Label: THEORIE ANTIMICROBIAL HAND WASH- benzalkonium chloride soap

  • NDC Code(s): 73857-003-00, 73857-003-01
  • Packager: Dynastis, 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 January 11, 2023

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  • DRUG FACTS

    Benzalkonium Chloride 0.13%

  • Uses

    For hand washing to decrease bacteria that can potentially cause disease.

  • Warnings

    For external use only. If swallowed, get medical help or contact a Poison Control Center immediately.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • Do not use

    • in children less than 2 months of age
    • on open skin wounds

  • WHEN USING

    When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water. Children must be supervised when using this product.

  • INDICATIONS & USAGE

    Stop use and ask a doctor if: irritation or rash occurs. These maybe signs of a serious condition.

  • Directions

    For maximum efficiency, pump the product into wet hands, lather vigorously, sinse and dry.

  • Inactive Ingredients

    Water, Sodium C14-16 Olefin Sulfonate, Cocamidopropyl Betaine, Coco Glucoside, Glycerin, Polysorbate-20, PEG-150 Pentaerythrityl Tetrastearate, PEG-6 Caprylic/Capric Glycerides, Guar Hydroxypropyltrimonium Chloride, Polyquaternium-10, Sodium Hyaluronate, Tocopheryl Acetate, Argania Spinosa Kernel (Argan) Oil, Phenoxyethanol, Ethylhexylglycerin, Citric Acid, Fragrance.

  • Other Information

    Store at room temperature 68°F to 77°F (20° to 25°C)
    Do not expose to excessive heat.
    You may report a serious adverse reaction to: Hautehouse, LLC, 909 NW Terrace, Fort Lauderdale, FL 33311 USA

  • For Questions

    HAUTEHOUSE INC.
    909 NW Terrace
    Fort Lauderdale, FL 33311 USA
    +1 (954) 376-8966
    www.hautehouse.com

  • PRINCIPAL DISPLAY PANEL

    400ml label

  • PRINCIPAL DISPLAY PANEL

    1.5L label

  • INGREDIENTS AND APPEARANCE
    THEORIE ANTIMICROBIAL HAND WASH 
    benzalkonium chloride soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73857-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE.0013 kg  in 1 kg
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PEG-150 PENTAERYTHRITYL TETRASTEARATE (UNII: 8L4OOQ76AM)  
    PEG-6 CAPRYLIC/CAPRIC GLYCERIDES (UNII: GO50W2HWO8)  
    GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)  
    POLYQUATERNIUM-10 (30000 MPA.S AT 2%) (UNII: C7RDC8Y4JS)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    SCLEROCARYA BIRREA SEED OIL (UNII: WDO4TLS35F)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73857-003-000.400 kg in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/14/202012/31/2023
    2NDC:73857-003-011.5 kg in 1 POUCH; Type 0: Not a Combination Product08/28/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E04/14/2020
    Labeler - Dynastis, LLC (021238554)
    Registrant - Dynastis, LLC (021238554)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosco International, Inc.016433141manufacture(73857-003) , label(73857-003) , pack(73857-003)
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