MEDICATED SOFT N SURE HEALTHCARE PERSONNEL HANDWASH- triclosan liquid

Medicated Soft N Sure by

Drug Labeling and Warnings

Medicated Soft N Sure by is a Otc medication manufactured, distributed, or labeled by Deb USA, Inc., STERIS Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

MEDICATED SOFT N SURE   HEALTHCARE PERSONNEL HANDWASH
triclosan liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11084-810
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Triclosan (UNII: 4NM5039Y5X) (Triclosan - UNII:4NM5039Y5X)	Triclosan	0.5 g  in 1000 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	WHITE (Off-white)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11084-810-13	444 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2018	04/02/2020
2	NDC: 11084-810-41	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2018	06/25/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part333E	02/01/2018	06/25/2020

Labeler - Deb USA, Inc. (607378015)

Establishment
Name	Address	ID/FEI	Business Operations
STERIS Corporation		139424188	MANUFACTURE(11084-810)