Label: CHEMSTAR- 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 14, 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 to hands and forearms
    • scrub thoroughly 
    • Rinse and dry
  • Other information

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

    Inactive ingredientsWater (Aqua), Potassium Cocoate, Hexylene Glycol, Sodium Sulfate, Tetrasodium EDTA, Sodium lauryl sulfate, Glycerin, Sodium Citrate, Glyceryl Oleate, fragrance, sodium glycolate, caprylyl/capryl glucoside, Lauryl Glucoside, Magnesium Nitrate, Sodium Hydroxide, Methylchloroisothiazolinone, Magnesium Chloride, Yellow 5, Methylisothiazolinone, Red 4

  • QUESTIONS

    Questions? call 1.800.529-5458

  • Principal display panel and representative label

    CHEMSTAR 

    Foaming Antibacterial 

    Hand Soap

    KEEP OUT OF REACH OF CHILDREN

    Chloroxylenol 0.5%

    Net Contents 42 US fl ox (1250 mL)

    111280

    Distributed by: Kay Chemical Company

    8300 Capital Drive - Greensboro, NC 27409

    Made in USA

    CSUSA 779394/8000/0621

    representative label

  • INGREDIENTS AND APPEARANCE
    CHEMSTAR 
    chloroxylenol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63146-315
    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)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MONOSODIUM CITRATE (UNII: 68538UP9SE)  
    GLYCERYL 1-OLEATE (UNII: D3AEF6S35P)  
    SODIUM GLYCOLATE (UNII: B75E535IMI)  
    CAPRYLYL/CAPRYL OLIGOGLUCOSIDE (UNII: E00JL9G9K0)  
    LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
    MAGNESIUM NITRATE (UNII: 77CBG3UN78)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63146-315-101250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/23/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/23/2021
    Labeler - Kay Chemical Co. (003237021)
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