KLEENEX ANTIMICROBIAL FOAM SKIN CLEANSER- benzalkonium chloride solution

KLEENEX Antimicrobial Foam Skin Cleanser by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Benzalkonium Chloride 0.1% w/w

Purpose

Antiseptic cleanser

Use

For personal hand hygiene to help prevent the spread of certain bacteria.

Warnings

For External Use Only. Do not ingest

Use with caution in children

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

Discontinue use and consult a health care practitioner if irritation develops

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

Do not use if you are allergic to any ingredients.

Directions

Apply a small amount and lather hands in water for at least 30 seconds. Rinse well. Adults: Supervise children when using this product. Do not dilute product. For occasional use as needed.

Other Information

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

Inactive Ingredients

Aloe Barbadensis Leaf Juice Powder, Citric Acid, Coco-Betaine, Glycerin, Panthenol, Sodium Benzoate, Sodium Chloride, Sodium Hydroxide, Tocopheryl Acetate, Water.

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 - 50.7 fl oz Bottle Label

Kleenex®
BRAND

Antimicrobial Foam
Skin Cleanser

Benzalkonium Chloride Solution, NF

new active ingredient
Benzalkonium
Chloride

DIN: 02443244
For Personal / Domestic Use Only

1.5 Liters (50.7 fl oz)

INGREDIENTS AND APPEARANCE

KLEENEX ANTIMICROBIAL FOAM SKIN CLEANSER 
benzalkonium chloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55118-700
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Benzalkonium Chloride (UNII: F5UM2KM3W7) (Benzalkonium - UNII:7N6JUD5X6Y)	Benzalkonium Chloride	1 mg  in 1000 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Coco-Betaine (UNII: 03DH2IZ3FY)
Glycerin (UNII: PDC6A3C0OX)
Sodium Chloride (UNII: 451W47IQ8X)
Sodium Benzoate (UNII: OJ245FE5EU)
Citric Acid Monohydrate (UNII: 2968PHW8QP)
Aloe (UNII: V5VD430YW9)
Panthenol (UNII: WV9CM0O67Z)
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)
Sodium Hydroxide (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55118-700-18	532 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	09/01/2015
2	NDC: 55118-700-63	6 in 1 CARTON	09/01/2015
2	NDC: 55118-700-10	1000 mL in 1 CARTRIDGE; Type 0: Not a Combination Product
3	NDC: 55118-700-65	2 in 1 CARTON	09/01/2015
3	NDC: 55118-700-12	1200 mL in 1 CARTRIDGE; Type 0: Not a Combination Product
4	NDC: 55118-700-66	2 in 1 CARTON	09/01/2015
4	NDC: 55118-700-15	1500 mL in 1 BOTTLE, DISPENSING; 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	09/01/2015

Labeler - Kimberly-Clark (830997032)