Label: PUREFORCE- chloroxylenol 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 May 19, 2023

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  • Active ingredient

    Chloroxylenol 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 this 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 skin and spread a small amount on hands and forearms
    • scrub well, rinse thoroughly and dry
  • Other information

    • read Safety Data Sheet (SDS) before using this product
    • emergency Healthcare Information: 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), potassium cocoate, hexylene glycol, sodium sulfate, tetrasodium EDTA, sodium lauryl sulfate, hydroxyethylcellulose, glycerin, cocoglucoside, glyceryl oleate, citric acid, fragrance, methylchloroisothiazolinone, methylisothiazolinone, FD&C Red #40, FD&C Yellow #5, D&C Red #33

  • Questions?

    call 1 866 444 7450

  • Representative label and principal display panel

    Antibacterial

    Hand Soap

    Hand Care

    Cuidado de las manos

    Active ingredient: Chloroxylenol 0.5%

    Ingrediente activo: Cloroxilenol 0.5%

    Product No.

    8000354

    1 US GAL (3.78 L)         pureFORCE

    For questions or comments,

    call 1-866-444-7450

    Distributed by

    PureForce
    370 Wabasha Street North
    St. Paul MN 55102 USA
    © 2016 Ecolab USA Inc
    All rights reserved
    Made in U.S.A.
    766544/7101/0716

    representative label

  • INGREDIENTS AND APPEARANCE
    PUREFORCE 
    chloroxylenol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47593-571
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    POTASSIUM COCOATE (UNII: F8U72V8ZXP)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    SODIUM SULFATE (UNII: 0YPR65R21J)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    GLYCERYL OLEATE (UNII: 4PC054V79P)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47593-571-113780 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/27/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E07/27/2016
    Labeler - Ecolab Inc. (006154611)
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