FDA.reportPublic FDA data

BZK Antiseptic Swab

Manufacturer
JIANGSU HAIDA INTERNATIONAL TRADING CO., LTD.
Effective date
2023-12-26
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:05:40

Label at a glance#

ProductBZK Antiseptic Swab
Active ingredientBENZALKONIUM CHLORIDE
Label structure10 sections

Dosage and administration

Clean the affected area. Apply a small amount of this product on the area 1 to 3 times daily. May be covered with a sterile bandage. If bandaged,let dry first.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13%

Purpose

OTC - PURPOSE SECTION

First Aid Antiseptic.

USE

INDICATIONS & USAGE SECTION

First aid antiseptic to help prevent infection in minor cuts,scrapes and burns.

WARNINGS

WARNINGS SECTION

For external use only.

Do not use

In the eyes or apply over large areas of the body.

In case of deep or puncture wounds,animal bites or serious burns,consult a doctor.

Stop use

If the condition persists or gets worse,consult a doctor.

Do not use longer than 1 week unless directed by a doctor.

DIRECTIONS

INSTRUCTIONS FOR USE SECTION

Clean the affected area.

Apply a small amount of this product on the area 1 to 3 times daily.

May be covered with a sterile bandage.

If bandaged,let dry first.

Other Information

OTHER SAFETY INFORMATION

Store at room temperature:15-30℃(59-86℉)

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Purified water, sodium bicarbonate.

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 Poison control Center right away.

DOSAGE & ADMINISTRATION SECTION

Apply a small amount of this product on the area 1 to 3 times daily.

Label principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label-1 BZK antiseptic swablabel-1 BZK antiseptic swab

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
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
80514-003-012025-01-30C16284748780-12cef2736-97c0-d83d-e063-dadaa90ab31fae71a05b-8ec8-bf9f-e053-2995a90a5a4c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80514-003-01BZK Antiseptic Swab0.5 g in 1 POUCHSWAB0.52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80514-003BZK ANTISEPTIC SWAB (BENZALKONIUM CHLORIDE) SWAB [JIANGSU HAIDA INTERNATIONAL TRADING CO., LTD.]2Legacy NDC, 1 package rows20231226_ae71a05b-8ec8-bf9f-e053-2995a90a5a4c.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80514-00380514-003-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
SODIUM BICARBONATE8MDF5V39QOIACT

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
0d636430-a360-7ce8-e063-6394a90a7197ae71a05b-8ec8-bf9f-e053-2995a90a5a4c2023-12-26WarningsExact identifier
spl id: 0d636430-a360-7ce8-e063-6394a90a7197
spl set id: ae71a05b-8ec8-bf9f-e053-2995a90a5a4c

Reported adverse events (FAERS/openFDA)#

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