Label: ANTIBACTERIAL SANITIZING AND MOISTURIZING HAND- benzalkonium chloride cream

  • 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 April 10, 2023

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  • Drug Facts - Active Ingredient

    Benzalkonium Chloride 0.09%

    Purpose

    Antiseptic

  • Uses

    Hand sanitizer to help reduce bacteria that potentially can cause disease.

  • Warnings

    For external use only

    Avoid contact with eyes.

    In case of contact, rinse eyes thoroughly with water.

    Do not Use

    on open skin wounds.

    If irritation develops

    Discontinue use and consult a doctor.

    Keep out of reach of children.

    If swallowed, get medical help or contact poison control center right away.

  • Directions

    Apply product thoroughly to hands.
    Rub hands together until absorbed.
    Do not wipe off or rinse. Apply to
    hands as needed.

  • Other Information

    Avoid direct sunlight. Store below
    50°C. Do not refrigerate.

  • Inactive Ingredients

    Purified Water, Mineral Oil, Glyceryl
    Stearate, Stearic Acid, Fragrance,
    Cetearyl Alcohol, Acrylates /C10-30
    Alkyl Acrylate, Glycerin, Sodium
    Hydroxide, Crosspolymer, Vitamin B,
    Vitamin E, Titanium Dioxide.

  • Questions or comment?

    1-833-387-9949

  • PDP

    NDC: 83388-001-15

    box

    label

    label 2

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL SANITIZING AND MOISTURIZING HAND 
    benzalkonium chloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83388-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.9 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    WATER (UNII: 059QF0KO0R)  
    CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83388-003-501 in 1 BOX04/10/2023
    150 mL in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/10/2023
    Labeler - QBLUE TECHNOLOGIES, INC. (118928041)
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