FDA.reportPublic FDA data

ProStat Bandage Spray

Manufacturer
ProStat First Aid | Dixon Investments, Inc.
Effective date
2014-02-24
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:38:29

Label at a glance#

ProductProStat Protective Coating Bandage First Aid
Active ingredientBENZETHONIUM CHLORIDE, BENZOCAINE
Label structure10 sections

Indications and uses

First aid to help protect against infection in minor cuts scrapes burns 

Dosage and administration

clean the affected area shake can well before using hold 4-6 inches from surface and spray area until wet for adult institutional use only not intended for use on children 

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Benzethonium Chloride 0.2% w/w
Benzocaine 3.2% w/w 

Purpose

OTC - PURPOSE SECTION

Topical antiseptic
Topical anesthetic 

Uses

INDICATIONS & USAGE SECTION

First aid to help protect against infection in

minor cuts
scrapes
burns 

Warnings

WARNINGS SECTION

For external use only

Flammable
keep away from fire or flame
contents under pressure
do not puncture or incinerate container
do not expose to temperatures above 120° F 

Do not use

OTC - DO NOT USE SECTION

in or near eyes or other mucous membranes
in case of serious burns
in deep puncture wounds
for a prolonged period of time
on large portions of the body 

Stop use and ask a doctor if

OTC - STOP USE SECTION

redness, swelling, or irritation occurs
infection occurs
condition persists or worsens
symptoms persist for more than 7 days 

Directions

DOSAGE & ADMINISTRATION SECTION

clean the affected area
shake can well before using
hold 4-6 inches from surface and spray area until wet
for adult institutional use only
not intended for use on children 

Other information

OTHER SAFETY INFORMATION

avoid inhaling
use only as directed
intentional misuse by deliberately concentrating and inhaling contents may be harmful or fatal 

Inactive ingredients

INACTIVE INGREDIENT SECTION

Ethyl alcohol, PVP-VA copolymer, N-Butane, Propane, Isobutane

Principal Display

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049110benzethonium Cl 0.2 % / benzocaine 3.2 % Topical SprayPSN2
1049110benzethonium chloride 2 MG/ML / benzocaine 32 MG/ML Topical SpraySCD2
1049110benzethonium Cl 0.2 % / benzocaine 3.2 % Topical SpraySY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BENZOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58228-0102-32019-11-27C16284748780-19855e2a2-4512-60a7-e053-dbdaa90a05bdProStat Bandage Spray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58228-0102-3ProStat Protective Coating Bandage First Aid85 g in 1 BOTTLE, SPRAYAEROSOL, SPRAY852

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58228-0102PROSTAT PROTECTIVE COATING BANDAGE FIRST AID (BENZETHONIUM CHLORIDE AND BENZOCAINE) AEROSOL, SPRAY [PROSTAT FIRST AID]2Legacy NDC, 1 package rows20140226_25e25261-71e1-4fc0-98c6-c1deb9e6b6f9.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BENZETHONIUM CHLORIDEACTIVE INGREDIENTPH41D057442
BENZOCAINEACTIVE INGREDIENTU3RSY48JW52
BENZETHONIUMACTIVE MOIETY1VU15B70BP2
BENZOCAINEACTIVE MOIETYU3RSY48JW52
ALCOHOLINACTIVE INGREDIENT3K9958V90M2
BUTANEINACTIVE INGREDIENT6LV4FOR43R2
COPOVIDONE K25-31INACTIVE INGREDIENTD9C330MD8B2
ISOBUTANEINACTIVE INGREDIENTBXR49TP6112
PROPANEINACTIVE INGREDIENTT75W9911L62

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58228-010258228-0102-3
52982-105

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
BENZETHONIUM CHLORIDEPH41D05744ACTIB
BENZOCAINEU3RSY48JW5ACTIB
ALCOHOL3K9958V90MIACT
ISOBUTANEBXR49TP611IACT
BUTANE6LV4FOR43RIACT
PROPANET75W9911L6IACT
COPOVIDONE K25-31D9C330MD8BIACT

