Label: ANTIBACTERIAL- triclosan 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 January 31, 2012

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  • ACTIVE INGREDIENT

    Active ingredient
    Triclosan 0.15%

    Purpose
    Antibacterial
  • INDICATIONS & USAGE

    Uses for handwashing to decrease bacteria on the skin.
  • WARNINGS

    Warnings
    For external use only

    When using this product •do not get into eyes.  If contact occurs, rinse eyes thoroughly with water.
  • DOSAGE & ADMINISTRATION

    Directions •Wet hands • Apply palmful to hands • Scrub thoroughly • Rinse

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

    Inactive Ingredients water, sodium laureth sulfate, sodium lauryl sulfate, cocamidopropyl betaine, sodium chloride,
    decyl glucoside, glycerin, PE-18 glyceryl oleate/cocoate, fragrance, cocamide MEA, DMDM hydantoin, tetrasodium EDTA,
    citric acid, yellow 5, red 4
  • SPL UNCLASSIFIED SECTION

    This product is not manufactured or distributed by the Dial Corporation, distributor of Dial Gold Antibacterial Soap
  • ADVERSE REACTIONS

    Distributed by Cardinal Health, Dublin, Ohio 43017
    www.myleader.com   1-800-200-6313
  • PRINCIPAL DISPLAY PANEL

    LEADER
    Compare to Dial
    Antibacterial
    Hand Soap
    with Moisturizers
    Original Scent
    7.5 FL OZ (221 mL)
    image of principal display panel
  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL 
    triclosan soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-243
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN0.15 mL  in 100 L
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37205-243-96.221 L in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/19/2007
    Labeler - Cardinal Health (097537435)
    Registrant - Vi-Jon (088520668)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon088520668manufacture
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