Label: ANTIMICROBIAL CLEANSER- 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 16, 2013

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  • Active ingredient

    Chloroxylenol 0.3% w/w

  • Purpose

    Antimicrobial

  • Keep out of reach of children

    If swallowed, get medical attention or contact a poison control center immediately.

  • Uses

    • Handwash to help decrease bacteria on the skin.  Recommended for repeated use.
  • Warnings

    For external use only

    When using this product do not use in or near eyes. In case of contact, rinse eyes thoroughly with water.

    Stop use and ask a doctor if irritation or rash appears and lasts

  • Directions

     wet hands  apply small amount of product and work into a lather   rinse well and dry hands completely

  • Inactive ingredients:

    Water, Sodium laureth sulfate, Sodium chloride, Cocamidopropyl betaine, PEG-120 Methyl glucose dioleate, DMDM hydantoin, Linear alcohol ethoxylate, Propylene glycol, Methylchloroisothiazolinone, Methylisothiazolinone, Fragrance, Tetrasodium EDTA, Isopropyl myristate, Citric acid, FD&C Red #40, FD&C Red #33.

  • PRINCIPAL DISPLAY PANEL - 3785 mL Bottle Label AFFLAB™ Antimicrobial Lotion Cleanser Antimicrobiano Loción Limpiadora CAUTION/PRECAUCIONKeep out of reach of children.See back panel for further precautions and first aid. Net Contents 1 U.S. GALLON (3.78 Liters)      Instrucciones Atras All Hands™  Hand Care Products

    image description

  • INGREDIENTS AND APPEARANCE
    ANTIMICROBIAL CLEANSER 
    chloroxylenol soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54057-524
    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)  
    C9-11 PARETH-6 (UNII: KCE0V8JT7W)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Product Characteristics
    ColorpinkScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54057-524-283785 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E10/16/2013
    Labeler - AFFLAB, Affiliated Laboratories, a Division of AFFLINK (023121150)
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