Aerocool Cold Spray: Package Insert and Label Information

AEROCOOL COLD SPRAY-
Aero Healthcare, LLC.

Active Ingredients

Isobutane
N-Butane
Propane

Purpose

Topical Coolant
Topical Coolant
Topical Coolant

Uses

First aid to help

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

Warnings

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

  • 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

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

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • 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

  • avoid inhaling
  • use only as directed
  • intentional misuse by deliberately concentrating and inhaling the contents may be harmful or fatal

Principal Display

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AEROCOOL COLD SPRAY
Product Information
Product Type Item Code (Source) NHRIC:55305-112
Ingredients
Ingredient Name Quantity
ISOBUTANE
BUTANE
PROPANE
Packaging
# Item Code Package Description Multilevel Packaging
1 NHRIC:55305-112-10 113 g in 1 BOTTLE, SPRAY None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
premarket notification K033720 08/20/2014
Labeler — Aero Healthcare, LLC. (008186174)

Revised: 08/2014 Aero Healthcare, LLC.

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