GOJO E2 Foam Handwash with BAK: Package Insert and Label Information

GOJO E2 FOAM HANDWASH WITH BAK- benzalkonium chloride liquid
GOJO Industries, Inc.

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%

Purpose

Antimicrobial

Uses

• Handwash to help decrease bacteria on the skin

• Recommended for repeated use

Warnings

For external use only

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash appears and lasts

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

Directions

• Wet hands

• Apply a small amount of soap and work into a rich lather

• Rinse thoroughly with potable water

• Dry hands completely

Inactive Ingredients

Water (Aqua), Propanediol, Glycerin, Cocamidopropyl Betaine, PEG-80 Sorbitan Laurate, Citric Acid, Ethylhexylglycerin, Lauramine Oxide, Polyquaternium-10, Trisodium Ethylenediamine Disuccinate, Phenoxyethanol

GOJO E2 FOAM HANDWASH WITH BAK benzalkonium chloride liquid

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:21749-112 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Benzalkonium Chloride (BENZALKONIUM) Benzalkonium Chloride 0.0013 mg in 1 mL

Inactive Ingredients Ingredient Name Strength Water PROPANEDIOL Glycerin Cocamidopropyl Betaine PEG-80 Sorbitan Laurate CITRIC ACID MONOHYDRATE Ethylhexylglycerin Lauramine Oxide POLYQUATERNIUM-10 (10000 MPA.S AT 2%) TRISODIUM ETHYLENEDIAMINE DISUCCINATE PHENOXYETHANOL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:21749-112-89 1200 mL in 1 PACKAGE None 2 NDC:21749-112-90 1250 mL in 1 PACKAGE None 3 NDC:21749-112-20 2000 mL in 1 PACKAGE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 03/01/2019

Labeler — GOJO Industries, Inc. (004162038)

Establishment
Name	Address	ID/FEI	Operations
GOJO Industries, Inc.		036424534	manufacture (21749-112)

Establishment
Name	Address	ID/FEI	Operations
GOJO Industries, Inc.		088312414	label (21749-112), pack (21749-112)

Revised: 03/2019 GOJO Industries, Inc.