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DermaFreezeTM
(Ethyl Chloride USP)

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Webmaster's Notes: Similar information applies to the bottled form of the product. This information is from the package insert for the product and should be studied carefully.

Prescribing Information DermaFreezeTM is a colorless, flammable, volatile liquid. It will vaporize at room temperature when applied from its metal container.

Indications and Usage DermaFreezeTM is a vapor coolant intended for topical application for the control of pain associated with minor surgical procedures (such as lancing boils, or incision and drainage of small abscesses), injections, and contusions.

Precautions Inhalation of DermaFreezeTM should be avoided as it may produce narcotic and general anesthetic effects, and may produce deep anesthesia or fatal coma with respiratory or cardiac arrest. DermaFreezeTM is FLAMMABLE and should never be used in the presence of an open flame, or electrical cautery equipment. When used to produce local freezing of tissues, adjacent skin areas should be protected by application of petrolatum. The thawing process may be painful and freezing may lower local resistance to infection and delay healing.

Adverse Reactions Cutaneous sensitization may occur, gut appears to be extremely rare. Freezing can occasionally alter pigmentation.

Contraindications DermaFreezeTM is contraindicated in individuals with a history of hypersensitivity to Ethyl Chloride. This product should not be used on patients having vascular impairment of the extremities.

Warnings

  • Caution: federal law (USA) restricts this product to sale by or on the order of a physician or other practitioner licensed by state law to use or order use of this product.
  • For external use only.
  • Skin absorption can occur; no cases of chronic poisoning have been reported.
  • DermaFreezeTM is known as a liver and kidney toxin; long term exposure may cause liver or kidney damage.
  • This product contains a chemical known to the State of California to cause cancer.
  • Keep out of the reach of children!
  • Administration by or to a pregnant or nursing woman is not recommended.
  • Contents under pressure. Do not puncture or incinerate.
  • Do not use near open flame or expose to heat.
  • Store in a cool place. Do Not store on or near high frequency ultrasound equipment.

Dosage and Administration To apply DermaFreezeTM from its metal container, hold the container approximately 3 inches (7.5 cm) from the area of the skin to be treated. Depress the actuator button for the length of time necessary to achieve the desired effect as described below.

I. Topical Anesthesia in Minor Surgery  The operative site should be cleansed with a suitable antiseptic. Apply petrolatum to protect the adjacent area. Spray DermaFreezeTM for a few seconds until the tissue begins to frost and turn white. Avoid spraying the skin beyond this state. The anesthetic action of DermaFreezeTM rarely lasts more than a few seconds to a minute. Quickly swab the operative site with antiseptic and promptly make incision.

II. Temporary Relief of Minor Sports Injuries The pain caused by bruises, contusions, swelling, and minor sprains may be controlled with DermaFreezeTM. Spray affected area for a few seconds until the tissue begins to frost and turn white. Avoid spraying the skin beyond this state. Use as you would ice. The amount of cooling will depend on the dosage. The smallest dose needed to produce the desired effect should be used. Determine the extent of injury (fracture, sprain, etc.). The anesthetic effect of DermaFreezeTM rarely lasts more than a few seconds to a minute. This time interval is usually sufficient to help reduce or relieve the initial trauma of the injury.

III. Pre-Injection Anesthesia Prepare a syringe and have it ready. Spray skin with DermaFreezeTM from a distance of about 3 inches (7.5 cm) continuously for 2 to 4 seconds. Do not frost the skin. Swab the skin with alcohol and quickly introduce the needle with the skin taut.

How Supplied: Made for and distributed exclusively by Medix Pharmaceuticals Americas Inc., Greenbelt, MD 20770 under license from Rhealm Pharmaceuticals, Inc. 3.6 Fl Oz, (106.5 ml) can

U.S. Patent 5941243
© 1999, Medix Pharmaceuticals Americas, Inc.
Rev. 01/00 MG #14924

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Copyright 1999, 2000 by Chase-Simmons Industries, Inc.
ethylchl.htm: Last revised: December 16, 2004 by webmaster