FDA.reportPublic FDA data

Antibacterial

Manufacturer
Brands International Corporation | Sante Manufacturing Inc
Effective date
2022-12-12
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:52:25

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 - 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

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

spa hangspa hang

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapPSN3
1046593benzalkonium chloride 1.3 MG/ML Medicated Liquid SoapSCD3
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapSY3
1046593benzalkonium chloride 1.33 MG/ML Medicated Liquid SoapSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50157-005-902024-01-30C16284748780-1ba0f9c33-37a7-a910-e053-dadaa90a0b85824742f1-a585-41ef-bb93-0552aa0ba4cd
50157-005-902022-12-12C16284748780-1ba0f9c33-37a7-a910-e053-dadaa90a0b85824742f1-a585-41ef-bb93-0552aa0ba4cd
50157-005-902021-01-29C16284748780-1ba0f9c33-37a7-a910-e053-dadaa90a0b85824742f1-a585-41ef-bb93-0552aa0ba4cd

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50157-005-90Antibacterial2X500 mL in 1 BOTTLE, PLASTICLIQUID5003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50157-005ANTIBACTERIAL 2X (BENZALKONIUM CHLORIDE) LIQUID [BRANDS INTERNATIONAL CORPORATION]3Legacy NDC, 1 package rows20221213_824742f1-a585-41ef-bb93-0552aa0ba4cd.zip

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50157-00550157-005-90

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
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
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
efa6a439-a602-2542-e053-2995a90a1963824742f1-a585-41ef-bb93-0552aa0ba4cd2022-12-12WarningsExact identifier
spl id: efa6a439-a602-2542-e053-2995a90a1963
spl set id: 824742f1-a585-41ef-bb93-0552aa0ba4cd

Reported adverse events (FAERS/openFDA)#

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