Label: REGIMEN ANTIMICROBIAL- chloroxylenol soap

  • 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 September 24, 2013

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  • Active ingredient

    Chloroxylenol 0.5% w/w

  • Purpose

    Antimicrobial

  • Keep out of reach of children

    In case of accidental ingestion, seek medical attention or contact a poison control center immediately.

  • Uses

    • specially formulated for the sensitive skin of today's healthcare professional
    • protects hands from germs and bacteria
    • antimicrobial hand cleaner
    • for repeated washings on a daily basis
  • Warnings

    For external use only

    When using this product

    • do not use in or near eyes
  • Directions

     wet hands  apply small amount  wash hands vigorously  rinse thoroughly.

  • Other information

     store at room temperature

  • Inactive ingredients:

    Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Sodium Chloride, Glycol Stearate, PEG 120 Methyl Glucose Dioleate, DMDM Hydantoin, Fragrance,  Methyl Paraben, Propyl Paraben, Methylchloroisothiazolinone (and) Methylisothiazolinone, FD&C Blue #1.

  • PRINCIPAL DISPLAY PANEL - 3785 mL Bottle Label REGIMEN Antimicrobial Antiseptic Hand WashContains 0.5% PCMX (Chloroxylenol), broad spectrum antimicrobial agent Manufactured for PSS World Medical, Inc.4345 Southpoint Blvd, Jacksonville, FL 32216  Net Contents 1 Gallon (3.78 L)

    image description

  • INGREDIENTS AND APPEARANCE
    REGIMEN ANTIMICROBIAL 
    chloroxylenol soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63843-547
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL5 g  in 1000 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCOL STEARATE (UNII: 0324G66D0E)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Product Characteristics
    ColorblueScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63843-547-25532 mL in 1 BOTTLE, PLASTIC
    2NDC:63843-547-283785 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E09/24/2013
    Labeler - HealthLink (807714126)
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