Label: IRIS ANTIMICROBIAL HAND- 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 October 15, 2013

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  • Active ingredient

    Chloroxylenol 0.3% 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

    • Antimicrobial hand soap
  • Warnings

    For external use only

    When using this product

    • do not use in or near eyes
  • Directions

     wet hands  dispense a small amount of soap into the palm of the hand.  work up a lather, adding water as needed.   rinse.

  • Other information

     store at room temperature

  • Inactive ingredients:

    Water, Sodium laureth sulfate, Sodium chloride, Cocamidopropyl betaine, PEG-120 Methyl glucose dioleate, DMDM hydantoin, Propylene glycol, Methylchloroisothiazolinone, Methylisothiazolinone, Fragrance, Tetrasodium EDTA, Glycerin, Citric acid, FD&C Yellow #5, FD&C Red #4.

  • PRINCIPAL DISPLAY PANEL - 3785 mL Bottle Label Kills 99% Germs Instantly IRIS AntimicrobialHand Soap CAUTION:Keep out of reach of children.See back panel for additional precautions.                     1 GALLON  (3.78 L)

    image description

  • INGREDIENTS AND APPEARANCE
    IRIS ANTIMICROBIAL HAND 
    chloroxylenol soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59860-545
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL3 g  in 1000 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Product Characteristics
    ColororangeScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59860-545-283785 mL in 1 BOTTLE, PLASTIC
    2NDC:59860-545-681892 mL in 1 BOTTLE, PLASTIC
    3NDC:59860-545-84473 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E10/15/2013
    Labeler - SMART AND FINAL STORES (556948354)
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