FDA.reportPublic FDA data

Foaming Hand Sanitizer

Manufacturer
National Chemical Laboratories Of PA., Inc. | Kutol Products Company
Effective date
2024-10-03
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 20:53:23

Label at a glance#

ProductFoaming Hand Sanitizer
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 Agent

INDICATIONS & USAGE SECTION

Uses - Hand sanitizer to help reduce bacteria on the skin that could cause disease.

WARNINGS SECTION

Warnings

For external use only.

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

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

Directions

Apply a small amount to palm. Briskly rub, covering hands with product until dry.

INACTIVE INGREDIENT SECTION

Inactive ingredients

Water, Propylene Glycol, Cocamidopropyl Betaine, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate (Vitamin E), PEG-7 Glyceryl Cocoate, Fragrance/Parfum, Phenoxyethanol, Tetrasodium EDTA.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AFIA Alcohol Free Fm Hand SanitizerAFIA Alcohol Free Fm Hand Sanitizer

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71023-20771023-207-41

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ALOE VERA LEAFZY81Z83H0XIACT
FRAGRANCE LINEN ORC1900779658A7B6MY1IACT
PEG-7 GLYCERYL COCOATEVNX7251543IACT
PHENOXYETHANOLHIE492ZZ3TIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT

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
23975e36-b3ab-1b81-e063-6394a90ab7e31b2c1126-c44b-2cb3-e063-6394a90a4b7f2024-10-03WarningsExact identifier
spl id: 23975e36-b3ab-1b81-e063-6394a90ab7e3
spl set id: 1b2c1126-c44b-2cb3-e063-6394a90a4b7f

Reported adverse events (FAERS/openFDA)#

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