FDA.reportPublic FDA data

ProStat Pain Relieving Burn Spray

Manufacturer
ProStat First Aid | Dixon Investments, Inc.
Effective date
2014-03-07
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 22:38:38

Label at a glance#

ProductProStat Burn First Aid
Active ingredientBENZETHONIUM CHLORIDE, BENZOCAINE, MENTHOL
Label structure10 sections

Indications and uses

For temporary relief of pain, itching and to help protect against infection in minor cuts and scrapes burns sunburns insect bites minor skin irritations 

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

Benzocaine 10% w/w
Benzethonium Chloride .2% w/w
Menthol .33% w/w

Purpose

OTC - PURPOSE SECTION

Topical Anesthetic
Topical Antiseptic
Topical Anesthetic

Uses

INDICATIONS & USAGE SECTION

For temporary relief of pain, itching and to help protect against infection in

minor cuts and scrapes
burns
sunburns
insect bites
minor skin irritations 

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 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
conditions worsen or 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 spraying in eyes
use only as directed
intentional misuse by deliberately concentrating and inhaling the contents may be harmful or fatal 

Inactive Ingredients

INACTIVE INGREDIENT SECTION

dipropylene glycol, isobutane, n-butane, propane

Principal Display

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1192516benzethonium chloride 0.2 % / benzocaine 10 % / menthol 0.33 % Topical SprayPSN4
1192516benzethonium chloride 2 MG/ML / benzocaine 100 MG/ML / menthol 3.3 MG/ML Topical SpraySCD4
1192516benzethonium chloride 0.2 % / benzocaine 10 % / menthol 0.33 % Topical SpraySY4

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
58228-0105-32019-11-27C16284748780-19855e2a2-36db-60a7-e053-dbdaa90a05bdProStat Pain Relieving Burn Spray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58228-0105-3ProStat Burn First Aid85 g in 1 BOTTLE, SPRAYAEROSOL, SPRAY854

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58228-0105PROSTAT BURN FIRST AID (BENZETHONIUM CHLORIDE, BENZOCAINE, AND MENTHOL) AEROSOL, SPRAY [PROSTAT FIRST AID]4Legacy NDC, 1 package rows20140307_0d490ebb-adc9-4f06-8e23-992abafbf151.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BENZETHONIUM CHLORIDEACTIVE INGREDIENTPH41D057444
BENZOCAINEACTIVE INGREDIENTU3RSY48JW54
MENTHOLACTIVE INGREDIENTL7T10EIP3A4
BENZETHONIUMACTIVE MOIETY1VU15B70BP4
BENZOCAINEACTIVE MOIETYU3RSY48JW54
MENTHOLACTIVE MOIETYL7T10EIP3A4
BUTANEINACTIVE INGREDIENT6LV4FOR43R4
DIPROPYLENE GLYCOLINACTIVE INGREDIENTE107L85C404
ISOBUTANEINACTIVE INGREDIENTBXR49TP6114
PROPANEINACTIVE INGREDIENTT75W9911L64

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
58228-010558228-0105-3
52982-101

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
MENTHOLL7T10EIP3AACTIB
DIPROPYLENE GLYCOLE107L85C40IACT
ISOBUTANEBXR49TP611IACT
BUTANE6LV4FOR43RIACT
PROPANET75W9911L6IACT

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 · 7 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
DIPROPYLENE GLYCOLDIPROPYLENE GLYCOLE107L85C40FILM, EXTENDED RELEASE / TRANSDERMAL296 mgExact identifier — unii candidate
3 equally ranked IID candidates
DIPROPYLENE GLYCOLDIPROPYLENE GLYCOLE107L85C40SYSTEM / TRANSDERMAL6 mgExact identifier — unii candidate
3 equally ranked IID candidates
BUTANEBUTANE6LV4FOR43RAEROSOL, FOAM / TOPICAL27 %w/wExact identifier — unii+route
2 equally ranked IID candidates
PROPANEPROPANET75W9911L6AEROSOL, FOAM / TOPICAL55 %w/wExact identifier — unii+route
ISOBUTANEISOBUTANEBXR49TP611AEROSOL, SPRAY / TOPICAL4484 mgExact identifier — unii+route+dosage form
BUTANEBUTANE6LV4FOR43RAEROSOL / TOPICALNAExact identifier — unii+route
2 equally ranked IID candidates
DIPROPYLENE GLYCOLDIPROPYLENE GLYCOLE107L85C40FILM, EXTENDED RELEASE / BUCCAL30 mgExact identifier — unii candidate
3 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 Burn First AidBENZOCAINE, BENZETHONIUM CHLORIDE, AND MENTHOLDixon Investments, Inc.57d1a917-d635-4e7b-a49a-6b3d175af3262025-01-28WarningsExact identifier
ndc (product): 52982-101
7518092e-2c65-42be-bf2e-8a665defe6c10d490ebb-adc9-4f06-8e23-992abafbf1512014-03-07WarningsExact identifier
spl id: 7518092e-2c65-42be-bf2e-8a665defe6c1
spl set id: 0d490ebb-adc9-4f06-8e23-992abafbf151

Reported adverse events (FAERS/openFDA)#

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