Label: MEDICATED SOFT N SURE HEALTHCARE PERSONNEL HANDWASH- 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 June 1, 2015

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  • 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, cocamide MIPA, glycerin, acrylates/PEG-10 maleate/styrene copolymer, hydrolyzed collagen, tetrasodium EDTA, sodium chloride, iodopropynyl butylcarbamate, fragrance

  • Questions or comments?

    800-548-4873

  • PRINCIPAL DISPLAY PANEL - 1 Liter Bottle Label

    NDC 0519-1229-41

    Medicated Soft 'N Sure®

    Healthcare Personnel Handwash

    Net Contents: 1 Liter (33.8 fl oz) (1.05 qt)

    1229-87

    ANTIMICROBIAL

    Principal Display Panel - 1 Liter Bottle Label
  • INGREDIENTS AND APPEARANCE
    MEDICATED SOFT N SURE   HEALTHCARE PERSONNEL HANDWASH
    triclosan liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0519-1229
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Triclosan (UNII: 4NM5039Y5X) (Triclosan - UNII:4NM5039Y5X) Triclosan0.5 g  in 1000 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:0519-1229-9218 in 1 CASE
    1NDC:0519-1229-13444 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:0519-1229-8712 in 1 CASE
    2NDC:0519-1229-411000 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 FINALpart333E11/01/1995
    Labeler - STERIS Corporation (139424188)
    Establishment
    NameAddressID/FEIBusiness Operations
    STERIS Corporation139424188MANUFACTURE(0519-1229)
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