Diclofenac Sodium Gel
FDA Label NDC 71085-084

Diclofenac sodium (NSAID*) 1% (equivalent to 0.93% diclofenac)

*nonsteroidal anti-inflammatory drug

Arthritis pain reliever

• for the temporary relief of arthritis pain ONLY inthe following areas:
  • hand, wrist, elbow (upper body areas)
  • foot, ankle, knee (lower body areas)
  • this product may take up to 7 days to work for arthritis pain; it is not for immediate relief. If no pain relief in 7 days, stop use

For external use only

Allergy alert:Diclofenac may cause a severe allergic reaction, especially in people allergic to aspirin.

Symptoms may include:

• hives  • asthma (wheezing)  • skin reddening  • blisters  • facial swelling  • shock   • rash

If an allergic reaction occurs, stop use and seek medical help right away.

Liver warning:This product contains diclofenac. Liver damage may occur if you apply

• more or for a longer time than directed
• when using other drugs containing diclofenac

Stomach bleeding warning:This product contains an NSAID, which may cause severe stomach bleeding. The chance is small but higher if you

• are age 60 or older
• have had stomach ulcers or bleeding problems
• take a blood thinning (anticoagulant) or steroid drug
• take other drugs containing prescription or non-prescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
• have 3 or more alcoholic drinks every day while using this product
• apply more or for longer than directed

Heart attack and stroke warning:NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.

• if you have ever had an allergic reaction to any other pain reliever or to a fever reducer
• for strains, sprains, bruises or sports injuries. This product has not been shown to work for these types of injuries.
• right before or after heart surgery
• on more than 2 body areas at the same time
• in the eyes, nose or mouth

• you have problems or serious side effects from taking pain relievers or fever reducers
• stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn
• you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke
• you are taking a diuretic
• you are under age 18 years. It is not known if this drug works or is safe in children under age 18 years.

• under a doctor’s care for any serious condition
• taking any other drug

• avoid contact with eyes, nose, or mouth      
• if eye contact occurs, rinse thoroughly with water

• pain gets worse or lasts more than 21 days    
• redness or swelling is present in the painful area
• fever occurs                                                    
• skin irritation occurs
• any new symptoms appear. These could be signs of a serious condition.
• you experience any of the following signs of stomach bleeding
• feel faint
• have bloody or black stools
• vomit blood
• have stomach pain that does not get better
• you have symptoms of heart problems or stroke
• chest pain
• trouble breathing
• leg swelling
• weakness in one part or side of body
• slurred speech

ask a health professional before use. It is especially important not to use diclofenac at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

If swallowed, get medical help or contact a Poison Control Center right away.

Use up to 21 days unless directed by your doctor

Not for strains, sprains, bruises or sports injuries. This product has not been shown to work for these types of injuries.

Read the enclosed User Guidefor complete instructions:

• use only as directed
• do not use more than directed or for longer than directed
• apply only to clean, dry skin that does not have any cuts, open wounds, infections or rashes
• do not apply in same area as any other product
• do not apply with external heat such as heating pad
• do not apply a bandage over the treated area

store ENCLOSED DOSING CARD with your Diclofenac Sodium Topical Gel, 1% Arthritis Pain. The dosing card is re-usable.

Answers to questions you may ask about Diclofenac Sodium Topical Gel.

Can I use Diclofenac Sodium Topical Gel for the
immediate relief of pain like that associated with
sprains, strains, bruises or sports Injuries?
No
Do not use for strains, sprains, bruises, or sports injuries.This product has not been shown to work for these types of Injuries. It's Intended only for the temporary relief of arthritis pain.

How quickly will Diclotenac Sodium Topical Gel work for arthritis pain?

Diclofenac Sodium Topical Gel may take up to 7 days to work for your arthritis pain; it is not for immediate relief. With 4 times-a-day use, you may start to feel relief within a few days. You should feel significant pain relief within 7 days of continuous use. If there is no pain relief in 7 days,
stop use.

