Label at a glance#

ProductAntibacterial 2X

Active ingredientBENZALKONIUM CHLORIDE

Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride - 0.13%

OTC - PURPOSE SECTION

Purpose: Antibacterial

DOSAGE & ADMINISTRATION SECTION

Direction

wet hands
apply palmful to hands
scrub thoroughly
rinse

WARNINGS SECTION

For external use only

OTC - WHEN USING SECTION

When using this product

do not get it into eyes. If contact occurs, rinse eye thoroughly with water

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or redness develops

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

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

INACTIVE INGREDIENT SECTION

Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Sodium Chloride, Citric Acid, Glycerin, Fragrance, Tetrasodium EDTA, Methylchloroisothiazolinone, Methylisothiazolinone, Yellow# 5 (Cl 19140), Red# 4 (Cl 14700)

INDICATIONS & USAGE SECTION

Uses for handwashing or decrease bacteria to the skin

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

16-16

2X

RxCUI, Display, Full name table
RxCUI	Display	Full name	Type	Form / route
1046593	Benzalkonium (Soap)	benzalkonium chloride 1.3 MG/ML Medicated Liquid Soap	SCD Active

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1046593	benzalkonium chloride 0.13 % Medicated Liquid Soap	PSN	3
1046593	benzalkonium chloride 1.3 MG/ML Medicated Liquid Soap	SCD	3
1046593	benzalkonium chloride 0.13 % Medicated Liquid Soap	SY	3
1046593	benzalkonium chloride 1.33 MG/ML Medicated Liquid Soap	SY	3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50157-016-16	2025-01-30	C162847	48780-1	ba0f9c33-378f-a910-e053-dadaa90a0b85	f4baf52f-7632-4d6c-bbd0-9e883d5afb4f
50157-016-16	2021-08-26	C162847	48780-1	ba0f9c33-378f-a910-e053-dadaa90a0b85	f4baf52f-7632-4d6c-bbd0-9e883d5afb4f
50157-016-16	2021-01-29	C162847	48780-1	ba0f9c33-378f-a910-e053-dadaa90a0b85	f4baf52f-7632-4d6c-bbd0-9e883d5afb4f

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50157-016-16	Antibacterial2X	500 mL in 1 BOTTLE, PLASTIC	LIQUID	500		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50157-016	ANTIBACTERIAL 2X (BENZALKONIUM CHLORIDE) LIQUID [BRANDS INTERNATIONAL CORPORATION]	3	Legacy NDC, 1 package rows	20210827_f4baf52f-7632-4d6c-bbd0-9e883d5afb4f.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

Antibacterial 2X
Benzalkonium Chloride
WATER
SODIUM LAURETH SULFATE
COCAMIDOPROPYL BETAINE
SODIUM CHLORIDE
GLYCERIN
DITETRACYCLINE TETRASODIUM EDETATE
METHYLCHLOROISOTHIAZOLINONE
METHYLISOTHIAZOLINONE
FD&C YELLOW NO. 5
FD&C RED NO. 4
BENZALKONIUM

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
50157-016	50157-016-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
WATER	059QF0KO0R	IACT
SODIUM LAURETH SULFATE	BPV390UAP0	IACT
COCAMIDOPROPYL BETAINE	5OCF3O11KX	IACT
SODIUM CHLORIDE	451W47IQ8X	IACT
GLYCERIN	PDC6A3C0OX	IACT
DITETRACYCLINE TETRASODIUM EDETATE	WX0A0IT7K5	IACT
METHYLCHLOROISOTHIAZOLINONE	DEL7T5QRPN	IACT
METHYLISOTHIAZOLINONE	229D0E1QFA	IACT
FD&C YELLOW NO. 5	I753WB2F1M	IACT
FD&C RED NO. 4	X3W0AM1JLX	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
ca7b4f22-7472-d16f-e053-2a95a90a95cc			f4baf52f-7632-4d6c-bbd0-9e883d5afb4f	2021-08-26	Warnings	Exact identifier spl id: ca7b4f22-7472-d16f-e053-2a95a90a95cc spl set id: f4baf52f-7632-4d6c-bbd0-9e883d5afb4f

Reported adverse events (FAERS/openFDA)#

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

Antibacterial