Label: AEROCOOL COLD SPRAY-

  • Category: OTC MEDICAL DEVICE LABEL
  • DEA Schedule: None
  • Marketing Status: Premarket Notification

Drug Label Information

Updated August 20, 2014

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  • 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

    image description

  • INGREDIENTS AND APPEARANCE
    AEROCOOL COLD SPRAY 
    refrigerant, topical (vapocoolant)
    Product Information
    Product TypeOTC MEDICAL DEVICEItem Code (Source)NHRIC:55305-112
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRISOBUTANE (UNII: BXR49TP611)  
    INGRBUTANE (UNII: 6LV4FOR43R)  
    INGRPROPANE (UNII: T75W9911L6)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:55305-112-10113 g in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    premarket notificationK03372008/20/2014
    Labeler - Aero Healthcare, LLC. (008186174)
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