Label: SATIN PINK- 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 April 15, 2014

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient (in each dose unit)

    Triclosan 0.11%

  • Purpose

    Antibacterial

  • Uses

    • For washing to decrease bacteria on skin
    • Recommended for repeated use
  • Warnings

    For external use only

    When using this product

    • avoid contact with eyes. If contact occurs, rinse with water.

    Stop use and ask a doctor if

    • irritation and redness develops.

    If pregnant or breast-feeding, ask a health professional before use.

    Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

  • Directions

    • Wet hands
    • Apply small amount to hands
    • Scrub thoroughly
    • Rinse
  • Other information

    • Store at room temperature
  • Inactive ingredients

    Almond fragrance, Ammonium lauryl sulfate, Cocoamidopropyl betaine, Cocoamide DEA, EDTA, FD+C Yellow No. 5 and FD+C Red No. 40, Glycerine, Isopropanol, PEG75 lanolin, Styrene acrylic emulsion, Sodium chloride and Water

  • Questions?

    1-888-834-2001

  • SPL UNCLASSIFIED SECTION

    Manufacturered by Tomco-Harwel Industries, Inc. Tulsa, OK 74116

  • PRINCIPAL DISPLAY PANEL - 3.8 Liter Bottle Label

    PROFESSIONAL
    SUMMIT

    SATIN PINK
    Antibacterial Hand Soap

    Net Contents: 1 Gallon (3.8 liters)

    Principal Display Panel - 3.8 Liter Bottle Label
  • INGREDIENTS AND APPEARANCE
    SATIN PINK 
    triclosan liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60549-2108
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Triclosan (UNII: 4NM5039Y5X) (Triclosan - UNII:4NM5039Y5X) Triclosan1.08 g  in 1 L
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)  
    LANOLIN (UNII: 7EV65EAW6H)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60549-2108-13.8 L in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333A04/01/2007
    Labeler - Tomco-Harwel Industries Inc (150527406)
    Establishment
    NameAddressID/FEIBusiness Operations
    Tomco-Harwel Industries Inc150527406MANUFACTURE(60549-2108)
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