E2 SANITIZING HAND: Package Insert and Label Information

E2 SANITIZING HAND- benzalkonium chloride soap
KUTOL PRODUCTS COMPANY

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.

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.

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

1703 label

1703 label
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1707 label

1707 label
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1709 label

1709 label
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1765 label

1765 label
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1767 label

1767 label
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E2 SANITIZING HAND
e2 sanitizing hand soap
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:50865-017
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE 0.003 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
COCAMIDOPROPYL BETAINE
COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE
PEG-6 COCAMIDE
HYDROXYETHYL CELLULOSE (280 MPA.S AT 2%)
LAURTRIMONIUM CHLORIDE
METHYLISOTHIAZOLINONE
IODOPROPYNYL BUTYLCARBAMATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50865-017-03 209000 mL in 1 DRUM None
2 NDC:50865-017-07 4000 mL in 1 BOTTLE, PLASTIC None
3 NDC:50865-017-09 4000 mL in 1 BOTTLE, PLASTIC None
4 NDC:50865-017-65 800 mL in 1 BAG None
5 NDC:50865-017-67 2000 mL in 1 BOTTLE, PLASTIC None
6 NDC:50865-017-41 1000 mL in 1 BAG None
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 Operations
Kutol Products Company, Inc. 004236139 manufacture (50865-017), analysis (50865-017), label (50865-017), pack (50865-017)

Revised: 12/2019 KUTOL PRODUCTS COMPANY

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