FDA.reportPublic FDA data

Benzalkonium Chloride

Manufacturer
Brands International Corporation
Effective date
2018-05-01
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:55:20

Label at a glance#

ProductBenzalkonium Chloride
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

Use for handwashing to decrease bacteria on the skin

WARNINGS SECTION

Warning - For external use only - hands only

OTC - WHEN USING SECTION

When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • irritaion or redness develops
  • condition persists for more than 72 hours

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 thoroughly

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Water (Aqua),Acrylates/C10-30 Alkyl Acrylate crosspolymer, Citrtic Acid, Cocamidopropyl Betaine,Cocamide MEA,Decyl Glucoside, DMDM Hydantoin,Sodium Benzoate, Sodium Laureth Sulfate, Sodium Chloride, Sodium Hydroxide, Glycerin, Fragrance,Panthenol (Parfum),PEG-12 Methyl Glucose Dioleate, Polyquatenium 10, Tetrasodium EDTA, Blue 1, Red# 4 (Cl 14700)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CuticuraCuticura

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapPSN2
1046593benzalkonium chloride 1.3 MG/ML Medicated Liquid SoapSCD2
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapSY2
1046593benzalkonium chloride 1.33 MG/ML Medicated Liquid SoapSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50157-210-012021-01-29C16284748780-1ba0f9c33-4197-a910-e053-dadaa90a0b85Cuticura- Antibacterial Hand Soap with Moisturizer & Pro-Vitamin B5

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50157-210-01Benzalkonium Chloride221 mL in 1 BOTTLELIQUID2212

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50157-210BENZALKONIUM CHLORIDE (ANTIBACTERIAL HAND SOAP) LIQUID [BRANDS INTERNATIONAL CORPORATION]2Legacy NDC, 1 package rows20180501_85fdc257-cb12-45ee-92eb-72c516802771.zip

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50157-21050157-210-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
CITRIC ACID ACETATEDSO12WL7AUIACT
DECYL GLUCOSIDEZ17H97EA6YIACT
DMDM HYDANTOINBYR0546TOWIACT
POLYQUATERNIUM-10 (1000 MPA.S AT 2%)GMR4PEN8PKIACT
SODIUM LAURETH SULFATEBPV390UAP0IACT
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM HYDROXIDE55X04QC32IIACT
GLYCOL STEARATE0324G66D0EIACT
GLYCERINPDC6A3C0OXIACT
DITETRACYCLINE TETRASODIUM EDETATEWX0A0IT7K5IACT
PANTHENOLWV9CM0O67ZIACT
POLYETHYLENE GLYCOL 600NL4J9F21N9IACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C RED NO. 4X3W0AM1JLXIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
COCO MONOETHANOLAMIDEC80684146DIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB

Source Document#

Source XML · Source PDF

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
6b265eab-234e-6a0a-e053-2a91aa0ad46885fdc257-cb12-45ee-92eb-72c5168027712018-05-01WarningsExact identifier
spl id: 6b265eab-234e-6a0a-e053-2a91aa0ad468
spl set id: 85fdc257-cb12-45ee-92eb-72c516802771

Reported adverse events (FAERS/openFDA)#

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