KLEENEX FOAM HAND SANITIZER- benzalkonium chloride solution

KLEENEX Foam Hand Sanitizer by

Drug Labeling and Warnings

KLEENEX Foam Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Kimberly-Clark, Tri-Pac Inc., Cyan Labs. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Benzalkonium Chloride 0.13% 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 small amount and rub thoroughly into hands for at least 30 seconds. Allow to dry. Not to be rinsed off with water (i.e. not to be used as a handwash ). For occasional use as needed. Adults: Supervise children when using this product.

Other Information

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

Inactive Ingredients

Aloe Barbadensis Leaf Juice Powder, Calcium, Citric Acid, Cocamidopropyl PG-Dimonium Chloride Phosphate, Methylpropanediol, Panthenol, PEG-14M, Silica, Sodium Hydroxide, 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 - 473 mL Bottle Label

Kleenex®
BRAND

Foam Hand Sanitizer

Benzalkonium Chloride Solution, NF

alcohol
free

DIN: 02443252

For Personal /
Domestic Use Only

16 fl oz (473 mL)

20-14-637-0-02

INGREDIENTS AND APPEARANCE

KLEENEX FOAM HAND SANITIZER 
benzalkonium chloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55118-701
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Benzalkonium Chloride (UNII: F5UM2KM3W7) (Benzalkonium - UNII:7N6JUD5X6Y)	Benzalkonium Chloride	1.3 mg  in 1000 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Methylpropanediol (UNII: N8F53B3R4R)
Cocamidopropyl Propylene Glycol-Dimonium Chloride Phosphate (UNII: H2KVQ74JM4)
Polyethylene Oxide 600000 (UNII: 2126FD486L)
Citric Acid Monohydrate (UNII: 2968PHW8QP)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Aloe (UNII: V5VD430YW9)
Panthenol (UNII: WV9CM0O67Z)
Calcium (UNII: SY7Q814VUP)
Sodium Hydroxide (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55118-701-64	24 in 1 CARTON	09/01/2015
1	NDC: 55118-701-11	45 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
2	NDC: 55118-701-99	473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	09/01/2015
3	NDC: 55118-701-10	1000 mL in 1 CARTRIDGE; Type 0: Not a Combination Product	09/01/2015
4	NDC: 55118-701-12	1200 mL in 1 CARTRIDGE; Type 0: Not a Combination Product	09/01/2015
5	NDC: 55118-701-67	4 in 1 CARTON	09/01/2015
5	NDC: 55118-701-18	532 mL in 1 BOTTLE, PUMP; 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)