FDA.reportPublic FDA data

Antibacterial

Manufacturer
Thornton Industries, Inc.
Effective date
2020-06-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:19:44

Label at a glance#

ProductAntibacterial
Active ingredientBENZALKONIUM CHLORIDE
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride - 0.13%......................Purpose - Antibacterial

OTC - PURPOSE SECTION

Purpose - Antibacterial

INDICATIONS & USAGE SECTION

Uses for handwashing or decrease bacteria to the skin

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 the product

  • do not get 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 (Cl14700)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

3232

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANELPACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
65260-000-322022-01-28C16284748780-1d6a99b39-4128-a426-e053-dadaa90af4c2Spa Soap: Antibacterial Soap
65260-000-642022-01-28C16284748780-1d6a99b39-4128-a426-e053-dadaa90af4c2Spa Soap: Antibacterial Soap

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65260-000-32Antibacterial946 mL in 1 BOTTLE, PLASTICLIQUID9461
65260-000-64Antibacterial1900 mL in 1 BOTTLE, PLASTICLIQUID19001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65260-000ANTIBACTERIAL (BENZALKONIUM CHLORIDE) LIQUID [THORNTON INDUSTRIES, INC.]1Legacy NDC, 2 package rows20200701_a954ae54-534b-4e2d-e053-2995a90aa038.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
65260-00065260-000-32, 65260-000-64

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
GLYCERINPDC6A3C0OXIACT
DITETRACYCLINE TETRASODIUM EDETATEWX0A0IT7K5IACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
WATER059QF0KO0RIACT
SODIUM LAURETH SULFATEBPV390UAP0IACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
SODIUM CHLORIDE451W47IQ8XIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
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
a954ae54-534c-4e2d-e053-2995a90aa038a954ae54-534b-4e2d-e053-2995a90aa0382020-06-30WarningsExact identifier
spl id: a954ae54-534c-4e2d-e053-2995a90aa038
spl set id: a954ae54-534b-4e2d-e053-2995a90aa038

Reported adverse events (FAERS/openFDA)#

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