MEDICATED SOFT N SURE  HEALTHCARE PERSONNEL HANDWASH- triclosan liquid 
Deb USA, Inc.

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

Triclosan 0.5%

Purpose

Antiseptic

Uses

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

Warnings

For external use only.

Stop use and ask a doctor if irritation and redness develop and symptoms persist for more than 3 days.

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

Aqua (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, Parfum (Fragrance).

Questions or comments?

1-866-783-0422

PRINCIPAL DISPLAY PANEL - 1 Liter Bottle Label

NDC 11084-810-41

Medicated Soft 'N Sure®

Healthcare Personnel Handwash

ANTIMICROBIAL

1229-87

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:11084-810
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 DIETHANOLAMIDE (UNII: 92005F972D)  
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:11084-810-13444 mL in 1 BOTTLE; Type 0: Not a Combination Product02/01/201804/02/2020
2NDC:11084-810-411000 mL in 1 BOTTLE; Type 0: Not a Combination Product02/01/201806/25/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart333E02/01/201806/25/2020
Labeler - Deb USA, Inc. (607378015)
Establishment
NameAddressID/FEIBusiness Operations
STERIS Corporation139424188MANUFACTURE(11084-810)

Revised: 9/2019
Document Id: 1c298787-a1c3-47d2-8bdd-e0066702a4f8
Set id: fb6db121-b1aa-46c6-9092-e5e887b92d7b
Version: 2
Effective Time: 20190927
 
Deb USA, Inc.