Just received my medication

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Just received my medication

Postby Chi » Sat Feb 11, 2006 4:03 am

I ordered this product called skin zinc that my friends and coworkers heard on the radio. I just picked it up today and I just put some on my skin, stings a tiny bit hope it works.
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SkinZinc has in the past been a spin off from Skin Cap!

Postby Nick Balgowan » Sat Feb 11, 2006 5:33 pm

Hi Chi,

Glad to see our forum is starting to be used and thanks for all your support! Please don't get me wrong, I am all for people trying various treatments. It is well known what works for one may or may not work for another. Psoriasis treatment is often by trial and error.

I am also unsure where you are located, but a product was advertised heavily in the past called SkinZinc which was actually found to be BlueCap that is a steroid based product, although the steroid was not included in the ingredients which is why it was illegal. User's were under the impression they had a natural cure, when it turned out to be a strong chemical treatment. I thought it important to mention this in light of your post regarding SkinZinc.

The FDA's comment on zinc treatment for psoriasis is "Pyrithione zinc is not acceptable for the control of eczema or psoriasis." and "Under the regulations cited above, OTC drugs containing pyrithione zinc as the active ingredient are not generally recognized as safe and effective for the treatment of psoriasis and eczema."

Zinc has been found ineffective for psoriasis treatment. From what you have said, it sounds like they may be back in business? In 1997 the FDA in theUSA banned a product specifically called SkinZinc. If what you have purchased does infact contain a steroid, that may explain the stinging sensation.

"Since 1999, there have been various telemarketing campaigns of newspaper and radio ads for topical zinc pyrithione products such as SkinZinc, Acadia Skin Care, Skin-Plaque and others. In 1990, the FDA specifically banned the promotion of zinc pyrithione products for psoriasis treatment. Recent clinical trials of such products have found them generally ineffective for psoriasis. There are a few public reports of people having success with a topical zinc pyrithione shampoo (such as Head & Shoulders) on the skin, but that's not a typical response. Generic dandruff shampoos have about ten times the concentration of active ingredient compared to the overhyped "Zinc" sprays."


***************

Public Health Service
Food and Drug Administration

One Montvale Avenue
Stoneham, Massachusetts 02180
(781) 596-7700
FAX: (781) 596-7896

WARNING LETTER
NWE-13103W

April 9, 2003
Reissued April 17, 2003

VIA FEDEX

Jeffrey V. Kral, President
Selfworx.Com, LLC
51 Nonesuch River Plaza, Suite I
Scarborough, Maine 04074

Dear Mr. Kral:

This letter is in reference to your marketing of “Skin Zinc Spray” and “Skin Zinc Cream.” Statements on the immediate container and the promotional material that accompanies these products states that the “Skin Zinc Spray” is useful in treating psoriasis, eczema, seborrheic dermatitis, and dandruff, and the “Skin Zinc Cream” is useful in treating psoriasis, eczema, and seborrheic dermatitis.

Based on the above claims, these products are drugs according to Section 201(g) of the Federal Food, Drug, and Cosmetic Act (Act). Over-the-counter (OTC) drugs for the Control of Dandruff, Seborrheic Dermatitis, and Psoriasis are subject to regulations at Title 21 Code of Federal Regulations Part 358 Subpart H (21 CFR 358 Subpart H).
Regulation 21 CFR 358.710 lists the acceptable active ingredients and their concentration for products labeled for the control of dandruff, seborrheic dermatitis, or psoriasis. Regulation 21 CFR 358.750 states the acceptable labeling for products labeled for the control of dandruff, seborrheic dermatitis, or psoriasis. OTC drugs subject to this final rule must be formulated and labeled in accord with the final rule to be generally recognized as safe and effective and not misbranded.

“Skin Zinc Spray” is labeled to contain pyrithione zinc 0.25% as the active ingredient, and its label states “Helps eliminate skin and scalp redness, scaling, itching, flaking and irritation associated with psoriasis, eczema, seborrheic dermatitis and dandruff.” Regulations 21 CFR 358.710 and 21 CFR 358.750 set forth conditions when OTC drug products containing pyrithione zinc between 0.1 and 0.25 percent are generally recognized as safe and effective when applied and left on the skin or scalp for the control of dandruff, and seborrheic dermatitis. Pyrithione zinc is not acceptable for the control of eczema or psoriasis.

