Label: ANTIMICROBIAL CLEANSER- chloroxylenol soap

  • NDC Code(s): 54057-524-28
  • Packager: AFFLAB, Affiliated Laboratories, a Division of AFFLINK
  • 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

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  • Purpose

    Antimicrobial

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  • Keep out of reach of children

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

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  • Uses

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

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  • Directions

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

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  • 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.

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  • PRINCIPAL DISPLAY PANEL - 3785 mL Bottle Label AFFLAB™ Antimicrobial Lotion Cleanser Antimicrobiano Loción Limpiadora CAUTION/PRECAUCION Keep 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
  • INGREDIENTS AND APPEARANCE
    ANTIMICROBIAL CLEANSER 
    chloroxylenol soap
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:54057-524
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL 3 g  in 1000 mL
    Inactive Ingredients
    Ingredient Name Strength
    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
    Color pink Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54057-524-28 3785 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333E 10/16/2013
    Labeler - AFFLAB, Affiliated Laboratories, a Division of AFFLINK (023121150)
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