Application Information

This drug has been submitted to the FDA under the reference 021005/001.

Names and composition

"SOLARAZE" is the commercial name of a drug composed of DICLOFENAC SODIUM.

Forms

ApplId/ProductId Drug name Active ingredient Form Strenght
021005/001 SOLARAZE DICLOFENAC SODIUM GEL/TOPICAL 3%

Similar Active Ingredient

ApplId/ProductId Drug name Active ingredient Form Strenght
019201/001 VOLTAREN DICLOFENAC SODIUM TABLET, DELAYED RELEASE/ORAL 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
019201/002 VOLTAREN DICLOFENAC SODIUM TABLET, DELAYED RELEASE/ORAL 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
019201/003 VOLTAREN DICLOFENAC SODIUM TABLET, DELAYED RELEASE/ORAL 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
020037/001 VOLTAREN DICLOFENAC SODIUM SOLUTION/DROPS/OPHTHALMIC 0.1%
020254/001 VOLTAREN-XR DICLOFENAC SODIUM TABLET, EXTENDED RELEASE/ORAL 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
020809/001 DICLOFENAC SODIUM DICLOFENAC SODIUM SOLUTION/DROPS/OPHTHALMIC 0.1%
020947/001 PENNSAID DICLOFENAC SODIUM SOLUTION/TOPICAL 1.5%
021005/001 SOLARAZE DICLOFENAC SODIUM GEL/TOPICAL 3%
022122/001 VOLTAREN DICLOFENAC SODIUM GEL/TOPICAL 1%
022396/001 DYLOJECT DICLOFENAC SODIUM SOLUTION/INTRAVENOUS 37.5MG per ML (37.5MG per ML)
074376/001 DICLOFENAC SODIUM DICLOFENAC SODIUM TABLET, DELAYED RELEASE/ORAL 25MG
074376/002 DICLOFENAC SODIUM DICLOFENAC SODIUM TABLET, DELAYED RELEASE/ORAL 50MG
074390/001 DICLOFENAC SODIUM DICLOFENAC SODIUM TABLET, DELAYED RELEASE/ORAL 75MG
074391/001 DICLOFENAC SODIUM DICLOFENAC SODIUM TABLET, DELAYED RELEASE/ORAL 25MG
074391/002 DICLOFENAC SODIUM DICLOFENAC SODIUM TABLET, DELAYED RELEASE/ORAL 50MG
074391/003 DICLOFENAC SODIUM DICLOFENAC SODIUM TABLET, DELAYED RELEASE/ORAL 75MG
074394/001 DICLOFENAC SODIUM DICLOFENAC SODIUM TABLET, DELAYED RELEASE/ORAL 75MG
074432/002 DICLOFENAC SODIUM DICLOFENAC SODIUM TABLET, DELAYED RELEASE/ORAL 50MG
074432/003 DICLOFENAC SODIUM DICLOFENAC SODIUM TABLET, DELAYED RELEASE/ORAL 75MG
074459/001 DICLOFENAC SODIUM DICLOFENAC SODIUM TABLET, DELAYED RELEASE/ORAL 25MG
074459/002 DICLOFENAC SODIUM DICLOFENAC SODIUM TABLET, DELAYED RELEASE/ORAL 50MG
074459/003 DICLOFENAC SODIUM DICLOFENAC SODIUM TABLET, DELAYED RELEASE/ORAL 75MG
074514/001 DICLOFENAC SODIUM DICLOFENAC SODIUM TABLET, DELAYED RELEASE/ORAL 50MG
074514/002 DICLOFENAC SODIUM DICLOFENAC SODIUM TABLET, DELAYED RELEASE/ORAL 75MG
074723/001 DICLOFENAC SODIUM DICLOFENAC SODIUM TABLET, DELAYED RELEASE/ORAL 50MG
074986/001 DICLOFENAC SODIUM DICLOFENAC SODIUM TABLET, DELAYED RELEASE/ORAL 50MG
074986/002 DICLOFENAC SODIUM DICLOFENAC SODIUM TABLET, DELAYED RELEASE/ORAL 75MG
075185/001 DICLOFENAC SODIUM DICLOFENAC SODIUM TABLET, DELAYED RELEASE/ORAL 75MG
075185/002 DICLOFENAC SODIUM DICLOFENAC SODIUM TABLET, DELAYED RELEASE/ORAL 25MG
075185/003 DICLOFENAC SODIUM DICLOFENAC SODIUM TABLET, DELAYED RELEASE/ORAL 50MG
