FDA.reportPublic FDA data

Sterile Antibacterial Wound Wash

Manufacturer
Ascot Pharmaceuticals, Inc. | BOV Solutions Inc
Effective date
2016-06-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:46:31

Label at a glance#

ProductSterile Antibacterial Wound Wash
Active ingredientBENZALKONIUM CHLORIDE
Label structure9 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 shake well remove seal and cap 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

Benzalkonium 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 eyes
  • over large areas of the body
  • longer than 1 week unless directed by a doctor

Ask a doctor before use

OTC - ASK DOCTOR SECTION

in the event of deep puncture wounds, animal bites or severe burns

When using this product

OTC - WHEN USING SECTION

use only as directed

Stop use and ask a doctor if

OTC - STOP USE SECTION


  • conditions worsens
  • symptoms persists for more than seven days
  • symptoms disappear and reappear again within a few days

Keep out of reach of childrens

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 the affected area
  • shake well
  • remove seal and cap
  • 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


  • contents under pressure
  • do not puncture or incinerate can
  • do not drop can
  • do not store at temperatures above 120 degrees F.
  • do not use if tamper evident seal is broken

Inactive ingredients

INACTIVE INGREDIENT SECTION

Sodium Chloride U.S.P., Aloe Barbadensis Leaf Extract , Purified Water

Questions?

OTC - QUESTIONS SECTION

1-800-831-7210 

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70043-390-04

Ascot Pharmaceutical Inc.

Sterile Antibacterial

WOUND WASH

FIRST AID CLEANSER

  • Cleans wounds painlessly and effectively
  • No burn or sting
  • No Preservatives
  • No alcohol
  • No fragrance

ECO-FRIENDLY

No Fluorinated Hydrocarbon Propellants



  • COMPRESSED AIR IS THE PROPELLANT
  • SPRAYS UPSIDE DOWN OR AT ANY ANGLE
  • NO PUMPING NEEDED

3600 CONTINUOUS SPRAY

4 FL.OZ (120 mL)

LabelLabel





DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039012benzalkonium chloride 0.13 % Topical SprayPSN1
1039012benzalkonium chloride 1.3 MG/ML Topical SpraySCD1
1039012benzalkonium chloride 0.13 % Topical SpraySY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70043-390-042021-01-29C16284748780-1ba0f9c33-4ac9-a910-e053-dadaa90a0b85Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70043-390-04Sterile Antibacterial Wound Wash120 mL in 1 CANSPRAY1201

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70043-390STERILE ANTIBACTERIAL WOUND WASH (BENZALKONIUM CHLORIDE) SPRAY [ASCOT PHARMACEUTICALS, INC.]1Legacy NDC, 1 package rows20160711_71b24e53-0e25-4ad6-b754-80c06c2dcfac.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70043-39070043-390-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
SODIUM CHLORIDE451W47IQ8XIACT

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
817e487e-fe10-46a2-ac08-b324856690f171b24e53-0e25-4ad6-b754-80c06c2dcfac2016-06-23WarningsExact identifier
spl id: 817e487e-fe10-46a2-ac08-b324856690f1
spl set id: 71b24e53-0e25-4ad6-b754-80c06c2dcfac

Reported adverse events (FAERS/openFDA)#

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