LAGARDE (CHLOROXYLENOL) SOLUTION [KAY CHEMICAL CO.]

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LAGARDE (CHLOROXYLENOL) SOLUTION [KAY CHEMICAL CO.]
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NDC 63146-121-01, 63146-121-02
Set ID 5e9143d8-2857-461e-976f-abcaf500a9bd
Category HUMAN OTC DRUG LABEL
Packager Kay Chemical Co.
Generic Name
Product Class
Product Number
Application Number PART333E
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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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