E2 SANITIZING HAND by KUTOL PRODUCTS COMPANY / Kutol Products Company, Inc. E2 SANITIZING HAND soap

E2 SANITIZING HAND by

Drug Labeling and Warnings

E2 SANITIZING HAND by is a Otc medication manufactured, distributed, or labeled by KUTOL PRODUCTS COMPANY, Kutol Products Company, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Benzalkonium Chloride 0.13% w/w

Purpose

Antibacterial Agent

Uses

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

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. If swallowed, contact a physician or poison control center.

Directions

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

Inactive Ingredients

Water, Cocamidopropyl PG-Dimonium Chloride Phosphate, Cocamidopropyl Betaine, PEG-6 Cocamide, Hydroxyethyl Cellulose, Laurtrimonium Chloride, Iodopropynyl Butylcarbamate, Methylisothiazolinone.

QUESTIONS

Kutol Product Co.
Cincinnati, OH 45241
www.Kutol.com

1703 label

1707 label

1709 label

1765 label

1767 label

INGREDIENTS AND APPEARANCE

E2 SANITIZING HAND 
e2 sanitizing hand soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50865-017
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.003 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)
PEG-6 COCAMIDE (UNII: YZ6NLA4O1E)
HYDROXYETHYL CELLULOSE (280 MPA.S AT 2%) (UNII: 12VCE9HR9E)
LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50865-017-03	209000 mL in 1 DRUM; Type 0: Not a Combination Product	09/15/2015
2	NDC: 50865-017-07	4000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/15/2015
3	NDC: 50865-017-09	4000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/15/2015
4	NDC: 50865-017-65	800 mL in 1 BAG; Type 0: Not a Combination Product	09/15/2015
5	NDC: 50865-017-67	2000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	09/15/2015
6	NDC: 50865-017-41	1000 mL in 1 BAG; Type 0: Not a Combination Product	09/15/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	09/15/2015

Labeler - KUTOL PRODUCTS COMPANY (004236139)

Establishment
Name	Address	ID/FEI	Business Operations
Kutol Products Company, Inc.		004236139	manufacture(50865-017) , analysis(50865-017) , label(50865-017) , pack(50865-017)