Label: CV MEDICATED- triclosan soap

  • NDC Code(s): 0519-6262-03, 0519-6262-13, 0519-6262-41, 0519-6262-87, view more
    0519-6262-92, 0519-6262-94
  • Packager: STERIS Corporation
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 10/14

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient

    0.5% Triclosan

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  • Purpose

    Antiseptic

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  • Use

    Healthcare Personnel Handwash to decrease transient bacteria on the skin before contact with patients under medical care or treatment.

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  • Warnings

    For external use only

    Discontinue use if irritation and redness develop. If irritation persists for more than 3 days, consult a physician.

    When using this product do not get it in the eyes; this product causes eye irritation upon direct contact. In case of eye exposure, rinse thoroughly with water. If eye irritation persists, contact a physician.

    Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

    Warning

    This product contains a chemical known to the State of California to cause cancer.

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  • Directions

    Wet skin and spread a small amount on the hands. Wash hands, rinse thoroughly with water, and repeat as necessary between patient contacts.

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  • Inactive ingredients

    Water, alkali salts of fatty acids, sorbitol, disodium cocoamphodiacetate, cocoamide DEA, glycerin, acrylates/PEG-10 maleate/styrene copolymer, hydrolyzed collagen, tetrasodium EDTA, sodium chloride, iodopropynyl butylcarbamate, fragrance

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  • Questions or comments?

    800-548-4873 www.steris.com

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  • PRINCIPAL DISPLAY PANEL - 1 Liter Bottle Label

    CV® Medicated

    Lotion
    Soap

    NDC 0519-6262-41

    Hand Soap

    Moisturizing

    Antimicrobial

    15
    seconds
    Fast-acting

    REORDER #
    6262-87

    For Hospital and Professional Use Only.

    1 Liter SDS (33.8 fl oz) (1.05 qt)

    STERIS®

    STERIS Corporation ■7501 Page Avenue ■ St. Louis, MO 63133 ■ USA

    6262-86K(F)(814)

    61080

    Principal Display Panel - 1 Liter Bottle Label
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  • INGREDIENTS AND APPEARANCE
    CV MEDICATED 
    triclosan soap
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0519-6262
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    TRICLOSAN (TRICLOSAN) TRICLOSAN 0.5 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    SORBITOL  
    DISODIUM COCOAMPHODIACETATE  
    COCO DIETHANOLAMIDE  
    GLYCERIN  
    EDETATE SODIUM  
    METHACRYLATE/METHOXY PEG-10 MALEATE/STYRENE COPOLYMER  
    GELATIN HYDROLYSATE (PORCINE SKIN, MW 3000)  
    SODIUM CHLORIDE  
    IODOPROPYNYL BUTYLCARBAMATE  
    Product Characteristics
    Color WHITE (Off-white) Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0519-6262-94 72 in 1 CASE
    1 NDC:0519-6262-03 118 mL in 1 BOTTLE; Combination Product Type = C112160
    2 NDC:0519-6262-92 18 in 1 CASE
    2 NDC:0519-6262-13 444 mL in 1 BOTTLE; Combination Product Type = C112160
    3 NDC:0519-6262-87 12 in 1 CASE
    3 NDC:0519-6262-41 1000 mL in 1 BOTTLE; Combination Product Type = C112160
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333E 03/27/2003
    Labeler - STERIS Corporation (139424188)
    Establishment
    Name Address ID/FEI Business Operations
    STERIS Corporation 139424188 MANUFACTURE(0519-6262)
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