E2 Hand Sanitizer: Package Insert and Label Information

E2 HAND SANITIZER- benzalkonium chloride solution
US Chemical Corporation

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 Wet hands and apply about 5 mL to palm of hand. Vigorously rub the surfaces of the lathered fingers, finger tips, areas between the fingers, hands and arms. Wash hands thoroughly for 30 seconds. Rinse had thoroughly with potable water. Follow by thorough drying of cleaned hands and arms before handling food.

Inactive Ingredients Water, Cocamidoprpyl PG-Domonium Chloride Phosphate, Cocamidoprpyl Betaine, PEG-6 Cocamide, Hydroxyethylcellulose, Laurtrimonium Chloride, Iodopropynyl, Butylcarbamate, Methylisothiazolinone.

Uses For hand washing to decrease bacteria on skin.

Active Ingredient Benzalkonium Chloride 0.13% w/w

Kep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Purpose Antibacterial Agent

Warnings For external use only. Avoid contact with eyes. In case of contact, flush with plenty of water. Stop use and ask a doctor if irritation persists.

Principal Label
(click image for full-size original)

E2 HAND SANITIZER
e2 hand sanitizer solution
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:61307-017
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE 0.013 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
COCAMIDOPROPYL BETAINE
CETYL HYDROXYETHYLCELLULOSE (350000 MW)
COCAMIDOPROPYL PG-DIMONIUM CHLORIDE
PEG-6 COCAMIDE
METHYLISOTHIAZOLINONE
IODOPROPYNYL BUTYLCARBAMATE
LAURTRIMONIUM CHLORIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:61307-017-09 3785 mL in 1 BOTTLE None
2 NDC:61307-017-31 1500 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 12/10/2015
Labeler — US Chemical Corporation (031457842)
Registrant — Kutol Products Company (004236139)
Establishment
Name Address ID/FEI Operations
Kutol Products 004236139 manufacture (61307-017)

Revised: 03/2020 US Chemical Corporation

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