KLEENEX ANTIBACTERIAL SKIN CLEANSER- triclosan solution

KLEENEX Antibacterial Skin Cleanser by

Drug Labeling and Warnings

KLEENEX Antibacterial Skin Cleanser by is a Otc medication manufactured, distributed, or labeled by Kimberly-Clark Corporation, Marietta Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Triclosan, 0.50% w/w

Purpose

Antiseptic

Use

Antiseptic cleanser. For personal hand hygiene to help prevent the spead of certain bacteria.

Warnings

For External Use Only.

When using this product avoid contact with eyes; in case of contact, flush eyes with water.

Stop use & ask a health care practitioner if irritation or redness develops or persists.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

Wet hands and apply a palmful to hands. Scrub thoroughly for 15-20 seconds. Rinse and dry thoroughly. Use as part of your daily cleansing routine.

Other Information

Report serious side effects from this product to 1-877-561-6587.

Inactive Ingredients

Water/Eau, Propylene Glycol, Sodium Citrate, Sodium Cumenesulfonate, Sodium Laureth Sulfate, Citric Acid, Cocamidopropyl Betaine, PEG-7 Glyceryl Cocoate, Fragrance/Parfum, Disodium EDTA, Methylchloroisothiazolinone, Methylisothiazolinone.

Questions?

1-888-346-4652

SPL UNCLASSIFIED SECTION

Distributed in the U.S. by Kimberly-Clark Global Sales, LLC, Roswell, GA 30076-2199

Distributed in Canada by Kimberly-Clark Inc., Mississauga, Ontario L5B 3Y5

PRINCIPAL DISPLAY PANEL - 1.2 Liter Container Label

MARQUE
Kleenex®
BRAND

Antibacterial Foam Skin Cleanser

Triclosan Solution, House Std., 0.50%

DIN:02339641
For Personal / Domestic Use Only

1.2 Liters (40.5 fl oz)

20-14-700-0-00

INGREDIENTS AND APPEARANCE

KLEENEX ANTIBACTERIAL SKIN CLEANSER 
triclosan solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55118-565
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Triclosan (UNII: 4NM5039Y5X) (Triclosan - UNII:4NM5039Y5X)	Triclosan	5 g  in 1 L

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
Propylene Glycol (UNII: 6DC9Q167V3)
Sodium Citrate (UNII: 1Q73Q2JULR)
Sodium Cumenesulfonate (UNII: 5798KA13PG)
Sodium Laureth-3 Sulfate (UNII: BPV390UAP0)
Citric Acid Monohydrate (UNII: 2968PHW8QP)
Cocamidopropyl Betaine (UNII: 5OCF3O11KX)
PEG-7 Glyceryl Cocoate (UNII: VNX7251543)
Edetate Disodium (UNII: 7FLD91C86K)
Methylchloroisothiazolinone (UNII: DEL7T5QRPN)
Methylisothiazolinone (UNII: 229D0E1QFA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55118-565-10	1 L in 1 CONTAINER; Type 0: Not a Combination Product
2	NDC: 55118-565-12	1.2 L in 1 CONTAINER; Type 0: Not a Combination Product
3	NDC: 55118-565-15	1.5 L in 1 CONTAINER; 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	05/15/2012

Labeler - Kimberly-Clark Corporation (006072136)

Establishment
Name	Address	ID/FEI	Business Operations
Marietta Corporation		010765394	MANUFACTURE(55118-565) , ANALYSIS(55118-565) , RELABEL(55118-565)