075281/002 DICLOFENAC SODIUM DICLOFENAC SODIUM TABLET, DELAYED RELEASE/ORAL 50MG
075281/003 DICLOFENAC SODIUM DICLOFENAC SODIUM TABLET, DELAYED RELEASE/ORAL 75MG
075492/001 DICLOFENAC SODIUM DICLOFENAC SODIUM TABLET, EXTENDED RELEASE/ORAL 100MG
075910/001 DICLOFENAC SODIUM DICLOFENAC SODIUM TABLET, EXTENDED RELEASE/ORAL 100MG
076152/001 DICLOFENAC SODIUM DICLOFENAC SODIUM TABLET, EXTENDED RELEASE/ORAL 100MG
076201/001 DICLOFENAC SODIUM DICLOFENAC SODIUM TABLET, EXTENDED RELEASE/ORAL 100MG
077600/001 DICLOFENAC SODIUM DICLOFENAC SODIUM SOLUTION/DROPS/OPHTHALMIC 0.1%
077845/001 DICLOFENAC SODIUM DICLOFENAC SODIUM SOLUTION/DROPS/OPHTHALMIC 0.1%
077863/001 DICLOFENAC SODIUM DICLOFENAC SODIUM TABLET, DELAYED RELEASE/ ORAL 75MG
077863/003 DICLOFENAC SODIUM DICLOFENAC SODIUM TABLET, DELAYED RELEASE/ORAL 75MG
078031/001 DICLOFENAC SODIUM DICLOFENAC SODIUM SOLUTION/DROPS/OPHTHALMIC 0.1%
078553/001 DICLOFENAC SODIUM DICLOFENAC SODIUM SOLUTION/DROPS/OPHTHALMIC 0.1%
078792/001 DICLOFENAC SODIUM DICLOFENAC SODIUM SOLUTION/DROPS/OPHTHALMIC 0.1%
090066/001 DICLOFENAC SODIUM DICLOFENAC SODIUM TABLET, DELAYED RELEASE/ORAL 25MG
090066/002 DICLOFENAC SODIUM DICLOFENAC SODIUM TABLET, DELAYED RELEASE/ORAL 50MG
200936/001 DICLOFENAC SODIUM DICLOFENAC SODIUM GEL/TOPICAL 3%
202027/001 DICLOFENAC SODIUM DICLOFENAC SODIUM SOLUTION/TOPICAL 1.5%
202393/001 DICLOFENAC SODIUM DICLOFENAC SODIUM SOLUTION/TOPICAL 1.5%
202769/001 DICLOFENAC SODIUM DICLOFENAC SODIUM SOLUTION/TOPICAL 1.5%
202852/001 DICLOFENAC SODIUM DICLOFENAC SODIUM SOLUTION/TOPICAL 1.5%
203383/001 DICLOFENAC SODIUM DICLOFENAC SODIUM SOLUTION/DROPS/OPHTHALMIC 0.1%
203786/001 DICLOFENAC SODIUM DICLOFENAC SODIUM SOLUTION/TOPICAL 1.5% W per W
203818/001 DICLOFENAC SODIUM DICLOFENAC SODIUM SOLUTION/TOPICAL 1.5%
204132/001 DICLOFENAC SODIUM DICLOFENAC SODIUM SOLUTION/TOPICAL 1.5%
204623/001 PENNSAID DICLOFENAC SODIUM SOLUTION/TOPICAL 2%
205878/001 DICLOFENAC SODIUM DICLOFENAC SODIUM SOLUTION/TOPICAL 1.5%
206116/001 DICLOFENAC SODIUM DICLOFENAC SODIUM SOLUTION/TOPICAL 1.5%
206298/001 DICLOFENAC SODIUM DICLOFENAC SODIUM GEL/TOPICAL 3%
206493/001 DICLOFENAC SODIUM DICLOFENAC SODIUM GEL/TOPICAL 3%
207238/001 DICLOFENAC SODIUM DICLOFENAC SODIUM SOLUTION/TOPICAL 2%
208021/001 DICLOFENAC SODIUM DICLOFENAC SODIUM SOLUTION/TOPICAL 2%
208068/001 DICLOFENAC SODIUM DICLOFENAC SODIUM SOLUTION/TOPICAL 2%
208077/001 DICLOFENAC SODIUM DICLOFENAC SODIUM GEL/TOPICAL 1%
208098/001 DICLOFENAC SODIUM DICLOFENAC SODIUM SOLUTION/TOPICAL 2%
208198/001 DICLOFENAC SODIUM DICLOFENAC SODIUM SOLUTION/TOPICAL 2%
208301/001 DICLOFENAC SODIUM DICLOFENAC SODIUM GEL/TOPICAL 3%

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Answered questions

Why is solaraze gel prescribed for pain management?
i was prescribed solaraze gel for pain relief...after doing some research online i found that it was for skin problems. surprisingly, it works and my pain does go away. anyone know why? Asked by Michael Cleavenger 1 year ago.

