Label: KITCHEN LEMON ZEST ANTIBACTERIAL FOAMING HAND- 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 21, 2019

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  • Active ingredient

    Benzalkonium Chloride 0.13%

    Purpose

    Antibacterial

  • Uses

    for washing to decrease bacteria on the skin.

  • 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

    irritation ad redness develops and lasts.

    Keep out of reach of children.

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

  • Directions

    • apply onto dry hands
    • lather and rinse thoroughly
  • Other information

    store at room temperature

  • Inactive ingredients

    Water (Aqua), Cocamidopropyl Betaine, Glycerin, Hydroxyethylcellulose, Polyquaternium-7, Benzophenone-4, Tetrasodium EDTA, Fragrance (Parfum), Citric Acid, Methylchloroisothiazolinone, Methylisothiazolinone, Yellow 5 (CI 19140), Red 40 (CI 16035).

  • Questions or comments?

    1-866-695-3030

  • Label copy

    Image of the label

  • INGREDIENTS AND APPEARANCE
    KITCHEN LEMON ZEST ANTIBACTERIAL FOAMING HAND 
    benzalkonium chloride soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63148-016
    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
    WATER (UNII: 059QF0KO0R)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROXYETHYL CELLULOSE (5000 CPS AT 1%) (UNII: X70SE62ZAR)  
    POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y)  
    SULISOBENZONE (UNII: 1W6L629B4K)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63148-016-12355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/20/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E08/20/2019
    Labeler - Apollo Health and Beauty Care Inc. (201901209)
    Registrant - Apollo Health and Beauty Care Inc. (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apollo Health and Beauty Care Inc.201901209manufacture(63148-016)
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