FDA.reportPublic FDA data

Antiseptic

Manufacturer
MCL Enterprises
Effective date
2017-12-28
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:53:51

Label at a glance#

ProductAntiseptic
Active ingredientBENZALKONIUM CHLORIDE
Label structure6 sections

Dosage and administration

Tear pouch and clean the affected area

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride, 0.13% W/W

Purpose

OTC - PURPOSE SECTION

First Aid Antiseptic

Use:

INDICATIONS & USAGE SECTION

To prevent infection in minor cuts, scrapes and burns

Warnings:

WARNINGS SECTION

  • For external use only

Do not use:

OTC - DO NOT USE SECTION

  • for deep puncture wounds, animal bites, or serious burns. 
  • in eyes or over large areas of the body

Stop use and ask a doctor if:

OTC - STOP USE SECTION

  • irritation, redness, or symptoms develop
  • the condition persists or gets worse

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions:

DOSAGE & ADMINISTRATION SECTION

Tear pouch and clean the affected area

Inactive Ingredient:

INACTIVE INGREDIENT SECTION

Purified Water

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71622-001-002020-09-27C16284748780-1ab0e2407-2dc6-f274-e053-dbdaa90a6471Antiseptic Wipe
71622-001-002020-09-25C16284748780-1ab0e2407-2dc6-f274-e053-dbdaa90a6471Antiseptic Wipe
71622-001-002020-07-22C16284748780-1ab0e2407-2dc6-f274-e053-dbdaa90a6471Antiseptic Wipe

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71622-001-00Antiseptic1.4 g in 1 PATCHSWAB1.42
71622-001-00Antiseptic1 in 1 POUCHSWAB12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71622-001ANTISEPTIC (BENZALKONIUM CHLORIDE) SWAB [MCL ENTERPRISES]2Legacy NDC, 2 package rows20171229_a8214d4a-f613-43de-8aef-9675eca3efb9.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
71622-00171622-001-00

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
616d73b6-86fb-af5f-e053-2991aa0ad70fa8214d4a-f613-43de-8aef-9675eca3efb92017-12-28WarningsExact identifier
spl id: 616d73b6-86fb-af5f-e053-2991aa0ad70f
spl set id: a8214d4a-f613-43de-8aef-9675eca3efb9

Reported adverse events (FAERS/openFDA)#

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