FDA.reportPublic FDA data

Antibacterial Hand Cleanser

Manufacturer
Kimball Midwest | Kutol Products, Inc.
Effective date
2024-11-08
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 20:50:04

Label at a glance#

ProductAntibacterial Hand Cleanser
Active ingredientBENZALKONIUM CHLORIDE
Label structure8 sections

Indications and uses

Uses Handwash to help decrease bacteria on skin.

Dosage and administration

Directions Apply a small amount, covering hands with product for 30 seconds. Add water, lather and rinse. Children under 6 years of age should be supervised when using this product.

Label contents#

Full prescribing information#

Dosage and Administration

DOSAGE & ADMINISTRATION SECTION

Directions Apply a small amount, covering hands with product for 30 seconds. Add water, lather and rinse.

Children under 6 years of age should be supervised when using this product.

Inactive Ingredient Section

Inactive Ingredients Water, Cetrimonium Chloride, Lauramine Oxide, Sorbitol, Cocamide MEA, Sodium Chloride, PEG-120 Methyl Glucose Dioleate, Sodium Lauraminodipropionate, Citric Acid, Fragrance, Disodium EDTA, Methyllisothiazolinone, Methylchloroisothiazolinone, Yellow 5, Red 33

Indications and Usage Section

INDICATIONS & USAGE SECTION

Uses Handwash to help decrease bacteria on skin.

Keep Out Of Reach Of Children Section

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep Out Of Reach Of Children If swallowed, get medical help or contact a Poison Control Center right away.

Purpose Section

OTC - PURPOSE SECTION

Purpose Antibacterial Handwashing

Active Ingredient Section

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient Benzalkonium Chloride 0.13% w/w

Warnings Section

Warnings

For external use only.

Do not use in eyes. In case of contact, immediately flush with water.

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

Principal Display Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Pricipal Label DisplayPricipal Label Display

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66608-21566608-215-78, 66608-215-65, 66608-215-09

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
METHYLISOTHIAZOLINONE229D0E1QFAIACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
COCOYL METHYL MONOETHANOLAMINE79G1T427CFIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
ACID RED 3502BXM5Q7GEIACT
WATER059QF0KO0RIACT
CETRIMONIUM CHLORIDEUC9PE95IBPIACT
SORBITOL506T60A25RIACT
PEG-120 METHYL GLUCOSE DIOLEATEYM0K64F20VIACT
CITRIC ACID ACETATEDSO12WL7AUIACT
SODIUM CHLORIDE451W47IQ8XIACT
LAURAMINE OXIDE4F6FC4MI8WIACT
DISODIUM EDTA-COPPER6V475AX06UIACT
SODIUM LAURIMINODIPROPIONATE7G447D0DH9IACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB

Source Document#

Source XML

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
1716d292-0aee-4c1d-903c-ed80030ff6479ce9489e-39a1-d51c-e053-2995a90a3e5c2024-11-08WarningsExact identifier
spl id: 1716d292-0aee-4c1d-903c-ed80030ff647
spl set id: 9ce9489e-39a1-d51c-e053-2995a90a3e5c

Reported adverse events (FAERS/openFDA)#

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