Label: SBS ULTRAPINK- triclosan gel

  • 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 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

    Avoid contact with eyes

    Keep out of reach of children

    Consult with a physician or poison control center if ingested

  • DOSAGE & ADMINISTRATION

    Directions

    Apply soap to dry hands

    Add water

    Lather for 15-20 seconds

    Rinse and dry

  • INACTIVE INGREDIENT

    Inactive Ingredients

    Water, Sodium Laureth Sulfate, Cocamide DEA, Propylene Glycol, Sodium Chloride, Chloroxylenol, Acrylic Copolymer, Tetrasodium EDTA, Citric Acid, Glycol Distearate, Cocamide MEA, Sodium Hydroxide, Fragrance, Laureth-10, Magnesium Nitrate, Methylchloroisothiazolinone, Magnesium Chloride, Methylisothiazolinone, Red 40 (CI16035).

  • PRINCIPAL DISPLAY PANEL

    SBS UltaPink

    Pearlescent Antibacterial Gel

    Ideal for Healthcare, Food Services, Office Environments, Schools, Professional Buildings

    Proudly made in the USA

    77127-01-116

    1 Liter -  33.8 Fluid Ounces

    container label

  • INGREDIENTS AND APPEARANCE
    SBS ULTRAPINK 
    triclosan gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11084-077
    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 RED NO. 40 (UNII: WZB9127XOA)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    MAGNESIUM NITRATE (UNII: 77CBG3UN78)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11084-077-271000 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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