LUXURY (TRICLOSAN) LIQUID [TOMCO-HARWEL INDUSTRIES INC]

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LUXURY (TRICLOSAN) LIQUID [TOMCO-HARWEL INDUSTRIES INC]
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NDC 60549-1129-1
Set ID 2cbd7082-c38a-41c1-8b2e-55cd3c057005
Category HUMAN OTC DRUG LABEL
Packager Tomco-Harwel Industries Inc
Generic Name
Product Class
Product Number
Application Number PART333A
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient (in each dose unit)

    Triclosan 0.15%

  • 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

    • Squeeze onto wet hands or body sponge.
    • Work into lather
    • Wash hands/skin, rinse and dry thoroughly
  • Other information

    • Store at room temperature
  • Inactive ingredients

    Ammonium lauryl sulfate, Cocoamide DEA, Cocoamidopropyl betaine, EDTA, Glycerine, Isopropanol, PEG75 lanolin, Pina colada fragrance, Styrene acrylic emulsion, and Water

  • Questions?

    1-888-834-2001

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 3.8 L Bottle Label

    PROFESSIONAL
    SUMMIT

    LUXURY

    Antibacterial Hand
    and Body Wash

    Net Contents: 1 Gallon (3.8 liters)

    Principal Display Panel - 3.8 L Bottle Label
  • INGREDIENTS AND APPEARANCE
    LUXURY 
    triclosan liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60549-1129
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Triclosan (UNII: 4NM5039Y5X) (Triclosan - UNII:4NM5039Y5X) Triclosan1.5 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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60549-1129-13.8 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(60549-1129)
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