Kleenex Foam Hand Sanitizer (Benzalkonium Chloride) Solution [Kimberly-Clark Corporation] -

KLEENEX FOAM HAND SANITIZER (BENZALKONIUM CHLORIDE) SOLUTION [KIMBERLY-CLARK CORPORATION]
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NDC	55118-701-10, 55118-701-11, 55118-701-12, 55118-701-18, 55118-701-64, 55118-701-67, 55118-701-99
Set ID	1fa77ae2-b652-463d-8943-d338c591226e
Category	HUMAN OTC DRUG LABEL
Packager	Kimberly-Clark
Generic Name
Product Class
Product Number
Application Number	PART333E

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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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part333E	09/01/2015

Labeler - Kimberly-Clark (830997032)

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Medic

KLEENEX FOAM HAND SANITIZER (BENZALKONIUM CHLORIDE) SOLUTION [KIMBERLY-CLARK CORPORATION]

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