FDA.reportPublic FDA data

BZK Antiseptic Towelette

Manufacturer
MCURE HEALTH SOLUTIONS INC.
Effective date
2023-03-22
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 23:54:32

Label at a glance#

ProductBZK Antiseptic Towelette
Active ingredientBENZALKONIUM CHLORIDE
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Purpose - Benzalkonium Chloride 0.13% v/v....................Antiseptic

OTC - PURPOSE SECTION

Uses

For handwashing to decrease bacteria on the skin

WARNINGS SECTION

Warnings

For external use only.

OTC - DO NOT USE SECTION

Do not use

In the eyes. If this happens, rinse thoroughly with water.

OTC - STOP USE SECTION

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.

INDICATIONS & USAGE SECTION

Directions

  • Tear open packet, unfold and use as a washcloth. Allow hands to dry without wiping.

INACTIVE INGREDIENT SECTION

Inactive ingredients

Water

DOSAGE & ADMINISTRATION SECTION

Antiseptic Towelette

Sting-free

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

0000100001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSN5
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCD5
1038558benzalkonium chloride 0.13 % Topical ClothSY5
1038558benzalkonium chloride 0.13 % Topical SwabSY5
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSY5
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSY5
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSY5

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52486-610-012025-01-30C16284748780-19d75b9d1-1bb4-f424-e053-dadaa90a57ce7d523201-52c6-3d74-e053-2991aa0a5f0e
52486-610-012023-03-22C16284748780-19d75b9d1-1bb4-f424-e053-dadaa90a57ce7d523201-52c6-3d74-e053-2991aa0a5f0e
52486-610-012023-01-30C16284748780-19d75b9d1-1bb4-f424-e053-dadaa90a57ce7d523201-52c6-3d74-e053-2991aa0a5f0e
52486-610-012021-01-14C16284748780-19d75b9d1-1bb4-f424-e053-dadaa90a57ce7d523201-52c6-3d74-e053-2991aa0a5f0e
52486-610-012020-01-31C16284748780-19d75b9d1-1bb4-f424-e053-dadaa90a57ce7d523201-52c6-3d74-e053-2991aa0a5f0e

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52486-610-01BZK Antiseptic Towelette1.6 g in 1 POUCHCLOTH1.65

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52486-610BZK ANTISEPTIC TOWELETTE (BENZALKONIUM CHLORIDE) CLOTH [MCURE HEALTH SOLUTIONS INC.]5Legacy NDC, 1 package rows20230323_7d523201-52c6-3d74-e053-2991aa0a5f0e.zip

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
52486-61052486-610-01

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
f783f111-3a6b-0c11-e053-6294a90af7897d523201-52c6-3d74-e053-2991aa0a5f0e2023-03-22WarningsExact identifier
spl id: f783f111-3a6b-0c11-e053-6294a90af789
spl set id: 7d523201-52c6-3d74-e053-2991aa0a5f0e

Reported adverse events (FAERS/openFDA)#

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