Label: BENZETHONIUM CHLORIDE SOLUTION- dial spring water antibacterial hand soap solution

  • 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 November 25, 2014

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Benzethonium Chloride 0.10%

  • PURPOSE

    Antibacterial

  • PURPOSE

    Uses - For handwashing to decrease bacteria on the skin

  • WARNINGS

    For external use only

  • WHEN USING

    When using this product - Avoid contact with eyes. In case of eye contact, flush with water.

  • ASK DOCTOR

    Stop use and ask a doctor if irritation and redness develops

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • INSTRUCTIONS FOR USE

    Directions

    • pump into hands, wet as needed
    • lather vigorously for at least 15 seconds
    • wash skin, rinse thoroughly and dry
  • INACTIVE INGREDIENT

    Inactive Ingredients: Water, Centrimonium Chloride, Glycerin, Lauramine Oxide, Lauramidopropylamine Oxide, Sodium Chloride, Fragrance, PEG-120 Methyl Glucose Dioleate, Cocamide MEA, Citric Acid, Sodium Benzoate, Tetrasodium EDTA, Blue 1, Red 33

  • SPL UNCLASSIFIED SECTION

    * Encountered in household settings

  • QUESTIONS

    Questions? 1-800-258-DIAL (3425)

  • SPL UNCLASSIFIED SECTION

    Visit our web site at www.dialsoap.com

    © 2013 THE DIAL CORPORATION, A (HENKEL) COMPANY SCOTTSDALE, AZ 85255

    MADE IN USA

    The distinctive design and elements of this package are proprietary and owned by The Dial Corporation, A Henkel Company.

  • DOSAGE & ADMINISTRATION

    Topical Liquid

  • INDICATIONS & USAGE

    For handwashing to decrease bacteria on skin

  • PRINCIPAL DISPLAY PANEL

    KILLS 99.9% OF GERMS*

    New Active!

    TOTAL CLEAN FORMULA

    Refill ONLY with Dial® Total Clean Formula

    Dial Spring Water® Hand Soap with Moisturizer

    Antibacterial

    7.5 FL OZ (221 mL)

    SW 32 oz

    SW 9.375 oz

    SW 5.5 oz

    SW 7.5 oz

    SW 52 oz

  • INGREDIENTS AND APPEARANCE
    BENZETHONIUM CHLORIDE SOLUTION 
    dial spring water antibacterial hand soap solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54340-242
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE.1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    LAURAMIDOPROPYLAMINE OXIDE (UNII: I6KX160QTV)  
    LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
    PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54340-242-01162 mL in 1 BOTTLE, PUMP01/05/2015
    2NDC:54340-242-02221 mL in 1 BOTTLE, PUMP01/05/2015
    3NDC:54340-242-03277 mL in 1 BOTTLE, PUMP01/05/2015
    4NDC:54340-242-04946 mL in 1 BOTTLE, DISPENSING01/05/2015
    5NDC:54340-242-051530 mL in 1 BOTTLE, DISPENSING01/05/2015
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/05/2015
    Labeler - The Dial Corporation (070252531)
    Establishment
    NameAddressID/FEIBusiness Operations
    The Dial Corporation825091622manufacture(54340-242)
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