Because the molecules put into that medicine act differenly in the different parts of your body. When it senses pain it will go right to that area of your body and start to relief it but when you have a skin problem the medicine will sense it and heal that part of your body. Its a very unique substance Answered by Antonetta Nolting 1 year ago.


Does all cases of actinic keratosis develop to SCC?
Should they all be removed by surgery? Asked by Austin Sebesta 1 year ago.

what is actinic keratosis? sorry i could not answer this. best wishes. Answered by Vicky Hardeman 1 year ago.


Does acnitic keratosis always turn into squamous cell carcinoma or can it also turn into basal cell carcinoma?
Prior to 3 areas developing on my chin that will not go away, for several years I had an area on my chin that was wart-like, it was small and skin colored and from the research I have done it is called acnitic keratosis(pre-cancer). It would come and go. But now I have the sores on my chin that won't go away... Asked by Darcel Chard 1 year ago.

Prior to 3 areas developing on my chin that will not go away, for several years I had an area on my chin that was wart-like, it was small and skin colored and from the research I have done it is called acnitic keratosis(pre-cancer). It would come and go. But now I have the sores on my chin that won't go away for 2 months now. I do have an appointment at the end of this month with the dermatologist and I am on the cancellation list. Unfortunately I am one that loves the sun, I just returned from an Island and prior to going I did use the tanning bed like I do every year. I also have a Hx of CA in my family , my mother had breast CA and alot of my aunts and uncles on my mothers side has had some type of CA. I know with my Hx of CA and sun exposure you are probably saying how stupid could you be?? You just never think it will happen to you until it does. Maybe I'm overdiagnosing but I have to wait a month to find out. Answered by Madalyn Smeltz 1 year ago.

This Site Might Help You. RE: Does acnitic keratosis always turn into squamous cell carcinoma or can it also turn into basal cell carcinoma? Prior to 3 areas developing on my chin that will not go away, for several years I had an area on my chin that was wart-like, it was small and skin colored and from the research I have done it is called acnitic keratosis(pre-cancer). It would come and go. But now I have the sores on my chin that... Answered by Camie Mccomas 1 year ago.

I have acnitic keratosis. I just went to the dermatologist. I am VERY pale skinned. I burn walking from work to the car. I have some on my hands, chest and nose. She said 96% or so will not turn into cancer. You should start wearing sunblock and stop being a sun lover. Get a fake tan. That's what I've always had to do. It's not so bad. Who cares if you look like an albino. It's your life and skin. Protect it or die of cancer. With all that history of cancer in your family it looks like you would think twice before lying there and baking in the sun. You are at a very high risk. Answered by Garnett Eastburn 1 year ago.

Do you mean "Actinic keratosis"? Actinic keratosis (also called solar keratosis, senile keratosis, or AK) is a premalignant condition of thick, scaly, or crusty patches of skin. It is most common in fair-skinned people who are frequently exposed to the sun, because their pigment isn't very protective. It usually is accompanied by solar damage. Since some of these pre-cancers progress to squamous cell carcinoma, they should be treated. Please see the web pages for more details on Actinic keratosis. Answered by Lucio Toppings 1 year ago.


Weird thing happening to my muscles?
once when i play handball i can smack a ball hard and make a big sound out of it, but now for some reason when i put all my force and strength in it, it never have a hard sound just a small hit sound. I just remember using a product cuz my arm was sore and it hurted. It was some cream. Rx only Solaraze Gel... Asked by Roy Weyker 1 year ago.

once when i play handball i can smack a ball hard and make a big sound out of it, but now for some reason when i put all my force and strength in it, it never have a hard sound just a small hit sound. I just remember using a product cuz my arm was sore and it hurted. It was some cream. Rx only Solaraze Gel Diclofenac Sodium 3%. Answered by Joe Vanegdom 1 year ago.

well my swimming coach tol dme that when you train you are breaking down the muscle tissues and then you are rebuilding them back stronger so give it time? maybe? maybe your muscles are just broken down now. give them time to rebuild stronger Answered by Analisa Terepka 1 year ago.


Was I prescribed the wrong medication?
I sprained my ankle a week ago, and I got it checked out today. My doctor prescribed me an ointment to ease the pain. I just applied the ointment, only to read the tube and see "for the use of topical treatment of actinic keratosis"- which is thick, scaly, or crusty patches of skin when exposed to sun for... Asked by Melanie Asselta 1 year ago.

I sprained my ankle a week ago, and I got it checked out today. My doctor prescribed me an ointment to ease the pain. I just applied the ointment, only to read the tube and see "for the use of topical treatment of actinic keratosis"- which is thick, scaly, or crusty patches of skin when exposed to sun for too long. The ointment is Solaraze Gel 3%. I think I might have been prescribed the wrong ointment? Or am I wrong and does this gel actually help sprains? Answered by Tamra Mcanaw 1 year ago.

