FDA.reportPublic FDA data

Benzalkonium chloride

Manufacturer
Pharmacy Value Alliance, LLC | Nice-Pak Products, LLC
Effective date
2026-02-05
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:36:51

Label at a glance#

ProductBenzalkonium chloride
Active ingredientBENZALKONIUM CHLORIDE
Label structure11 sections

Dosage and administration

wet hands apply palmful to hands scrub thoroughly rinse thoroughly

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium chloride 0.13%

Purpose

OTC - PURPOSE SECTION

Antibacterial

Use

INDICATIONS & USAGE SECTION

for handwashing to decrease bacteria on the skin

Warnings

WARNINGS SECTION

For external use only: hands only

When using this product

OTC - WHEN USING SECTION

  • avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • irritation and redness develop
  • condition persists for more than 72 hours

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • wet hands
  • apply palmful to hands
  • scrub thoroughly
  • rinse thoroughly

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, cocamidopropyl betaine, lauramidopropylamine oxide, lauramine oxide, myristamidopropylamine oxide, glycerin, fragrance, citric acid, tetrasodium EDTA, benzophenone-4, sodium benzoate, blue 1, red 33

Adverse reactions

ADVERSE REACTIONS SECTION

INDEPENDANTLY TESTED • SATISFACTION GUARANTEED

If for any reason you are not satisfied with this product, please return it to the store where purchased for a full refund.

Distributed by: Pharmacy Value Alliance, LLC

407 East Lancaster Avenue,

Wayne, PA 19087

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Premier Value ®

Foaming

Hand Wash

antibacterial

Fresh scent

INDEPENDENTLY TESTED

SATISFACTION GUARANTEED

7.5 FL OZ (221 mL)

image descriptionimage descriptionimage descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapPSN4
1046593benzalkonium chloride 1.3 MG/ML Medicated Liquid SoapSCD4
1046593benzalkonium chloride 0.13 % Medicated Liquid SoapSY4
1046593benzalkonium chloride 1.33 MG/ML Medicated Liquid SoapSY4

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeData MatrixL0021291BAmm02.jpg
Data codeData MatrixL0021291FAmm01.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68016-866-45Benzalkonium chloride946 mL in 1 BOTTLE, PLASTICLIQUID9464
68016-866-96Benzalkonium chloride221 mL in 1 BOTTLE, PLASTICLIQUID2214

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
68016-86668016-866-96, 68016-866-45

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
LAURAMIDOPROPYLAMINE OXIDEI6KX160QTVIACT
LAURAMINE OXIDE4F6FC4MI8WIACT
MYRISTAMIDOPROPYLAMINE OXIDE3HSF539C9TIACT
GLYCERINPDC6A3C0OXIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
EDETATE SODIUMMP1J8420LUIACT
SULISOBENZONE1W6L629B4KIACT
SODIUM BENZOATEOJ245FE5EUIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
D&C RED NO. 339DBA0SBB0LIACT
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
Benzalkonium chlorideBENZALKONIUM CHLORIDEPharmacy Value Alliance, LLC5f9521f2-53f2-4d7e-9116-36e94e2d06952026-02-05Warnings, Adverse reactionsExact identifier
ndc (package): 68016-866-45
ndc (package): 68016-866-96
ndc (product): 68016-866
ndc11 (package): 68016086696
ndc11 (package): 68016086645
spl id: 4a1a0553-c314-c127-e063-6394a90aacb5
spl set id: 5f9521f2-53f2-4d7e-9116-36e94e2d0695

Reported adverse events (FAERS/openFDA)#

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