FDA.reportPublic FDA data

Aerocool Cold Spray

Manufacturer
Aero Healthcare, LLC.
Effective date
2014-08-20
Label type
OTC MEDICAL DEVICE LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:47:59

Label at a glance#

ProductAerocool Cold Spray
Label structure10 sections

Indications and uses

First aid to help minor pain and swelling from sprains, bruising, and contusion minor sports injuries 

Dosage and administration

hold can 4-6 inches away from treatment area apply using a sweeping motion until the skin just turns white do not spray after skin turns white

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Isobutane
N-Butane
Propane

Purpose

OTC - PURPOSE SECTION

Topical Coolant
Topical Coolant
Topical Coolant

Uses

INDICATIONS & USAGE SECTION

First aid to help

  • minor pain and swelling from sprains, bruising, and contusion
  • minor sports injuries 

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 a 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

  • hold can 4-6 inches away from treatment area
  • apply using a sweeping motion until the skin just turns white
  • do not spray after skin turns white

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 

Principal Display

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55305-112-10Aerocool Cold Spray113 g in 1 BOTTLE, SPRAY1132

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55305-112AEROCOOL COLD SPRAY () [AERO HEALTHCARE, LLC.]2Legacy NDC, 1 package rows20140820_53f81868-2efd-4cb2-bd47-97ee73cdbf89.zip

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55305-11255305-112-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
ISOBUTANEBXR49TP611INGR
BUTANE6LV4FOR43RINGR
PROPANET75W9911L6INGR

Source Document#

Source XML

Reported adverse events (FAERS/openFDA)#

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