FDA.reportPublic FDA data

Antibacterial

Manufacturer
Brands International Corporation | Sante Manufacturing Inc
Effective date
2021-05-25
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:40:31

Label at a glance#

ProductAntibacterial
Active ingredientBENZALKONIUM CHLORIDE
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride - 0.13%

OTC - PURPOSE SECTION

Purpose - Antibacterial

INDICATIONS & USAGE SECTION

Uses for handwashing or decrease bacteria to the skin

WARNINGS SECTION

Warnings For external use only

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or redness develops

OTC - WHEN USING SECTION

When using this product

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

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

DOSAGE & ADMINISTRATION SECTION

Directions

  • wet hands
  • apply palmful to hands
  • scrub thoroughly
  • rinse

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)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Antibacterial Liquid SoapAntibacterial Liquid Soap

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapPSN4
1046593benzalkonium chloride 1.3 MG/ML Medicated Liquid SoapSCD4
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapSY4
1046593benzalkonium chloride 1.33 MG/ML Medicated Liquid SoapSY4

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50157-004-642025-01-30C16284748780-1ba0f9c33-2351-a910-e053-dadaa90a0b8532bd63a1-1659-409d-a92c-65d1e46fce15
50157-004-642021-05-25C16284748780-1ba0f9c33-2351-a910-e053-dadaa90a0b8532bd63a1-1659-409d-a92c-65d1e46fce15
50157-004-642021-01-29C16284748780-1ba0f9c33-2351-a910-e053-dadaa90a0b8532bd63a1-1659-409d-a92c-65d1e46fce15

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50157-004-64Antibacterial1900 mL in 1 BOTTLE, PLASTICLIQUID19004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50157-004ANTIBACTERIAL (BENZALKONIUM CHLORIDE) LIQUID [BRANDS INTERNATIONAL CORPORATION]4Legacy NDC, 1 package rows20210526_32bd63a1-1659-409d-a92c-65d1e46fce15.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50157-00450157-004-64

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
SODIUM CHLORIDE451W47IQ8XIACT
GLYCERINPDC6A3C0OXIACT
DITETRACYCLINE TETRASODIUM EDETATEWX0A0IT7K5IACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
FD&C RED NO. 4X3W0AM1JLXIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
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
c32b409e-10ee-206d-e053-2995a90a4a4632bd63a1-1659-409d-a92c-65d1e46fce152021-05-25WarningsExact identifier
spl id: c32b409e-10ee-206d-e053-2995a90a4a46
spl set id: 32bd63a1-1659-409d-a92c-65d1e46fce15

Reported adverse events (FAERS/openFDA)#

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