“Skin Zinc Cream” is labeled to contain salicylic acid 2% as the active ingredient, and its label states “Helps eliminate Flaking, Itching, Irritation, Redness & Scaling associated with Psoriasis, Eczema & Seborrheic Dermatitis.” Regulations 21 CFR 358.710 and 21 CFR 358.750 set forth conditions when OTC drug products containing salicylic acid between 1.8 and 3 percent are generally recognized as safe and effective and is not misbranded for the treatment of psoriasis and seborreheic dermatitis. Eczema is not an acceptable indication under this regulation.

Under the regulations cited above, OTC drugs containing pyrithione zinc as the active ingredient are not generally recognized as safe and effective for the treatment of psoriasis and eczema. Also, OTC drugs containing Salicylic acid 2% as the active ingredient are not generally recognized as a safe and effective for the treatment for eczema. Therefore, Skin Zinc Spray and Skin Zinc Cream are new drugs within the meaning of 201(p) of the Act. Because neither of these two drugs is the subject of an FDA-approved new drug application, the marketing of these products violates section 505 of the Act.

This letter is not intended to be an all-inclusive review of all your labeling or your products your firm distributes. It is your responsibility to ensure that all products marketed by your firm are in compliance with the Act and its implementing regulations. We request that you take prompt action to correct these violations. Failure to correct these violations may result in regulatory action without further notice. Such action includes seizure and/or injunction.

Please notify this office in writing within fifteen (15) working days of receipt of this letter as to the specific steps you have taken to correct the stated violations. You should also include an explanation of each step being taken to identify and make corrections to assure that similar violations will not occur. If corrective action cannot be completed within fifteen (15) working days, state the reason for the delay and the time within which the correction will be implemented.

OTC drugs such as yours that are subject to final regulations must now also comply with the Drug Facts Format Labeling requirements in 21 CFR 201.66. If you relabel and reformulate your products to comply with the regulations cited in this letter, these products must also meet the requirements of this regulation.

You should address your response to Bruce R. Ota, Compliance Officer, Food and Drug Administration, One Montvale Avenue, Fourth Floor, Stoneham, Massachusetts 02180.

Sincerely,
/s/
Gail T. Costello
District Director
New England District
Nick Balgowan.
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Thanks

Postby Chi » Sun Feb 12, 2006 2:05 am

Yes I also read somewhere AFTER I bought the product and applied it that it's probably a clone from skin-cap, blue cap which was banned several times that contained steriods but they kept denying it.

Argh, dunno what to do, I don't have any form of medication at the moment and my psoriasis is breaking out so I'll just use this for now.

I live in Southern Ontario, Canada. It's cold now like 0 to -5 degree Celcius maybe that's why my skin's a bit bad.

If you have any form of treatment that seems good that's not too expensive I'm willing to try it too.
Chi
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psoriasis medications

Postby Nick Balgowan » Sun Feb 12, 2006 7:16 am

hi Chi,

Unfortunately there are only 2 medications recognised as psoriasis treatments in over the counter products. They are Coal Tar and Salicylic Acid that both effectively burns off the dry skin. So not actual treatments as such, by removing the dry excess or dead skin, they give the impression of helping. The other obvious treatments are steroids, we have most of the recognised treatments documented on our web page under psoriasis treatments. The current drastic medical treatments all work on surpressing your immune system which can obviously have other complication.
Nick Balgowan.
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Postby Chi » Sun Feb 12, 2006 10:57 am

I just hope they fixed some stuff about their product instead of relabelling it. I notice the spray didn't say was for psoriasis which uses zinc as active ingredient (so I bought it before reading, kinda my fault).

But the cream's active ingredient is 2% salicylic acid, so I just use the cream now instead of the spray just dunno what to do with the spray.
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Re: SkinZinc has in the past been a spin off from Skin Cap!

