FDA.reportPublic FDA data

Biocentris E2 Handwash

Manufacturer
Inopak, Ltd.
Effective date
2019-10-31
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:03:48

Label at a glance#

ProductBiocentris E2 Handwash
Active ingredientBenzalkonium chloride
Label structure11 sections

Indications and uses

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

Dosage and administration

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

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium chloride

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

  • For external use only.
  • Keep out of eyes, ears, or mouth. Incase 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, get medical help or contact a Poison Control Center right away.

When Using

OTC - WHEN USING SECTION

  • Incase of eye contact, flush eyes with water.

Stoppage

OTC - STOP USE SECTION

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

Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. 

Directions

DOSAGE & ADMINISTRATION SECTION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Cetrimonium chloride, chlorhexidine gluconate, cocamidopropyl PG-dimonium chloride phosphate, decyl glucoside, ethyl alcohol, isopropyl alcohol, phenoxyethanol, polyquatemium 10, polyquatemium 11, water.

E2 single label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

E2           FOAM HANDWASH

FOR FOOD INDUSTRY

PROFESSIONALS

One Step

Hand Wash

& Sanitizer

ADVANCED

QUAT FORMULA

50 mL

Part# BIO-5064-480

888-497-4375

info@biocentris.com

www.biocentris.com

bi centris

PHARMACEUTICALS

Drug Facts

Active Ingredient                                             Purpose

Benzalkonium chloride 0.13% w/w……..…Antiseptic

Uses

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

Warnings

  • For external use only.
  • Keep out of eyes, ears, or mouth. Incase 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, get medical help or contact a Poison Control Center right away.

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 Ingredients: Cetrimonium chloride, chlorhexidine gluconate, cocamidopropyl PG-dimonium chloride phosphate, decyl glucoside, ethyl alcohol, isopropyl alcohol, phenoxyethanol, polyquatemium 10, polyquatemium 11, water.

Questions? Call 1-888-497-4375

E2 single labelE2 single label

E2 case label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

E2           FOAM HANDWASH FOR FOOD

                INDUSTRY PROFESSIONALS

One Step Hand Wash

And Sanitizer

ADVANCED QUAT FORMULA

6/1000mL

BIO-5064-CS

888-497-4375

Info@biocentris.com

www.biocentris.com

biocentris

E2 case labelE2 case label

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58575-40258575-402-01, 58575-402-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
Benzalkonium chlorideF5UM2KM3W7ACTIB
CETRIMONIUM CHLORIDEUC9PE95IBPIACT
CHLORHEXIDINE GLUCONATEMOR84MUD8EIACT
COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATEH2KVQ74JM4IACT
DECYL GLUCOSIDEZ17H97EA6YIACT
METHYL ALCOHOLY4S76JWI15IACT
ISOPROPYL ALCOHOLND2M416302IACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYQUATERNIUM-10 (1000 MPA.S AT 2%)GMR4PEN8PKIACT
POLYQUATERNIUM-11 (1000000 MW)0B44BS5IJSIACT
WATER059QF0KO0RIACT

Source Document#

Source XML · Source PDF

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
b71704c4-42ce-4215-b650-1ee99a5e4fcdbdfb18cb-fdea-403e-8082-4cd0c9c4ee5b2019-10-31WarningsExact identifier
spl id: b71704c4-42ce-4215-b650-1ee99a5e4fcd
spl set id: bdfb18cb-fdea-403e-8082-4cd0c9c4ee5b

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.