FDA.reportPublic FDA data

Antibacterial

Manufacturer
DIAMO KOZMETIK SANAYI IC VE DIS TICARET LIMITED SIRKETI
Effective date
2020-06-22
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:18:42

Label at a glance#

ProductAntibacterial
Active ingredientBENZALKONIUM CHLORIDE
Label structure10 sections

Dosage and administration

apply onto wet hands. Lather and rinse thoeoughly.

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride - 0.13%

OTC - PURPOSE SECTION

Purpose - Antibacterial

INDICATIONS & USAGE SECTION

Use help eliminate bacteria on hands

Warnings For external use only

WARNINGS SECTION

Causes serious eye damage. Toxic to aquatic life.Avoid release to the environment.

Dispose of contents/container in accordance with national regulations.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or redness develops

When using this product

OTC - WHEN USING SECTION

Avoid contact with eyes.In case of contact, flush and rinse with water.

Remove contact lenses, if present and easy to do. Continue rinsing.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Except under adult supervision. DO NOT EAT DRINK.

Keep away from food,drink and animal feeding stuffs,

If swallowed get medical help or contact posion control right away.

Directions

DOSAGE & ADMINISTRATION SECTION

apply onto wet hands.

Lather and rinse thoeoughly.

INACTIVE INGREDIENT SECTION

Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Sodium Chloride, Citric Acid, Glycerin, Fragrance, Tetrasodium EDTA, Methylchloroisothiazolinone, Methylisothiazolinone, Benzophenone-4,Benzyl Alcohol,Cl 19140

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LEMONLEMON

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapPSN3
1046593benzalkonium chloride 1.3 MG/ML Medicated Liquid SoapSCD3
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapSY3
1046593benzalkonium chloride 1.33 MG/ML Medicated Liquid SoapSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
78242-003-012022-01-28C16284748780-1d6a99b39-c37e-a426-e053-dadaa90af4c2Antibacterial- Germout Hand Soap, Triclosan free, Kitchen Lemon

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78242-003-01Antibacterial325 mL in 1 BOTTLE, PLASTICLIQUID3253

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78242-003ANTIBACTERIAL (BENZALKONIUM CHLORIDE 0.13%) LIQUID [DIAMO KOZMETIK SANAYI IC VE DIS TICARET LIMITED SIRKETI]3Legacy NDC, 1 package rows20200623_bfbb7579-84eb-4887-a0a4-682dce44f019.zip

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
78242-00378242-003-01

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
WATER059QF0KO0RIACT
SODIUM LAURETH SULFATEBPV390UAP0IACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
COCO DIETHANOLAMIDE92005F972DIACT
SODIUM CHLORIDE451W47IQ8XIACT
GLYCERINPDC6A3C0OXIACT
DITETRACYCLINE TETRASODIUM EDETATEWX0A0IT7K5IACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
SULISOBENZONE1W6L629B4KIACT
BENZYL ALCOHOLLKG8494WBHIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
LIMONENE, (+)-GFD7C86Q1WIACT
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
a8b0cc59-5d57-a983-e053-2a95a90a5941bfbb7579-84eb-4887-a0a4-682dce44f0192020-06-22WarningsExact identifier
spl id: a8b0cc59-5d57-a983-e053-2a95a90a5941
spl set id: bfbb7579-84eb-4887-a0a4-682dce44f019

Reported adverse events (FAERS/openFDA)#

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