The Original Patient Comfort Solution

The only ingredient in Ethyl Chloride is the chemical ethyl chloride. As the grade and quality of the chemical ethyl chloride varies significantly from source to source, Gebauer Company only purchases and uses ethyl chloride that meets high quality standards.

Ethyl Chloride is a prescription-only medical device and contains no medication. It can be sold to and used by any healthcare practitioner who is licensed in the state in which they practice. It does not need a doctor’s order to be used on a patient in the healthcare setting.

Ethyl Chloride can be purchased by a patient who receives a prescription or “other order” from a licensed healthcare provider.

The expiration date of Ethyl Chloride is listed on the can/bottle. Since Ethyl Chloride is an FDA-cleared medical device, it does not fall under the Joint Commission standards for expiration dates of open bottles/vials of medication.

Ethyl Chloride is categorized by the FDA as a vapocoolant. When topically applied to the skin, Ethyl Chloride creates an immediate cooling effect on the surface of the site by the evaporation of the product from the skin’s surface. The cooling sensation produced is directly related to the type of stream and the distance from the point of contact.

The anesthetic property of Ethyl Chloride lasts approximately 60 seconds per application.

Ethyl Chloride is supplied in a variety of packaging formats: brown bottle, mist can, and Accu-Stream 360. All formats contain the same ingredient and the same amount of product. Ethyl Chloride “brown bottle” comes in fine and medium stream sprays and must be inverted to use. The difference between the two is the amount of product being applied over a similar time frame and the precision of the spray on the skin. They are both effective for cooling the skin at a specific site and for the treatment of myofascial pain caused by trigger points, restricted motion and muscle tension.

Ethyl Chloride is also available in a can that is sprayed upright as a mist. The mist is most effective for general cooling of the skin where precise contact is not indicated.

Accu-Stream 360 is available in both fine and medium stream sprays and can be sprayed at any angle.

Ethyl Chloride is an FDA cleared prescription medical device intended to instantly and temporarily control the pain associated with needle procedures (such as immunizations, IV starts, venipuncture, and subcutaneous and intramuscular injections) and minor surgical procedures (such as lancing boils, I&D of small abscesses), and minor sports injuries (such as contusions and bruises). Ethyl Chloride is to be used on intact skin only. Fine and medium streams are also intended for the treatment of myofascial pain caused by trigger points, restricted motion and muscle tension.

Ethyl Chloride is sprayed immediately prior to starting the procedure. For needle and minor surgical procedures, get the equipment ready, prep the site according to the facility protocol, spray as directed below, and perform the procedure.

When using the brown bottle:

• Hold the bottle inverted, 3-9 inches away from the treatment site (about a bottle’s length away).
• Depress the spring valve completely.
• Spray the site for 3-7 seconds, or until the skin begins to turn white, whichever comes first.
• Do not frost the skin or spray longer than 7 seconds.

When using the can:

• Hold the can upright 3-9 inches away from the treatment site (about a can’s length).
  • Accustream 360 can may be held in any direction.
• Depress the actuator completely.
• Spray the site for 4-10 seconds or until the skin begins to turn white, whichever comes first.
• Do not frost the skin or spray longer than 10 seconds.

For temporary relief of minor sports injuries, determine the extent of the injury and apply Ethyl Chloride using it as you would ice.

Ethyl Chloride is not sterile. However, Ethyl Chloride has been shown to be free from harmful microorganisms. Microbial Limit Testing in accordance with United States Pharmacopeia (USP) <61> and <62> demonstrate that Ethyl Chloride is negative for aerobic bacteria growth, mold and yeast growth, and the presence of Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli, and Salmonella. Additionally, a published clinical trial concluded Ethyl Chloride will not introduce or add microorganisms to a site prepped with an antiseptic.

Published clinical trials support the use in children three years of age and older. Ethyl Chloride is not cleared for use with neonates.

When used as intended, the long-term toxicity due to exposure is very low. There is no recorded data of carcinogenicity in humans. The EPA has not classified the chemical ethyl chloride as a carcinogen. Ethyl Chloride falls under California’s Proposition 65, and therefore has the same labeling requirements as many drugs, cosmetics, food, and consumer goods. The ethyl chloride studies for Prop 65 were done at high dosing and chronic exposure levels that are not representative of Gebauer’s Ethyl Chloride’s intended uses.

Ethyl Chloride has not been formally assigned to a pregnancy category by the FDA. There is no controlled data available for use in human pregnancy.

Ethyl Chloride is contraindicated in individuals with a history of hypersensitivity to the chemical ethyl chloride. If skin irritation develops, discontinue use. Consult the instructions for use for a full listing of all warnings and precautions.

When used as directed, Ethyl Chloride’s toxicity due to exposure is low and well below OSHA guidelines. For an average spray of 3-7 seconds, exposure would be minimal for both patients and professionals due to the small dose applied to the skin.

Ethyl Chloride is flammable and should never be used in the presence of an open flame or electrical cautery equipment.

According to OSHA (29CRF 1910/106), Ethyl Chloride glass bottles and cans can be left outside of flammable closets. It is recommended that Ethyl Chloride be stored away from high-frequency ultrasound equipment or non-explosion proof electric equipment. It should be stored in a cool, dry, well-ventilated area.

Since Ethyl Chloride is considered a hazardous material, it can be disposed of in the same manner as a variety of other hazardous goods such as sharps and expired pharmaceuticals, in compliance with local, state, and national regulations.

There are approximately 40 to 50, 5-second spray applications per bottle or can.

Yes, it is safe for use in children 3 years of age and older. It has not been FDA cleared for use on newborns.

Never use it near open flames or electrical cautery equipment. Store in a cool, dry, ventilated area, below 120 120°F (50°C). Use in a well-ventilated area to minimize vapor inhalation. Spray 3-7 seconds (bottle) or 4-10 seconds (can) from a distance of 3-9 inches, or until skin just begins to turn white. Overspraying may lead to frostbite or unwanted skin pigmentation changes. Never use on broken or irritated skin or on patients with a history of hypersensitivity to ethyl chloride.