Label: PROCLEAN- benzalkonium chloride solution

  • 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 January 15, 2019

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  • Active Ingredient

    Benzalkonium chloride 0.5%

  • Purpose

    Antiseptic handwash

  • Uses

    • for handwashing to decrease bacteria on the skin
  • Warning

    For external use only

    Do not use

    • in eyes

    When using the product

    • if in eyes, rinse promptly and thoroughly with water
    • discontinue use if irritation and redness develop

    Stop use and ask a physician if skin irritation or redness occurs 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 and apply foam
    • scrub hands and forearms
    • rinse thoroughly and dry
  • Other information

    • for additional information, see Safety Data Sheet (SDS)
    • for emergency medical information, in USA and Canada, call 1 800 328 0026
  • INACTIVE INGREDIENT

    Inactive ingredients water (aqua), cocamine oxide, hexylene glycol, PEG-180, glycerin, hydroxyethylcellulose, cocamidopropyl PG-dimonium chloride phosphate, phenoxyethanol, myristamide DIPA, myristamine oxide, methyl gluceth-20, glyceryl caprylate/caprate, alcohol, PEG-12 dimethicone, citric acid, polyquaternium-7, fragrance, potassium hydroxide, blue 1

  • QUESTIONS

    Questions? call 1-866-781-8787

  • Representative Label and Principal Display Panel

    PROCLEAN

    ADVANCED

    ANTIBACTERIAL

    HAND SOAP

    Antibacterial liquid hand soap

    Active ingredient: Benzalkonim chloride 0.5%

    6102017

    3.78 L (1 US GAL)

    For more ingredient information visit: www.shamrockfoodservice.com/proclean

    This product may be patented

    For questions or comments, call 1-866-444-7450.

    Manufactured by

    Ecolab · 1 Ecolab Place · St. Paul MN 55102 USA

    © 2018  Ecolab USA Inc. · All rights reserved

    774470/5400/1018

    Distributed by Shamrock Foods

    Phoenix, AZ

    representative label

  • INGREDIENTS AND APPEARANCE
    PROCLEAN 
    benzalkonium chloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47593-602
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    COCAMINE OXIDE (UNII: QWA2IZI6FI)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%) (UNII: ZYD53NBL45)  
    COCAMIDOPROPYL PROPYLENE GLYCOL-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    MYRISTIC DIISOPROPANOLAMIDE (UNII: 17DN142CTK)  
    MYRISTAMINE OXIDE (UNII: J086PM3RRT)  
    METHYL GLUCETH-20 (UNII: J3QD0LD11P)  
    GLYCERYL CAPRYLATE/CAPRATE (UNII: G7515SW10N)  
    ALCOHOL (UNII: 3K9958V90M)  
    PEG-12 DIMETHICONE (UNII: ZEL54N6W95)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47593-602-113780 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/29/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E10/29/2018
    Labeler - Ecolab Inc. (006154611)
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