YOUR LABEL HERE COLD SPRAY () [DIXON INVESTMENTS, INC.]

YOUR LABEL HERE COLD SPRAY () [DIXON INVESTMENTS, INC.]
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NDC 52982-103-03, 52982-103-04
Set ID c9d66146-9294-4d9f-acbc-9c00c0814036
Category OTC MEDICAL DEVICE LABEL
Packager Dixon Investments, Inc.
Generic Name
Product Class
Product Number
Application Number K033720
  • 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 contusions
    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 eyes or other mucous membranes
    in case of serious burn
    in deep puncture wounds
    for prolonged period of time
    on large portions 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 to 6 inches away from treatment area, using a sweeping motion spray area 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
    YOUR LABEL HERE COLD SPRAY 
    refrigerant, topical (vapocoolant)
    Product Information
    Product TypeOTC MEDICAL DEVICEItem Code (Source)NHRIC:52982-103
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRISOBUTANE (UNII: BXR49TP611)  
    INGRBUTANE (UNII: 6LV4FOR43R)  
    INGRPROPANE (UNII: T75W9911L6)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:52982-103-04113 g in 1 BOTTLE, SPRAY
    2NHRIC:52982-103-0385 g in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    premarket notificationK03372004/05/2013
    Labeler - Dixon Investments, Inc. (115315822)

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