Label: HIMARK- benzalkonium chloride liquid

  • NDC Code(s): 63148-401-07, 63148-401-50
  • Packager: Apollo Health and Beauty Care
  • Category: HUMAN OTC DRUG LABEL

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 June 24, 2023

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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. In case of contact, rinse thoroughly with water.

    Stop use and ask a doctor if

    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 control center immediately.

  • Directions

    • From Liquid Hand Soap pump bottle, apply onto wet hands
    • Lather and rinse thoroughly.
  • Other Information

    Store at room Temperature.

  • Inactive Ingredients

    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(CI19140), Red 33 (CI17200).

  • Questions

    1-866-795-8481

  • Principal Display Panel- 50 Oz

    Package Label-50

  • Principal Display Panel-7.5 Oz

    Package Label-7.5 Oz

  • INGREDIENTS AND APPEARANCE
    HIMARK 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63148-401
    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
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    BASIC YELLOW 5 (UNII: 07BP340B4T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYL GLUCOSE DIOLEATE (UNII: FA9KFJ4Z6P)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    LAURAMIDOPROPYLAMINE OXIDE (UNII: I6KX160QTV)  
    CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    SODIUM SULFATE (UNII: 0YPR65R21J)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63148-401-07221 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2023
    2NDC:63148-401-501478 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/01/2023
    Labeler - Apollo Health and Beauty Care (201901209)
    Registrant - Apollo Health and Beauty Care (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apollo Health and Beauty Care201901209manufacture(63148-401)
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