FDA.reportPublic FDA data

Foaming Antibacterial Hand Wash

Manufacturer
RJ Schinner | Kutol Products, Inc.
Effective date
2024-12-18
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 00:44:49

Label at a glance#

ProductFoaming Antibacterial Hand Wash
Active ingredientBENZALKONIUM CHLORIDE
Label structure8 sections

Indications and uses

Uses For handwashing to decrease bacteria on the skin.

Dosage and administration

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

Label contents#

Full prescribing information#

Dosage and Administration

DOSAGE & ADMINISTRATION SECTION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Inactive Ingredients Water, Cocamidopopyl Betaine, Cocamidoprpyl PG-Dimonium Chloride Phosphate, PEG-6 Cocamide, Laurtrimonium Chloride, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, Fragrance, Iodopropynyl Butylcarbamate, Methylisothiazolinone, Yellow 5, Red 33.

Indications and Uses

INDICATIONS & USAGE SECTION

Uses For handwashing to decrease bacteria on the skin.

Keep Out Of Reach Of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Purpose Section

OTC - PURPOSE SECTION

Purpose Antibacterial Agent

Active Ingredient Section

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient Benzalkonium Chloride 0.13% w/w

Warnings Section

Warnings

For external use only

Avoid contact with eyes. If contact occurs, flush with water.

Stop use and ask a doctor if, in rare instances, redness or irritation develops and persists for more than 72 hours

Primary Display Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Primary Display LabelPrimary Display Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71303-213-312022-01-31C16284748780-1d6a99b39-6c72-a426-e053-dadaa90af4c2RJ Schninner F213F
71303-213-412022-01-31C16284748780-1d6a99b39-6c72-a426-e053-dadaa90af4c2RJ Schninner F213F
71303-213-312022-01-28C16284748780-1d6a99b39-6c72-a426-e053-dadaa90af4c2RJ Schninner F213F
71303-213-412022-01-28C16284748780-1d6a99b39-6c72-a426-e053-dadaa90af4c2RJ Schninner F213F

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71303-213-31Foaming Antibacterial Hand Wash1000 mL in 1 BAGSOAP10007
71303-213-41Foaming Antibacterial Hand Wash1000 mL in 1 BAGSOAP10007

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71303-213FOAMING ANTIBACTERIAL HAND WASH (0.13% BENZALKONIUM CHLORIDE) SOAP [RJ SCHINNER]7Current NDC, Legacy NDC, 2 package rows20241220_9cbbd5d5-02cb-7119-e053-2995a90a1905.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71303-21371303-213-31, 71303-213-41

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
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
WATER059QF0KO0RIACT
D&C RED NO. 339DBA0SBB0LIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
IODOPROPYNYL BUTYLCARBAMATE603P14DHEBIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
LAURTRIMONIUM CHLORIDEA81MSI0FICIACT
ALOE VERA LEAFZY81Z83H0XIACT
COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATEH2KVQ74JM4IACT
PEG-6 COCAMIDEYZ6NLA4O1EIACT
HC YELLOW NO. 5I844A312T7IACT

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 Antibacterial Hand Wash0.13% BENZALKONIUM CHLORIDERJ Schinner9cbbd5d5-02cb-7119-e053-2995a90a19052024-12-18WarningsExact identifier
ndc (package): 71303-213-31
ndc (package): 71303-213-41
ndc (product): 71303-213
ndc11 (package): 71303021341
ndc11 (package): 71303021331
spl id: 298e354a-68ca-9de7-e063-6394a90a1216
spl set id: 9cbbd5d5-02cb-7119-e053-2995a90a1905

Reported adverse events (FAERS/openFDA)#

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