Compound W FREEZE OFF User manual

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

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.
G. How does Compound W™Freeze Off™Advanced work?
1. Compound W™Freeze Off™Advanced freezes warts on the spot. The
freezing kills both the virus and the infected skin. When the applicator is
pressed (applied) on the wart, freezing begins within a few seconds and the
skin will turn white (see diagram and instructions for use). A slight aching,
itching and/or stinging feeling will occur as a result of the freezing. After the
applicator is removed, color will return and the aching, itching, stinging
feeling will quickly decrease, disappearing within a few hours.
2. After the area thaws and color returns, a redness that is the same size as
the frozen region may appear. As a result of freezing, a blister may form
(sometimes filled with blood) under the wart within a few days. You may not
see this easily.
3. The frozen skin with the treated wart will fall off after about 10-14 days. In
the meantime, new skin will have formed under the blister.
H. Side Effects
• A stinging, itching, aching feeling during and after freezing that quickly
decreases after the area thaws.
• Possible changes in coloring from white to red.
• Possible blistering.
• Black dots may appear in the middle of the warts after a few days.
I. Instructions for use (Common Warts)
1. Remove the cap and place the can on a table or other flat surface holding it
by the collar. Firmly hold the collar between your thumb and index finger, then
twist the cone counter-clockwise to the “1” position with your other hand.
2. While holding the cone in the “1” position, push down on the cone for 3
seconds without touching the metal tip. You will hear a hissing sound, which
is the activation sound. Let go, and be sure the cone returns to its starting
position to lock the system before applying the product.
3. Wait 2 seconds for the applicator tip to freeze. Then precisely apply the
frozen metal tip on the common wart (hand) for maximum of 20 seconds,
following the application time included in this instruction leaflet.
I. Instructions for use (Plantar Warts)
1. Soak foot with plantar wart for 5 minutes in warm water. Dry thoroughly. File
the plantar wart area with a pumice stone or pumice file (not included) before
applying Compound W™Freeze Off™Advanced.
2. Follow steps 1 and 2, as indicated above for Common Warts.
3. Wait 2 seconds for the applicator tip to freeze. Then precisely apply the
frozen metal tip on the plantar wart (foot) for a maximum of 40 seconds,
following the application time included in the instruction leaflet.
Comfort pads (not included) can be used to protect the tender plantar wart
area after treatment has been completed. Carefully remove pad from backing.
Apply adhesive side of pad to skin with hole directly over the small tender
spot.
I. Instructions for use (Common and Plantar Warts)
For each common wart, only one treatment is necessary in most cases. Plantar
warts may require more than one treatment. In two weeks after treatment with
Compound W™Freeze Off™Advanced Wart Remover, common warts are
usually gone. If a wart or part of it is still there two weeks after treatment, you
may then safely treat it again. Do not treat each wart with Compound W™
Freeze Off™Advanced Wart Remover more than three times in total.
Consult your doctor if three treatments have not led to improvement. Do not
apply Compound W™Freeze Off™Advanced Wart Remover together with any
other method of wart removal because it is uncertain how the combination
may affect your skin. Combination usage may result in serious burns and
permanent scarring of the skin.
It is important that the instructions In the Information Leaflet are
followed exactly. Careless use can cause freezing too deeply,
causing permanent damage to the uppermost layer of the skin on
fingers and toes. This may result in permanent scars or nerve
damage.
J. Application times
Precisely apply the frozen metal tip on the common wart (hand) for 20
seconds or less, depending on the size of the wart. If you use it on a
plantar wart on an area of the foot with thicker or calloused skin,
such as the balls of the foot or the heel, hold the applicator on the
plantar wart for 40 seconds or less. Treat plantar warts occurring on
less calloused areas of the foot, such as the arch of the foot or toes,
for 20 seconds or less. Calloused areas of the foot vary from person to
person. If the area of the foot where the plantar wart occurs is not
calloused, do not apply Compound W™Freeze Off™Advanced for more
than 20 seconds.
[Figure 1]
Maximum Application Times for Plantar Warts and Various Parts of
Foot
- 20 Seconds Area arch and toes
- 40 Seconds Area heel and ball of foot
K. Follow-up treatment
• After application, the color of the skin may change, varying from white to red.
A blister may form under the wart and an aching/stinging feeling normally will
occur for up to a few hours. If the aching, stinging feeling continues until the
next day, or if another problem (such as freezing the skin beyond the size of
the wart or less of feeling) occurs, contact your doctor. It is normal for the
treated area to be sensitive for a few days.
• Black dots may appear in the center of the treated wart after a few days.
• Keep the treated area clean.
• You may swim or shower.
• Do not pick or scratch the treated area as this may result in infection.
• Protect blisters, if necessary, with a gauze or sterile adhesive bandage.
• Do not puncture blisters. Puncturing blisters will be painful and may result in
infection.
Compound W™Freeze Off™Advanced contains: Dimethyl ether
The product can be used until the expiration date indicated on both the carton
and the pressurized canister.
Questions? 1-800-443-4908
For more information including an instructional video please visit
www.CompoundW.com
‘PSSSSH’
sec.
3
sec.
sec.
sec.
collar
cone
Place the can on
the table
and hold the
collar.
With the can on the
table, turn the cone to
the “1” position and
press down on the
cone for 3 seconds
(you will hear a hiss)
The cone twists
back to “0”
automatically. Wait
2 seconds for the tip
to freeze.
Apply the tip
precisely on the
wart (maximum 20
seconds for
common warts, 40
seconds for plantar
warts).
I. Instructions for use
Common warts and plantar
warts on toes and arch of foot
Common warts and plantar
warts on toes and arch of foot
Common warts and plantar
warts on toes and arch of foot
Calloused Plantar warts on
heels and balls of feet
Smaller than 3/32 in
(2.5mm)
3/32 - 3/16 in
(2.5 - 5.0mm)
Larger than 3/16 in
(5.0mm)
All sizes
10 seconds
15 seconds
20 seconds
40 seconds
WART DIAMETER TREATMENT TIME
FREEZE OFF™
Wart Remover System
For Common and Plantar Warts
ADVANCED
© 2014 Distributed by
Medtech Products Inc.
Tarrytown, NY 10591,
A Prestige Brands Company
Patent Pending
CW044601