FDA.reportPublic FDA data

Antibacterial Hand Cleanser

Manufacturer
Kutol Products Company
Effective date
2023-08-28
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:44:39

Label at a glance#

ProductAntibacterial Hand Cleanser
Active ingredientBENZALKONIUM CHLORIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Benzalkonium Chloride 0.13% w/w

OTC - PURPOSE SECTION

Purpose

Antibacterial Handwashing

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.

INDICATIONS & USAGE SECTION

Uses Handwash to decrease bacteria on the skin.

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.

WARNINGS SECTION

Warnings

For external use only.

Do not usein the eyes. In case of contact, immediately flush with water.

Stop use and ask a doctor if redness and irritation appears and lasts.

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, methyisothiazolinone, methylchloroisothiazolinone, yellow 5, red 33

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labelabe

labellabel

labellabel

labellabel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50865-215-092024-12-18C16284748780-1ba0f9c33-429c-a910-e053-dadaa90a0b85Kutol F215F
50865-215-122024-12-18C16284748780-1ba0f9c33-429c-a910-e053-dadaa90a0b85Kutol F215F
50865-215-192024-12-18C16284748780-1ba0f9c33-429c-a910-e053-dadaa90a0b85Kutol F215F
50865-215-652024-12-18C16284748780-1ba0f9c33-429c-a910-e053-dadaa90a0b85Kutol F215F
50865-215-092021-01-29C16284748780-1ba0f9c33-429c-a910-e053-dadaa90a0b85Kutol F215F
50865-215-122021-01-29C16284748780-1ba0f9c33-429c-a910-e053-dadaa90a0b85Kutol F215F
50865-215-192021-01-29C16284748780-1ba0f9c33-429c-a910-e053-dadaa90a0b85Kutol F215F
50865-215-652021-01-29C16284748780-1ba0f9c33-429c-a910-e053-dadaa90a0b85Kutol F215F

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50865-215-09Antibacterial Hand Cleanser3785 mL in 1 BOTTLE, PLASTICSOAP37854
50865-215-12Antibacterial Hand Cleanser1200 mL in 1 BAGSOAP12004
50865-215-19Antibacterial Hand Cleanser237 mL in 1 BOTTLE, PUMPSOAP2374
50865-215-65Antibacterial Hand Cleanser800 mL in 1 BAGSOAP8004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50865-215ANTIBACTERIAL HAND CLEANSER (BENZALKONIUM CHLORIDE) SOAP [KUTOL PRODUCTS COMPANY]4Current NDC, Legacy NDC, 4 package rows20241220_56f50eda-5399-1bfe-e054-00144ff8d46c.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50865-21550865-215-09, 50865-215-12, 50865-215-19, 50865-215-65

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
WATER059QF0KO0RIACT
SODIUM CHLORIDE451W47IQ8XIACT
CETRIMONIUM CHLORIDEUC9PE95IBPIACT
LAURAMINE OXIDE4F6FC4MI8WIACT
SORBITOL506T60A25RIACT
COCO MONOETHANOLAMIDEC80684146DIACT
SODIUM LAURIMINODIPROPIONATE7G447D0DH9IACT
D&C RED NO. 339DBA0SBB0LIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
PEG-120 METHYL GLUCOSE DIOLEATEYM0K64F20VIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
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
Antibacterial Hand CleanserBENZALKONIUM CHLORIDEKutol Products Company56f50eda-5399-1bfe-e054-00144ff8d46c2023-08-28WarningsExact identifier
ndc (package): 50865-215-12
ndc (package): 50865-215-09
ndc (package): 50865-215-65
ndc (package): 50865-215-19
ndc (product): 50865-215
ndc11 (package): 50865021565
ndc11 (package): 50865021512
ndc11 (package): 50865021509
ndc11 (package): 50865021519
spl id: 03fbe342-a3b7-9a63-e063-6294a90a15f2
spl set id: 56f50eda-5399-1bfe-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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