Label: SERENE CLEAN AND PURE ANTIBACTERIAL HAND- benzakonium chloride liquid

  • 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 July 9, 2020

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  • Active ingredient

    Benzalkonium Chloride 0.13%

  • Purpose

    Antibacterial

  • Use

    For handwashing to help reduce bacteria on the skin

  • Warnings

    For external use only.

    When using this product

    keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

    Stop use and ask a doctor

    if irritation or redness develops and condition persists for more than 72 hours.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Pump into wet hands and work into a lather for at least 15 seconds
    • Rinse thoroughly and dry
  • Inactive ingredients

    Water, EDTA, Glycerin, Sodium Dodecylbenzenesulfonate, Coco-betaine, Sodium Laureth Sulfate, Phenoxyethanol

  • Package Label - Principal Display Panel

    Serene Clean & Pure

    Kills 99.99% of Germs & Bacteria

    Benzalkonium Chloride

    Antibacterial Hand Soap

    16 fl oz

    www.serenepure.com

    ABOUT

    Serene Clean & Pure is a family owned company that believes in honest and helpful products.

    Serene Clean & Pure hand soap is an antibacterial hand soap that leaves hands feeling gentle and soft, while moisturizing them. Use as often as needed for a germ and bacteria free life

    Distributed by:

    Serene Clean & Pure

    555 Anton Blvd. Suite 105

    Costa Mesa, CA 92626

    Label

  • INGREDIENTS AND APPEARANCE
    SERENE CLEAN AND PURE ANTIBACTERIAL HAND 
    benzakonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78643-200
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL
    WATER (UNII: 059QF0KO0R)  
    EDETIC ACID (UNII: 9G34HU7RV0)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    SODIUM DODECYLBENZENESULFONATE (UNII: 554127163Y)  
    COCO-BETAINE (UNII: 03DH2IZ3FY)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78643-200-01473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/09/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E07/09/2020
    Labeler - Serene Clean & Pure LLC (117539963)
    Registrant - Serene Clean & Pure LLC (117539963)
    Establishment
    NameAddressID/FEIBusiness Operations
    Morgan Gallacher Inc.028311595manufacture(78643-200)
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