Label: ANTIBACTERIAL SKIN CLEANSER 82- antibacterial hand soap 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 March 4, 2010

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  • ACTIVE INGREDIENT

    Active Ingredient
    Chloroxylenol 1% w/w
  • PURPOSE

    Purpose
    Health Care Personnel Hand Wash
  • INDICATIONS & USAGE

    Uses
    • Hand Wash to help reduce bacteria that cause disease
    • Repeated usage suggested
  • WARNINGS

    Warnings
    For external use only.
    Keep out of reach of children.
    Avoid contact with eyes and mouth.
    If redness or irritation develops, discontinue use immediately.  If condition persists for more than 72 hours, consult a physician.
    Not for use on children under 6 months of age.
  • DOSAGE & ADMINISTRATION

    Directions
    • Wash hands and forearms.
    • Apply 5 mL of product to hands.
    • Scrub well for 30 seconds.
    • Rinse and repeat.
  • INACTIVE INGREDIENT

    Inactive Ingredients
    Water, Sodium C14-16 Olefin Sulfonate, Sodium Laureth Sulfate, Lauramide DEA, Isopropyl Alcohol, Polyquaternium-7, Fragrance, Styrene Acrylates/Copolymer, Tetrasodium EDTA, Citric Acid
  • QUESTIONS

    In Case of Emergency
    Call: (800) 228-5635  ext. 167
  • PRINCIPAL DISPLAY PANEL

    Label for 500 mL Bottle
  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL SKIN CLEANSER 82 
    antibacterial hand soap soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42497-822
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Chloroxylenol (UNII: 0F32U78V2Q) (Chloroxylenol - UNII:0F32U78V2Q) Chloroxylenol1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Sodium Laureth Sulfate (UNII: BPV390UAP0)  
    Isopropyl Alcohol (UNII: ND2M416302)  
    Edetate Sodium (UNII: MP1J8420LU)  
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    Lauric Diethanolamide (UNII: I29I2VHG38)  
    Sodium C14-16 Olefin Sulfonate (UNII: O9W3D3YF5U)  
    Product Characteristics
    Colorwhite (opaque) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42497-822-14503 g in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33303/04/2010
    Labeler - Penco Products, Inc. (808679773)
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