Label: HANDSOAP- 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 August 12, 2022

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  • ACTIVE INGREDIENT

    Benzalkonium Chloride

  • PURPOSE

    Handwashing

  • WARNINGS

    For External Use only

  • WHEN USING

    Avoid contact with eyes. In case of contact, flush with water

  • STOP USE

    Stop using this product and ask a doctor if irritation or redness develops and lasts.

  • KEEP OUT OF REACH OF CHILDREN

    In case of accidental ingestion, get medical help or contact a Poison Control Center immediately

  • INDICATIONS & USAGE

    Directions

    . Use only to refill a Liquid Hand Soap pump bottle.
    . From pump bottle, apply onto wet hands.
    . Lather and rinse thoroughly.

  • Dosage Section

    Topical use only. Use when required.

  • STORAGE AND HANDLING

    Store at room temperature

  • INACTIVE INGREDIENT

    Water (Aqua), Lauramidopropylamine 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

    56 oz

  • INGREDIENTS AND APPEARANCE
    HANDSOAP 
    benzalkonium chloride soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-535
    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
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    LAURAMIDOPROPYLAMINE OXIDE (UNII: I6KX160QTV)  
    CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    SODIUM SULFATE (UNII: 0YPR65R21J)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-535-561650 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/12/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E08/12/2022
    Labeler - Topco Associates LLC (006935977)
    Registrant - Apollo Health and Beauty Care Inc (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    Spa Dent Inc203478896manufacture(36800-535)
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