FDA.reportPublic FDA data

Foaming Sanitizing Hand

Manufacturer
Kutol Products Company
Effective date
2024-12-18
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:44:48

Label at a glance#

ProductFoaming Sanitizing Hand
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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

INDICATIONS & USAGE SECTION

Uses For handwashing to decrease bacteria on skin

DOSAGE & ADMINISTRATION SECTION

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

WARNINGS SECTION

Warnings

For external use only. Do not use in the eyes. If eye contact occurs, flush eyes with water.

Stop use and ask a doctor if redness and irritation occur and last for more than 72 hours.

INACTIVE INGREDIENT SECTION

Inactive Ingredients

water,  cocamidopropyl PG-dimonium chloride phosphate,cocamidopropyl betaine, PEG-6 cocamide, laurtrimonium chloride, iodopropynyl butylcarbamate,methylisothiazolinone.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50865-683-032023-08-18C16284748780-1ba0f9c33-4908-a910-e053-dadaa90a0b85F683F Foaming sanitizing soap
50865-683-042023-08-18C16284748780-1ba0f9c33-4908-a910-e053-dadaa90a0b85F683F Foaming sanitizing soap
50865-683-092023-08-18C16284748780-1ba0f9c33-4908-a910-e053-dadaa90a0b85F683F Foaming sanitizing soap
50865-683-172023-08-18C16284748780-1ba0f9c33-4908-a910-e053-dadaa90a0b85F683F Foaming sanitizing soap
50865-683-412023-08-18C16284748780-1ba0f9c33-4908-a910-e053-dadaa90a0b85F683F Foaming sanitizing soap
50865-683-442023-08-18C16284748780-1ba0f9c33-4908-a910-e053-dadaa90a0b85F683F Foaming sanitizing soap
50865-683-782023-08-18C16284748780-1ba0f9c33-4908-a910-e053-dadaa90a0b85F683F Foaming sanitizing soap
50865-683-032021-01-29C16284748780-1ba0f9c33-4908-a910-e053-dadaa90a0b85F683F Foaming sanitizing soap
50865-683-042021-01-29C16284748780-1ba0f9c33-4908-a910-e053-dadaa90a0b85F683F Foaming sanitizing soap
50865-683-092021-01-29C16284748780-1ba0f9c33-4908-a910-e053-dadaa90a0b85F683F Foaming sanitizing soap
50865-683-172021-01-29C16284748780-1ba0f9c33-4908-a910-e053-dadaa90a0b85F683F Foaming sanitizing soap
50865-683-412021-01-29C16284748780-1ba0f9c33-4908-a910-e053-dadaa90a0b85F683F Foaming sanitizing soap
50865-683-442021-01-29C16284748780-1ba0f9c33-4908-a910-e053-dadaa90a0b85F683F Foaming sanitizing soap
50865-683-782021-01-29C16284748780-1ba0f9c33-4908-a910-e053-dadaa90a0b85F683F Foaming sanitizing soap

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50865-683-03Foaming Sanitizing Hand4000 mL in 1 DRUMSOAP40006
50865-683-04Foaming Sanitizing Hand1000 mL in 1 BAGSOAP10006
50865-683-09Foaming Sanitizing Hand1000 mL in 1 BOTTLE, PLASTICSOAP10006
50865-683-17Foaming Sanitizing Hand50 mL in 1 BOTTLE, PLASTICSOAP506
50865-683-41Foaming Sanitizing Hand1000 mL in 1 BAGSOAP10006
50865-683-44Foaming Sanitizing Hand1000 mL in 1 BAGSOAP10006
50865-683-78Foaming Sanitizing Hand950 mL in 1 BOTTLE, PLASTICSOAP9506

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50865-683FOAMING SANITIZING HAND (BENZALKONIUM CHLORIDE) SOAP [KUTOL PRODUCTS COMPANY]6Current NDC, Legacy NDC, 7 package rows20241220_95f0af0e-7889-4c2a-9573-4242acfd6684.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50865-68350865-683-03, 50865-683-41, 50865-683-78, 50865-683-44, 50865-683-17, 50865-683-04, 50865-683-09

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATEH2KVQ74JM4IACT
PEG-6 COCAMIDEYZ6NLA4O1EIACT
LAURTRIMONIUM CHLORIDEA81MSI0FICIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
IODOPROPYNYL BUTYLCARBAMATE603P14DHEBIACT
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
Foaming Sanitizing HandBENZALKONIUM CHLORIDEKutol Products Company95f0af0e-7889-4c2a-9573-4242acfd66842024-12-18WarningsExact identifier
ndc (package): 50865-683-04
ndc (package): 50865-683-09
ndc (package): 50865-683-41
ndc (package): 50865-683-17
ndc (package): 50865-683-78
ndc (package): 50865-683-44
ndc (package): 50865-683-03
ndc (product): 50865-683
ndc11 (package): 50865068344
ndc11 (package): 50865068378
ndc11 (package): 50865068317
ndc11 (package): 50865068341
ndc11 (package): 50865068309
ndc11 (package): 50865068303
ndc11 (package): 50865068304
spl id: 298dd564-db49-47a0-e063-6394a90ac4c3
spl set id: 95f0af0e-7889-4c2a-9573-4242acfd6684

Reported adverse events (FAERS/openFDA)#

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