FDA.reportPublic FDA data

Certus BZK Antiseptic Towelette

Manufacturer
Certus Medical, Inc.
Effective date
2011-04-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:27:53

Label at a glance#

ProductCertus BZK Antiseptic Towelette
Active ingredientBENZALKONIUM CHLORIDE
Label structure11 sections

Label contents#

Full prescribing information#

Drug Facts Box OTC Active Ingredient Section

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13%

Drug Facts Box OTC Purpose Section

OTC - PURPOSE SECTION

First Aid Antiseptic

Drug Facts Box OTC Indications & Usage Section

INDICATIONS & USAGE SECTION

First aid antiseptic to help prevent the risk of infection in minor cuts, scrapes and burns

Drug Facts Box OTC Warnings Section

WARNINGS SECTION

For external use only

Drug Facts Box OTC Do Not Use Section

OTC - DO NOT USE SECTION

in the eyes or apply over large areas of the body

longer than 1 week unless directed by a doctor

Drug Facts Box OTC Ask Doctor Section

OTC - ASK DOCTOR SECTION

in case of deep or puncture wounds, animal bites,  or serious burns

Drug Facts Box OTC Stop Use Section

OTC - STOP USE SECTION

and ask a doctor if the condition persists or gets worse

Drug Facts Box OTC Keep Out Of Reach Of Children Section

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Drug Facts Box OTC Dosage & Administration Section

DOSAGE & ADMINISTRATION SECTION

clean the affected area

apply a small amount of this product on the area 1 to 3 times daily

may be covered with a sterile bandage when dry

Drug Facts Box OTC Inactive Ingredient Section

INACTIVE INGREDIENT SECTION

purified water

Certus BZK Antiseptic Towelette 210014 pouch

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

210014.jpg  Certus BZK Antiseptic Towelette  pouch   image of pouch labelimage of pouch label

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
75990-5008-32020-01-31C16284748780-19d75b9cf-d9a6-f424-e053-dadaa90a57ceCertus BZK Antiseptic Towelette 210014 Drug Facts and Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75990-5008-3Certus BZK Antiseptic Towelette1.4 mL in 1 POUCHSWAB1.41

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75990-5008CERTUS BZK ANTISEPTIC TOWELETTE (BENZALKONIUM CHLORIDE) SWAB [CERTUS MEDICAL, INC.]1Legacy NDC, 1 package rows20110502_59f0dfee-7ebd-4566-a6ef-ac3b3cdab1d1.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BENZALKONIUM CHLORIDEACTIVE INGREDIENTF5UM2KM3W71
BENZALKONIUMACTIVE MOIETY7N6JUD5X6Y1
WATERINACTIVE INGREDIENT059QF0KO0R1

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
75990-500875990-5008-3

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
e5e298f9-51c0-42ed-bc49-163b6a8a2c9a59f0dfee-7ebd-4566-a6ef-ac3b3cdab1d12011-04-12WarningsExact identifier
spl id: e5e298f9-51c0-42ed-bc49-163b6a8a2c9a
spl set id: 59f0dfee-7ebd-4566-a6ef-ac3b3cdab1d1

Reported adverse events (FAERS/openFDA)#

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