Label: PROCLEAN FOAMING ANTIBACTERIAL NEXA- 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 March 2, 2022

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  • Active Ingredient

    Benzalkonium chloride 0.5%

  • Purpose

    Antiseptic handwash

  • Uses

    • for handwashing to decrease bacteria on the skin
  • Warnings

    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 doctor 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

    • READ SAFETY DATA SHEET (SDS) BEFORE USING THIS PRODUCT
    • EMERGENCY HEALTH INFORMATIN: 1 800 328 0026. If located outside the United States and Canada, call collect 1 651 222 5352 (number is in the US).
  • INACTIVE INGREDIENT

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

  • QUESTIONS

    Questions? call 1.800.352.5326

  • Principal display panel 

    PROCLEAN
    FOAMING ANTIBACTERIAL NEXA SOAP

    Active ingredient:
    Benzalkonium chloride 0.5%

    6102400
    750 mL
    (25 US FL OZ)

    778989/5400/0222

    This product may be patented | Este producto puede ser patentado:
    www.ecolab.com/patents

    Manufactured by | Fabricado por
    Ecolab · 1 Ecolab Place ·
    St. Paul MN 55102 USA
    © 2022 Ecolab USA Inc. · All rights reserved | Todos los derechos reservados
    Made in U.S.A. | Hecho en EE.UU.
    www.ecolab.com

    Distributed by | Distribuido por
    Shamrock Foods
    Phoenix, AZ

    representative label

  • INGREDIENTS AND APPEARANCE
    PROCLEAN FOAMING ANTIBACTERIAL NEXA 
    benzalkonium chloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47593-645
    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)  
    COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y)  
    MYRISTIC DIISOPROPANOLAMIDE (UNII: 17DN142CTK)  
    MYRISTAMINE OXIDE (UNII: J086PM3RRT)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    METHYL GLUCETH-20 (UNII: J3QD0LD11P)  
    GLYCERYL CAPRYLATE/CAPRATE (UNII: G7515SW10N)  
    ALCOHOL (UNII: 3K9958V90M)  
    PEG-12 DIMETHICONE (UNII: ZEL54N6W95)  
    POTASSIUM CITRATE (UNII: EE90ONI6FF)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47593-645-41750 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/02/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E03/02/2022
    Labeler - Ecolab Inc. (006154611)
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