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 21 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
COPOVIDONE K25-31COPOVIDONE K25-31D9C330MD8BCAPSULE, COATED PELLETS / ORAL88 mgExact identifier — unii candidate
16 equally ranked IID candidates
COPOVIDONE K25-31COPOVIDONE K25-31D9C330MD8BCAPSULE, EXTENDED RELEASE / ORAL200 mgExact identifier — unii candidate
16 equally ranked IID candidates
COPOVIDONE K25-31COPOVIDONE K25-31D9C330MD8BCAPSULE, DELAYED RELEASE / ORAL199 mgExact identifier — unii candidate
16 equally ranked IID candidates
COPOVIDONE K25-31COPOVIDONE K25-31D9C330MD8BTABLET, CHEWABLE / ORAL5 mgExact identifier — unii candidate
16 equally ranked IID candidates
BUTANEBUTANE6LV4FOR43RAEROSOL, FOAM / TOPICAL27 %w/wExact identifier — unii+route
2 equally ranked IID candidates
COPOVIDONE K25-31COPOVIDONE K25-31D9C330MD8BTABLET / ORAL6374 mgExact identifier — unii candidate
16 equally ranked IID candidates
COPOVIDONE K25-31COPOVIDONE K25-31D9C330MD8BTABLET, ORALLY DISINTEGRATING / ORAL35 mgExact identifier — unii candidate
16 equally ranked IID candidates
COPOVIDONE K25-31COPOVIDONE K25-31D9C330MD8BPOWDER, FOR SUSPENSION / ORAL5917 mgExact identifier — unii candidate
16 equally ranked IID candidates
COPOVIDONE K25-31COPOVIDONE K25-31D9C330MD8BTABLET / SUBLINGUAL54 mgExact identifier — unii candidate
16 equally ranked IID candidates
ISOBUTANEISOBUTANEBXR49TP611AEROSOL, SPRAY / TOPICAL4484 mgExact identifier — unii+route+dosage form
COPOVIDONE K25-31COPOVIDONE K25-31D9C330MD8BTABLET, EXTENDED RELEASE / ORAL300 mgExact identifier — unii candidate
16 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii+route+dosage form
COPOVIDONE K25-31COPOVIDONE K25-31D9C330MD8BTABLET, FILM COATED / ORAL5917 mgExact identifier — unii candidate
16 equally ranked IID candidates
COPOVIDONE K25-31COPOVIDONE K25-31D9C330MD8BTABLET, FILM COATED, EXTENDED RELEASE / ORAL53 mgExact identifier — unii candidate
16 equally ranked IID candidates
COPOVIDONE K25-31COPOVIDONE K25-31D9C330MD8BSUSPENSION / ORAL172 mgExact identifier — unii candidate
16 equally ranked IID candidates
COPOVIDONE K25-31COPOVIDONE K25-31D9C330MD8BTABLET, DELAYED RELEASE / ORAL168 mgExact identifier — unii candidate
16 equally ranked IID candidates
COPOVIDONE K25-31COPOVIDONE K25-31D9C330MD8BFILM, EXTENDED RELEASE / TRANSDERMALNAExact identifier — unii candidate
16 equally ranked IID candidates
BUTANEBUTANE6LV4FOR43RAEROSOL / TOPICALNAExact identifier — unii+route
2 equally ranked IID candidates
PROPANEPROPANET75W9911L6AEROSOL, FOAM / TOPICAL55 %w/wExact identifier — unii+route
COPOVIDONE K25-31COPOVIDONE K25-31D9C330MD8BCAPSULE / ORAL1346 mgExact identifier — unii candidate
16 equally ranked IID candidates
COPOVIDONE K25-31COPOVIDONE K25-31D9C330MD8BPELLET / ORAL1653 mgExact identifier — unii candidate
16 equally ranked IID candidates

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Your Logo Here Bandage AidBENZETHONIUM CHLORIDE AND BENZOCAINEDixon Investments, Inc.b2fdd15e-8305-4c0d-9475-c3a1b49a79a12025-01-28WarningsExact identifier
ndc (product): 52982-105
8af1b91c-d74f-4ba4-9543-2a176ed3631a25e25261-71e1-4fc0-98c6-c1deb9e6b6f92014-02-24WarningsExact identifier
spl id: 8af1b91c-d74f-4ba4-9543-2a176ed3631a
spl set id: 25e25261-71e1-4fc0-98c6-c1deb9e6b6f9

Reported adverse events (FAERS/openFDA)#

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