FDA.reportPublic FDA data

E2 SANITIZING HAND

Manufacturer
KUTOL PRODUCTS COMPANY | Kutol Products Company, Inc.
Effective date
2024-12-18
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 00:44:42

Label at a glance#

ProductE2 SANITIZING HAND
Active ingredientBENZALKONIUM CHLORIDE
Label structure12 sections

Indications and uses

For handwashing to help reduce bacteria on the skin that could cause disease.

Dosage and administration

To decrease bacteria on skin, apply small amount, covering hands with product for 30 seconds. Add water, lather, rinse.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13% w/w

Purpose

OTC - PURPOSE SECTION

Antibacterial Agent

Uses

INDICATIONS & USAGE SECTION

For handwashing to help reduce bacteria on the skin that could cause disease.

Warnings

WARNINGS SECTION

For external use only. Avoid contact with eyes. If contact occurs, flush with water.

OTC - STOP USE SECTION

Stop use and ask a doctor if, in rare instances, redness or irritation develops and persists for more than 72 hours.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

To decrease bacteria on skin, apply small amount, covering hands with product for 30 seconds. Add water, lather, rinse.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Cocamidopropyl PG-Dimonium Chloride Phosphate, Cocamidopropyl Betaine, PEG-6 Cocamide, Hydroxyethyl Cellulose, Laurtrimonium Chloride, Iodopropynyl Butylcarbamate, Methylisothiazolinone.

OTC - QUESTIONS SECTION

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

1703 label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1703 label1703 label

1707 label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1707 label1707 label

1709 label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1709 label1709 label

1765 label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1765 label1765 label

1767 label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1767 label1767 label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50865-017-032022-02-08C16284748780-1ba0f9c33-5cfd-a910-e053-dadaa90a0b85F017 LIQUID E2 SANITIZING HAND SOAP
50865-017-072022-02-08C16284748780-1ba0f9c33-5cfd-a910-e053-dadaa90a0b85F017 LIQUID E2 SANITIZING HAND SOAP
50865-017-092022-02-08C16284748780-1ba0f9c33-5cfd-a910-e053-dadaa90a0b85F017 LIQUID E2 SANITIZING HAND SOAP
50865-017-412022-02-08C16284748780-1ba0f9c33-5cfd-a910-e053-dadaa90a0b85F017 LIQUID E2 SANITIZING HAND SOAP
50865-017-652022-02-08C16284748780-1ba0f9c33-5cfd-a910-e053-dadaa90a0b85F017 LIQUID E2 SANITIZING HAND SOAP
50865-017-672022-02-08C16284748780-1ba0f9c33-5cfd-a910-e053-dadaa90a0b85F017 LIQUID E2 SANITIZING HAND SOAP
50865-017-032021-01-29C16284748780-1ba0f9c33-5cfd-a910-e053-dadaa90a0b85F017 LIQUID E2 SANITIZING HAND SOAP
50865-017-072021-01-29C16284748780-1ba0f9c33-5cfd-a910-e053-dadaa90a0b85F017 LIQUID E2 SANITIZING HAND SOAP
50865-017-092021-01-29C16284748780-1ba0f9c33-5cfd-a910-e053-dadaa90a0b85F017 LIQUID E2 SANITIZING HAND SOAP
50865-017-412021-01-29C16284748780-1ba0f9c33-5cfd-a910-e053-dadaa90a0b85F017 LIQUID E2 SANITIZING HAND SOAP
50865-017-652021-01-29C16284748780-1ba0f9c33-5cfd-a910-e053-dadaa90a0b85F017 LIQUID E2 SANITIZING HAND SOAP
50865-017-672021-01-29C16284748780-1ba0f9c33-5cfd-a910-e053-dadaa90a0b85F017 LIQUID E2 SANITIZING HAND SOAP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50865-017-03E2 SANITIZING HAND209000 mL in 1 DRUMSOAP2090009
50865-017-07E2 SANITIZING HAND4000 mL in 1 BOTTLE, PLASTICSOAP40009
50865-017-09E2 SANITIZING HAND4000 mL in 1 BOTTLE, PLASTICSOAP40009
50865-017-41E2 SANITIZING HAND1000 mL in 1 BAGSOAP10009
50865-017-65E2 SANITIZING HAND800 mL in 1 BAGSOAP8009
50865-017-67E2 SANITIZING HAND2000 mL in 1 BOTTLE, PLASTICSOAP20009

