Label: PANACHE- 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 February 23, 2011

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  • ACTIVE INGREDIENT

    Active ingredient

    Triclosan 0.5%

  • PURPOSE

    Antibacterial

  • INDICATIONS & USAGE

    Uses

    For washing to decrease bacteria on the skin

  • WARNINGS

    Warnings

    For external use only

    Avoid contact with the eyes

    Keep out of reach of children

    Consult with a physician if ingested

  • DOSAGE & ADMINISTRATION

    Directions

    Dispense product onto washcloth or directly onto skin

    Lather and wash for 15-20 seconds

    Rinse thoroughly

  • INACTIVE INGREDIENT

    Water, Sodium Laureth Sulfate, Propylene Glycol, Disodium Laureth Sulfosuccinate, Sodium Chloride, Cocamide DEA, Cocamidopropyl Betaine, Fragrance, Tetrasodium EDTA, Citric Acid, Methylchloroisothiazolinone, Methylisothiazolinone, FDC Red No. 40, FDC Yellow No. 5.


  • PRINCIPAL DISPLAY PANEL

    container label

  • INGREDIENTS AND APPEARANCE
    PANACHE   ANTIBACTERIAL BODY WASH
    triclosan liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11084-115
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Triclosan (UNII: 4NM5039Y5X) (Triclosan - UNII:4NM5039Y5X) Triclosan.55 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Sodium Laureth Sulfate (UNII: BPV390UAP0)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Disodium Laureth Sulfosuccinate (UNII: D6DH1DTN7E)  
    Sodium Chloride (UNII: 451W47IQ8X)  
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    Cocamidopropyl Betaine (UNII: 5OCF3O11KX)  
    Edetate Sodium (UNII: MP1J8420LU)  
    Anhydrous Citric Acid (UNII: XF417D3PSL)  
    FD&C Red No. 40 (UNII: WZB9127XOA)  
    FD&C Yellow No. 5 (UNII: I753WB2F1M)  
    Methylchloroisothiazolinone (UNII: DEL7T5QRPN)  
    Methylisothiazolinone (UNII: 229D0E1QFA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11084-115-34118 mL in 1 BOTTLE, PLASTIC
    2NDC:11084-115-271000 mL in 1 CARTRIDGE
    3NDC:11084-115-072000 mL in 1 CARTRIDGE
    4NDC:11084-115-053780 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/01/2010
    Labeler - Deb USA, Inc. (607378015)
    Establishment
    NameAddressID/FEIBusiness Operations
    Deb USA, Inc.607378015manufacture
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