Label: SANITAXE ANTIBACTERIAL- benzalkonium chloride gel

  • NDC Code(s): 72197-009-27
  • Packager: American Consumer Products Corp
  • 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 June 23, 2020

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  • Active Ingredient

    Active Ingredient

    Benzalkonium Chloride .26%

  • Purpose

    Purpose

    Antiseptic

  • Uses

    Uses ● Helps reduce bacteria on the skin that could cause disease. Recommended for repeated use.

  • Warnings

    Warnings – For external use only. Do not ingest or swallow.

    Flammable. Keep away from fire or flame.

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

  • When using this product

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

  • Stop use and ask a doctor

    Stop use and ask a doctor if redness or irritation develops and persists for more than 72 hours.

  • Keep out of reach of children

    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

    Directions ● pump as needed on your palms and thoroughly spread on both hands

    ● rub into skin until dry.

  • Other information

    Other information ● store at room 20° C (68° to 77° F) ● may discolor fabrics.

  • Inactive ingredients

    Inactive ingredients: Water (Aqua), Cocamidopropyl Betane, PEG-6000 Disterate, Sodium Cocoamphoacetate, Fragrance, Citric Acid, Methylisothiazolinone, Iodopropynyl Butylcarbamate

  • Sanitaxe Hand Soap

    Sanitaxe Hand Soap

  • INGREDIENTS AND APPEARANCE
    SANITAXE ANTIBACTERIAL 
    benzalkonium chloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72197-009
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.26 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM COCOAMPHOACETATE (UNII: W7Q5E87674)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    PEG-250 DISTEARATE (UNII: FHP1R1SR0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72197-009-27800 mL in 1 BOX; Type 0: Not a Combination Product06/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/30/2020
    Labeler - American Consumer Products Corp (081101181)
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