FDA.reportPublic FDA data

Antiseptic Wound Care

Manufacturer
ASCENT CONSUMER PRODUCTS, INC
Effective date
2023-11-22
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:02:42

Label at a glance#

ProductAntiseptic Wound Care MediCleanse Healing
Active ingredientBENZETHONIUM CHLORIDE
Label structure8 sections

Indications and uses

First aid to help prevent the risk of bacterial contamination in minor cuts, scrapes and burns.

Dosage and administration

clean the affected area spray a small amount of this product on the area 1 to 3 times a day may be covered with a sterile bandage if bandaged, let dry first

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Benzethonium Chloride 0.13%

Purpose

OTC - PURPOSE SECTION

First aid Antiseptic

Uses

INDICATIONS & USAGE SECTION

First aid to help prevent the risk of bacterial contamination in minor cuts, scrapes and burns.

Warnings

WARNINGS SECTION

For external use only

Do not use

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
  • for single patient use only

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

deep or puncture wounds, animal bites or serious burns

When using this product

OTC - WHEN USING SECTION

  • do not puncture or incinerate
  • contents under pressure

Stop use and consult a doctor if

OTC - STOP USE SECTION

  • condition persists or gets worse

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

  • clean the affected area
  • spray a small amount of this product on the area 1 to 3 times a day
  • may be covered with a sterile bandage
  • if bandaged, let dry first

Other information

SPL UNCLASSIFIED SECTION

  • Store between 59° and 86° F (15° and 30° C ).
  • See bottom of can for lot # and expiration date

Inactive ingredients

INACTIVE INGREDIENT SECTION

aloe barbadensis leaf extract (aloe vera), benzalkonium chloride, maltodextrin, purified water, sodium bicarbonate, sodium chloride

Questions?

OTC - QUESTIONS SECTION

1-888-547-5492

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
582205benzethonium chloride 0.13 % Topical SprayPSN3
582205benzethonium chloride 1.3 MG/ML Topical SpraySCD3
582205benzethonium chloride 0.13 % Topical SpraySY3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42829-002-21Antiseptic Wound CareMediCleanse Healing211 g in 1 BOTTLESOLUTION2113

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42829-002ANTISEPTIC WOUND CARE MEDICLEANSE HEALING (BENZETHONIUM CHLORIDE) SOLUTION [ASCENT CONSUMER PRODUCTS, INC]3Current NDC, Legacy NDC, 1 package rows20231123_e5c5add1-6fb5-5d9e-e053-2a95a90a50ba.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42829-00242829-002-21

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
MALTODEXTRIN7CVR7L4A2DIACT
WATER059QF0KO0RIACT
SODIUM BICARBONATE8MDF5V39QOIACT
SODIUM CHLORIDE451W47IQ8XIACT
BENZETHONIUM CHLORIDEPH41D05744ACTIB

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
Antiseptic Wound Care MediCleanse HealingBENZETHONIUM CHLORIDEASCENT CONSUMER PRODUCTS, INCe5c5add1-6fb5-5d9e-e053-2a95a90a50ba2023-11-22WarningsExact identifier
ndc (package): 42829-002-21
ndc (product): 42829-002
ndc11 (package): 42829000221
spl id: 0ac85b9a-3cfc-0c6a-e063-6294a90a479b
spl set id: e5c5add1-6fb5-5d9e-e053-2a95a90a50ba

Reported adverse events (FAERS/openFDA)#

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