Antibacterial

Manufacturer: TSM ITHALAT IHRACAT SANAYI VE DIS TICARET LIMITED SIRKETI
Effective date: 2020-05-01
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: full-release
Hydrated at: 2026-05-31 23:09:16

Label at a glance#

ProductAntibacterial

Active ingredientBENZALKONIUM CHLORIDE

Label structure11 sections

Dosage and administration

wet hands apply palmful to hands scrub thoroughly rinse toroughly

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

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

Purpose

OTC - PURPOSE SECTION

Antibacterial

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

wet hands
apply palmful to hands
scrub thoroughly
rinse toroughly

inactive ingredientsc

INACTIVE INGREDIENT SECTION

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

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

methylchloroisothiazolinone , methlisothiazolinone, blue 1, red 33

Adverse Reactions

ADVERSE REACTIONS SECTION

TSM BRANDS LLC

540 Equinox Ln Manlapan, NJ 07726

Made in TURKEY.

principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Untitled

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
777d68c6-a5ab-e06c-d314-677b0b9af0c8	Product name	2	20240508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
76772-004-80	2023-01-30	C162847	48780-1	f386c649-c725-0266-e053-dadaa90a7c1a	Luxury Hygiene Antibacterial Liquid Hand Soap - Lemon

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
76772-004-80	Antibacterial	500 mL in 1 BOTTLE, PUMP	LIQUID	500		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76772-004	ANTIBACTERIAL (BENZALKONIUM CHLORIDE 0.13%) LIQUID [TSM ITHALAT IHRACAT SANAYI VE DIS TICARET LIMITED SIRKETI]	3	Legacy NDC, 1 package rows	20200502_8021145a-b421-4ba6-ac45-135bbbd5edf0.zip

Products#

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

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

Antibacterial
Benzalkonium chloride 0.13%
WATER
SODIUM LAURETH SULFATE
COCAMIDOPROPYL BETAINE
POLYQUATERNIUM-10 (1000 MPA.S AT 2%)
SODIUM CHLORIDE
METHYLISOTHIAZOLINONE
GLYCERIN
COCAMIDOPROPYL PG-DIMONIUM CHLORIDE
METHYLCHLOROISOTHIAZOLINONE
CITRIC ACID ACETATE
EDETIC ACID
FD&C BLUE NO. 1
D&C RED NO. 33
BENZALKONIUM CHLORIDE
BENZALKONIUM

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
76772-004	76772-004-80

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
Name	UNII	Kind
WATER	059QF0KO0R	IACT
SODIUM LAURETH SULFATE	BPV390UAP0	IACT
COCAMIDOPROPYL BETAINE	5OCF3O11KX	IACT
POLYQUATERNIUM-10 (1000 MPA.S AT 2%)	GMR4PEN8PK	IACT
SODIUM CHLORIDE	451W47IQ8X	IACT
METHYLISOTHIAZOLINONE	229D0E1QFA	IACT
GLYCERIN	PDC6A3C0OX	IACT
COCAMIDOPROPYL PG-DIMONIUM CHLORIDE	205Z54J075	IACT
METHYLCHLOROISOTHIAZOLINONE	DEL7T5QRPN	IACT
CITRIC ACID ACETATE	DSO12WL7AU	IACT
EDETIC ACID	9G34HU7RV0	IACT
FD&C BLUE NO. 1	H3R47K3TBD	IACT
D&C RED NO. 33	9DBA0SBB0L	IACT
BENZALKONIUM CHLORIDE	F5UM2KM3W7	ACTIB

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
a49678b0-3629-f569-e053-2995a90aec81			8021145a-b421-4ba6-ac45-135bbbd5edf0	2020-05-01	Warnings, Adverse reactions	Exact identifier spl id: a49678b0-3629-f569-e053-2995a90aec81 spl set id: 8021145a-b421-4ba6-ac45-135bbbd5edf0

Reported adverse events (FAERS/openFDA)#

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