Postby Chi » Sun Feb 12, 2006 5:09 pm

“Skin Zinc Spray” is labeled to contain pyrithione zinc 0.25% as the active ingredient, and its label states “Helps eliminate skin and scalp redness, scaling, itching, flaking and irritation associated with psoriasis, eczema, seborrheic dermatitis and dandruff.” Regulations 21 CFR 358.710 and 21 CFR 358.750 set forth conditions when OTC drug products containing pyrithione zinc between 0.1 and 0.25 percent are generally recognized as safe and effective when applied and left on the skin or scalp for the control of dandruff, and seborrheic dermatitis. Pyrithione zinc is not acceptable for the control of eczema or psoriasis.

Probably that was what it labeled back then, now on their page and on label of bottle.
Zinc Pyrithione is the active ingredient in Skin Zinc™ Spray used to control dandruff and seborrheic dermatitis. 0.25% Zinc Pyrithione is listed safe by the FDA as an active ingredient for the relief of red, itchy, dry, and irritated skin and scalp associated with seborrheic dermatitis and dandruff.

---------------------------------------------------

“Skin Zinc Cream” is labeled to contain salicylic acid 2% as the active ingredient, and its label states “Helps eliminate Flaking, Itching, Irritation, Redness & Scaling associated with Psoriasis, Eczema & Seborrheic Dermatitis.” Regulations 21 CFR 358.710 and 21 CFR 358.750 set forth conditions when OTC drug products containing salicylic acid between 1.8 and 3 percent are generally recognized as safe and effective and is not misbranded for the treatment of psoriasis and seborreheic dermatitis. Eczema is not an acceptable indication under this regulation.

Now that's changed to
2% salicylic acid that helps eliminate skin flaking, irritation, itching, and redness associated with psoriasis and seborrheic dermatitis.


So I guess they're not lying anymore at least, but I just hope it's really 100% steriod free, that's the only thing I don't really want on my skin. They stated 100% steriod free guaranteed on their site.
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SkinZinc

Postby Nick Balgowan » Sun Feb 12, 2006 6:04 pm

Hello again Chi,

I am not sure if SkinZin as such ever contained steroids, but the BlueCap and SkinCap products, marketted in a very similar fashion most certainately did contain steroids. I have no other information on SkinZinc at this time, other than products with "safe" levels of Coal Tar and Acid are available from most pharmacies. I hope it does work well for you and would be very interested in hearing how you progress with the treatment/products and I am sure others would also be interested to know also!
Nick Balgowan.
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Postby Chi » Mon Feb 13, 2006 9:15 am

I hope it works too, so far I applied it for 3 times only and it seems to clear the psoriasis away. Just that it's also itchy too lol, like itchier than before I put anything on my skin.

Not bad I guess, even though I had to pay ship/handling + custom fees, it still works out cheaper than what I get from the doctor prescribed medication (usually ointment 60g, for about $120 CDN) or $103 USD.
whereas 1 cream of the cylic acid product cost like $30 CDN with 113g. (if I order 2, buy 2 get one free thing)

Anyway, if it clears my skin, I'll probably just use stuff like this than prescribed medication, since I don't have insurance of benefits from my company either.
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Re: Just received my medication

Postby David Dunlop » Wed Feb 15, 2006 10:48 pm

Chi wrote:I ordered this product called skin zinc that my friends and coworkers heard on the radio. I just picked it up today and I just put some on my skin, stings a tiny bit hope it works.


wow, I tried something called ZincCap, is that the same thing? I seem to remember it was advertised for a while, then they had a product recall or something. It didn't seem to do much for me, but I agree, it stung like all hell. I didn't use it for long as it was too painful.
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Postby Chi » Fri Feb 24, 2006 1:19 am

I think Zinc Cap was simular product but if it stings a lot, it might contain steriods. The one I used doesn't really sting much just tiny bit.

