Label: CLEANSE- benzalkonium chloride 0.13% solution

  • NDC Code(s): 53329-177-04, 53329-177-06, 53329-177-08, 53329-177-25, view more
    53329-177-74, 53329-177-84
  • Packager: Medline Industries, LP
  • 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 August 9, 2023

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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, disteareth-75 IPDI, fragrance, glycerin, lauramidopropylamine oxide, lauramine oxide, myristamidopropylamine oxide, PEG-150 distearate, red 40, red 33, sodium benzoate, sodium chloride, 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: HHABSP1200G

    V2 RB23VJO

  • Package Label

    Front Label V2 RB23VJO

    Back Label V2 RB23VJO

  • INGREDIENTS AND APPEARANCE
    CLEANSE 
    benzalkonium chloride 0.13% solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-177
    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
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
    PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
    SULISOBENZONE (UNII: 1W6L629B4K)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DISTEARETH-75 ISOPHORONE DIISOCYANATE (UNII: 5365FJ30SC)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    LAURAMIDOPROPYLAMINE OXIDE (UNII: I6KX160QTV)  
    WATER (UNII: 059QF0KO0R)  
    MYRISTAMIDOPROPYLAMINE OXIDE (UNII: 3HSF539C9T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53329-177-04118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/19/2016
    2NDC:53329-177-08221 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/19/2016
    3NDC:53329-177-841000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/19/2016
    4NDC:53329-177-253790 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/19/2016
    5NDC:53329-177-06473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/19/2016
    6NDC:53329-177-741200 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 not finalpart333A08/19/2016
    Labeler - Medline Industries, LP (025460908)
    Registrant - Medline Industries, LP (025460908)
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