FDA.reportPublic FDA data

Antibacterial

Manufacturer
McKesson | Central Solutions
Effective date
2024-10-11
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:24:29

Label at a glance#

ProductAntibacterial
Active ingredientBENZETHONIUM CHLORIDE
Label structure13 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Benzethonium Chloride @ 0.13%

OTC - PURPOSE SECTION

PurposeAntiseptic

INDICATIONS & USAGE SECTION

Uses

For handwashing to decrease bacteria on the skin.

WARNINGS SECTION

Warnings
For external use only.

Do not use in the eyes. Discontinue use if irritation and redness develops. If condition persists for more than 72 hours consult a doctor.

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
• Apply to hands and wet as needed.
• Lather vigorously for at least 15 seconds.
• Wash skin, rinse thoroughly and dry.

SPL UNCLASSIFIED SECTION

Other information- Protect from freezing. Avoid excessive heat.

INACTIVE INGREDIENT SECTION

Inactive Ingredients:
Purified Water, Cocamidopropyl Betaine, Lauramine Oxide, Glycerin, Cetrimonium Chloride, Fragrance, DMDM Hydantoin, Iodopropynyl Carbamate, Yellow 5, Red 4, (may contain Citric Acid, Sodium Hydroxide)

OTC - QUESTIONS SECTION

General Questions?Call 1-800-777-4908

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 68599-5502-1
McKesson
Foaming Antibacterial Soap
Clean Scent with Pump
Net Contents
8.5 fl oz
(251 mL)

53-23123-8.553-23123-8.5

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 68599-5502-2
McKesson
Foaming Antibacterial Soap
Clean Scent
Refill for McKesson Pump and Automatic Foam Dispensers MFR#s 53-FOAM and 53-Foam-Auto
Net Contents
1000 mL
(34 fl oz)

53-23126-1000 (2)53-23126-1000 (2)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 68599-5502-3
McKesson
Foaming Antibacterial Soap
Clean Scent with Pump
Net Contents
18 fl oz
(532 mL) 53-23127-18 (2)53-23127-18 (2)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039026benzethonium chloride 0.13 % Medicated Liquid SoapPSN3
1039026benzethonium chloride 1.3 MG/ML Medicated Liquid SoapSCD3
1039026benzethonium chloride 0.13 % Medicated Liquid SoapSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68599-5502-12020-03-28C16284748780-19d75b9d0-e4b2-f424-e053-dadaa90a57ceMcKESSON FOAMING ANTIBACTERIAL SOAP
68599-5502-22020-03-28C16284748780-19d75b9d0-e4b2-f424-e053-dadaa90a57ceMcKESSON FOAMING ANTIBACTERIAL SOAP
68599-5502-32020-03-28C16284748780-19d75b9d0-e4b2-f424-e053-dadaa90a57ceMcKESSON FOAMING ANTIBACTERIAL SOAP
68599-5502-12020-01-31C16284748780-19d75b9d0-e4b2-f424-e053-dadaa90a57ceMcKESSON FOAMING ANTIBACTERIAL SOAP
68599-5502-22020-01-31C16284748780-19d75b9d0-e4b2-f424-e053-dadaa90a57ceMcKESSON FOAMING ANTIBACTERIAL SOAP
68599-5502-32020-01-31C16284748780-19d75b9d0-e4b2-f424-e053-dadaa90a57ceMcKESSON FOAMING ANTIBACTERIAL SOAP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68599-5502-1Antibacterial251 mL in 1 BOTTLE, PUMPLIQUID2513
68599-5502-2Antibacterial1000 mL in 1 BOTTLELIQUID10003
68599-5502-3Antibacterial532 mL in 1 BOTTLE, PUMPLIQUID5323

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68599-5502ANTIBACTERIAL (BENZETHONIUM CHLORIDE) LIQUID [MCKESSON]3Current NDC, Legacy NDC, 3 package rows20241013_588a89cd-9481-6163-e053-2991aa0a9e3d.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68599-550268599-5502-1, 68599-5502-2, 68599-5502-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
LAURAMINE OXIDE4F6FC4MI8WIACT
CETRIMONIUM CHLORIDEUC9PE95IBPIACT
DMDM HYDANTOINBYR0546TOWIACT
IODOPROPYNYL BUTYLCARBAMATE603P14DHEBIACT
WATER059QF0KO0RIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
GLYCERINPDC6A3C0OXIACT
FD&C RED NO. 4X3W0AM1JLXIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
BENZETHONIUM CHLORIDEPH41D05744ACTIB

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
AntibacterialBENZETHONIUM CHLORIDEMcKesson588a89cd-9481-6163-e053-2991aa0a9e3d2024-10-11WarningsExact identifier
ndc (package): 68599-5502-2
ndc (package): 68599-5502-3
ndc (package): 68599-5502-1
ndc (product): 68599-5502
ndc11 (package): 68599550203
ndc11 (package): 68599550201
ndc11 (package): 68599550202
spl id: 24381ab3-73eb-f89a-e063-6394a90ab30a
spl set id: 588a89cd-9481-6163-e053-2991aa0a9e3d

Reported adverse events (FAERS/openFDA)#

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