It helps actually, only if I use it like 2x a day but I sometimes use once only.. lol.. lazy
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Re: Thanks

Postby nightangel67 » Thu Mar 23, 2006 7:14 am

Chi wrote:Yes I also read somewhere AFTER I bought the product and applied it that it's probably a clone from skin-cap, blue cap which was banned several times that contained steriods but they kept denying it.

Argh, dunno what to do, I don't have any form of medication at the moment and my psoriasis is breaking out so I'll just use this for now.

I live in Southern Ontario, Canada. It's cold now like 0 to -5 degree Celcius maybe that's why my skin's a bit bad.

If you have any form of treatment that seems good that's not too expensive I'm willing to try it too.




Hi, I live in Southern Ontario too.
It's a small world!
I just went to my derm about a week ago.
He did a biopsy because have something on my face and I was concerned.
I have been diagnosed with psoriasis on my extremities.
Finally.
I am lucky because he gave me some samples.
He had already given me a prescription for the coal tar.
Depending on the area I use different things.
One for my elbows, one for my feet (right foot) in combination with the coal tar, and a different one for my face.
Have you seen a derm?
It is the best thing I ever did, my family doctor had to refer me.
I get my stitches out tomorrow by my family doctor.
Should know in about a month the results of the biopsy.
Right now I am using alcohol and vaseline on my face and the a prescription I already had meant for this area.
Glad I found this place.
It is awesome.
Hope you get some help dealing with your psoriasis.
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Re: Thanks

Postby Nick Balgowan » Thu Mar 23, 2006 7:43 am

nightangel67 wrote:
Chi wrote:Yes I also read somewhere AFTER I bought the product and applied it that it's probably a clone from skin-cap, blue cap which was banned several times that contained steriods but they kept denying it.

Argh, dunno what to do, I don't have any form of medication at the moment and my psoriasis is breaking out so I'll just use this for now.

I live in Southern Ontario, Canada. It's cold now like 0 to -5 degree Celcius maybe that's why my skin's a bit bad.

If you have any form of treatment that seems good that's not too expensive I'm willing to try it too.




Hi, I live in Southern Ontario too.
It's a small world!
I just went to my derm about a week ago.
He did a biopsy because have something on my face and I was concerned.
I have been diagnosed with psoriasis on my extremities.
Finally.
I am lucky because he gave me some samples.
He had already given me a prescription for the coal tar.
Depending on the area I use different things.
One for my elbows, one for my feet (right foot) in combination with the coal tar, and a different one for my face.
Have you seen a derm?
It is the best thing I ever did, my family doctor had to refer me.
I get my stitches out tomorrow by my family doctor.
Should know in about a month the results of the biopsy.
Right now I am using alcohol and vaseline on my face and the a prescription I already had meant for this area.
Glad I found this place.
It is awesome.
Hope you get some help dealing with your psoriasis.


Hello NightAngel. What is the alcohol for? Or are you waiting on the biopsy before you know what you have? I would have thought alcohol would only be suitable as a surface disinfectant. Do they think you have an infection or skin fungas of some kind? Just curious as if they suspected a fungas, a skin scrape would have been adequate rather than a full biopsy. Just my idol curiosity :shock:
Nick Balgowan.
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http://www.dermaray.com
http://www.beatpsoriasis.com
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Re: Thanks

Postby nightangel67 » Thu Mar 23, 2006 8:05 am

Nick Balgowan wrote:
nightangel67 wrote:
Chi wrote:Yes I also read somewhere AFTER I bought the product and applied it that it's probably a clone from skin-cap, blue cap which was banned several times that contained steriods but they kept denying it.

Argh, dunno what to do, I don't have any form of medication at the moment and my psoriasis is breaking out so I'll just use this for now.

I live in Southern Ontario, Canada. It's cold now like 0 to -5 degree Celcius maybe that's why my skin's a bit bad.

If you have any form of treatment that seems good that's not too expensive I'm willing to try it too.




