FDA.reportPublic FDA data

Foaming Sanitizer

Manufacturer
RJ Schinner | Kutol Products, Inc. | Kutol Products, Inc
Effective date
2023-08-24
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 21:26:54

Label at a glance#

ProductFoaming Sanitizer
Active ingredientBENZALKONIUM CHLORIDE
Label structure8 sections

Indications and uses

Uses For handwashing to help reduce bacteria on the skin that could cause disease.

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 Ingredient Section

Inactive Ingredients Water, Cocamidopropyl Betaine, Laurtrimonium Chloride, Cocamidopropyl PG-Dimonium Chloride Phosphate, Peg-6 Cocamide, Iodopropynyl Butylcarbamate, Methylisothiazolinone

Indications and Usage Section

INDICATIONS & USAGE SECTION

Uses For handwashing to help reduce bacteria on the skin that could cause disease.

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.

OTC Purpose Section

OTC - PURPOSE SECTION

Purpose Antibacterial Agent

Warnings Section

Warnings

For external use only.

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

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

OTC - Active Ingredient Section

Active Ingredient Benzalkonium Chloride 0.13% w/w

Package Label Display

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Label DisplayPrincipal Label Display

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71303-683-412022-01-31C16284748780-1d6a99b39-6c9e-a426-e053-dadaa90af4c2RJ Schinner F683
71303-683-412022-01-28C16284748780-1d6a99b39-6c9e-a426-e053-dadaa90af4c2RJ Schinner F683

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71303-68371303-683-41

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
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
WATER059QF0KO0RIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
IODOPROPYNYL BUTYLCARBAMATE603P14DHEBIACT
COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATEH2KVQ74JM4IACT
LAURTRIMONIUM CHLORIDEA81MSI0FICIACT
PEG-6 COCAMIDEYZ6NLA4O1EIACT

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
03a8fa2d-97ab-9f63-e063-6394a90afe689cbcf79b-1b5f-24ad-e053-2995a90a5eac2023-08-24WarningsExact identifier
spl id: 03a8fa2d-97ab-9f63-e063-6394a90afe68
spl set id: 9cbcf79b-1b5f-24ad-e053-2995a90a5eac

Reported adverse events (FAERS/openFDA)#

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