EndWarts Freeze

EndWarts Freeze

Manufacturer:

Mylan Healthcare

Distributor:

DKSH
Full Prescribing Info
Contents
Nitrous oxide.
Description
It is the first home treatment with nitrous oxide, a very cold gas. Through an Ultra Freeze Technology, it freezes the wart at -80°C and reaches the deepest layer of the wart.
EndWarts FREEZE starts off at a very low temperature (-80°C) that remains during application. EndWarts FREEZE is by far the coldest home freeze treatment, which is shown in an in-vitro temperature test including several freeze devices for home treatment. EndWarts FREEZE is therefore more efficient. In a clinical efficacy study, at least twice as many subjects were cured after one treatment with EndWarts FREEZE compared with competitor products. (Clinical trial to demonstrate the comparative efficacy of a cryogenic treatment (medical device) in common and plantar warts management, Pharmscan, Poland, 2017).
EndWarts FREEZE is a high tech device that is quick and easy to use.
Indications/Uses
EndWarts FREEZE is a rapid home treatment that effectively removes warts on hands, arms and feet.
The treatment is suitable for adults and children over 4 years old.
Dosage/Direction for Use
BEFORE PATIENT STARTS THE TREATMENT, READ THE FOLLOWING STEPS.
ACTIVATE:
Before the very first use only: EndWarts FREEZE needs to be activated once. Do not remove the cap yet.
Turn the white part of the device minimum one full turn in the direction of the arrow until patient notices a loud click. Some force is needed.
After patient activates the device successfully, never repeat this step.
1. LOAD: Before each treatment, EndWarts FREEZE needs to be loaded with cold gas.
Place EndWarts FREEZE upright on a table, with the transparent cap down. Hold the device with a steady grip. With the other hand, push the white part of the device downward for exactly 2 seconds.
Pushing for longer will waste useful doses. Pushing shorter, reduces the freeze effect.
2. CHECK: Remove the transparent cap and use the product immediately. Check the ice vapour. If there is no ice vapour, repeat step 1.
3: TREAT: Press the tip firmly against the wart. For best results - the time is crucial.
15 seconds on thin skin (hands, fingers, toes, side/top of feet and arms); 40 seconds on thick, callous skin (soles of feet).
Put the cap back on.
After use, store in a refrigerator.
The wart will slowly disappear after 10 to 14 days. If the wart, or part of it, does not disappear within 14 days repeat steps 1, 2 and 3.
Does the patient need to repeat the treatment? EndWarts FREEZE is very efficient - the core of the wart will be reached quickly and will be destroyed because of the cold temperature. Normally, only one treatment is sufficient. Old or large warts may need more than one treatment, especially if they are under the soles of the feet.
The wart will slowly disappear after 10 to 14 days. If the wart, or part of it, does not disappear within 14 days patient needs to repeat the treatment and steps 1, 2 and 3 previously mentioned.
If a wart does not go away after 3 treatments, consult the doctor.
Consult the doctor: if patient experiences any unexpected side effects; if the wart does not heal; if the wart has not disappeared after 3 treatments.
Contraindications
Do not use EndWarts FREEZE: On children under 4 years of age;
On the face, groin, genitals, scalp or mucosa;
On healthy skin (skin without warts);
On warts located on sensitive skin and take particular care when treating areas of thin skin (e.g. around joints);
If the wart and/or surrounding skin is bleeding or open, irritated, itchy, infected or red;
If patient is not sure if the growth is a common wart, consult the doctor before use;
On moles, corns, blisters, other skin defects or anything that might be skin cancer (melanoma);
On liquid filled vesicles on the skin (called "molluscum contagiosum") or any other vesicles or blisters;
If the patient is diabetic or a person with blood circulation or blood clotting problems;
On warts in a cluster or warts are closer than 3 cm, treat one wart and wait 14 days before patient treats the next wart;
If patient is pregnant or breast-feeding, check with the doctor whether patient can use this device.
Special Precautions
Do not inhale. For external use only.
