Label: TOTAL SANITIZER ALCOHOL FREE HAND SANITING FOAM- benzalkonium 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 September 10, 2020

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  • Drug Facts

  • Active Ingredient

    Benzalkonium Chloride 0.12%

    Purpose

    Antiseptic

  • Uses

    • For handwashing to decrease bacteria on the skin.
    • After changing diapers.
    • After assisting ill persons.
    • Before contact with a person under medical care or treatment.
    • Recommended for repeat use.
  • Warnigns

    For external use only.

    Do not use

    in the eyes.

    When using this product

    do not get into eyes. If contact occurs. rinse thoroughly with water.

    Stop use and ask a doctorif

    irritation and redness develop. If condition persists for more than 72 hours consult a doctor.

    Keep out of reach of children.

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

  • Directions

    • Wet hands thoroughly with product and allow to dry.
    • Children under six years of age should be supervised when using this product.
  • Other information

    • Store in a cool, dry place.
  • Inactive Ingredients

    Water, Aloe Barbadensis Leaf Juice, Polysorbate 20, Glycerin, Potassium Sorbate, Fragrnace, Citric Acid, Disodium EDTA, Tocopheryl Acetate (Vitamin E).

  • Package Labeling:

    Label3

  • INGREDIENTS AND APPEARANCE
    TOTAL SANITIZER ALCOHOL FREE HAND SANITING FOAM 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80463-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.2 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80463-003-003785 mL in 1 BOTTLE; Type 0: Not a Combination Product07/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E07/01/2020
    Labeler - Total Sanitizer, LLC (080216348)
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