Foaming Advanced Antibacterial Hand

Manufacturer
Kutol Products Company
Effective date
2024-12-18
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 00:44:43

Label at a glance#

ProductFoaming Advanced Antibacterial 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 Handwash to help decrease bacteria on the skin

DOSAGE & ADMINISTRATION SECTION

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

WARNINGS SECTION

Warnings

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

Stop use if, in rare instances, redness or irritation develops. If condition persists for more than 72 hours, consult a physician.

INACTIVE INGREDIENT SECTION

Inactive Ingredients

water, cocamidopropyl betaine, cocamidopropyl PG-dimonium chloride phosphate, PEG-6 cocamide, laurtrimonium chloride, aloe barbadensis leaf juice, tocopheryl acetate (vitamin E), fragrance, iodopropynyl butylcarbamade, methylisothiazolinone, yellow 5, red 33.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50865-213-092023-08-21C16284748780-1f386c64a-40cc-0266-e053-dadaa90a7c1aF213F Foaming advanced antibacterial soap
50865-213-102023-08-21C16284748780-1f386c64a-40cc-0266-e053-dadaa90a7c1aF213F Foaming advanced antibacterial soap
50865-213-132023-08-21C16284748780-1f386c64a-40cc-0266-e053-dadaa90a7c1aF213F Foaming advanced antibacterial soap
50865-213-142023-08-21C16284748780-1f386c64a-40cc-0266-e053-dadaa90a7c1aF213F Foaming advanced antibacterial soap
50865-213-172023-08-21C16284748780-1f386c64a-40cc-0266-e053-dadaa90a7c1aF213F Foaming advanced antibacterial soap
50865-213-242023-08-21C16284748780-1f386c64a-40cc-0266-e053-dadaa90a7c1aF213F Foaming advanced antibacterial soap
50865-213-412023-08-21C16284748780-1f386c64a-40cc-0266-e053-dadaa90a7c1aF213F Foaming advanced antibacterial soap
50865-213-442023-08-21C16284748780-1f386c64a-40cc-0266-e053-dadaa90a7c1aF213F Foaming advanced antibacterial soap
50865-213-502023-08-21C16284748780-1f386c64a-40cc-0266-e053-dadaa90a7c1aF213F Foaming advanced antibacterial soap
50865-213-522023-08-21C16284748780-1f386c64a-40cc-0266-e053-dadaa90a7c1aF213F Foaming advanced antibacterial soap
50865-213-782023-08-21C16284748780-1f386c64a-40cc-0266-e053-dadaa90a7c1aF213F Foaming advanced antibacterial soap
50865-213-092023-01-30C16284748780-1f386c64a-40cc-0266-e053-dadaa90a7c1aF213F Foaming advanced antibacterial soap
50865-213-102023-01-30C16284748780-1f386c64a-40cc-0266-e053-dadaa90a7c1aF213F Foaming advanced antibacterial soap
50865-213-132023-01-30C16284748780-1f386c64a-40cc-0266-e053-dadaa90a7c1aF213F Foaming advanced antibacterial soap
50865-213-142023-01-30C16284748780-1f386c64a-40cc-0266-e053-dadaa90a7c1aF213F Foaming advanced antibacterial soap
50865-213-172023-01-30C16284748780-1f386c64a-40cc-0266-e053-dadaa90a7c1aF213F Foaming advanced antibacterial soap
50865-213-242023-01-30C16284748780-1f386c64a-40cc-0266-e053-dadaa90a7c1aF213F Foaming advanced antibacterial soap
50865-213-412023-01-30C16284748780-1f386c64a-40cc-0266-e053-dadaa90a7c1aF213F Foaming advanced antibacterial soap
50865-213-442023-01-30C16284748780-1f386c64a-40cc-0266-e053-dadaa90a7c1aF213F Foaming advanced antibacterial soap
50865-213-502023-01-30C16284748780-1f386c64a-40cc-0266-e053-dadaa90a7c1aF213F Foaming advanced antibacterial soap
50865-213-522023-01-30C16284748780-1f386c64a-40cc-0266-e053-dadaa90a7c1aF213F Foaming advanced antibacterial soap
50865-213-782023-01-30C16284748780-1f386c64a-40cc-0266-e053-dadaa90a7c1aF213F Foaming advanced antibacterial soap

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50865-213-13Foaming Advanced Antibacterial Hand3785 mL in 1 BOTTLE, PLASTICSOAP37859
50865-213-17Foaming Advanced Antibacterial Hand50 mL in 1 BOTTLE, PLASTICSOAP509
50865-213-24Foaming Advanced Antibacterial Hand1000 mL in 1 BOTTLE, PLASTICSOAP10009
50865-213-41Foaming Advanced Antibacterial Hand1000 mL in 1 BAGSOAP10009
50865-213-50Foaming Advanced Antibacterial Hand1200 mL in 1 BAGSOAP12009
50865-213-52Foaming Advanced Antibacterial Hand1000 mL in 1 BOTTLE, PLASTICSOAP10009
50865-213-78Foaming Advanced Antibacterial Hand950 mL in 1 BOTTLE, PLASTICSOAP9509

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50865-213FOAMING ADVANCED ANTIBACTERIAL HAND (BENZALKONIUM CHLORIDE) SOAP [KUTOL PRODUCTS COMPANY]9Current NDC, Legacy NDC, 7 package rows20241220_7abc56b5-4446-4464-9b94-6c55f8bb9b74.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50865-21350865-213-24, 50865-213-41, 50865-213-50, 50865-213-78, 50865-213-13, 50865-213-17, 50865-213-52

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

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 Advanced Antibacterial HandBENZALKONIUM CHLORIDEKutol Products Company7abc56b5-4446-4464-9b94-6c55f8bb9b742024-12-18WarningsExact identifier
ndc (package): 50865-213-52
ndc (package): 50865-213-13
ndc (package): 50865-213-41
ndc (package): 50865-213-50
ndc (package): 50865-213-24
ndc (package): 50865-213-17
ndc (package): 50865-213-78
ndc (product): 50865-213
ndc11 (package): 50865021378
ndc11 (package): 50865021324
ndc11 (package): 50865021317
ndc11 (package): 50865021350
ndc11 (package): 50865021313
ndc11 (package): 50865021352
ndc11 (package): 50865021341
spl id: 298e23fa-a68d-383f-e063-6294a90a2e34
spl set id: 7abc56b5-4446-4464-9b94-6c55f8bb9b74

Reported adverse events (FAERS/openFDA)#

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