FDA.reportPublic FDA data

Benzalkonium Chloride Antiseptic

Manufacturer
NANTONG STRIP MEDICAL SUPPLY CO.,LTD.
Effective date
2010-05-26
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:24:38

Label at a glance#

ProductBenzalkonium Chloride Antiseptic
Active ingredientBENZALKONIUM CHLORIDE
Label structure7 sections

Dosage and administration

Adults and Children 2 year and older; Apply to cleaned affected area not more than 3 times daily. Children under 2 years of age ; Consult a doctor

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride  0.4%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

Prevent infection in minor scrapes

Warnings

WARNINGS SECTION

For external use only
Flammable,keep away for fire or flame

Do not use:

    * In large quantities
    * over large areas of the body
    * in eyes
    * over raw or blistered areas

Stop use and ask a doctor if conditions worsen or persist for more than 7 days or clear up and occur again within a few days.

Keep out of reach of children.if swallowed get medical help or contact Poison control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and Children 2 year and older; Apply to cleaned affected area not more than 3 times daily.
Children under 2 years of age ; Consult a doctor

Inactive Ingredient

INACTIVE INGREDIENT SECTION

Purified Water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BZK cleansing towelette
BZK cleansing towelette

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1038561benzalkonium Cl 0.4 % Medicated PadPSN2
1038561benzalkonium chloride 4 MG/ML Medicated PadSCD2
1038561benzalkonium chloride 0.4 % Medicated ToweletteSY2
1038561benzalkonium chloride 0.4 % Topical SwabSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
35617-393-012019-10-21C16284748780-1956f9ecf-d57e-621f-e053-dbdaa90a74adDrug fact

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35617-393-01Benzalkonium Chloride Antiseptic1 in 1 PACKETSWAB12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35617-393BENZALKONIUM CHLORIDE ANTISEPTIC (BENZALKONIUM CHLORIDE) SWAB [NANTONG STRIP MEDICAL SUPPLY CO.,LTD. ]2Legacy NDC, 1 package rows20100526_4a8a9173-cd11-4d79-82c3-1ea0a26568b8.zip

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
35617-39335617-393-01

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
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
806658e8-00f1-4184-96cf-695a09bb882b4a8a9173-cd11-4d79-82c3-1ea0a26568b82010-05-26WarningsExact identifier
spl id: 806658e8-00f1-4184-96cf-695a09bb882b
spl set id: 4a8a9173-cd11-4d79-82c3-1ea0a26568b8

Reported adverse events (FAERS/openFDA)#

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