Label: DEB GOLD- triclosan liquid

  • Category: HUMAN OTC DRUG LABEL

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 September 9, 2010

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  • ACTIVE INGREDIENT

    Active Ingredient

    Triclosan, 0.15%

  • PURPOSE

    Purpose

    Antibacterial

  • INDICATIONS & USAGE

    Uses

    For handwashing to reduce bacteria on the skin

  • WARNINGS

    Warnings

    For external use only

    Avoid contact with the eyes

    Keep out of reach of children

    Consult a physician or poison control center if ingested

  • DOSAGE & ADMINISTRATION

    Directions

    Wet hands

    Apply small amount of soap and work into lather

    Wash for 15 to 20 seconds

    Rinse completely

    Dry hands thoroughly

  • INACTIVE INGREDIENT

    Inactive Ingredients

    Water, Sodium Laureth Sulfate, Cocamide DEA, Propylene Glycol, Sodium Chloride, Chloroxylenol. Acrylic Copolymer, Tetrasodium EDTA, Citric Acid, Fragrance, Sodium Hydroxide, Magnesium Nitrate, Methylchloroisothiazolinone, Magnesium Chloride, Methylisothiazolinone, Yellow 5 (C! 19140), Red 33 (CI 17200).

  • PRINCIPAL DISPLAY PANEL

    DEB

    GOLD

    Antibacterial Lotion Soap with Moisturizers

    Cleans hands!

    Kills germs!

    Moisturizes skin!

    One Gallon 3.78 Liters

    76105-01-116

    MADE IN U.S.A.

    container label

  • INGREDIENTS AND APPEARANCE
    DEB GOLD 
    triclosan liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11084-076
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN0.15 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    CHLOROXYLENOL (UNII: 0F32U78V2Q)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    MAGNESIUM NITRATE (UNII: 77CBG3UN78)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11084-076-053780 mL in 1 BOTTLE, PLASTIC
    2NDC:11084-076-36222 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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