FDA.reportPublic FDA data

Antibacterial

Manufacturer
McKesson | Central Solutions
Effective date
2024-10-11
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:24:29

Label at a glance#

ProductAntibacterial
Active ingredientBENZETHONIUM CHLORIDE
Label structure14 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Benzethonium Chloride @ 0.13%

OTC - PURPOSE SECTION

Purpose

Antiseptic

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:
Benzyl Alcohol, Cetrimonium Chloride, Citric Acid, Cocamide MEA, Cocamidopropylamine Oxide, Fragrance,
Glycerin, PEG-200 Glyceryl Stearate, Red 4, Salicylic Acid, Sorbic Acid, Tetrasodium EDTA, Water, Yellow 5,
(may contain Sodium Hydroxide)

OTC - QUESTIONS SECTION

General Questions?Call 1-800-777-4908

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 68599-5501-1

McKesson
Antibacterial Soap
Clean Scent
Net Contents
1 gal
(3.79L)

53-28061-GL53-28061-GL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 68599-5501-3
McKesson
Antibacterial Soap
Clean Scent with Pump
Net Contents
8 fl oz
(237 mL)

53-28063-853-28063-8

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

53-28066-100053-28066-1000NDC 68599-5501-2
McKesson
Antibacterial Soap
Clean Scent
Refill for McKesson Pump Dispensers MFR#53-1000
Net Contents
1000 mL
(34 fl oz)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 68599-5501-4
McKesson
Antibacterial Soap
Clean Scent with Pump
Net Contents
18 fl oz
(532 mL)

53-28067-1853-28067-18

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039026benzethonium chloride 0.13 % Medicated Liquid SoapPSN4
1039026benzethonium chloride 1.3 MG/ML Medicated Liquid SoapSCD4
1039026benzethonium chloride 0.13 % Medicated Liquid SoapSY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68599-5501-12020-03-28C16284748780-19d75b9d0-e4af-f424-e053-dadaa90a57ceMcKesson Antibacterial Soap
68599-5501-22020-03-28C16284748780-19d75b9d0-e4af-f424-e053-dadaa90a57ceMcKesson Antibacterial Soap
68599-5501-32020-03-28C16284748780-19d75b9d0-e4af-f424-e053-dadaa90a57ceMcKesson Antibacterial Soap
68599-5501-42020-03-28C16284748780-19d75b9d0-e4af-f424-e053-dadaa90a57ceMcKesson Antibacterial Soap
68599-5501-12020-01-31C16284748780-19d75b9d0-e4af-f424-e053-dadaa90a57ceMcKesson Antibacterial Soap
68599-5501-22020-01-31C16284748780-19d75b9d0-e4af-f424-e053-dadaa90a57ceMcKesson Antibacterial Soap
68599-5501-32020-01-31C16284748780-19d75b9d0-e4af-f424-e053-dadaa90a57ceMcKesson Antibacterial Soap
68599-5501-42020-01-31C16284748780-19d75b9d0-e4af-f424-e053-dadaa90a57ceMcKesson Antibacterial Soap

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68599-5501-1Antibacterial3785 mL in 1 BOTTLELIQUID37854
68599-5501-2Antibacterial1000 mL in 1 BOTTLELIQUID10004
68599-5501-3Antibacterial237 mL in 1 BOTTLE, DISPENSINGLIQUID2374
68599-5501-4Antibacterial532 mL in 1 BOTTLE, DISPENSINGLIQUID5324

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68599-5501ANTIBACTERIAL (BENZETHONIUM CHLORIDE) LIQUID [MCKESSON]4Current NDC, Legacy NDC, 4 package rows20241013_58892abf-e0b9-83d9-e053-2a91aa0ad035.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68599-550168599-5501-1, 68599-5501-2, 68599-5501-3, 68599-5501-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
SALICYLIC ACIDO414PZ4LPZIACT
SORBIC ACIDX045WJ989BIACT
EDETATE SODIUMMP1J8420LUIACT
COCAMIDOPROPYLAMINE OXIDEM4SL82J7HKIACT
PEG-200 GLYCERYL STEARATEZ8ROG2A0LZIACT
BENZYL ALCOHOLLKG8494WBHIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
WATER059QF0KO0RIACT
COCO MONOETHANOLAMIDEC80684146DIACT
GLYCERINPDC6A3C0OXIACT
CETRIMONIUM CHLORIDEUC9PE95IBPIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
FD&C RED NO. 4X3W0AM1JLXIACT
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 CHLORIDEMcKesson58892abf-e0b9-83d9-e053-2a91aa0ad0352024-10-11WarningsExact identifier
ndc (package): 68599-5501-1
ndc (package): 68599-5501-3
ndc (package): 68599-5501-4
ndc (package): 68599-5501-2
ndc (product): 68599-5501
ndc11 (package): 68599550103
ndc11 (package): 68599550104
ndc11 (package): 68599550101
ndc11 (package): 68599550102
spl id: 24381ab3-73da-f89a-e063-6394a90ab30a
spl set id: 58892abf-e0b9-83d9-e053-2a91aa0ad035

Reported adverse events (FAERS/openFDA)#

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