FDA.reportPublic FDA data

BZK Antiseptic

Manufacturer
Lights Medical Manufacture Co., Ltd.
Effective date
2026-01-21
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 01:34:28

Label at a glance#

ProductBZK Antiseptic
Active ingredientBENZALKONIUM CHLORIDE
Label structure8 sections

Indications and uses

Antiseptic cleaning of face, hands and body without soap and water.

Dosage and administration

Tear open packet, unfold and use as a washcloth. Allow hands to dry with wiping

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

benzalkonium chloride 0.13%

Purpose

OTC - PURPOSE SECTION

First aid antiseptic

Uses

INDICATIONS & USAGE SECTION

Antiseptic cleaning of face, hands and body without soap and water.

Warnings

WARNINGS SECTION

For external use only.

Do not use in the eyes.  If this happens, rinse thoroughly with water

Stop use and ask a doctor if irritation or redness develops and persists for more than 72 hours

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.

Directions

DOSAGE & ADMINISTRATION SECTION

Tear open packet, unfold and use as a washcloth. Allow hands to dry with wiping

INACTIVE INGREDIENT SECTION

Water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSN9
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCD9
1038558benzalkonium chloride 0.13 % Topical ClothSY9
1038558benzalkonium chloride 0.13 % Topical SwabSY9
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSY9
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSY9
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSY9

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61333-500-012021-06-02C16284748780-19d75b9d0-9e4a-f424-e053-dadaa90a57ce61333-500 BZK Antiseptic Swab
61333-500-012020-01-31C16284748780-19d75b9d0-9e4a-f424-e053-dadaa90a57ce61333-500 BZK Antiseptic Swab

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61333-500-01BZK Antiseptic1 in 1 PACKAGESWAB19
61333-500-01BZK Antiseptic0.4 mg in 1 POUCHSWAB0.49

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
benzalkonium chlorideACTIVE INGREDIENTF5UM2KM3W72
BENZALKONIUMACTIVE MOIETY7N6JUD5X6Y2
WaterINACTIVE INGREDIENT059QF0KO0R2

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
61333-50061333-500-01

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
WATER059QF0KO0RIACT
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
BZK AntisepticBENZALKONIUM CHLORIDELights Medical Manufacture Co., Ltd.698ed472-9204-46e3-95a4-d59e204628ac2026-01-21WarningsExact identifier
ndc (package): 61333-500-01
ndc (product): 61333-500
ndc11 (package): 61333050001
spl id: 48efec8f-83e6-0744-e063-6394a90a0c29
spl set id: 698ed472-9204-46e3-95a4-d59e204628ac

Reported adverse events (FAERS/openFDA)#

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