Label: FOAMING ANTIBACTERIAL HAND- lavish antibacterial soap

  • NDC Code(s): 61307-640-10
  • Packager: US Chemical Corporation
  • 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 August 24, 2023

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  • DOSAGE & ADMINISTRATION

    Directions Apply a small amount , covering hands with product for 30 seconds. Add water, lather and rinse.

  • INACTIVE INGREDIENT

    Inactive Ingredients Water, Lauramine Oxide, PEG-7 Glyceryl Cocate, Glycerin, Laurtrimonium Chloride, Cocamidopropyl PG-Dimonium Chloride Phosphate, Polyquaternium-7, Fragrance, Wheat Amono Acid, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, Methylisothiazolinone, Methylchloroisothiazolinone.

  • INDICATIONS & USAGE

    Uses For handwashing to decrease bacteria on skin.

  • ACTIVE INGREDIENT

    Active Ingredient Benzalkonium Chloride 0.13% w/w

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, contact a physician or Poison Control Center right away.

  • PURPOSE

    Purpose Antibacterial Agent

  • WARNINGS

    Warnings For external use only. Avoid contact with eyes. If contact occurs, flush eyes with plenty of water. Stop use and ask a doctor if irritation or rash appears and persists.

  • PRINCIPAL DISPLAY PANEL

    Principal Label

  • INGREDIENTS AND APPEARANCE
    FOAMING ANTIBACTERIAL HAND 
    lavish antibacterial soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61307-640
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.013 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM COCOYL WHEAT AMINO ACIDS (UNII: JW3VT57I11)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)  
    COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)  
    POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) (UNII: 0L414VCS5Y)  
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61307-640-101000 mL in 1 BAG; Type 0: Not a Combination Product10/28/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/28/2018
    Labeler - US Chemical Corporation (031457842)
    Registrant - Kutol Products Company (004236139)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kutol Products Company004236139manufacture(61307-640)
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