Label: SANITAXE ANTIBACTERIAL AMBER HAND 27 FL OZ- benzalkonium chloride liquid

  • NDC Code(s): 76176-124-01
  • Packager: NINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD.
  • 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 September 1, 2020

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  • Drug Facts Active Ingredient

    Benzalkonium Chloride 0.13 percent

  • Purpose

    Antibacterial

  • Uses

    • Helps reduce bacteria on the skin that could cause disease.
    • Recommended for repeated use.
  • Warnings

    For external use only. Do not ingest or swallow.

    Do not apply around eyes. Do not use in ears and mouth.

    When using this product, avoid contact with eyes. In case of contact, flush eyes with water.

  • Stop use and ask a doctor

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

  • Keep out of reach of children.

    Do not use on children less than 2 months of age. Supervise use in children under 6 years of age to prevent accidental swallowing. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Pump onto wet hands
    • Work into lather
    • Wash hands, rinse and dry thoroughly.
  • Inactive ingredients:

    Water (Aqua), Cocamidopropye Betaine, Sodium Cocoamphoacetate, PEG-150 Distearate, Fragrance, Citric Acid, Methylisothiazolinone, Iodopropynyl Butylcarbamate, FD&C Yellow No.5, D&C Red No.40

  • Loading Instructions

    1. Tear tab off of box and pull out tube. Pull down nozzle until tube extends from bottom of box.

    2. Place Bag-In-Box into dispenser. Guide nozzle fitment into valve channel and close dispenser. Push button to prime.

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    SANITAXE ANTIBACTERIAL AMBER HAND 27 FL OZ 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76176-124
    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
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    WATER (UNII: 059QF0KO0R)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    SODIUM COCOAMPHOACETATE (UNII: W7Q5E87674)  
    PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76176-124-01800 mL in 1 BAG; Type 0: Not a Combination Product01/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/01/2015
    Labeler - NINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD. (530766098)
    Registrant - NINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD. (530766098)
    Establishment
    NameAddressID/FEIBusiness Operations
    NINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD.530766098manufacture(76176-124)
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