Compound W FREEZE OFF Manuals

Table of contents A. Indications for use B. Contents of Compound W™ Freeze Off™ Advanced C. Background on warts D. Warnings E. Cautions F. What to do if you are uncertain if the condition is a wart? G. How does Compound W™ Freeze Off™ Advanced work? H. Side effects I. Instructions for use J. Application times K. Follow-up treatment A. Indications for use Compound W™ Freeze Off™ Advanced Wart Remover is indicated for the over-the-counter treatment of common warts and plantar warts, for patients aged 4 years and older. B. Contents of Compound W™ Freeze Off™ Advanced A pressurized canister filled with 50mL of the compressed liquid gas dimethyl ether. A custom application unit used to administer the cold delivered by the cryogen to the wart. This information leaflet in which you can read about the product, how it works, how to use the product to treat warts, warnings and limitations. C. Background on warts Common warts and plantar warts are harmless growths that consist of a center of inner skin (or connective tissue) with blood vessels covered with layers of outer skin (or epidermis tissue). Common warts are skin-colored, usually appear on the hands and feet and are easily recognized by the rough “cauliflower-like” appearance of the surface. Plantar warts only occur on the bottom of the foot and are often flat due to the pressure caused by walking. Plantar warts grow inward, are often calloused, and can be very painful. The footprint pattern is smooth over the area where the plantar wart occurs because “skin lines” do not grow across the surface of plantar warts. Warts are growths on the skin or mucous membranes (such as inside mouth, nose, anus, genitals, lips) that are caused by the human papilloma virus (HPV). There are more than 80 different types of HPV. Many are attracted to the skin where they cause different skin-related warts including plantar warts and common warts. Others are attracted to the mucus membranes where they can cause warts on the genitals or anus. Skin-related warts such as common warts and plantar warts are generally harmless. However, genital warts have been linked to cancer in the cervix. Warts affect 7 to 10% of the general population. They are most common in children and adolescents. Warts are very contagious and may appear more often if the body’s defense system is weak. Warts are passed from person to person or from one body location to another on the same person by touch or contact with flakes of skin. More than 50% of warts disappear within two years with no treatment. However, they are unsightly and can cause pain in the case of plantar warts. Therefore, patients often choose to treat warts rather than wait for them to disappear. Treatments for warts include different topical acid preparations, surgical removal, burning or cryotherapy (freezing). Duct tape has also recently been reported in the news to be effective. Liquid nitrogen is the most commonly applied freezing method, but it is only available through the physician. Compound W™ Freeze Off™ Advanced is an alternative to liquid nitrogen. It contains dimethyl ether and is as effective and well tolerated as liquid nitrogen. D. Warnings • Do not use if you cannot see clearly to read the information on the container or this Information Leaflet. Use only as directed. • Do not use if you cannot clearly see the wart you are treating. If you mistakenly apply Compound W™ Freeze Off™ Advanced on the conditions that are not warts, it may cause serious burns and permanent scarring of the skin. • Do not use on children under the age of 4 years. It is uncertain how Compound W™ Freeze Off™ Advanced may affect the child’s skin. • Do not use if you are diabetic or if you have poor blood circulation. Compound W™ Freeze Off™ Advanced works by freezing the wart. The frozen area in diabetic patients and those with poor blood circulation may not heal as quickly or completely. • Do not use if you are pregnant or breast-feeding. It is uncertain how Compound W™ Freeze Off™ Advanced may affect patients under these conditions. • Do not use on area with thin skin such as the face, armpits, breasts, bottom, or genital area. Use on these areas may cause burns and permanent scarring. • Do not use on irritated skin, or on any area that is infected, reddened or showing any signs of inflammation, such as itching or swelling. Treating these areas with Compound W™ Freeze Off™ Advanced will result in worsening of the condition and possible further infection. These conditions may not be warts and should be examined by doctor. • Do not use on moles, birthmarks, warts with hair growing from them, genital (on