FDA.reportPublic FDA data

Benzalkonium Chloride Antiseptic

Manufacturer
Nantong Sirius Packing Products Co., Ltd.
Effective date
2018-02-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:54:20

Label at a glance#

ProductBenzalkonium Chloride Antiseptic
Active ingredientBENZALKONIUM CHLORIDE
Label structure6 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  0.13%

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.

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.

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

11

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
72059-004-012020-01-31C16284748780-19d75b9cf-e56a-f424-e053-dadaa90a57ce72059-004

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72059-004-01Benzalkonium Chloride Antiseptic1 in 1 POUCHSWAB11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72059-004BENZALKONIUM CHLORIDE ANTISEPTIC (BENZALKONIUM CHLORIDE) SWAB [NANTONG SIRIUS PACKING PRODUCTS CO., LTD.]1Legacy NDC, 1 package rows20180201_64291ca2-e7a7-b650-e053-2a91aa0a49f4.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
72059-00472059-004-01

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
6428f7a5-bc12-5f4c-e053-2a91aa0a3c9d64291ca2-e7a7-b650-e053-2a91aa0a49f42018-02-01WarningsExact identifier
spl id: 6428f7a5-bc12-5f4c-e053-2a91aa0a3c9d
spl set id: 64291ca2-e7a7-b650-e053-2a91aa0a49f4

Reported adverse events (FAERS/openFDA)#

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