FOAMING SANITIZER- benzalkonium chloride 0.13% liquid

Foaming Sanitizer by

Drug Labeling and Warnings

Foaming Sanitizer by is a Otc medication manufactured, distributed, or labeled by RJ Schinner, Kutol Products, Inc., Kutol Products, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Dosage and Administration

Directions Apply small amount, covering hands with product for 30 seconds. Add water, lather, rinse.

Inactive Ingredient Section

Inactive Ingredients Water, Cocamidopropyl Betaine, Laurtrimonium Chloride, Cocamidopropyl PG-Dimonium Chloride Phosphate, Peg-6 Cocamide, Iodopropynyl Butylcarbamate, Methylisothiazolinone

Indications and Usage Section

Uses For handwashing to help reduce bacteria on the skin that could cause disease.

Keep Out of Reach of Children

Keep Out Of Reach Of Children If swallowed, contact a physician or poison control center.

OTC Purpose Section

Purpose Antibacterial Agent

Warnings Section

Warnings

For external use only.

Avoid contact with eyes. If contact ocurrs, flush with water

Stop use and ask a doctor if, in rare instances, redness or irritation develops and persists for more than 72 hours.

OTC - Active Ingredient Section

Active Ingredient Benzalkonium Chloride 0.13% w/w

Package Label Display

INGREDIENTS AND APPEARANCE

FOAMING SANITIZER 
benzalkonium chloride 0.13% liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71303-683
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.013 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)
PEG-6 COCAMIDE (UNII: YZ6NLA4O1E)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
WATER (UNII: 059QF0KO0R)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71303-683-41	1000 mL in 1 BAG; Type 0: Not a Combination Product	03/30/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	03/30/2017

Labeler - RJ Schinner (023432909)

Registrant - Kutol Products, Inc. (004236139)

Establishment
Name	Address	ID/FEI	Business Operations
Kutol Products, Inc		004236139	manufacture(71303-683)