFIED SECTION

    Made in USA for Jurlique,
    52-54 Oborn Rd., Mt. Barker, SA 5251.
    Jurlique, London, W4 1NP U.K.
    www.jurlique.com

  • PRINCIPAL DISPLAY PANEL - 50mL Bottle Label

    Jurlique

    Moisturizing
    Hand Sanitizer

    Natural
    antibacterial

    1.7 fl.oz. / 50mL e

    Principal Display Panel - 50mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    JURLIQUE MOISTURIZING HAND SANITIZER   NATURAL ANTIBACTERIAL
    alcohol lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68105-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL613.8 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SAFFLOWER (UNII: 4VBL71TY4Y)  
    EQUISETUM ARVENSE BRANCH (UNII: 1L0VKZ185E)  
    LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)  
    HAMAMELIS VIRGINIANA LEAF (UNII: T07U1161SV)  
    ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    MENTHA PIPERITA LEAF (UNII: A389O33LX6)  
    MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)  
    SWEET MARJORAM OIL (UNII: ICH7BE016E)  
    ROSEMARY (UNII: IJ67X351P9)  
    SAGE (UNII: 065C5D077J)  
    URTICA DIOICA LEAF (UNII: X6M0DRN46Q)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68105-003-0150 mL in 1 BOTTLE, PLASTIC
    2NDC:68105-003-02175 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333E01/17/2011
    Labeler - Jurlique International Pty. Ltd. (752025791)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmetic Laboratories of America617165329MANUFACTURE