E2 Hand Sanitizer: Package Insert and Label Information

E2 HAND SANITIZER- benzalkonium chloride solution
State Industrial Products

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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

Active Ingredient 0.13% Benzalkonium Chloride

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

Purpose Antibacterial Agent

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.

Uses For handwashing to decrease bacteria on skin.

E2 HAND SANITIZER e2 hand sanitizer solution

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

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE 0.13 g in 100 mL

Inactive Ingredients Ingredient Name Strength COCAMIDOPROPYL BETAINE LAURTRIMONIUM CHLORIDE METHYLISOTHIAZOLINONE CETYL HYDROXYETHYLCELLULOSE (350000 MW) COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PEG-6 COCAMIDE IODOPROPYNYL BUTYLCARBAMATE WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:64542-017-41 1000 mL in 1 BAG None 2 NDC:64542-017-09 3785 mL in 1 BOTTLE None 3 NDC:64542-017-94 3000 mL in 1 BOTTLE None 4 NDC:64542-017-46 675 mL in 1 BOTTLE, PUMP None 5 NDC:64542-017-03 208197 mL in 1 DRUM None

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	Operations
Kutol Products Company		004236139	manufacture (64542-017)

Revised: 01/2022 State Industrial Products