FDA.reportPublic FDA data

Foaming Hand Cleaner

Manufacturer
National Chemical Laboratories Of PA., Inc. | Kutol Products Company
Effective date
2024-10-03
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 20:53:23

Label at a glance#

ProductFoaming Hand Cleaner
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 - Antivacterial Agent

INDICATIONS & USAGE SECTION

Uses - For handwashing to decrease bacteria on skin.

WARNINGS SECTION

Warnings

For external use only.

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

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

Directions

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

INACTIVE INGREDIENT SECTION

Inactive ingredients

Water, Cocamidopropyl PG-Dimonium Chloride Phosphate, Cocamidopropyl Betaine, PEG-6 Cocamide, Lautrimonium Chloride, Iodopropynyl Butlcarbamate, Methylisothiazolinone.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AFIA FM E2 Sanitizing Hand CleanerAFIA FM E2 Sanitizing Hand Cleaner

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
71023-21371023-213-41

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
METHYLISOTHIAZOLINONE229D0E1QFAIACT
BASIC YELLOW 507BP340B4TIACT
D&C RED NO. 339DBA0SBB0LIACT
PEG-6 COCAMIDEYZ6NLA4O1EIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
FRAGRANCE FLORAL ORC0902236R66Z4YW3X0IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATEH2KVQ74JM4IACT
LAURTRIMONIUM CHLORIDEA81MSI0FICIACT
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
IODOPROPYNYL BUTYLCARBAMATE603P14DHEBIACT

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
23971cce-b83b-d1e5-e063-6394a90a60811b2b6579-7259-4e34-e063-6394a90afe082024-10-03WarningsExact identifier
spl id: 23971cce-b83b-d1e5-e063-6394a90a6081
spl set id: 1b2b6579-7259-4e34-e063-6394a90afe08

Reported adverse events (FAERS/openFDA)#

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