FDA.reportPublic FDA data

Foaming Antibacterial Hand Wash

Manufacturer
Global Equipment Company | Kutol Products Company | Kutol Product Company
Effective date
2023-08-24
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:26:57

Label at a glance#

ProductFoaming Antibacterial Hand Wash
Active ingredientBENZALKONIUM CHLORIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient - Benzalkonium Chloride

OTC - PURPOSE SECTION

Purpose - Antibacterial

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 with water.

Stop use and ask a doctor if, in rare instances, redness or irritation develop 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 physician or poison control center.

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Primary LabelPrimary LabelPrimary Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78641-213-502022-01-31C16284748780-1d6a99b39-db1d-a426-e053-dadaa90af4c2Global Equipment F213F
78641-213-502022-01-28C16284748780-1d6a99b39-db1d-a426-e053-dadaa90af4c2Global Equipment F213F

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78641-21378641-213-50

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
.ALPHA.-TOCOPHEROL ACETATE, D-A7E6112E4NIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
D&C RED NO. 339DBA0SBB0LIACT
LAURTRIMONIUM CHLORIDEA81MSI0FICIACT
IODOPROPYNYL BUTYLCARBAMATE603P14DHEBIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
ALOE VERA LEAFZY81Z83H0XIACT
COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATEH2KVQ74JM4IACT
PEG-6 COCAMIDEYZ6NLA4O1EIACT
WATER059QF0KO0RIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB

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
03a91ad5-cb3a-beac-e063-6294a90a7976a7331431-df40-7ff4-e053-2995a90af9e52023-08-24WarningsExact identifier
spl id: 03a91ad5-cb3a-beac-e063-6294a90a7976
spl set id: a7331431-df40-7ff4-e053-2995a90af9e5

Reported adverse events (FAERS/openFDA)#

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