FDA.reportPublic FDA data

Benzalkonium chloride

Manufacturer
Old East Main Co. | Nice-Pak Products, LLC
Effective date
2026-03-02
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:48:23

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 with water.

Stop use and ask a doctor

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, linalool, butylphenyl methylpropional, limonene, geraniol, citric acid, tetrasodium EDTA, benzophenone-4, sodium benzoate, yellow 10, green 3

Adverse Reaction

ADVERSE REACTIONS SECTION

100% Satisfaction Guaranteed!

(888) 309-9030

DISTRIBUTED BY OLD EAST MAIN CO.

100 MISSION RIDGE

GOODLETTSVILLE, TN 37072

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

STUDIO SELECTION™

antibacterial

FOAMING HAND SOAP

Helps kill harmful germs

fresh pear scent

7.5 FL OZ (221 mL)

mm01mm01mm02mm02

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeData MatrixL0022497BAmm02.jpg
Data codeData MatrixL0022497FAmm01.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75712-575-96Benzalkonium chloride221 mL in 1 BOTTLE, PLASTICLIQUID2212

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
75712-57575712-575-96

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
SODIUM BENZOATEOJ245FE5EUIACT
WATER059QF0KO0RIACT
BUTYLPHENYL METHYLPROPIONALT7540GJV69IACT
LAURAMIDOPROPYLAMINE OXIDEI6KX160QTVIACT
LIMONENE, (+)-GFD7C86Q1WIACT
GERANIOLL837108USYIACT
SULISOBENZONE1W6L629B4KIACT
MYRISTAMIDOPROPYLAMINE OXIDE3HSF539C9TIACT
D&C YELLOW NO. 1035SW5USQ3GIACT
LAURAMINE OXIDE4F6FC4MI8WIACT
EDETATE SODIUMMP1J8420LUIACT
LINALOOL, (+)-F4VNO44C09IACT
FD&C GREEN NO. 33P3ONR6O1SIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12026-01-21monthly-update2026-06-03 17:53:13

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 CHLORIDEOld East Main Co.48e813ce-3893-b95f-e063-6294a90a18f22026-03-02Warnings, Adverse reactionsExact identifier
ndc (package): 75712-575-96
ndc (product): 75712-575
ndc11 (package): 75712057596
spl id: 4c0faf92-e9ab-2047-e063-6394a90a3f9a
spl set id: 48e813ce-3893-b95f-e063-6294a90a18f2

Reported adverse events (FAERS/openFDA)#

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