Label: TOPCARE ANTIBACTERIAL HAND FRESH AND CLEAN- benzalkonium chloride liquid

  • NDC Code(s): 36800-534-50, 36800-534-56
  • Packager: Topco Associates LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated May 9, 2024

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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 contac, flush with water.

    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.

  • Directions

    • Use only to refill a Liquid Hand Soap pump bottle.
    • From 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 (CI 19140), Red 33 (CI 17200).

  • Questions or comments?

    1-888-423-0139

  • Principal Display Panel- 50 Oz

    Principal Display Panel

  • Principal Display Panel- 56 Oz

    Image of the label

  • INGREDIENTS AND APPEARANCE
    TOPCARE ANTIBACTERIAL HAND FRESH AND CLEAN 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-534
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    LAURAMIDOPROPYLAMINE OXIDE (UNII: I6KX160QTV)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    SODIUM SULFATE (UNII: 0YPR65R21J)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    WATER (UNII: 059QF0KO0R)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:36800-534-561656 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/20/2019
    2NDC:36800-534-501470 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 Drug505G(a)(3)06/20/2019
    Labeler - Topco Associates LLC (006935977)
    Registrant - Apollo Health and Beauty Care Inc. (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apollo Health and Beauty Care Inc.201901209manufacture(36800-534)
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