Label: CLEANSE- benzalkonium chloride solution

  • NDC Code(s): 53329-184-08, 53329-184-74, 53329-184-84
  • Packager: Medline Industries, LP
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated May 29, 2024

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  • Active ingredient

    Benzalkonium chloride 0.13%

  • Purpose

    Antibacterial

  • Use

    for handwashing to decrease bacteria on the skin

  • Warnings

    For external use only: hands only

    When using this product

    • avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.

    Stop use and ask a doctor if

    • irritation or redness develops
    • condition persists for more than 72 hours

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • wet hands
    • apply palmful to hands
    • scrub thoroughly
    • rinse thoroughly
  • Inactive ingredients

    benzophenone-4, citric acid, cocamidopropyl betaine, fragrance, glycerin, lauramidopropylamine oxide, lauramine oxide, myristamidopropylamine oxide, red 4, sodium benzoate, tetrasodium EDTA, water, yellow 5

  • Manufacturing Information

    Manufactured for:

    Medline Industries, LP

    Three Lakes Drive, Northfield, IL 60093 USA

    Made in USA with domestic and foreign materials

    www.medline.com

    1-800-MEDLINE (633-5463)

    REF: HHABSP1200F

    V2 RG23VJO

  • Package Label

    Front Label V2 RG23VJO

    Back Label V2 RG23VJO

  • INGREDIENTS AND APPEARANCE
    CLEANSE 
    benzalkonium chloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-184
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    SULISOBENZONE (UNII: 1W6L629B4K)  
    MYRISTAMIDOPROPYLAMINE OXIDE (UNII: 3HSF539C9T)  
    LAURAMIDOPROPYLAMINE OXIDE (UNII: I6KX160QTV)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53329-184-841000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product09/26/2016
    2NDC:53329-184-08221 mL in 1 BOTTLE; Type 0: Not a Combination Product01/01/2021
    3NDC:53329-184-741200 mL in 1 BOTTLE; Type 0: Not a Combination Product08/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)09/26/2016
    Labeler - Medline Industries, LP (025460908)
    Registrant - Medline Industries, LP (025460908)
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