FDA.reportPublic FDA data

Foaming Advanced Antibacterial Hand

Manufacturer
OPI Correctional Industries | Kutol Products Company
Effective date
2018-09-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:56:47

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
43196-213-092020-01-31C16284748780-19d75b9cf-e0a2-f424-e053-dadaa90a57ceFoaming advanced antibacterial hand soap
43196-213-242020-01-31C16284748780-19d75b9cf-e0a2-f424-e053-dadaa90a57ceFoaming advanced antibacterial hand soap
43196-213-412020-01-31C16284748780-19d75b9cf-e0a2-f424-e053-dadaa90a57ceFoaming advanced antibacterial hand soap
43196-213-502020-01-31C16284748780-19d75b9cf-e0a2-f424-e053-dadaa90a57ceFoaming advanced antibacterial hand soap
43196-213-782020-01-31C16284748780-19d75b9cf-e0a2-f424-e053-dadaa90a57ceFoaming advanced antibacterial hand soap

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43196-213-09Foaming Advanced Antibacterial Hand4000 mL in 1 BOTTLE, PLASTICSOAP40001
43196-213-24Foaming Advanced Antibacterial Hand1000 mL in 1 BOTTLE, PLASTICSOAP10001
43196-213-41Foaming Advanced Antibacterial Hand1000 mL in 1 BAGSOAP10001
43196-213-50Foaming Advanced Antibacterial Hand1250 mL in 1 BAGSOAP12501
43196-213-78Foaming Advanced Antibacterial Hand950 mL in 1 BOTTLE, PLASTICSOAP9501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43196-213FOAMING ADVANCED ANTIBACTERIAL HAND (BENZALKONIUM CHLORIDE) SOAP [OPI CORRECTIONAL INDUSTRIES]1Legacy NDC, 5 package rows20180914_75c6a1fa-9d19-6e01-e053-2a91aa0ac287.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
43196-21343196-213-09, 43196-213-24, 43196-213-41, 43196-213-50, 43196-213-78

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATEH2KVQ74JM4IACT
PEG-6 COCAMIDEYZ6NLA4O1EIACT
LAURTRIMONIUM CHLORIDEA81MSI0FICIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
IODOPROPYNYL BUTYLCARBAMATE603P14DHEBIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
D&C RED NO. 339DBA0SBB0LIACT
ALOE VERA LEAFZY81Z83H0XIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
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
75c6deb6-70ed-771b-e053-2a91aa0ae17c75c6a1fa-9d19-6e01-e053-2a91aa0ac2872018-09-13WarningsExact identifier
spl id: 75c6deb6-70ed-771b-e053-2a91aa0ae17c
spl set id: 75c6a1fa-9d19-6e01-e053-2a91aa0ac287

Reported adverse events (FAERS/openFDA)#

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