Label: ANTIBACTERIAL HAND- triclosan liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 June 1, 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-hands only

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

    Stop use and ask a doctor if •irritation or redness develops

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

    Directions •wet hands •apply palmful to hands •scrub thoroughly •rinse
  • INACTIVE INGREDIENT

    Inactive ingredients water, sodium laureth sulfate, sodium lauryl sulfate, cocamidopropyl betaine, sodium chloride, decyl glucoside, glycerin, PEG-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 The Dial Corporation, distributor of Dial Gold Antibacterial Soap
  • ADVERSE REACTIONS

    Distributed By: DZA Brands, LLC
    2110 Executive Drive
    Salisbury, NC 28147
    1-866-322-2439
  • PRINCIPAL DISPLAY PANEL

    Healthy
    Accents
    Antibacterial
    Liquid
    Hand Soap
    compare to Dial
    Gold Antibacterial Soap
    7.5 FL OZ (221 mL)
    image of principal display panel
  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL HAND 
    triclosan liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55316-243
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN0.15 kg  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)  
    PEG-18 GLYCERYL OLEATE/COCOATE (UNII: VD2D270332)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    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:55316-243-96.221 L in 1 BOTTLE, PLASTIC
    2NDC:55316-243-031.47 L in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333A01/05/2009
    Labeler - DZA Brands LLC (090322194)
    Registrant - Vi-Jon (088520668)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon088520668manufacture
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