FDA.reportPublic FDA data

Benzalkonium Chloride

Manufacturer
Progressive
Effective date
2022-10-14
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:51:02

Label at a glance#

ProductBenzalkonium Chloride
Active ingredientBENZALKONIUM CHLORIDE
Label structure8 sections

Indications and uses

For hand sanitizing to decrease bacteria on the skin. Apply topically to the skin to help prevent cross contamination. Recommended for repeated use. Dries in seconds.

Dosage and administration

Tear V notch on top of plastic bag. Pull first wipe from the center of roll through opening of bag. Thread first wipe through the dispensing nozzle in lid of floor stand or Thread first wipe through the dispensing nozzle in top of wall mounted dispenser. Close dispenser door. Wipe dispensing tension may be adjusted on top of dispenser. Dispenser must be mounted with wipes disepensing up.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

  • For hand sanitizing to decrease bacteria on the skin.
  • Apply topically to the skin to help prevent cross contamination.
  • Recommended for repeated use.
  • Dries in seconds.

Warnings

WARNINGS SECTION

For external use only.

May irritate eyes.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children unless under adult supervision

Directions

DOSAGE & ADMINISTRATION SECTION

  • Tear V notch on top of plastic bag.
  • Pull first wipe from the center of roll through opening of bag.
  • Thread first wipe through the dispensing nozzle in lid of floor stand or
  • Thread first wipe through the dispensing nozzle in top of wall mounted dispenser.
  • Close dispenser door. Wipe dispensing tension may be adjusted on top of dispenser. Dispenser must be mounted with wipes disepensing up.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Juice, Tocopherol Acetate, Sodium Hydroxide, Dehydroacetic Acid, Tetrasodium EDTA, Benzoic Acid, PEG 40 Hydrogenated Castor Oil, Benzalkonium Chloride, Cocamidapropyl Betaine, Fragrance, Propylene Glycol, Phenoxyethanol, Water.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

wipes plus

SANITIZING ALCOHOL FREE WIPES

  • Kills 99.9% of germs

800 CT

800CT800CT

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSN2
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCD2
1038558benzalkonium chloride 0.13 % Topical ClothSY2
1038558benzalkonium chloride 0.13 % Topical SwabSY2
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSY2
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSY2
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
67151-323-072024-01-30C16284748780-11030e365-45a7-111a-e063-dadaa90a10e2Wipe Plus 800ct

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67151-323-07Benzalkonium Chloride800 in 1 CANISTERCLOTH8002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67151-323BENZALKONIUM CHLORIDE (SANITIZING WIPES) CLOTH [PROGRESSIVE]2Legacy NDC, 1 package rows20221015_dc149dd3-b9f1-9050-e053-2a95a90a33a8.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67151-32367151-323-07

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
ALOE VERA WHOLEKIZ4X2EHYXIACT
DEHYDROACETIC ACID2KAG279R6RIACT
WATER059QF0KO0RIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
EDETATE SODIUMMP1J8420LUIACT
PHENOXYETHANOLHIE492ZZ3TIACT
HYDROGENATED CASTOR OILZF94AP8MEYIACT
BENZOIC ACID8SKN0B0MIMIACT
SODIUM HYDROXIDE55X04QC32IIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT

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
eaff252d-4ffa-0d2a-e053-2a95a90ae392dc149dd3-b9f1-9050-e053-2a95a90a33a82022-10-14WarningsExact identifier
spl id: eaff252d-4ffa-0d2a-e053-2a95a90ae392
spl set id: dc149dd3-b9f1-9050-e053-2a95a90a33a8

Reported adverse events (FAERS/openFDA)#

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