FDA.reportPublic FDA data

ProStat Blood Clotting 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 Blood Clotting First Aid
Active ingredientLIDOCAINE, BENZETHONIUM CHLORIDE
Label structure9 sections

Indications and uses

for help in control of superficial bleeding for temporary relief of pain and to help protect against infection in: minor cuts scrapes burns 

Dosage and administration

shake can well before using hold 6-8 inches from moist injured area spray until area is covered scab-like cover will gradually disappear as healing takes place or may be removed with soap and water 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
Lidocaine 4% w/w 

Purpose

OTC - PURPOSE SECTION

Topical antiseptic
Topical anesthetic 

Uses

INDICATIONS & USAGE SECTION

for help in control of superficial bleeding
for temporary relief of pain and 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 eyes or other mucous membranes
on large portions of the body
in case of deep or puncture wounds
on raw surfaces
on blistered areas
on animal bites
on serious burns 

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

shake can well before using
hold 6-8 inches from moist injured area
spray until area is covered
scab-like cover will gradually disappear as healing takes place or may be removed with soap and water
for adult institutional use only
not intended for use on children 

Inactive ingredients

INACTIVE INGREDIENT SECTION

isobutane, isopropyl myristate, karaya, n-butane, propane, silica, silicone, sorbitan monooloate, talc, tragacanth.

Principal Display

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1545716benzethonium Cl 0.2 % / lidocaine 4 % Topical SprayPSN3
1545716benzethonium chloride 2 MG/ML / lidocaine 40 MG/ML Topical SpraySCD3
1545716benzethonium Cl 0.2 % / lidocaine 4 % Topical SpraySY3

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58228-0103-32019-11-27C16284748780-19855e2a2-37c5-60a7-e053-dbdaa90a05bdProStat Blood Clotting Spray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58228-0103-3ProStat Blood Clotting First Aid85 g in 1 BOTTLE, SPRAYAEROSOL, SPRAY853

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58228-0103PROSTAT BLOOD CLOTTING FIRST AID (BENZETHONIUM CHLORIDE AND LIDOCAINE) AEROSOL, SPRAY [PROSTAT FIRST AID]3Legacy NDC, 1 package rows20140307_09b1372c-a5a3-4d89-9b8e-4523f6a0341f.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BENZETHONIUM CHLORIDEACTIVE INGREDIENTPH41D057443
LIDOCAINEACTIVE INGREDIENT98PI2009873
BENZETHONIUMACTIVE MOIETY1VU15B70BP3
LIDOCAINEACTIVE MOIETY98PI2009873
BUTANEINACTIVE INGREDIENT6LV4FOR43R3
ISOBUTANEINACTIVE INGREDIENTBXR49TP6113
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJS3
KARAYA GUMINACTIVE INGREDIENT73W9IQY50Q3
PROPANEINACTIVE INGREDIENTT75W9911L63
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU43
SORBITAN MONOOLEATEINACTIVE INGREDIENT06XEA2VD563
TALCINACTIVE INGREDIENT7SEV7J4R1U3
TRAGACANTHINACTIVE INGREDIENT2944357O2O3

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58228-010358228-0103-3
52982-106

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
LIDOCAINE98PI200987ACTIB
BENZETHONIUM CHLORIDEPH41D05744ACTIB
ISOBUTANEBXR49TP611IACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
KARAYA GUM73W9IQY50QIACT
BUTANE6LV4FOR43RIACT
PROPANET75W9911L6IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SORBITAN MONOOLEATE06XEA2VD56IACT
TALC7SEV7J4R1UIACT
TRAGACANTH2944357O2OIACT

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 · 15 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GEL / TOPICAL6 mgExact identifier — unii+route
ISOPROPYL MYRISTATEISOPROPYL MYRISTATE0RE8K4LNJSAEROSOL, SPRAY / TOPICAL6.89 %w/wExact identifier — unii+route+dosage form
BUTANEBUTANE6LV4FOR43RAEROSOL, FOAM / TOPICAL27 %w/wExact identifier — unii+route
2 equally ranked IID candidates
PROPANEPROPANET75W9911L6AEROSOL, FOAM / TOPICAL55 %w/wExact identifier — unii+route
TRAGACANTHTRAGACANTH2944357O2OJELLY / TOPICALNAExact identifier — unii+route
TALCTALC7SEV7J4R1UOINTMENT / TOPICAL74.6 %w/wExact identifier — unii+route
2 equally ranked IID candidates
SORBITAN MONOOLEATESORBITAN MONOOLEATE06XEA2VD56EMULSION / TOPICAL34050 mgExact identifier — unii+route
6 equally ranked IID candidates
ISOBUTANEISOBUTANEBXR49TP611AEROSOL, SPRAY / TOPICAL4484 mgExact identifier — unii+route+dosage form
BUTANEBUTANE6LV4FOR43RAEROSOL / TOPICALNAExact identifier — unii+route
2 equally ranked IID candidates
SORBITAN MONOOLEATESORBITAN MONOOLEATE06XEA2VD56CREAM / TOPICAL11000 mgExact identifier — unii+route
6 equally ranked IID candidates
SORBITAN MONOOLEATESORBITAN MONOOLEATE06XEA2VD56GEL / TOPICAL20 mgExact identifier — unii+route
6 equally ranked IID candidates
SORBITAN MONOOLEATESORBITAN MONOOLEATE06XEA2VD56SPRAY / TOPICAL8 mgExact identifier — unii+route
6 equally ranked IID candidates
SORBITAN MONOOLEATESORBITAN MONOOLEATE06XEA2VD56OINTMENT / TOPICALNAExact identifier — unii+route
6 equally ranked IID candidates
SORBITAN MONOOLEATESORBITAN MONOOLEATE06XEA2VD56LOTION / TOPICAL7 mgExact identifier — unii+route
6 equally ranked IID candidates
TALCTALC7SEV7J4R1UPOWDER / TOPICAL9235 mgExact identifier — unii+route
2 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 Label Here Blood Clotting First AidBENZETHONIUM CHLORIDE AND LIDOCAINEDixon Investments, Inc.b07ff274-6d4e-424a-89d2-6839219478892025-01-28WarningsExact identifier
ndc (product): 52982-106
0cde8593-950a-43ce-be26-3c6f39291cd009b1372c-a5a3-4d89-9b8e-4523f6a0341f2014-03-07WarningsExact identifier
spl id: 0cde8593-950a-43ce-be26-3c6f39291cd0
spl set id: 09b1372c-a5a3-4d89-9b8e-4523f6a0341f

Reported adverse events (FAERS/openFDA)#

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