Benzalkonium Chloride

Manufacturer
Purocor LLC
Effective date
2022-11-29
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:51:56

Label at a glance#

ProductBenzalkonium Chloride
Active ingredientBENZALKONIUM CHLORIDE
Label structure12 sections

Dosage and administration

Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use(s)

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria that potentially can cause disease.

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

  • In children less than 2 months of age
  • On open skin wounds

When using this product

OTC - WHEN USING SECTION

keep out of eyes, ears and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask doctor

OTC - STOP USE SECTION

If irritation or rash appears.

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

  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

OTHER SAFETY INFORMATION

  • Store between 15-30ºC (59-86ºF)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Extract, Citric Acid, Decyl Glucoside, Disodium EDTA, Fragrance, Phenoxyethanol, Potassium Sorbate, Purified Water, Sodium Benzoate

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PuroCor

CLINICAL STRENGTH FORMULA

SANITIZING

WIPES

1200 WET WIPES

Lemon Scent

ALCOHOL

FREE

8" X 5.65" (20.3cm x 14.4cm)

11

22

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
82663-001-012024-01-30C16284748780-11030e365-4ff8-111a-e063-dadaa90a10e2Sanitizing Wipes

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82663-001-01Benzalkonium Chloride1 mg in 1 CANISTERCLOTH12
82663-001-01Benzalkonium Chloride1200 in 1 CANISTERCLOTH12002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82663-001BENZALKONIUM CHLORIDE (SANITIZING WIPES) CLOTH [PUROCOR LLC]2Legacy NDC, 2 package rows20221130_dc763fd1-0600-21d5-e053-2a95a90ae437.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82663-00182663-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

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
eea1e68b-042d-a9bd-e053-2a95a90a3df6dc763fd1-0600-21d5-e053-2a95a90ae4372022-11-29WarningsExact identifier
spl id: eea1e68b-042d-a9bd-e053-2a95a90a3df6
spl set id: dc763fd1-0600-21d5-e053-2a95a90ae437

Reported adverse events (FAERS/openFDA)#

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