Label: PREMIUM ANTIBACTERIAL HAND- benzalkonium chloride soap

  • 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 December 10, 2020

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  • ACTIVE INGREDIENT

    Benzalkonium Chloride 0.13%

  • PURPOSE

    Antibacterial

  • USE

    For washing to decrease bacteria on the skin

  • WARNINGS

    For external use only

  • WHEN USING

    WHEN USING THIS PRODUCT AVOID CONTACT WITH EYES. Incase of eye contact flush with water.

  • STOP USE

    STOP USE AND ASK A DOCTOR IF irritation and redness develops

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF THE REACH OF CHILDREN IF SWALLOWED, get medical help or contact a poision control
    center right away.

  • DIRECTIONS

    Pump into dry hands and forearms, lather for atleast 15 seconds, rinse and dry.

  • INACTIVE INGREDIENTS

    Water, Caprylyl / Capryl Glucosides, Laurtrimonium Chloride, Cocamidoprpylamine Oxide, Citric Acid, Fragrance

  • PRINCIPAL DISPLAY PANEL

    PREMIUM ANTIBACTERIAL HAND SOAP

    LEMON BLOSSOM

    12 FL. OZ. (354 mL)

    image description

  • INGREDIENTS AND APPEARANCE
    PREMIUM ANTIBACTERIAL HAND 
    benzalkonium chloride soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74811-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)  
    COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74811-002-02354 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product12/08/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A12/08/2020
    Labeler - Insolcorp, LLC (080539371)
    Establishment
    NameAddressID/FEIBusiness Operations
    Insolcorp, LLC080539371manufacture(74811-002)
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