Label: CV MEDICATED- triclosan soap

  • 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 May 29, 2015

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    0.5% Triclosan

  • Purpose

    Antiseptic

  • Use

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

  • 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.

  • Directions

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

  • 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

  • Questions or comments?

    800-548-4873 www.steris.com

  • 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

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

    STERIS®

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

    6262-86L(F)(515)

    61080

    Principal Display Panel - 1 Liter Bottle Label
  • INGREDIENTS AND APPEARANCE
    CV MEDICATED 
    triclosan soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0519-6262
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN0.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)  
    COCO MONOISOPROPANOLAMIDE (UNII: 21X4Y0VTB1)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    METHACRYLATE/METHOXY PEG-10 MALEATE/STYRENE COPOLYMER (UNII: 39DK5WQ2PR)  
    GELATIN HYDROLYSATE (PORCINE SKIN, MW 3000) (UNII: 0K9R94573C)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    Product Characteristics
    ColorWHITE (Off-white) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0519-6262-9472 in 1 CASE
    1NDC:0519-6262-03118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:0519-6262-9218 in 1 CASE
    2NDC:0519-6262-13444 mL in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:0519-6262-8712 in 1 CASE
    3NDC:0519-6262-411000 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E03/27/2003
    Labeler - STERIS Corporation (139424188)
    Establishment
    NameAddressID/FEIBusiness Operations
    STERIS Corporation139424188MANUFACTURE(0519-6262)