What is Diclofenac Sodium Topical Gel used for?
Diclofenac Sodium Topical Gel can be used for the temporary relief of arthritis pain in the hands, wrists, elbows, feet, ankles, and knees. Osteoarthritis (OA) is the most common form of arthritis. It mainly affects a type of tissue called cartilage, which cushions the joints and
prevents the bones from rubbing against each other. With OA, cartilage begins to break down and wear away, resulting in joint pain and stiffness. OA occurs more frequently as you get older. Pain develops slowly and can gradually worsen over time.

How does Diclotenac Sodium Topical Gel work?
Diclofenac sodium, the medicine in Diclofenac Sodium Topical Gel is a nonsteroidal anti-inflammatory drug (NSAID). NSAIDs are used to treat pain from medical conditions such as arthritis. Diclofenac Sodium Topical Gel works similarly to oral NSAIDs like ibuprofen or naproxen by temporarily blocking the production of pain signaling chemicals called prostaglandins. However, when taking a pill, the medication is distributed to the site of pain through the bloodstream. Compared to oral diclofenac, only 6% of the medicine in Diclofenac Sodium Topical Gel is absorbed into the bloodstream. It works by penetrating through your skin at the application site to deliver arthritis pain relief.

How does over-the-counter Diclofenac Sodium Topical Gel differ from prescription Diclofenac Sodium Topical Gel,1%?
Over-the-counter Diclofenac Sodium Topical Gel, is the same strength and formula as original full prescription strength Diclofenac Sodium Topical Gel, 1% but is available without a prescription. Apply Diclofenac Sodium Topical Gel 4 times a day to ensure you get the full effect of the medicine.

Can I apply Diclofenac Sodium Topical Gel to upper and lower body areas at the same time?
Yes.
You can use Diclofenac Sodium Topical Gel on up to 2 body areas at the same time. The areas can include the foot, ankle, knee, hand, wrist, and elbow.

Some correct examples include:

Image Description (Example Image)

Do not use Diclotenac Sodium Topical Gel on more than 2 body areas at once.

Can I apply Diclofenac Sodium Topical Gel without measuring it out on the dosing card first?
No.
Use the dosing card to make sure you are getting the correct amount of medicine.

Can I use Diclofenac Sodium Topical Gel, on my spine,hips, or shoulders?
No.
The use of Diclofenac Sodium Topical Gel on the spine, hips, and shoulders has not been studied.

Can I take any other pain medications with Diclofenac Sodium Topical Gel?
Ask your doctor or pharmacist before using Diclofenac Sodium Topical Gel if you are taking any other pain reliever or are planning on taking any other pain reliever, especially prescription or nonprescription NSAIDs
(aspirin, ibuprofen, naproxen, or others).

Can I take any other pain medications during the first 7 days I use Diclofenac Sodium Topical Gel?
Taking other pain medications is generally not recommended. Speak with your doctor or pharmacist before taking other pain medications when using Diclofenac Sodium Topical Gel.

How long can I use Diclofenac Sodium Topical Gel?
Use Diclofenac Sodium Topical Gel 4 times a day every day for up to 21 days for treatment of arthritis pain or as
directed by your doctor. Diclofenac Sodium Topical Gel should be part of an overall program for managing your arthritis pain. The program should also include activities such as appropriate movement or exercise, specific lifestyle changes, and weight maintenance. Regular visits and
discussions with your doctor can help incorporate Diclofenac Sodium Topical Gel, into a complete program to help manage your arthritis pain.

What do I do if I get Diclofenac Sodium Topical Gel in my eyes?
If eye contact occurs, rinse thoroughly with water and consult a doctor if irritation lasts more than an hour.

How do I clean the dosing card?
Wash the dosing card with water, and store dosing card and tube out of reach of children.

What if I miss a dose of Diclofenac Sodium Topical Gel?
If you forget to apply Diclofenac Sodium Topical Gel, don't double your dose. Just apply the next dose as scheduled.

• Store at 20-25 ^oC (68°F - 77°F). Keep from freezing.
• read all product information before using. Keep the dossing card, the carton and accompanying User guide for important information.

carbomer homopolymer type C, cocoyl caprylocaprate, ispropyl alcohol, mineral oil, polyoxyl 20 cetostearyl ether, propylene glycol, purified water, strong ammonia solution.