Label: LAGARDE- chloroxylenol solution

  • NDC Code(s): 63146-121-01, 63146-121-02
  • Packager: Kay Chemical Co.
  • 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 July 26, 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
    • Apply 5 ml (teaspoonful) or palmful to hands and forearms
    • Scrub throughly for 20 seconds
    • Rinse and repeat
  • Other information

    • for additional information, see Material Safety Data Sheet (MSDS)
    • for emergency medical information in USA, call 1-800-391-1504
  • 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

  • Principal display panel and representative label

    NDC 63149-121-01

    LAGARDE™

    Antibacterial Hand Soap

    Active ingredient

    Chloroxylenol 0.5%

    SSDC Sustainable Solutions

    1 US gallon (3.78 liters)

    Distributed by: SSDC Division, Kay Chemical Company

    4050 Corporate Drive, #100 • Grapevine, Texas 76051, USA • 800.532.7732

    ©2013 Kay Chemical Company • All Rights Resevrved

    1111917

    747932-01 747932/7300/0613

    representative label

  • INGREDIENTS AND APPEARANCE
    LAGARDE 
    chloroxylenol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63146-121
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL0.5 mg  in 100 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:63146-121-013780 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/31/2016
    2NDC:63146-121-02800 mL in 1 POUCH; Type 0: Not a Combination Product05/31/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E05/31/2016
    Labeler - Kay Chemical Co. (003237021)
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