KEYSTONE (BENZALKONIUM CHLORIDE) SOLUTION [ECOLAB INC.]

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KEYSTONE (BENZALKONIUM CHLORIDE) SOLUTION [ECOLAB INC.]
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NDC 47593-561-41
Set ID 6860a80e-9a5f-40e4-bec3-e7386e541f5b
Category HUMAN OTC DRUG LABEL
Packager Ecolab Inc.
Generic Name
Product Class
Product Number
Application Number PART333E
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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 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

    • 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, 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 1 866 781 8787

  • Representative Label and Principal Display Panel

    KEYSTONE™

    Sysco®

    Advanced Antibacterial Foaming Hand Soap

    Active Ingredient: Benzalkonium chloride 0.5%

    Sysco® 4596843 6101146 ECOLAB®

    750 mL (25.3 US FL OZ) 764502/5401/0918

    This product may be patented: www.ecolab.com/patents

    For SDS information visit:

    www.cleanwithkeystone.com

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

    tel: 1 800 35 CLEAN (352 5326)

    © 2018 Ecolab USA Inc. · All rights reserved

    Made in U.S.A.

    www.ecolab.com

    Representative label

  • INGREDIENTS AND APPEARANCE
    KEYSTONE 
    benzalkonium chloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47593-561
    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
    POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 900000 MW) (UNII: B70CUU14M9)  
    WATER (UNII: 059QF0KO0R)  
    COCAMINE OXIDE (UNII: QWA2IZI6FI)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    COCAMIDOPROPYL PROPYLENE GLYCOL-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 CAPRYLOCAPRATE (UNII: U72Q2I8C85)  
    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:47593-561-41750 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/21/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E12/21/2016
    Labeler - Ecolab Inc. (006154611)
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