BIOCENTRIS E2 HANDWASH- benzalkonium chloride liquid

Biocentris E2 Handwash by

Drug Labeling and Warnings

Biocentris E2 Handwash by is a Otc medication manufactured, distributed, or labeled by Biocentris Pharmaceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient

Benzalkonium chloride 0.13% w/w

PURPOSE

Purpose

Antiseptic

INDICATIONS & USAGE

Uses

• Handwash to help reduce bacteria on the skin that potentially can cause disease.
• Recommended for repeated use.

WARNINGS

Warnings

For external use only.

When using this product keep away from eyes. In case of eye contact, flush eyes with water.

Stop use and ask a doctor if irritation and redness develop or if condition persists for more than 72 hours.

Keep out of reach of children. If swallowed, contact a physician or poison control center.

DOSAGE & ADMINISTRATION

Directions

• Dispense a golf ball size amount of foam onto dry hands and rub vigorously for 15 seconds
• Rinse with water and towel dry.

INACTIVE INGREDIENT

Inactive ingredients Water, Ethanol, Cocamidopropyl PG-Dimonium Chloride Phosphate, Phenoxyethanol, Polyquatemium 11, Decyl Glucoside, Cetrimonium Chloride, Polyquatemium-10, Chlorhexidine Gluconate

SPL UNCLASSIFIED SECTION

Manufactured for:

biocentris PHARMACEUTICALS

24 Executive Parkway, Ringwood, NJ 07456

888-497-4375

info@biocentris.com www.biocentris.com

PRINCIPAL DISPLAY PANEL

E2 FOAM HANDWASH FOR FOOD INDUSTRY PROFESSIONALS

One Step Hand Wash & Sanitizer

KILLS 99.99% of most germs

NET CONTENTS: 33.8 FL. OZ. (1000 ML)

INGREDIENTS AND APPEARANCE

BIOCENTRIS E2 HANDWASH 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81232-402
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)
COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
ALCOHOL (UNII: 3K9958V90M)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYQUATERNIUM-10 (1000 MPA.S AT 2%) (UNII: GMR4PEN8PK)
POLYQUATERNIUM-11 (1000000 MW) (UNII: 0B44BS5IJS)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81232-402-03	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2018
2	NDC: 81232-402-10	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2018
3	NDC: 81232-402-01	1000 mL in 1 POUCH; Type 0: Not a Combination Product	04/20/2021
4	NDC: 81232-402-17	532 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/20/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	01/01/2018

Labeler - Biocentris Pharmaceuticals, LLC (015882747)