FDA.reportPublic FDA data

FOAMING ANTIBACTERIAL WASH

Manufacturer
KUTOL PRODUCTS
Effective date
2018-01-10
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 01:05:13

Label at a glance#

ProductFOAMING ANTIBACTERIAL WASH
Active ingredientBENZALKONIUM CHLORIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

BENZALKONIUM CHLORIDE ........0.13% w/w

OTC - PURPOSE SECTION

PURPOSE ....Antibacterial agent

INDICATIONS & USAGE SECTION

USES

For handwashing to decrease bacteria on skin

DOSAGE & ADMINISTRATION SECTION

Directions

To decrease bacteria on skin, apply small amount, covering hands with product for 30 seconds. Add water, lather, rinse.

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 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 physician or poison control center

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTS

Water, lauramine oxide, PEG-7 glyceryl cocoate, glycerin, laurtrimonium chloride, cocamido PG-dimonium chloride phosphate polyquaternium-7, fragrance, wheat amino acids, aloe barbadensis leaf juice, tocopheryl acetate, methyisothiazolinone, methylchloroisothiazolinone, red 33.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

labellabel

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
50865-64550865-645-17, 50865-645-31

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
WATER059QF0KO0RIACT
ALOE VERA LEAFZY81Z83H0XIACT
LAURAMINE OXIDE4F6FC4MI8WIACT
LAURTRIMONIUM CHLORIDEA81MSI0FICIACT
PEG-7 GLYCERYL COCOATEVNX7251543IACT
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD)0L414VCS5YIACT
COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATEH2KVQ74JM4IACT
GLYCERINPDC6A3C0OXIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
D&C RED NO. 339DBA0SBB0LIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
AMINO ACIDS, WHEAT0370GZL32FIACT

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
cdda8e48-d212-593d-e053-2a95a90ab2ba59149427-ce58-5a87-e053-2a91aa0a73992021-10-08WarningsExact identifier
spl set id: 59149427-ce58-5a87-e053-2a91aa0a7399

Reported adverse events (FAERS/openFDA)#

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