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 23:41:35

Label at a glance#

ProductAntibacterial
Active ingredientBENZALKONIUM CHLORIDE
Label structure10 sections

Dosage and administration

Squeeze onto wet hands or body sponge  Work into lather  Wash skin,rinse and dry toroughly

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

for handwashing to decrease bacteria on the skin

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

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • Squeeze onto wet hands or body sponge 
  • Work into lather 
  • Wash skin,rinse and dry toroughly

INACTIVE INGREDIENT SECTION

water, sodium laureth sulfate , cocamidopropyl betaine, sodium chloride, glycerin,

fragrance, polyquatemium-10 , PEG-8 , citric acid, tetrasodium EDTA, cocamidopropyl pg-dimonium chrolide,

methylchloroisothiazolinone, methlisothiazolinone, Yellow (CI 19140)

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

33P

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76772-032-502023-01-30C16284748780-1f386c649-cd7f-0266-e053-dadaa90a7c1aTop Care Antibacterial Liquid Hand Soap - Lemon

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76772-032-50Antibacterial500 mL in 1 BOTTLE, PUMPLIQUID5002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76772-032ANTIBACTERIAL (BENZALKONIUM CHLORIDE 0.13%) LIQUID [TSM ITHALAT IHRACAT SANAYI VE DIS TICARET LIMITED SIRKETI]2Legacy NDC, 1 package rows20210720_b0f93481-0c62-4f26-94ed-d6b2e63dd457.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76772-03276772-032-50

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
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
EDETIC ACID9G34HU7RV0IACT
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
c781a7c8-f5e8-53b9-e053-2995a90aa482b0f93481-0c62-4f26-94ed-d6b2e63dd4572021-07-19WarningsExact identifier
spl id: c781a7c8-f5e8-53b9-e053-2995a90aa482
spl set id: b0f93481-0c62-4f26-94ed-d6b2e63dd457

Reported adverse events (FAERS/openFDA)#

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