FDA.reportPublic FDA data

Antibacterial

Manufacturer
Sante Manufacturing Inc
Effective date
2016-10-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:47:25

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

OTC - STOP USE SECTION

Stop use and ask a doctor If irritation or redness develops

WARNINGS SECTION

Warning for external use only

OTC - WHEN USING SECTION

When using this product

  • do not get into eyes. If contact occurs, rinse eyes 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

Direction

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

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Spa Soap Antibacterial Liquid Soap 2X UltraSpa Soap Antibacterial Liquid Soap 2X Ultra

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapPSN1
1046593benzalkonium chloride 1.3 MG/ML Medicated Liquid SoapSCD1
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapSY1
1046593benzalkonium chloride 1.33 MG/ML Medicated Liquid SoapSY1

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
71020-002-162020-01-31C16284748780-19d75b9d0-613c-f424-e053-dadaa90a57ce3e5c387e-7e1d-5998-e054-00144ff88e88

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71020-002-16Antibacterial500 mL in 1 BOTTLE, PLASTICLIQUID5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71020-002ANTIBACTERIAL (BENZALKONIUM CHLORIDE) LIQUID [SANTE MANUFACTURING INC]1Legacy NDC, 1 package rows20161009_3e5c387e-7e1d-5998-e054-00144ff88e88.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
71020-00271020-002-16

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
DITETRACYCLINE TETRASODIUM EDETATEWX0A0IT7K5IACT
FD&C RED NO. 4X3W0AM1JLXIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
WATER059QF0KO0RIACT
SODIUM CHLORIDE451W47IQ8XIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
GLYCERINPDC6A3C0OXIACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
SODIUM LAURETH SULFATEBPV390UAP0IACT

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
3e5c387e-7e1e-5998-e054-00144ff88e883e5c387e-7e1d-5998-e054-00144ff88e882016-10-08WarningsExact identifier
spl id: 3e5c387e-7e1e-5998-e054-00144ff88e88
spl set id: 3e5c387e-7e1d-5998-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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