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50865-017E2 SANITIZING HAND SOAP [KUTOL PRODUCTS COMPANY]9Current NDC, Legacy NDC, 6 package rows20241220_70357eaf-8cd8-4c5e-b7a8-ae2fbba0ca2e.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BENZALKONIUM CHLORIDEACTIVE INGREDIENTF5UM2KM3W71
BENZALKONIUMACTIVE MOIETY7N6JUD5X6Y1
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KX1
COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATEINACTIVE INGREDIENTH2KVQ74JM41
HYDROXYETHYL CELLULOSE (280 MPA.S AT 2%)INACTIVE INGREDIENT12VCE9HR9E1
IODOPROPYNYL BUTYLCARBAMATEINACTIVE INGREDIENT603P14DHEB1
LAURTRIMONIUM CHLORIDEINACTIVE INGREDIENTA81MSI0FIC1
METHYLISOTHIAZOLINONEINACTIVE INGREDIENT229D0E1QFA1
PEG-6 COCAMIDEINACTIVE INGREDIENTYZ6NLA4O1E1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50865-01750865-017-03, 50865-017-07, 50865-017-09, 50865-017-65, 50865-017-67, 50865-017-41

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATEH2KVQ74JM4IACT
PEG-6 COCAMIDEYZ6NLA4O1EIACT
HYDROXYETHYL CELLULOSE (280 MPA.S AT 2%)12VCE9HR9EIACT
LAURTRIMONIUM CHLORIDEA81MSI0FICIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
IODOPROPYNYL BUTYLCARBAMATE603P14DHEBIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 7 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
HYDROXYETHYL CELLULOSE (280 MPA.S AT 2%)HYDROXYETHYL CELLULOSE (280 MPA.S AT 2%)12VCE9HR9ESPRAY / TOPICAL0.05 %w/wExact identifier — unii+route
7 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (280 MPA.S AT 2%)HYDROXYETHYL CELLULOSE (280 MPA.S AT 2%)12VCE9HR9ESPRAY / TOPICAL0.05 %w/wExact identifier — unii+route
7 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (280 MPA.S AT 2%)HYDROXYETHYL CELLULOSE (280 MPA.S AT 2%)12VCE9HR9ESPRAY / TOPICAL0.05 %w/wExact identifier — unii+route
7 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (280 MPA.S AT 2%)HYDROXYETHYL CELLULOSE (280 MPA.S AT 2%)12VCE9HR9ESPRAY / TOPICAL0.05 %w/wExact identifier — unii+route
7 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (280 MPA.S AT 2%)HYDROXYETHYL CELLULOSE (280 MPA.S AT 2%)12VCE9HR9ESPRAY / TOPICAL0.05 %w/wExact identifier — unii+route
7 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (280 MPA.S AT 2%)HYDROXYETHYL CELLULOSE (280 MPA.S AT 2%)12VCE9HR9ESPRAY / TOPICAL0.05 %w/wExact identifier — unii+route
7 equally ranked IID candidates
HYDROXYETHYL CELLULOSE (280 MPA.S AT 2%)HYDROXYETHYL CELLULOSE (280 MPA.S AT 2%)12VCE9HR9ESPRAY / TOPICAL0.05 %w/wExact identifier — unii+route
7 equally ranked IID candidates

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
E2 SANITIZING HANDE2 SANITIZING HANDKUTOL PRODUCTS COMPANY70357eaf-8cd8-4c5e-b7a8-ae2fbba0ca2e2024-12-18WarningsExact identifier
ndc (package): 50865-017-65
ndc (package): 50865-017-03
ndc (package): 50865-017-09
ndc (package): 50865-017-41
ndc (package): 50865-017-07
ndc (package): 50865-017-67
ndc (product): 50865-017
ndc11 (package): 50865001741
ndc11 (package): 50865001765
ndc11 (package): 50865001709
ndc11 (package): 50865001767
ndc11 (package): 50865001703
ndc11 (package): 50865001707
spl id: 298f1da8-676b-6cb9-e063-6294a90a78ab
spl set id: 70357eaf-8cd8-4c5e-b7a8-ae2fbba0ca2e

Reported adverse events (FAERS/openFDA)#

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