Label: BERKLEY JENSEN- benzalkonium chloride soap

  • NDC Code(s): 63148-350-11
  • Packager: Apollo Health and Beauty Care
  • 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 15, 2022

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  • Active Ingredient.

    Benzalkonium Chloride (0.13%)

  • Purpose

    Antibacterial

  • Uses

    Helps eliminate bacteria on hands.

  • Warnings

    For external use only

    When using this product

    Avoid contact with eyes. If this occurs, rinse thoroughly with water.

    Stop use and ask a doctor if

    irritation or redness develops and lasts

    Keep out of reach of children.

    In case of accidental ingestion, seek medical attention or contact a poison center immediately.

  • Directions

    • Apply a small amount onto wet hands
    • Work into a lather and rinse
  • Other Information

    Store at room temperature

  • Inactive Ingredients

    Water (Aqua), Lauramidopropylamide Oxide, Glycerin, Cetrimonium Chloride, Sodium Chloride, Cocamide MEA, PEG – 120 Methyl Glucose Dioleate, Fragrance (Parfum), Citric Acid, Tetrasodium EDTA, Sodium Sulfate, Methylchloroisothiazolinone, Methylisothiazolinone, Red 40 (CI 16035), Yellow 5 (CI 19140), Red 33 (CI 17200),

  • Principal Display Panel

    PDP 11.25

  • INGREDIENTS AND APPEARANCE
    BERKLEY JENSEN 
    benzalkonium chloride soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63148-350
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE130 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM SULFATE (UNII: 0YPR65R21J)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    LAURAMIDOPROPYLAMINE OXIDE (UNII: I6KX160QTV)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    WATER (UNII: 059QF0KO0R)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)  
    FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    BASIC YELLOW 5 (UNII: 07BP340B4T)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63148-350-11333 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/15/2022
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E08/15/2022
    Labeler - Apollo Health and Beauty Care (201901209)
    Registrant - Apollo Health and Beauty Care (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apollo Health and Beauty Care201901209manufacture(63148-350)
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