FDA.reportPublic FDA data

Antibacterial

Manufacturer
Uline | Kutol Products Company
Effective date
2023-08-24
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
legacy-cache
Hydrated at
2026-08-01 21:26:54

Label at a glance#

ProductAntibacterial
Active ingredientBENZALKONIUM CHLORIDE
Label structure8 sections

Label contents#

Full prescribing information#

INACTIVE INGREDIENT SECTION

Inactive Ingredient SectionInactive Ingredient Section

INDICATIONS & USAGE SECTION

Indications and Usage SectionIndications and Usage Section

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

OTC Keep out of Reach of Children SectionOTC Keep out of Reach of Children Section

OTC - PURPOSE SECTION

OTC Purpose SectionOTC Purpose Section

OTC - ACTIVE INGREDIENT SECTION

OTC Active Ingredient SectionOTC Active Ingredient Section

WARNINGS SECTION

Warnings SectionWarnings Section

DOSAGE & ADMINISTRATION SECTION

DosageDosage

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label ExampleLabel Example

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69790-640-072022-01-31C16284748780-1d6a99b39-c973-a426-e053-dadaa90af4c2ULine F640F
69790-640-242022-01-31C16284748780-1d6a99b39-c973-a426-e053-dadaa90af4c2ULine F640F
69790-640-312022-01-31C16284748780-1d6a99b39-c973-a426-e053-dadaa90af4c2ULine F640F
69790-640-072022-01-28C16284748780-1d6a99b39-c973-a426-e053-dadaa90af4c2ULine F640F
69790-640-242022-01-28C16284748780-1d6a99b39-c973-a426-e053-dadaa90af4c2ULine F640F
69790-640-312022-01-28C16284748780-1d6a99b39-c973-a426-e053-dadaa90af4c2ULine F640F

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69790-64069790-640-07, 69790-640-24, 69790-640-31

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
LAURAMINE OXIDE4F6FC4MI8WIACT
PEG-7 GLYCERYL COCOATEVNX7251543IACT
GLYCERINPDC6A3C0OXIACT
CITRUS RETICULATA FRUIT OIL25P9H3QU5EIACT
AMINO ACIDS, WHEAT0370GZL32FIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
WATER059QF0KO0RIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
LAURTRIMONIUM CHLORIDEA81MSI0FICIACT
COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATEH2KVQ74JM4IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
D&C RED NO. 339DBA0SBB0LIACT
ALOE VERA LEAFZY81Z83H0XIACT
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD)0L414VCS5YIACT

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
03a8a3c7-0f60-277e-e063-6294a90ac88d92730c66-127f-c90b-e053-2995a90a48232023-08-24WarningsExact identifier
spl id: 03a8a3c7-0f60-277e-e063-6294a90ac88d
spl set id: 92730c66-127f-c90b-e053-2995a90a4823

Reported adverse events (FAERS/openFDA)#

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