VOLTAREN ARTHRITIS PAIN

Active ingredient

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

*nonsteroidal anti-inflammatory drug

Purpose

Arthritis pain reliever

Uses

• 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.

Warnings

For external use only

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

Symptoms may include:

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

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

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.

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

Do not use

• 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

Ask a doctor before use if

• 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.

Ask a doctor or pharmacist before use if you are

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

When using this product

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

Stop use and ask a doctor if

• 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 fainthave bloody or black stoolsvomit bloodhave stomach pain that does not get better
• you have symptoms of heart problems or stroke: chest paintrouble breathingleg swellingweakness in one part or side of bodyslurred speech

If pregnant or breast-feeding,

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.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

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 Voltaren Arthritis Pain. The dosing card is re-usable.

Other information

• store at 20-25°C (68-77°F). Keep from freezing.
• read all product information before using. Keep the dosing card, this carton and accompanying User Guide for important information.

Inactive ingredients

carbomer homopolymer Type C, cocoyl caprylocaprate, fragrance, isopropyl alcohol, mineral oil, polyoxyl 20 cetostearyl ether, propylene glycol, purified water, strong ammonia solution

SPL UNCLASSIFIED SECTION

Additional Information

ORIGINAL PRESCRIPTION STRENGTH

Medicated Gel Clinically Proven to Relieve Arthritis Pain

TREATMENT AREAS

TREATMENT AREAS

Use Enclosed Dosing Card to Measure a Dose

Voltaren ARTHRITIS PAIN

diclofenac sodium topical gel, 1% (NSAID) – arthritis pain reliever

Dosing Card (NOT ACTUAL SIZE)

Read product User Guide before use

Not for immediate pain relief

Upper body dose2.25 inches long (2 grams)

Lower body dose4.5 inches long (4 grams)

How to Use

• Hand Wrist Elbow Foot Ankle Knee
• Not for use on any other body area (such as back, hip, or shoulder)

Medication Guide

Medication Guide for Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)

What is the most important information I should know about medicines called Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)?

NSAIDs can cause serious side effects, including:

Do not take NSAIDs right before or after a heart surgery called a “coronary artery bypass graft (CABG).”

Avoid taking NSAIDs after a recent heart attack, unless your healthcare provider tells you to. You may have an increased risk of another heart attack if you take NSAIDs after a recent heart attack.

The risk of getting an ulcer or bleeding increases with:

NSAIDs should only be used:

What are NSAIDs?

NSAIDs are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as different types of arthritis, menstrual cramps, and other types of short-term pain

Who should not take NSAIDs?

Do not take NSAIDs :

Before taking NSAIDs, tell your healthcare provider about all of your medical conditions, including if you:

Tell your healthcare provider all of the medicines you take, including prescription or over-the-counter medicines, vitamins or herbal supplements. NSAIDs and some other medicines can interact with each other and cause serious side effects. Do not start taking any new medicine without talking to your healthcare provider first.

What are the possible side effects of NSAIDs?

NSAIDs can cause serious side effects, including:

See “What is the most important information I should know about medicines called Nonsteroidal Anti-inflammatory Drugs (NSAIDs)?”

Get emergency help right away if you have any of the following symptoms:

Stop taking your NSAID and call your healthcare provider right away if you get any of the following symptoms:

If you take too much of your NSAID, call your healthcare provider or get medical help right away.

These are not all the possible side effects of NSAIDs. For more information, ask your healthcare provider or pharmacist about NSAIDs.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other information about NSAIDs

General Information about the safe and effective use of NSAIDs

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use NSAIDs for a condition for which it was not prescribed. Do not give NSAIDs to other people, even if they have the same symptoms that you have. It may harm them.

If you would like more information about NSAIDs, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about NSAIDs that is written for health professionals.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Marketed by:

Manufactured by:

Novartis Pharma Produktions GmbH,

Wehr, Germany for

Sandoz Inc., Princeton, NJ 08540

Revised: April 2016

• •Increased risk of a heart attack or stroke that can lead to death. This risk may happen early in treatment and may increase:owith increasing doses of NSAIDsowith longer use of NSAIDs

HOW SUPPLIED

Product: 50090-6202

NDC: 50090-6202-0 50 g in a TUBE / 24 in a CASE

diclofenac sodium