Label: FORTRESS- 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 November 11, 2022

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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 hands and forearms
    • Dispense a palmful of product to hands
    • Scrub hands and forearms for 20 seconds
    • Rinse thoroughly and dry
  • Other Information

    • for additional information, see Material Safety Data Sheet (MSDS)
    • for emergency medical information in USA, call (877) 231-2615 or call collect 0 (952) 853-1713
  • INACTIVE INGREDIENT

    Inactive ingredients:  water (aqua), potassium cocoate, hexylene glycol, sodium sulfate, tetrasodium EDTA, sodium lauryl sulfate, glycerin, citric acid, coco-glucoside, glyceryl oleate, fragrance, methychloroisothiazolinone, CI 19140 (FD&C Yellow No. 5), methylisothiazolinone, CI 14700 (FDC Red No. 4)

  • QUESTIONS

    Questions?  Call 1-800-529-5458

  • Principal display panel and representative label

    FORTRESS® Foaming Antibacterial Hand Soap

    KEEP OUT OF REACH OF CHILDREN/FOR INSTITUTIONAL USE ONLY

    FORTRESS® Foaming Antibacterial Hand Soap is a rich lather hand soap with a balanced blend of cleaning agents and skin protecting moisturizers.

    • Instant foam lathers fast • Mild, pH-balanced formula
    • Fresh, clean fragrance

    To obtain Spanish instructions, see outer carton.

    Para obtener las instrucciones en español, véase la caja exterior.

    NDC.: 63146-105-03

    KAY CHEMICAL COMPANY

    8300 Capital Drive

    Greensboro, NC 27409-3790, USA

    Customer Service: (800) 529-5458

    706402-04

    KUSA 706402/8004/0412

    ©2012 Kay Chemical Company

    All Rights Reserved

    25 US fl OZ (750 ml)

    representative label

  • INGREDIENTS AND APPEARANCE
    FORTRESS 
    chloroxylenol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63146-105
    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)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    GLYCERYL OLEATE (UNII: 4PC054V79P)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63146-105-03750 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/16/2005
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E05/16/2005
    Labeler - Kay Chemical Co. (003237021)
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