Hi, I live in Southern Ontario too.
It's a small world!
I just went to my derm about a week ago.
He did a biopsy because have something on my face and I was concerned.
I have been diagnosed with psoriasis on my extremities.
Finally.
I am lucky because he gave me some samples.
He had already given me a prescription for the coal tar.
Depending on the area I use different things.
One for my elbows, one for my feet (right foot) in combination with the coal tar, and a different one for my face.
Have you seen a derm?
It is the best thing I ever did, my family doctor had to refer me.
I get my stitches out tomorrow by my family doctor.
Should know in about a month the results of the biopsy.
Right now I am using alcohol and vaseline on my face and the a prescription I already had meant for this area.
Glad I found this place.
It is awesome.
Hope you get some help dealing with your psoriasis.


Hello NightAngel. What is the alcohol for? Or are you waiting on the biopsy before you know what you have? I would have thought alcohol would only be suitable as a surface disinfectant. Do they think you have an infection or skin fungas of some kind? Just curious as if they suspected a fungas, a skin scrape would have been adequate rather than a full biopsy. Just my idol curiosity :shock:


Hi Nick,
I have had the skin scrape actually lots of them...ouch
Guess this is kind of puzzling because it is very rare to have it on your face.
I was told only less 2% of the pop have it and also maybe 1 in 1000.
My derm isn't sure so they aren't ruling out cancer but basically told me it isn't a concern , he thinks it could be psoriasis, or the one with the "e" (lousy speller) lol, or it could be an allergic reaction to the sun.
So the alcohol was to keep it clean, and the vaseline to keep it from drying out.
Stitches come out tomorrow, thank god.
The emotional impact of this also really needs to be addressed.
Just playing the waiting game.
Having this on your face is a lot harder to "cover up".
I have to let it have the air get at it so they rather you didn't cover it if possible, needs to heal.
It is just dealing ppl asking or staring.
Personally I would rather ppl ask than assume.
PPL have thought I was the victim of domestic violence.
Nobody hit me. Honestly!
I know it looks bad, I really don't need to be told. lol lmao
Hello, I think I noticed it when I looked in the mirror, omg what is it?
lol...lmao
helps have a sense of humour
Stress will just...
Anyways thanks Nick...I do appreciate your question.
Hoping everything turns out alright.
Positive attitude.
Last edited by nightangel67 on Thu Mar 23, 2006 8:13 am, edited 2 times in total.
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Hey

Postby AznBoi101210 » Thu Mar 23, 2006 8:08 am

Hey I was wondering if you know any type of medication that helps relieve the purplish/red color on the skin. I'm only 14 and I've almost tried everything there is for this curse. I've had it for about 2-3 years so I was wondering if you had any sort of advice.
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Re: Just received my medication

Postby Nick Balgowan » Sun May 14, 2006 10:36 am

Chi wrote:I ordered this product called skin zinc that my friends and coworkers heard on the radio. I just picked it up today and I just put some on my skin, stings a tiny bit hope it works.


Hi Chi,

I know this is an older post now, but I was just forwarded this information that you may find interesting.

The Skin-Cap Story

In a matter of months, consumer’s word of mouth, presentations at scientific meetings and Internet hype result in spectacular sales for an unlabelled use of Skin-Cap®. This OTC product is eventually banned after the presence of a potent corticosteroid is suggested by the private sector and later confirmed by drug agencies.

Nothing quite like this has taken place in the modern era of dermatology. With all-powerful drug regulatory agencies, evidence based medicine and sophisticated, accurate drug assays, how could this saga take place?

A Chronology of Events

Manufacture
Early 1980s
Skin-Cap® developed by Cheminova Internacional S.A., Spain.
Active ingredient is listed as zinc pyrithione and the labelled indication is seborrheic dermatitis (dandruff).

Marketing

Marketed as an OTC in many countries. Patients treating their own psoriasis spread the word about good results and usage increases.
Mid 1990’s
In the USA, available from distributors through mail-order with dandruff as the labelled indication.
Early 1997
Rumors of unlabelled corticosteroid present in Skin-Cap®.
March, 1997
Preliminary results from a clinical trial in progress at the University of Minnesota, presented at the AAD by Dr CE Crutchfield III, are reported widely generating much interest.
Patient psoriasis self-help groups and discussion on the Internet fuel further interest in the product.
Mid 1997
Skin-Cap is widely endorsed by some dermatologists after they witness improvement in patients’ psoriasis.
World-wide demand for Skin-Cap® reaches 1,000,000 units per month.

