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 23:41:33

Label at a glance#

ProductAntibacterial
Active ingredientBENZALKONIUM CHLORIDE
Label structure10 sections

Dosage and administration

Wet hands and apply soap. Lather front and back, between your fingers and under your nails. Scrub for at least 20 seconds 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

helps 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.  
  • In case of contact,
  • flush 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

If swallowed, get medical help or contact a Poison Control Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENT SECTION

Water, Cetrimonium Chloride , Cocamidopropyl Betaine, Sodium Chloride, Glycerin,

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

Methylchloroisothiazolinone, Methlisothiazolinone, Blue 1,Red 33

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

66

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
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
76772-035-332023-01-30C16284748780-1f386c64a-2f7f-0266-e053-dadaa90a7c1aBerkley Jensen Antibacterial Liquid Hand Soap - White Tea& berry

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76772-035-33Antibacterial332 mL in 1 BOTTLE, PUMPLIQUID3322

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76772-035ANTIBACTERIAL (BENZALKONIUM CHLORIDE 0.13%) LIQUID [TSM ITHALAT IHRACAT SANAYI VE DIS TICARET LIMITED SIRKETI]2Legacy NDC, 1 package rows20210720_018a991c-7eba-4670-af99-8d5cfe758dd8.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76772-03576772-035-33

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
WATER059QF0KO0RIACT
CETRIMONIUM CHLORIDEUC9PE95IBPIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
POLYQUATERNIUM-10 (1000 MPA.S AT 2%)GMR4PEN8PKIACT
SODIUM CHLORIDE451W47IQ8XIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
GLYCERINPDC6A3C0OXIACT
COCAMIDOPROPYL PG-DIMONIUM CHLORIDE205Z54J075IACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
CITRIC ACID ACETATEDSO12WL7AUIACT
STRAWBERRY4J2TY8Y81VIACT
EDETIC ACID9G34HU7RV0IACT
D&C RED NO. 339DBA0SBB0LIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
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
c781b12b-b1b7-fcd7-e053-2995a90ae1f8018a991c-7eba-4670-af99-8d5cfe758dd82021-07-19WarningsExact identifier
spl id: c781b12b-b1b7-fcd7-e053-2995a90ae1f8
spl set id: 018a991c-7eba-4670-af99-8d5cfe758dd8

Reported adverse events (FAERS/openFDA)#

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