PUREFORCE (BENZALKONIUM CHLORIDE) SOLUTION [ECOLAB INC.]

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PUREFORCE (BENZALKONIUM CHLORIDE) SOLUTION [ECOLAB INC.]
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NDC 47593-568-41, 47593-568-59
Set ID e624ea46-e502-4d2d-aaa1-59954f69be05
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, myristamine oxide, phenoxyethanol, polyquaternium 7, citric acid, myristamide DIPA, methyl gluceth-20, caprylic/capric glycerides, PEG-12 dimethicone, potassium hydroxide, fragrance, FD&C blue 1

  • QUESTIONS

    Questions? call 1-866-444-7450

  • Representative Label and Principal Display Panel

    Advanced Antibacterial

    Foaming Hand Soap

    Hand Care

    Cuidado de las manos

    Active ingredient Benzalkonium chloride 0.5%

    Ingrediente activo: Cloruro de benzalkonium 0.5%

    766424/7100/0616

    Product No.

    8000329

    42.3 US FL OZ (1250 mL)

    For questions or comments,

    call 1-866-444-7450.

    Distributed by

    PureForce
    370 Wabasha Street N
    St Paul MN 55102-1390 USA
    © 2016 Ecolab USA Inc
    All rights reserved
    Made in U.S.A.

    Representative label

  • INGREDIENTS AND APPEARANCE
    PUREFORCE 
    benzalkonium chloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47593-568
    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
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    METHYL GLUCETH-20 (UNII: J3QD0LD11P)  
    MYRISTIC DIISOPROPANOLAMIDE (UNII: 17DN142CTK)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 900000 MW) (UNII: B70CUU14M9)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    MYRISTAMINE OXIDE (UNII: J086PM3RRT)  
    COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    WATER (UNII: 059QF0KO0R)  
    COCAMINE OXIDE (UNII: QWA2IZI6FI)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47593-568-591250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/26/2016
    2NDC:47593-568-41750 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/26/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E07/26/2016
    Labeler - Ecolab Inc. (006154611)
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