FDA.reportPublic FDA data

AEROBURN BURN SPRAY

Manufacturer
Aero Healthcare, LLC. | Dixon Investments, Inc.
Effective date
2014-09-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:40:17

Label at a glance#

ProductAeroburn Burn First Aid
Active ingredientBENZETHONIUM CHLORIDE, BENZOCAINE, MENTHOL
Label structure11 sections

Indications and uses

For temporary relief of pain, treatment and helps prevent infection in minor cuts and scrapes insect bites minor skin irritations burns sunburns

Dosage and administration

clean the affected area shake can well before using for adult institutional use only hold 4-6 inches from surface and spray area until wet not for use on children  may be covered with a sertile bandage. If bandaged, let dry first. 

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, treatment and helps prevent infection in

  • minor cuts and scrapes
  • insect bites
  • minor skin irritations
  • burns
  • sunburns

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 mucous membranes
  • on serious burns
  • on deep puncture wounds
  • for prolonged period of time
  • on a large portion 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

Keep out of reach of children.

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 can well before using
  • for adult institutional use only
  • hold 4-6 inches from surface and spray area until wet
  • not for use on children 
  • may be covered with a sertile bandage. If bandaged, let dry first. 

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
1192516benzethonium chloride 0.2 % / benzocaine 10 % / menthol 0.33 % Topical SprayPSN1
1192516benzethonium chloride 2 MG/ML / benzocaine 100 MG/ML / menthol 3.3 MG/ML Topical SpraySCD1
1192516benzethonium chloride 0.2 % / benzocaine 10 % / menthol 0.33 % Topical SpraySY1

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-139341394006737GTIN-13: 9341394006737
EAN-13: 9341394006737
GTIN storage (14 digits): 09341394006737		burn.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55305-116-102019-11-27C16284748780-19855e2a2-3396-60a7-e053-dbdaa90a05bdAEROBURN BURN SPRAY

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55305-116-10Aeroburn Burn First Aid85 g in 1 BOTTLE, SPRAYAEROSOL, SPRAY851

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55305-116AEROBURN BURN FIRST AID (BENZETHONIUM CHLORIDE, BENZOCAINE, AND MENTHOL) AEROSOL, SPRAY [AERO HEALTHCARE, LLC.]1Legacy NDC, 1 package rows20140924_b780da38-8568-43e1-ab4a-5b69e4f55b19.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BENZETHONIUM CHLORIDEACTIVE INGREDIENTPH41D057441
BENZOCAINEACTIVE INGREDIENTU3RSY48JW51
MENTHOLACTIVE INGREDIENTL7T10EIP3A1
BENZETHONIUMACTIVE MOIETY1VU15B70BP1
BENZOCAINEACTIVE MOIETYU3RSY48JW51
MENTHOLACTIVE MOIETYL7T10EIP3A1
BUTANEINACTIVE INGREDIENT6LV4FOR43R1
DIPROPYLENE GLYCOLINACTIVE INGREDIENTE107L85C401
ISOBUTANEINACTIVE INGREDIENTBXR49TP6111
PROPANEINACTIVE INGREDIENTT75W9911L61

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
55305-11655305-116-10
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

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 / BUCCAL30 mgExact identifier — unii candidate
3 equally ranked IID candidates
DIPROPYLENE GLYCOLDIPROPYLENE GLYCOLE107L85C40SYSTEM / TRANSDERMAL6 mgExact identifier — unii candidate
3 equally ranked IID candidates
PROPANEPROPANET75W9911L6AEROSOL, FOAM / TOPICAL55 %w/wExact identifier — unii+route
BUTANEBUTANE6LV4FOR43RAEROSOL, FOAM / TOPICAL27 %w/wExact identifier — unii+route
2 equally ranked IID candidates
DIPROPYLENE GLYCOLDIPROPYLENE GLYCOLE107L85C40FILM, EXTENDED RELEASE / TRANSDERMAL296 mgExact identifier — unii candidate
3 equally ranked IID candidates
BUTANEBUTANE6LV4FOR43RAEROSOL / TOPICALNAExact identifier — unii+route
2 equally ranked IID candidates
ISOBUTANEISOBUTANEBXR49TP611AEROSOL, SPRAY / TOPICAL4484 mgExact identifier — unii+route+dosage form

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
d0e2594d-82eb-47d1-992d-c22824c639cfb780da38-8568-43e1-ab4a-5b69e4f55b192014-09-24WarningsExact identifier
spl id: d0e2594d-82eb-47d1-992d-c22824c639cf
spl set id: b780da38-8568-43e1-ab4a-5b69e4f55b19

Reported adverse events (FAERS/openFDA)#

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