Label: SANITAXE ANTIBACTERIAL AMBER HAND- chloroxylenol liquid

  • NDC Code(s): 76176-118-01
  • Packager: NINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD.
  • 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 1, 2019

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  • Drug Facts Active ingredients

    Chloroxylenol 0.1 percent

  • Purpose

    Antibacterial

  • Uses

    for handwashing to eliminate bacterial and germs on the skin.

  • Warnings

    For external use only.

    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.

    Children must be supervised in use of this product.

  • Directions

    wet hands. Apply palmful to hands. Scrub thoroughly. Rinse.

  • Other information

    • store at 20 Degree Celsius (68 to 77 Fahrenheit). May discolor fabrics.
  • Inactive ingredients

    Water (Aqua), Sodium Laureth Sulfate, Cocamidopropyl Betaine, Sodium Lauryl Sulfate, Glycerin, Sodium Chloride, Fragrance, Citric Acid, PEG-150 Distearate, Methylchloroisothiazolinone, Methylisothiazolinone, FD&C Yellow No.5.

  • 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 
    chloroxylenol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76176-118
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL0.1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
    PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76176-118-01800 mL in 1 BAG; Type 0: Not a Combination Product01/01/2015
    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(76176-118)
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