LYSOL I.C. ANTIMICROBIAL (TRICLOSAN) SOLUTION [RECKITT BENCKISER LLC]

LYSOL I.C. ANTIMICROBIAL (TRICLOSAN) SOLUTION [RECKITT BENCKISER LLC]
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NDC 63824-499-37, 63824-499-51
Set ID f3591efa-4bd6-4048-aef2-3fcec6b1d28d
Category HUMAN OTC DRUG LABEL
Packager Reckitt Benckiser LLC
Generic Name
Product Class
Product Number
Application Number PART333E
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Triclosan 0.3%

  • Purpose

    Health-care personnel handwash

  • Uses

    For handwashing to decrease bacteria on the skin

  • Warnings

    For external use only.

    When using this product

    • Keep out of reach of children
    • Avoid contact with eyes. In case of eye contact, flush with water.
    • If irritation or redness develops, discontinue use immediately and consult a doctor.
    • If swallowed, get medical help or contact a Poison Control Center immediately.
  • Directions

    • Wet hands with water.
    • Add soap and vigorously rub together all surfaces of lathered hands for at least 10 seconds.
    • Thoroughly rinse under a stream of water.
    • Dry thoroughly.
  • Other information

    Store at room temperature. Keep from freezing.

  • Inactive ingredients

    Citric Acid, Disodium Wheat Germamido PEG-2 Sulfosuccinate, Fragrance, Glycol Stearate, Lauramide DEA, Methylchloroisothiazolinone, Methylisothiazolinone, PEG-150 Distearate, Polyquaternium-7, Propylene Glycol, Sodium Chloride, Sodium Laureth Sulfate, Styrene/Acrylates Copolymer, Tallowaminopropylamine, Tetrasodium EDTA, Water

  • Questions? Comments?

    Call 1-800-677-9218

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Reckitt Benckiser Inc., Parsippany, NJ 07054-0225

  • PRINCIPAL DISPLAY PANEL - 517.5 mL Bottle Label

    READY-TO-USE

    Lysol®
    BRAND

    I.C.

    Antimicrobial
    Soap

    Part of your
    Infection Control
    Program

    • Broad Spectrum
      Antimicrobial Effectiveness
    • Mild and Nondrying to Skin
    • Pleasant Fragrance

    HEALTH CARE
    PERSONNEL HANDWASH

    ACTIVE INGREDIENT: 0.3% TRICLOSAN

    NET CONTENTS: 17.5 FL. OZ. (517.5 mL)

    Principal Display Panel - 517.5 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    LYSOL I.C.   ANTIMICROBIAL
    triclosan solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63824-499
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Triclosan (UNII: 4NM5039Y5X) (Triclosan - UNII:4NM5039Y5X) Triclosan0.3 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    Glycol Stearate (UNII: 0324G66D0E)  
    Lauric Diethanolamide (UNII: I29I2VHG38)  
    Methylchloroisothiazolinone (UNII: DEL7T5QRPN)  
    Methylisothiazolinone (UNII: 229D0E1QFA)  
    PEG-150 Distearate (UNII: 6F36Q0I0AC)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Sodium Chloride (UNII: 451W47IQ8X)  
    Sodium Laureth Sulfate (UNII: BPV390UAP0)  
    Edetate Sodium (UNII: MP1J8420LU)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63824-499-51517.5 mL in 1 BOTTLE
    2NDC:63824-499-373790 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333E12/31/2004
    Labeler - Reckitt Benckiser LLC (094405024)

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