Label: ANTIBACTERIAL- triclosan liquid

  • 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 May 6, 2016

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  • ACTIVE INGREDIENT

    Active Ingredient - Triclosan 0.115%

  • PURPOSE

    Purpose - Antibacterial

  • INDICATIONS & USAGE

    Use for handwashing to decrease bacteria on the skin

  • WARNINGS

    Warning

    For external use only - hands only

  • WHEN USING

    When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water

  • STOP USE

    Stop use and ask a doctor if irritation or redness develops and condition persists for more than 72 hours

  • 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

  • DOSAGE & ADMINISTRATION

    Direction

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

    Water (Aqua), Sodium Laureth Sulfate, Sodium Chloride, Cocamidopropyl Betaine, Fragrance (Parfum), Sodium Lauroamphoacetate, Polyquaternium 7, Glycerin, Citric Acid, Tocopheryl Acetate (Vit E Actetate), Methylchloroisothiazolinone, Methylisothiazolinone, Red 33 (Cl 17200), Blue 1 (42090)

  • PRINCIPAL DISPLAY PANEL

    Paris Antibacterial Hand Soap

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL 
    triclosan liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50157-203
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN1.15 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM LAUROAMPHOACETATE (UNII: SLK428451L)  
    POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) (UNII: 0L414VCS5Y)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50157-203-14414 mL in 1 BOTTLE; Type 0: Not a Combination Product05/06/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/06/2016
    Labeler - Brands International Corp (243748238)
    Establishment
    NameAddressID/FEIBusiness Operations
    Brands International Corp243748238manufacture(50157-203)
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