It contains Diclofenac. It's a generic anti-inflammatory medication, quite good when dealing with joints. Basically what it does is reduce pain and swelling, and lower the inflammatory response, which is the source of the pain in a sprained ankle, and involved in actinic keratosis as well. Answered by Concha Pich 1 year ago.


Was I prescribed the wrong medication?
I sprained my ankle a week ago, and I got it checked out today. My doctor prescribed me an ointment to ease the pain. I just applied the ointment, only to read the tube and see "for the use of topical treatment of actinic keratosis"- which is thick, scaly, or crusty patches of skin when exposed to sun for... Asked by Cecilia Kuhr 1 year ago.

I sprained my ankle a week ago, and I got it checked out today. My doctor prescribed me an ointment to ease the pain. I just applied the ointment, only to read the tube and see "for the use of topical treatment of actinic keratosis"- which is thick, scaly, or crusty patches of skin when exposed to sun for too long. The ointment is Solaraze Gel 3%. I think I might have been prescribed the wrong ointment? Or am I wrong and does this gel actually help sprains? Answered by Ignacia Nall 1 year ago.

You were not prescribed the wrong medication, maybe not the best medication but not wrong. The ingredient in the gel that helps you with your ankle pain is a NSAID called Diclofenac. It is also available in oral tablets. It mainly works by reducing hormones that cause inflammation and pain in the body It is used to reduce pain caused by different reasons Answered by Roxann Sous 1 year ago.


Does anyone know the name of the medication used to treat tension headaches?
Asked by Jared Cisowski 1 year ago.

The standard treatments for tension-type headaches are nonsteroidal anti-inflammatory drugs (NSAIDs) such as aspirin and ibuprofen, and tricyclic antidepressants, usually amitriptyline, (Elavil) Over the counter NSAID's include; aspirin, ibuprofen (Motrin IB, Advil, Nuprin), and naproxen (Aleve). Prescription NSAIDs include ibuprofen (Motrin), naproxen (Naprosyn, Anaprox, diclofenac (Voltaren, Cataflam, Solaraze), and tolmetin (Tolectin) Those are the common medications used to treat mild to moderate tension headaches with a good measure of success. However, on the experimental tip there is currently a medication called "Valproate". This anticonvulsant medication has been effective, resulting in the cessation of headaches in some patients with *persistent* migraines and tension-type *chronic daily* headaches. Another experimental option: Botox. That's right... those injections widely used to relax muscles and reduce skin wrinkles are also being investigated as relief for those suffering chronic daily tension headaches. Hopefully one of my suggestions was what you were looking for. If not, please provide additional details and I will try to be of assistance. Take care, and best of luck and good health to you! Answered by Tamar Broadbent 1 year ago.

Did you ever meditate? Not to sound like some Yuppie hippy, but it works. My Yuppie hippy psychology 101 professor taught us all to meditate. I use it sometimes to get rid of bad headaches and to help me sleep. Simply lie down and imagine a ball of light is at your feet, about to enter your body. As it enters your feet, you imagine the ball's purpose is relaxing each muscle. It moves slowly to each part of your foot...toes, arch, heel. It is important you imagine each part. You will feel your muscles relax. As you go through out the rest of your body, you will become increasingly relaxed. When you get to your neck, or wherever the tension is occurring, spend more time there. Kind of like spending more time on a messy spot on your carpet with a vacuum. It takes concentration, but it works. Oh, and soothing music, like Bach, Ocean waves, etc. helps greatly. Answered by Ozella Fon 1 year ago.

I have tension headaches almost everyday.My docto put me on 50 mg of amitriptyline Hcl and butalbital/apap-325/caff. or Fioricet.They seem to help.They tried to put me on topamax,but it had too many bad side effects. Answered by Christiane Westcote 1 year ago.

Excedrin? Works for me. Answered by Shaquita Grosso 1 year ago.


Is it Basal Cell Carcinoma on my face?
So I've had this mark on my face for a few years now. I've included the link below to see the pictures. I'm worried it might be cancerous or precancerous. It started as a dry rough spot which seemed harmless and now has flared to this. I made an appointment to have it checked. It does not really hurt just a... Asked by Beverlee Konye 1 year ago.

It looks like solar keratosis(solar =sun) damage to the skin. Doc will either freeze it off with liquid nitrogen or give you some gel called Solaraze(diclofenac) to apply. Nothing to worry about! If you leave them there is a chance that they can change into cancerous lesions, but caught in time they are OK. Answered by Cherryl Fullmore 1 year ago.


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