FDA.reportPublic FDA data

BZK Antiseptic

Manufacturer
Aero-Med Ltd
Effective date
2012-05-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:31:45

Label at a glance#

ProductBZK Antiseptic
Active ingredientBENZALKONIUM CHLORIDE
Label structure10 sections

Indications and uses

General antiseptic Ask a doctor before use if you have deep or puncture wounds animal bites serious burns

Dosage and administration

Directions: Tear at notch, remove towelette, use only once As a first aid antiseptic clean affeected area apply 1 to 3 times daily may be covered with a sterile bandage if bandaged let dry first

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient                                     Purpose

Benzalkonium Chloride 0.13% v/v              Antiseptic

Use: towelette

OTC - PURPOSE SECTION

  • First aid antiseptic to help prevent skin infection in minor cuts, scrapes and burns
  • Antiseptic cleansing
  • Perineal and maternity care

Warnings

WARNINGS SECTION

For external use only

Indications and Usage

INDICATIONS & USAGE SECTION


General antiseptic

Ask a doctor before use if you have
  • deep or puncture wounds
  • animal bites
  • serious burns

Stop use if

OTC - STOP USE SECTION

Stop Use if:

  • irritation and redness develop
  • if condition persists for more than 72 hours, consult a physician.

Directions

DOSAGE & ADMINISTRATION SECTION

Directions:

  • Tear at notch, remove towelette, use only once
As a first aid antiseptic

  • clean affeected area
  • apply 1 to 3 times daily
  • may be covered with a sterile bandage
  • if bandaged let dry first

Keep out of reach of children

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.

Do not use

OTC - DO NOT USE SECTION

Do not use

  • as a first aid antiseptic for more than 1 week
  • in the eyes
  • over large areas of the body

Inactive Ingredient

INACTIVE INGREDIENT SECTION

Inactive Ingredient: Water

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Aeromed Benzalkonium Chloride Antiseptic Towelette

Aeromed BZK.jpg

BenzalkoniumBenzalkonium

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSN1
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCD1
1038558benzalkonium chloride 0.13 % Topical ClothSY1
1038558benzalkonium chloride 0.13 % Topical SwabSY1
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSY1
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSY1
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42449-210-132020-01-31C16284748780-19d75b9d0-b374-f424-e053-dadaa90a57ceBZK Towelettes

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42449-210-13BZK Antiseptic10 in 1 CASESWAB101
42449-210-13BZK Antiseptic100 in 1 BOXSWAB1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42449-210BZK ANTISEPTIC (BENZALKONIUM CHLORIDE) SWAB [AERO-MED LTD]1Legacy NDC, 2 package rows20120511_765b83f2-0806-4d94-bc2b-fd0ab1f545cd.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BENZALKONIUM CHLORIDEACTIVE INGREDIENTF5UM2KM3W71
BENZALKONIUMACTIVE MOIETY7N6JUD5X6Y1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42449-21042449-210-13

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
WATER059QF0KO0RIACT

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
5553f6f3-4b9d-4d9e-a683-713b888cc4f9765b83f2-0806-4d94-bc2b-fd0ab1f545cd2012-05-09WarningsExact identifier
spl id: 5553f6f3-4b9d-4d9e-a683-713b888cc4f9
spl set id: 765b83f2-0806-4d94-bc2b-fd0ab1f545cd

Reported adverse events (FAERS/openFDA)#

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