FDA.reportPublic FDA data

Cut Care Benzalkonium Chloride Antiseptic

Manufacturer
Zeus Medical Holdings LLC
Effective date
2013-09-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:36:54

Label at a glance#

ProductCut Care Benzalkonium Chloride Antiseptic
Active ingredientBENZALKONIUM CHLORIDE
Label structure7 sections

Indications and uses

First aid antiseptic to help prevent skin infection in minor cuts, scrapes and burns

Dosage and administration

clean affected area apply 1 to 3 times daily may be covered with a sterile bandage if bandaged let dry first

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

First aid antiseptic to help prevent skin infection in minor cuts, scrapes and burns

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

  • as a first aid antiseptic for more than 1 week
  • in the eyes
  • over large areas of the body

Ask a doctor before use

OTC - ASK DOCTOR SECTION

  • deep or puncture wounds
  • animal bites
  • serious burns

Stop use if

OTC - STOP USE SECTION

  • irritation and redness develop
  • if condition persists for more than 72 hours, consult a physician.

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

  • clean affected area
  • apply 1 to 3 times daily
  • may be covered with a sterile bandage
  • if bandaged let dry first

Inactive ingredient

INACTIVE INGREDIENT SECTION

purified water

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 53439-130-10
Cut Care
Benzalkonium Chloride Antiseptic Towelette
First aid antiseptic
Contents: 100 Towelettes

PRINCIPAL DISPLAY PANEL NDC 53439-130-10 Cut Care Benzalkonium Chloride Antiseptic Towelette First aid antiseptic Contents: 100 TowelettesPRINCIPAL DISPLAY PANEL NDC 53439-130-10 Cut Care Benzalkonium Chloride Antiseptic Towelette First aid antiseptic Contents: 100 Towelettes

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049254benzalkonium chloride 0.13 % Topical SolutionPSN1
1049254benzalkonium chloride 1.3 MG/ML Topical SolutionSCD1
1049254benzalkonium chloride 0.13 % Topical SolutionSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53439-130-102019-11-27C16284748780-19855d018-e390-cd31-e053-dbdaa90ab51aCut Care Benzalkonium Chloride Antiseptic Towlette

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53439-130-01Cut Care Benzalkonium Chloride Antiseptic1 in 1 POUCHSWAB11
53439-130-10Cut Care Benzalkonium Chloride Antiseptic100 in 1 CARTONSWAB1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53439-130CUT CARE BENZALKONIUM CHLORIDE ANTISEPTIC (BENZALKONIUM CHLORIDE) SWAB [ZEUS MEDICAL HOLDINGS LLC]1Legacy NDC, 2 package rows20130915_afceaa8e-af4c-4451-a13b-54659da36714.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
53439-13053439-130-01, 53439-130-10

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
f1633a33-a170-441d-a74f-304b0993807dafceaa8e-af4c-4451-a13b-54659da367142013-09-09WarningsExact identifier
spl id: f1633a33-a170-441d-a74f-304b0993807d
spl set id: afceaa8e-af4c-4451-a13b-54659da36714

Reported adverse events (FAERS/openFDA)#

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