Label: FOAMING ADVANCED 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 September 13, 2018

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  • ACTIVE INGREDIENT

    Active Ingredient

    Benzalkonium Chloride 0.13% w/w

  • PURPOSE

    Purpose

    Antibacterial

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, contact a physician or poison control center. 

  • INDICATIONS & USAGE

    Uses Handwash to help decrease bacteria on the skin

  • DOSAGE & ADMINISTRATION

    Directions To decrease bacteria on the skin, apply a small amount, covering hands with product for 30 seconds. Add water, lather, rinse.

  • WARNINGS

    Warnings

    For external use only. Avoid contact with eyes. If eye contact occurs, flush eyes with water.

    Stop use if, in rare instances, redness or irritation develops. If condition persists for more than 72 hours, consult a physician.

  • INACTIVE INGREDIENT

    Inactive Ingredients

    water, cocamidopropyl betaine, cocamidopropyl PG-dimonium chloride phosphate, PEG-6 cocamide, laurtrimonium chloride, aloe barbadensis leaf juice, tocopheryl acetate (vitamin E), fragrance, iodopropynyl butylcarbamade, methylisothiazolinone, yellow 5, red 33.

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    FOAMING ADVANCED ANTIBACTERIAL HAND 
    benzalkonium chloride soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43196-213
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.003 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)  
    PEG-6 COCAMIDE (UNII: YZ6NLA4O1E)  
    LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43196-213-094000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/13/2018
    2NDC:43196-213-241000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/13/2018
    3NDC:43196-213-411000 mL in 1 BAG; Type 0: Not a Combination Product09/13/2018
    4NDC:43196-213-501250 mL in 1 BAG; Type 0: Not a Combination Product09/13/2018
    5NDC:43196-213-78950 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/13/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E09/13/2018
    Labeler - OPI Correctional Industries (809174501)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kutol Products Company004236139manufacture(43196-213)
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