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 STERIS Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

MEDICATED SOFT N SURE   HEALTHCARE PERSONNEL HANDWASH
triclosan liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0519-1229
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 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
Color	WHITE (Off-white)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0519-1229-92	18 in 1 CASE
1	NDC: 0519-1229-13	444 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 0519-1229-87	12 in 1 CASE
2	NDC: 0519-1229-41	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part333E	11/01/1995

Labeler - STERIS Corporation (139424188)

Establishment
Name	Address	ID/FEI	Business Operations
STERIS Corporation		139424188	MANUFACTURE(0519-1229)