Regulatory concerns

Regulatory agencies in Spain, Austria, Belgium and the Netherlands express concern about the possibility that Skin-Cap® contains corticosteroids.
Acting on concerns expressed by the National Psoriasis Foundation and others, the FDA in the USA and the HPB in Canada decide to investigate the formulation.
1st August, 1997
At the AAD Summer meeting, Professor Mark Lebwohl, Mt. Sinai School of Medicine, announces that clobetasol proprionate was present in several units of Skin-Cap® tested.
FDA detects "prescription" levels of clobetasol proprionate.
Analysis at the Mayo Clinic and assays conducted independently in several other laboratories in North America detect the presence of corticosteroids in Skin-Cap®
4th August, 1997
Cheminova repeatedly deny that the US product contains steroid. Most recent denial dated 4th August in a letter to the National Psoriasis Foundation.

Warnings and regulatory action
8th August, 1997
FDA issues a warning about Skin-Cap® containing steroids and orders detention of shipments at all border entries.
National Psoriasis Foundation issues a warning.
AP, Reuters and other news agencies circulate the warnings and mentions appear in daily newspapers.
12th August, 1997
AAD president circulates an alert to all members.
13th August, 1997
Health Canada issues a warning and states that the Canadian distributor has voluntarily stopped sale of Skin-Cap® in Canada.
26th August, 1997
Withdrawn in Belgium
September, 1997
It is rumored that the 7-8 American distributors of Skin-Cap® are meeting to consider whether or not to start a class-action against Cheminova.
Manufacturers of DermaZinc®, through a Florida distributor, are attempting to meet the needs of psoriatics unable to obtain Skin-Cap®.

Counter-claims

Cheminova, still claiming that appropriate assay procedures will show that corticosteroids are not present, submits samples to an assay using a MALDI-TOF mass spectrophotometer located in Vancouver, Canada. This test was positive for the presence of corticosteroid.
September 5th, 1997
An independent laboratory (Michigan State University, Dept. of Biochemistry), using specified extraction techniques and Fast Atom Bombardment Mass Spectroscopy, is unable to detect clobetasol.
September 9th, 1997
Cheminova International states that Skin-Cap® is once again allowed to be marketed in the Netherlands, that new batches have been dispatched to Germany, Holland, France and Italy, and the product is legal in all these markets.

With regard to the reintroduction of Skin-Cap® into the Netherlands, it should be understood that tests conducted at four different laboratories in the Netherlands DID show the presence of prescription amounts of steroids and the original formulation is not allowed to be marketed and sold there. A REFORMULATED product can be marketed if it does not contain steroids, and if the accompanying patient information leaflets make no medical claims about psoriasis. The reformulated product will be subjected to random testing for the presence of steroids.

Future

After reviewing the events that have unfolded, it is quite likely that in the future Skin-Cap® reformulated without corticosteroids, or similar products containing zinc pyrithione, will continue to be promoted for dandruff and/or psoriasis.

The Internet Angle

Dermatology feels the influence of the Internet

Physicians treating AIDS patients are no strangers to the power of the Internet, but this is the first time that dermatologists have experienced such pressures.
A quick surf demonstrates intense interest and lively debate about Skin-Cap®.
A web-site is spreading the message – Save Skin-Cap®! Psoriatic patients find the product effective and don’t want any interruption in the availability of Skin-Cap®, regardless of whether steroids are present.
Advice is given on obtaining "cross border" supplies from Mexico.
As one would expect, rumours of a conspiracy between regulatory agencies, drug companies and the dermatologic establishment abound. The National Psoriasis Foundation is said to be influenced by heavy sponsorship from drug companies. Dermatologists are said to be trying to protect their income.
Nick Balgowan.
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http://www.dermaray.com
http://www.beatpsoriasis.com
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