E2 HAND SANITIZER solution

E2 Hand Sanitizer by

Drug Labeling and Warnings

E2 Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by State Industrial Products, Kutol Products Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DOSAGE & ADMINISTRATION

Directions To decrease bacteria on skin, apply a small amount covering hands with product for 30 seconds. Add water, lather and rinse.

ACTIVE INGREDIENT

Active Ingredient 0.13% Benzalkonium Chloride

INACTIVE INGREDIENT

Inactive Ingredients Water, Cocamidopropyl PG-Dimonium Chloride Phosphate, Cocammidopropyl Betaine, PEG-6 Cocamide, Hydroxyethylcellulose, Laurtrimonium Chloride, Iodopropynl Butylcarbamate, Methylisothiazolinone

PURPOSE

Purpose Antibacterial Agent

WARNINGS

Warnings For external use only. Avoid contact with eyes. If contact occurs, flush with water. Stop use and ask a doctor if, in rare instances, redness or irritation develops and persists for more than 72 hours.

KEEP OUT OF REACH OF CHILDREN

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

INDICATIONS & USAGE

Uses For handwashing to decrease bacteria on skin.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

E2 HAND SANITIZER 
e2 hand sanitizer solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64542-017
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CETYL HYDROXYETHYLCELLULOSE (350000 MW) (UNII: T7SWE4S2TT)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
COCAMIDOPROPYL PG-DIMONIUM CHLORIDE (UNII: 205Z54J075)
PEG-6 COCAMIDE (UNII: YZ6NLA4O1E)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64542-017-41	1000 mL in 1 BAG; Type 0: Not a Combination Product	02/07/2018
2	NDC: 64542-017-09	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/07/2018
3	NDC: 64542-017-94	3000 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/07/2018
4	NDC: 64542-017-46	675 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	02/07/2018
5	NDC: 64542-017-03	208197 mL in 1 DRUM; Type 0: Not a Combination Product	02/07/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	02/07/2018

Labeler - State Industrial Products (004520987)

Registrant - Kutol Products Company (004236139)

Establishment
Name	Address	ID/FEI	Business Operations
Kutol Products Company		004236139	api manufacture(64542-017)