FDA.reportPublic FDA data

Antiseptic

Manufacturer
Genuine First Aid LLC
Effective date
2012-04-29
Label type
HUMAN OTC DRUG LABEL
Version
16
Source
full-release
Hydrated at
2026-05-31 22:31:34

Label at a glance#

ProductAntiseptic
Active ingredientBENZALKONIUM CHLORIDE
Label structure12 sections

Dosage and administration

Tear open packet, unfold towelette and use to cleanse desired skin area.  Discard towelette appropriately after single use.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient:                        

Benzalkonium Chloride 0.13

Purpose

OTC - PURPOSE SECTION


Antiseptic

Use

INDICATIONS & USAGE SECTION

For Professional and Hospital use.  Helps prevent infection.  Antiseptic cleansing of face, hands and body without soap and water.

Warnings

WARNINGS SECTION

Warning:   For external use only.

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.

OTC - STOP USE SECTION

Stop use if unusual redness, swelling or other symptoms occur. Consult a physician immediately.

OTC - DO NOT USE SECTION

Do not use in the eyes or over large areas of the body.

Directions

DOSAGE & ADMINISTRATION SECTION

Tear open packet, unfold towelette and use to cleanse desired skin area.  Discard towelette appropriately after single use.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Inactive Ingredient:   Purified water

SPL UNCLASSIFIED SECTION

LOT/EXP:                           Made in CHINA

20130301

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Antiseptic Towelette

Genuine First Aid LLC, Clearwater FL 33755

www.GenuineFirstAid.com

1/pouch

GENUINE FIRST AID

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AntisepticTowelette
AntisepticTowelette

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52124-0001-12019-11-13C16284748780-197449f38-c9a4-f6ea-e053-dbdaa90aa703Antiseptic Towelette
52124-0001-22019-11-13C16284748780-197449f38-c9a4-f6ea-e053-dbdaa90aa703Antiseptic Towelette
52124-0001-32019-11-13C16284748780-197449f38-c9a4-f6ea-e053-dbdaa90aa703Antiseptic Towelette

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52124-0001-1Antiseptic0.8 mL in 1 PACKAGESWAB0.816
52124-0001-2Antiseptic10 in 1 BOXSWAB1016
52124-0001-2Antiseptic0.8 mL in 1 PACKETSWAB0.816
52124-0001-3Antiseptic100 in 1 BOXSWAB10016
52124-0001-3Antiseptic0.8 mL in 1 PACKETSWAB0.816

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52124-0001ANTISEPTIC (BENZALKONIUM CHLORIDE) SWAB [GENUINE FIRST AID LLC]16Legacy NDC, 5 package rows20120501_1362778d-2ad4-492a-a2c6-a46be54b54ac.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BENZALKONIUM CHLORIDEACTIVE INGREDIENTF5UM2KM3W716
BENZALKONIUMACTIVE MOIETY7N6JUD5X6Y16
WATERINACTIVE INGREDIENT059QF0KO0R16

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
52124-000152124-0001-1, 52124-0001-2, 52124-0001-3

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
e4f2d7c1-511f-4c61-b38c-567727801f1f1362778d-2ad4-492a-a2c6-a46be54b54ac2012-04-29WarningsExact identifier
spl id: e4f2d7c1-511f-4c61-b38c-567727801f1f
spl set id: 1362778d-2ad4-492a-a2c6-a46be54b54ac

Reported adverse events (FAERS/openFDA)#

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