Do not apply for longer than 15 seconds on thin skin (hands, fingers, toes, top/side of feet and arms), or 40 seconds on thick, callous skin (soles of feet). Excessive or incorrect application can cause pain and skin or nerve damage.
EndWarts FREEZE should be used by an adult when treating warts on children.
Nitrous oxide is a non-toxic, non-flammable gas, but it will support combustion in case of fire. Keep away from heat/sparks/ open flames/hot surfaces. Do not smoke or use close to a naked flame.
Pressurized container. May burst if heated. Do not pierce or burn the cartridge even after use - the device is under high pressure and cannot be opened.
Use In Pregnancy & Lactation
If patient is pregnant or breast-feeding, check with the doctor whether patient can use this device.
Side Effects
Possible side effects include: Blisters (possible blood blisters) around the treated area - which varies from case to case, see 'After using EndWarts FREEZE' under Cautions for Usage.
The skin losing its colour - called "depigmentation".
Minor burns and scar formation.
Risk of skin/nerve damage (in case of overexposure).
Transient disturbed sensation (tingling, prickling feeling).
Caution For Usage
For best results on foot warts: Hard skin on top of the wart makes freezing more difficult: Soak the affected area in lukewarm water until the skin is soft.
Gently remove any overlaying skin on inward growing warts on the foot with e.g. a tweezer.
Make sure that the wart and surrounding skin are completely dry before treatment.
Do not file the wart itself; it may become tender and will form a new hard surface.
After using EndWarts FREEZE: Using EndWarts Freeze will cause a tingling feeling and the skin may feel sore or irritated. These effects should go away after a few hours. Immediately after treatment the treated area will turn white. After a little while the skin will go back to its normal colour and the wart will look red.
Within a few minutes to several days after freezing, a blister can develop, occasionally filled with blood. This is a normal result of the freezing process and usually indicates that the treatment was successful. Do not attempt to burst the blister. If necessary, protect it with a sterile bandage, or if the blister has opened, disinfect it properly.
The treated wart will slowly disappear after 10 to 14 days. However, it may take longer for the skin to fully recover.
If the wart is located on the sole of the foot it may feel painful to walk on it. To make it less painful, apply a round corn plaster to the area.
Do not pick at the treated area or try to tear the wart off.
Keep the treated area clean and disinfect if needed. This is important to avoid an infection of the treated skin.
Bathing and showering is allowed immediately after treatment.
What to do if the device is empty or broken: If patient does not see frost or ice vapour after a successful activation and loading of the device (see DOSAGE & ADMINISTRATION) it has run out of gas - use a new EndWarts FREEZE.
If there is a continuous hiss sound after patient has activated the product and all the gas runs out, the device is broken. Do not try to open or repair it, even if patient thinks it is empty - return the product to the pharmacy.
Storage
Before first use: Store in a dry and cool place (between 5 - 25°C). Protect from sunlight.
Do not store in the freezer.
Do not expose to temperatures above 50°C. Do not store in cars, caravans, or other places that heat up. An increase in temperature will damage the device and disable it permanently.
After each use: Put the cap on and store in the refrigerator - this will give EndWarts FREEZE a longer shelf life and increase the number of useful doses.
Do not store in the freezer.
Do not expose the activated device to temperatures above 35°C, as this will activate a safety feature that disables the device permanently.
Wait two minutes after use, discard the disposable tip and insert a new tip. EndWarts FREEZE is now ready for the next use.
If patient will clean the plastic parts of the device, use a damp cloth only.
Shelf life in the refrigerator after activation: 2 month.
Dispose the empty product according to current regulations on disposal of urban waste.
MIMS Class
Warts & Calluses Preparations
ATC Classification
N01AX13 - nitrous oxide ; Belongs to the class of other general anesthetics.
Presentation/Packing
Pen (cartridge) 7.5 g + 7 disposable tips.
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