FDA.reportPublic FDA data

ANTIBACTERIAL HAND

Manufacturer
CUSTOM RESEARCH LABS INC
Effective date
2022-03-29
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 23:48:59

Label at a glance#

ProductANTIBACTERIAL HAND
Active ingredientBENZALKONIUM CHLORIDE
Label structure8 sections

Indications and uses

HELPS ELIMINATE BACTERIA ON HANDS

Dosage and administration

WASH HANDS AND RINSE.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

BENZALKONIUM CHLORIDE  0.13%

PURPOSE

OTC - PURPOSE SECTION

ANTISEPTIC

USES

INDICATIONS & USAGE SECTION

HELPS ELIMINATE BACTERIA ON HANDS

WARNINGS

WARNINGS SECTION

FOR EXTERNAL USE ONLY.

WHEN USING THIS PRODUCT, AVOID CONTACT WITH EYES. IN CASE OF CONTACT, FLUSH WITH WATER.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN EXCEPT UNDER ADULT SUPERVISION. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

WASH HANDS AND RINSE.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

WATER (AQUA), SODIUM C14-16 OLEFIN SULFONATE, COCAMIDOPROPYL BETAINE, COCAMIDE MIPA, GLYCERIN, PHENOXYETHANOL, POLYSORBATE 20, CITRUS LIMON (LEMON) SEED OIL, D-LIMONENE, SODIUM CHLORIDE, CITRUS AURANTIUM DULCIS (ORANGE) OIL, CITRUS SINENSIS (BLOOD ORANGE) OIL, ETHYLHEXYL GLYCERIN, CITRIC ACID, POLYQUATERNIUM-10.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

01b LBL_Antibacterial Hand Soap_12oz01b LBL_Antibacterial Hand Soap_12oz

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapPSN5
1046593benzalkonium chloride 1.3 MG/ML Medicated Liquid SoapSCD5
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapSY5
1046593benzalkonium chloride 1.33 MG/ML Medicated Liquid SoapSY5

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50518-309-112024-01-30C16284748780-11030e365-60ab-111a-e063-dadaa90a10e2CRL (as CMO) - ANTIBACTERIAL HAND SOAP (50518-309)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50518-309-11ANTIBACTERIAL HAND355 mL in 1 BOTTLESOAP3555

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50518-309ANTIBACTERIAL HAND (BENZALKONIUM CHLORIDE) SOAP [CUSTOM RESEARCH LABS INC]5Legacy NDC, 1 package rows20220330_eca1f9e7-c8c6-42d2-9240-5130aaf2d52b.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50518-30950518-309-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
SODIUM C14-16 OLEFIN SULFONATEO9W3D3YF5UIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
COCO MONOISOPROPANOLAMIDE21X4Y0VTB1IACT
GLYCERINPDC6A3C0OXIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYSORBATE 207T1F30V5YHIACT
LEMON OILI9GRO824LLIACT
LIMONENE, (+)-GFD7C86Q1WIACT
SODIUM CHLORIDE451W47IQ8XIACT
ORANGE OILAKN3KSD11BIACT
CITRUS SINENSIS SEED OIL9WMM6OQ58AIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
POLYQUATERNIUM-10 (1000 MPA.S AT 2%)GMR4PEN8PKIACT
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
db64e907-3919-7025-e053-2995a90a8684eca1f9e7-c8c6-42d2-9240-5130aaf2d52b2022-03-29WarningsExact identifier
spl id: db64e907-3919-7025-e053-2995a90a8684
spl set id: eca1f9e7-c8c6-42d2-9240-5130aaf2d52b

Reported adverse events (FAERS/openFDA)#

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