FDA.reportPublic FDA data

ProStat Antiseptic Spray

Manufacturer
ProStat First Aid | Dixon Investments, Inc.
Effective date
2014-03-07
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 22:38:38

Label at a glance#

ProductProStat Antiseptic First Aid
Active ingredientBENZETHONIUM CHLORIDE, BENZOCAINE
Label structure10 sections

Indications and uses

Treatment of minor cuts and abrasions Pain relief Helps prevent infection Soothes itching 

Dosage and administration

Hold 4-6 inches from surface Spray area until wet Clean the affected area Shake can well before using 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 10% w/w 

Purpose

OTC - PURPOSE SECTION

Topical antiseptic
Topical anesthetic 

Uses

INDICATIONS & USAGE SECTION

Treatment of minor cuts and abrasions
Pain relief
Helps prevent infection
Soothes itching 

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 eyes or near mucous membranes
For serious burns
Deep puncture wounds
For a prolonged period of time

Stop use and ask a doctor if

OTC - STOP USE SECTION

Irritation, redness, or swelling increases
Rash or infection occurs
Condition worsens or symptoms persist for more than 7 days. 

Directions

DOSAGE & ADMINISTRATION SECTION

Hold 4-6 inches from surface
Spray area until wet
Clean the affected area
Shake can well before using
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 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
1192505benzethonium Cl 0.2 % / benzocaine 10 % Topical SprayPSN3
1192505benzethonium chloride 2 MG/ML / benzocaine 100 MG/ML Topical SpraySCD3
1192505benzethonium Cl 0.2 % / benzocaine 10 % Topical SpraySY3

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
58228-0104-32019-11-27C16284748780-19855e2a2-3b01-60a7-e053-dbdaa90a05bdProStat Antiseptic Spray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58228-0104-3ProStat Antiseptic First Aid85 g in 1 BOTTLE, SPRAYAEROSOL, SPRAY853

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58228-0104PROSTAT ANTISEPTIC FIRST AID (BENZOCAINE AND BENZETHONIUM CHLORIDE) AEROSOL, SPRAY [PROSTAT FIRST AID]3Legacy NDC, 1 package rows20140307_42d1edd9-e529-4995-8d85-f40b1cec4958.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BENZETHONIUM CHLORIDEACTIVE INGREDIENTPH41D057443
BENZOCAINEACTIVE INGREDIENTU3RSY48JW53
BENZETHONIUMACTIVE MOIETY1VU15B70BP3
BENZOCAINEACTIVE MOIETYU3RSY48JW53
BUTANEINACTIVE INGREDIENT6LV4FOR43R3
DIPROPYLENE GLYCOLINACTIVE INGREDIENTE107L85C403
ISOBUTANEINACTIVE INGREDIENTBXR49TP6113
PROPANEINACTIVE INGREDIENTT75W9911L63

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
58228-010458228-0104-3
52982-100

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZETHONIUM CHLORIDEPH41D05744ACTIB
BENZOCAINEU3RSY48JW5ACTIB
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 GLYCOLE107L85C40SYSTEM / TRANSDERMAL6 mgExact identifier — unii candidate
3 equally ranked IID candidates
PROPANEPROPANET75W9911L6AEROSOL, FOAM / TOPICAL55 %w/wExact identifier — unii+route
DIPROPYLENE GLYCOLDIPROPYLENE GLYCOLE107L85C40FILM, EXTENDED RELEASE / BUCCAL30 mgExact identifier — unii candidate
3 equally ranked IID candidates
ISOBUTANEISOBUTANEBXR49TP611AEROSOL, SPRAY / TOPICAL4484 mgExact identifier — unii+route+dosage form
BUTANEBUTANE6LV4FOR43RAEROSOL, FOAM / TOPICAL27 %w/wExact identifier — unii+route
2 equally ranked IID candidates
BUTANEBUTANE6LV4FOR43RAEROSOL / TOPICALNAExact identifier — unii+route
2 equally ranked IID candidates
DIPROPYLENE GLYCOLDIPROPYLENE GLYCOLE107L85C40FILM, EXTENDED RELEASE / TRANSDERMAL296 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 Antiseptic First AidBENZOCAINE AND BENZETHONIUM CHLORIDEDixon Investments, Inc.12b32b5e-cef0-47fe-a526-a4a3454fbf682025-01-28WarningsExact identifier
ndc (product): 52982-100
76ed0b78-ff53-4140-82d1-3d1fa32f8c6342d1edd9-e529-4995-8d85-f40b1cec49582014-03-07WarningsExact identifier
spl id: 76ed0b78-ff53-4140-82d1-3d1fa32f8c63
spl set id: 42d1edd9-e529-4995-8d85-f40b1cec4958

Reported adverse events (FAERS/openFDA)#

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