MEDICATED SOFT N SURE  HEALTHCARE PERSONNEL HANDWASH- triclosan liquid 
STERIS Corporation

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.

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Medicated Soft 'N Sure®
Healthcare Personnel Handwash

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
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)

Revised: 6/2015
Document Id: 9440d943-3cbb-45fb-8d0d-1b2e9e5e7d89
Set id: 311663b8-0652-4b56-86ef-92e3caa81558
Version: 3
Effective Time: 20150601
 
STERIS Corporation