CLINISHIELD HEALTH CARE PERSONNEL HANDWASH- triclosan liquid

CliniShield Health Care Personnel Handwash by

Drug Labeling and Warnings

CliniShield Health Care Personnel Handwash by is a Otc medication manufactured, distributed, or labeled by Deb USA, Inc., Deb-STOKO USA, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Triclosan (1%)

Purpose

Antimicrobial

Uses

For handwashing to decrease bacteria on the skin.

Warnings

For external use only.

Do not get into eyes.  If contact occurs, rinse eyes thoroughly with water.

Stop use and ask doctor if

Skin or eye irritation persists for more than 72 hours.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Wet hands with water, then dispense an adequate amount of handwash onto the skin. Wash vigorously all parts of the hands, fingers and nails for at least 15 seconds. Rinse and dry thoroughly.

Inactive ingredients

Water, Propylene Glycol, Citric Acid, Sodium Laureth Sulfate, Sodium Cumenesulfonate, Ethanolamine, PEG-75 Lanolin, Hydroxyethyl Cellulose, Fragrance, Disodium EDTA, Yellow 6.

PRINCIPAL DISPLAY PANEL

NDC: 11084-943-22
DIN 02244159
Health Care Personnel
HANDWASH
WITH 1% TRICLOSAN
NETTOYANT POUR LES MAINS
Pour Le Personnel Soignant
CONTIENT 1% DE TRICLOSAN
CliniShield®
Manufactured in U.S.A.
Fabrique aux E.-U.
Deb USA, Inc.
Charlotte, NC 28217
1-800-248-7190 www.CliniShield.com
Distributed in Canada by/Distribue au Canada par
Deb Canada
Waterford ON NOE 1Y0
1-888-332-7627
NET CONTENTS 54.04 FL OZ (1600ml)
CONTENU NET 1,6 L
STOCK NO. 64106
No. De STOCK 64106

INGREDIENTS AND APPEARANCE

CLINISHIELD HEALTH CARE PERSONNEL HANDWASH 
triclosan liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11084-943
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
SODIUM CUMENESULFONATE (UNII: 5798KA13PG)
MONOETHANOLAMINE (UNII: 5KV86114PT)
PEG-75 LANOLIN (UNII: 09179OX7TB)
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)
EDETATE DISODIUM (UNII: 7FLD91C86K)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11084-943-50	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/01/2014	12/31/2021
2	NDC: 11084-943-22	1600 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	06/01/2014	12/31/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/01/2014	12/31/2021

Labeler - Deb USA, Inc. (607378015)

Establishment
Name	Address	ID/FEI	Business Operations
Deb-STOKO USA, LLC		055861874	manufacture(11084-943)