penis or vaginal area) warts, or warts on the face or mucus membranes (such as inside mouth, nose, anus, genital, lips, ears or near eyes). Use on these areas may cause burns and permanent scarring of the skin or blindness. Use Compound W™ Freeze Off™ Advanced only if you are sure the skin condition is a wart. If you are not sure, consult your doctor. If you treat a skin condition as a wart with Compound W™ Freeze Off™ Advanced and it is not a wart, you delay proper treatment. This delay may lead to a more serious skin condition or disease. Avoid Contact with Eyes. Contact with eyes may cause blindness. Do not rub or touch eyes with hands if Compound W™ Freeze Off™ Advanced has been applied to them. If product gets into eyes, flush with water for 15 minutes and call medical help right away. Do not Swallow. Content is toxic and may cause serious internal damage. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away. For External Use Only. Use only as directed. If Compound W™ Freeze Off™ Advanced is not used exactly as instructed or you mistakenly apply it directly to the skin or use it on conditions that are not warts, it may cause serious burns and permanent scarring of the skin. Keep out or Reach of Children. Children cannot understand the instructions to properly use this product. Content is hazardous if swallowed, inhaled, sprayed on parts other than the wart, or exposed to heat. E. Cautions • Do not use Compound W™ Freeze Off™ Advanced: if the cone is stuck to position “1” after activation, and/or; • if you do not hear the “hissing” sound during activation (release of aerosol), and/or; • if the “hissing” sound continues after activation, and/or; • if the tip does not become cold after activation. An “icy surface” should become visible on the metal tip. In case one or more of the above mentioned conditions are not fulfilled, the device may not be functioning properly. Failure of the device may lead to injury or insufficient/incomplete treatment. • The metal tip is coated with nickel, which may cause allergic reaction. • If being used by more than one person and/or after each application, clean the applicator with alcohol on a small piece of cloth. • If there is more than one wart on a finger or toe, only treat one wart at a time. Freezing more than one wart on a single finger or toe is too large of an area to freeze at one time and may take longer to heal or the area may not heal properly. Treat each remaining wart on a single finger or toe separately, with a two-week period between treatments. • In most cases, only one treatment is needed for each wart. Warts are usually gone in two weeks after treatment with Compound W™ Freeze Off™ Advanced. If a wart or a part of it is still there two weeks after treatment, you may then safely treat again. Do not treat each wart with Compound W™ Freeze Off™ Advanced more than three times in total. Consult your doctor if three treatments have not led to improvement. • The aching/stinging feeling in treated common warts should disappear within few hours after application. For plantar warts, the aching/stinging feeling may last 24 hours. If discomfort or aching/ stinging feeling beyond this time, 3 hours for common warts and 24 hours for plantar warts, talk to your doctor. This may mean that the area has been frozen too deeply and medical attention may be needed. • Do not inhale vapor/spray and use only in well-ventilated areas because it is uncertain how the vapor/spray will affect the lungs. Breathing vapor/spray may be toxic. • Wash hands (except treated area) immediately after use. Washing the treated area immediately may be uncomfortable since you may still be experiencing some aching/stinging. The treated area may be washed after the aching/stinging subsides. Extremely Flammable. Content under pressure. Do not pierce or burn aerosol spray can, even after use. Protect from sunlight and do not expose to temperature above 120° F (50° C). Store at room temperature away from heat. Keep away from fire or flame and from source of sparks or ignition. Do not smoke while using Compound W™ Freeze Off™ Advanced Wart Remover. Piercing the container or exposure to the heat may cause the container to explode, causing serious injury. Do not breathe vapor/spray and use only in well-ventilated areas because it is uncertain how the vapor/spray will affect the lungs. Breathing vapor/spray may be toxic. F. What to do if you are uncertain if the condition is a wart? See “Warnings” and “Cautions.” Use Compound W™ Freeze Off™ Advanced only if you are sure the skin condition is a wart. If you are not FREEZE OFF ™ Wart Remover System For Common and Plantar Warts ADVANCED