FDA.reportPublic FDA data

Antibacterial

Manufacturer
TSM ITHALAT IHRACAT SANAYI VE DIS TICARET LIMITED SIRKETI
Effective date
2021-07-19
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:41:34

Label at a glance#

ProductAntibacterial
Active ingredientBENZALKONIUM CHLORIDE
Label structure10 sections

Dosage and administration

Wet hand and apply soap. Lather front and back between your fingers and under your nails. Scrub for at least 20 second  rinse and dry.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium chloride 0.13%.................Anitbacterial Hand soap

Purpose

OTC - PURPOSE SECTION

Antibacterial Hand Soap

Use

INDICATIONS & USAGE SECTION

help eliminate bacteria on hands.

Warnings

WARNINGS SECTION

For external use only: hands only

When using this product

OTC - WHEN USING SECTION

  • avoid contact with eyes.  If contact occurs, rinse eyes with water

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • irritation or redness develops
  • condition persists for more than 72 hours

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • Except under adult supervision.
  • If swallowed, get medical help or contact a Poison Control Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

  • Wet hand and apply soap.
  • Lather front and back between your fingers and under your nails.
  • Scrub for at least 20 second 
  • rinse and dry.

INACTIVE INGREDIENT SECTION

Water, Cetrimonium chloride , Cocamidopropyl betaine, Sodium chloride, glycerin,PEG-40

Fragrance, Polyquatemium-10 , PEG-8 , Citric Acid, Tetrasodium EDTA, Cocamidopropyl PG-Dimonium Chrolide,

Methylchloroisothiazolinone, Methlisothiazolinone, Aloe Vera

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76772-030-182023-01-30C16284748780-1f386c64a-3a55-0266-e053-dadaa90a7c1aBerkley Jensen Liquid Hand Soap -Aloe vera & Silk proteins For Soft Skin

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76772-030-18Antibacterial1890 mL in 1 BOTTLE, PUMPLIQUID18902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76772-030ANTIBACTERIAL (BENZALKONIUM CHLORIDE 0.13%) LIQUID [TSM ITHALAT IHRACAT SANAYI VE DIS TICARET LIMITED SIRKETI]2Legacy NDC, 1 package rows20210720_163cc2b2-9d3d-4fa6-95d9-39208ee635b1.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
76772-03076772-030-18

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
CETRIMONIUM CHLORIDEUC9PE95IBPIACT
SODIUM LAURETH SULFATEBPV390UAP0IACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
POLYQUATERNIUM-10 (1000 MPA.S AT 2%)GMR4PEN8PKIACT
SODIUM CHLORIDE451W47IQ8XIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
GLYCERINPDC6A3C0OXIACT
COCAMIDOPROPYL PG-DIMONIUM CHLORIDE205Z54J075IACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
CITRIC ACID ACETATEDSO12WL7AUIACT
ALOE VERA LEAFZY81Z83H0XIACT
EDETATE SODIUMMP1J8420LUIACT
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
c781940a-6998-617e-e053-2a95a90a7b29163cc2b2-9d3d-4fa6-95d9-39208ee635b12021-07-19WarningsExact identifier
spl id: c781940a-6998-617e-e053-2a95a90a7b29
spl set id: 163cc2b2-9d3d-4fa6-95d9-39208ee635b1

Reported adverse events (FAERS/openFDA)#

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