FDA.reportPublic FDA data

Foaming Antibacterial Hand

Manufacturer
US Chemical Corporation | Kutol Products Company
Effective date
2023-08-24
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:55:58

Label at a glance#

ProductFoaming Antibacterial Hand
Active ingredientBENZALKONIUM CHLORIDE
Label structure8 sections

Label contents#

Full prescribing information#

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENT SECTION

Inactive Ingredients Water, Lauramine Oxide, PEG-7 Glyceryl Cocate, Glycerin, Laurtrimonium Chloride, Cocamidopropyl PG-Dimonium Chloride Phosphate, Polyquaternium-7, Fragrance, Wheat Amono Acid, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, Methylisothiazolinone, Methylchloroisothiazolinone.

INDICATIONS & USAGE SECTION

Uses For handwashing to decrease bacteria on skin.

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient Benzalkonium Chloride 0.13% w/w

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, contact a physician or Poison Control Center right away.

OTC - PURPOSE SECTION

Purpose Antibacterial Agent

WARNINGS SECTION

Warnings For external use only. Avoid contact with eyes. If contact occurs, flush eyes with plenty of water. Stop use and ask a doctor if irritation or rash appears and persists.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal LabelPrincipal Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61307-640-102022-01-31C16284748780-1d6a99b39-d59d-a426-e053-dadaa90af4c2US Chem F640F
61307-640-102022-01-28C16284748780-1d6a99b39-d59d-a426-e053-dadaa90af4c2US Chem F640F

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61307-64061307-640-10

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
PEG-7 GLYCERYL COCOATEVNX7251543IACT
GLYCERINPDC6A3C0OXIACT
SODIUM COCOYL WHEAT AMINO ACIDSJW3VT57I11IACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
.ALPHA.-TOCOPHEROL ACETATE, D-A7E6112E4NIACT
LAURTRIMONIUM CHLORIDEA81MSI0FICIACT
COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATEH2KVQ74JM4IACT
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD)0L414VCS5YIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
WATER059QF0KO0RIACT
ALOE VERA LEAFZY81Z83H0XIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
LAURAMINE OXIDE4F6FC4MI8WIACT

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
03a8c5b9-b07f-8b10-e063-6294a90ac578a19d177c-89ca-37ed-e053-2995a90a4a6a2023-08-24WarningsExact identifier
spl id: 03a8c5b9-b07f-8b10-e063-6294a90ac578
spl set id: a19d177c-89ca-37ed-e053-2995a90a4a6a

Reported adverse events (FAERS/openFDA)#

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