DOSAGE & ADMINISTRATION SECTION.

Directions Use up to 21 days unless directed by your doctorNot for strains, sprains, bruises or sports injuries. This product has not been shown to work for these types of injuries.DailyPer DoseFor your arthritis pain:oUse times per day every dayoDo not use on more than body areas at the same timeUse ENCLOSED DOSING CARD to measure doseoFor each upper body area (hand, wrist, or elbow) Squeeze out 2.25 inches (2 grams)oFor each lower body area (foot, ankle or knee) -Squeeze out 4.5 inches (4 grams)Read the enclosed User Guide for complete instructions:ouse only as directedodo not use more than directed or for longer than directedoapply only to clean, dry skin that does not have any cuts, open wounds, infections or rashesodo not apply in same area as any other productodo not apply with external heat such as heating padodo not apply bandage over the treated areaostore ENCLOSED DOSING CARD with your Diclofenac Sodium Topical Gel, 1% product. The dosing card is re-usable.. oUse times per day every day. oDo not use on more than body areas at the same time. oFor each upper body area (hand, wrist, or elbow) Squeeze out 2.25 inches (2 grams). oFor each lower body area (foot, ankle or knee) -Squeeze out 4.5 inches (4 grams). ouse only as directed. odo not use more than directed or for longer than directed. oapply only to clean, dry skin that does not have any cuts, open wounds, infections or rashes. odo not apply in same area as any other product. odo not apply with external heat such as heating pad. odo not apply bandage over the treated area. ostore ENCLOSED DOSING CARD with your Diclofenac Sodium Topical Gel, 1% product. The dosing card is re-usable.

INACTIVE INGREDIENT SECTION.

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

INDICATIONS & USAGE SECTION.

Uses ofor the temporary relief of arthritis pain ONLY in the following areas:ohand, wrist, elbow (upper body areas)ofoot, ankle, knee (lower body areas)othis product may take up to days to work for arthritis pain; it is not for immediate relief. If no pain relief in days, stop use.. ofor the temporary relief of arthritis pain ONLY in the following areas:. ohand, wrist, elbow (upper body areas). ofoot, ankle, knee (lower body areas). othis product may take up to days to work for arthritis pain; it is not for immediate relief. If no pain relief in days, stop use.

OTC - ACTIVE INGREDIENT SECTION.

Active ingredient Diclofenac sodium (NSAID) 1% (equivalent to 0.93% diclofenac)nonsteroidal anti-inflammatory drug.

OTC - ASK DOCTOR SECTION.

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

OTC - ASK DOCTOR/PHARMACIST SECTION.

Ask doctor or pharmacist before use if you are ounder doctors care for any serious conditionotaking any other drug. ounder doctors care for any serious condition. otaking any other drug.

OTC - DO NOT USE SECTION.

Do not use oif you have ever had an allergic reaction to any other pain reliever or to fever reducerofor strains, sprains, bruises or sports injuries. This product has not been shown to work for these types of injuries.oright before or after heart surgeryoon more than body areas at the same timeoin the eyes, nose or mouth. oif you have ever had an allergic reaction to any other pain reliever or to fever reducer. ofor strains, sprains, bruises or sports injuries. This product has not been shown to work for these types of injuries.. oright before or after heart surgery. oon more than body areas at the same time. oin the eyes, nose or mouth.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION.

Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away (1-800-222-1222).

OTC - PREGNANCY OR BREAST FEEDING SECTION.

If pregnant or breast-feeding, ask health professional before use. It is especially important not to use this product during the last months of pregnancy unless definitely directed to do so by doctor because it may cause problems in the unborn child or complications during delivery.

OTC - PURPOSE SECTION.

Purpose Arthritis pain reliever.

OTC - QUESTIONS SECTION.

Questions or comments 1-800-719-9260.

OTC - STOP USE SECTION.

Stop use and ask doctor if opain gets worse or lasts more than 21 daysoredness or swelling is present in the painful areaofever occursoskin irritation occursoany new symptoms appear. These could be signs of serious condition.oyou experience any of the following signs of stomach bleeding:ofeel faintohave bloody or black stoolsovomit bloodohave stomach pain that does not get betteroyou have symptoms of heart problems or stroke:ochest painotrouble breathingoleg swellingoweakness in one part or side of bodyoslurred speech. opain gets worse or lasts more than 21 days. oredness or swelling is present in the painful area. ofever occurs. oskin irritation occurs. oany new symptoms appear. These could be signs of serious condition.. oyou experience any of the following signs of stomach bleeding:. ofeel faint. ohave bloody or black stools. ovomit blood. ohave stomach pain that does not get better. oyou have symptoms of heart problems or stroke:. ochest pain. otrouble breathing. oleg swelling. oweakness in one part or side of body. oslurred speech.

OTC - WHEN USING SECTION.

When using this product oavoid contact with eyes, nose, or mouthoif eye contact occurs, rinse thoroughly with water. oavoid contact with eyes, nose, or mouth. oif eye contact occurs, rinse thoroughly with water.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

Package/Label Principal Display Panel ORIGINAL PRESCRIPTION STRENGTHDiclofenac GelCompare to Voltaren(R) Arthritis Pain active ingredientDICLOFENAC SODIUM TOPICAL GEL, 1% (NSAID) ARTHRITIS PAIN RELIEVERNEWANTI-INFLAMMATORYFor daily treatment of arthritis painFOR EXTERNAL USE ONLYNET WT 5.29 oz (150 g). diclofenac gel image 1. diclofenac gel image 2.

SPL UNCLASSIFIED SECTION.

Diclofenac Sodium Topical Gel, 1% (NSAID) Arthritis Pain RelieverUser GuideHow to use Diclofenac Sodium Topical Gel, 1% with answers to frequently asked questionsQuick StartHow to get started right away with Diclofenac Sodium Topical Gel, 1%Understanding Diclofenac Sodium Topical Gel, 1%Diclofenac Sodium Topical Gel, 1% (NSAID) arthritis pain reliever is an arthritis pain relief medication that you apply to your skin.Before You Use Diclofenac Sodium Topical Gel, 1%Read the Drug Facts Label, which appears on the carton.Remove the dosing card from the inside of the carton. You should always use the dosing card to measure out the correct dose of Diclofenac Sodium Topical Gel, 1%. The first time you use tube of Diclofenac Sodium Topical Gel, 1%:1. Take the cap off the tube.2. Open the safety seal by firmly pressing the point on the top of the cap onto the seal on the tube. Do not open the safety seal with scissors or other sharp objects.3. After use, put the cap back on the end of the tube.Using Diclofenac Sodium Topical Gel, 1%How often to use Diclofenac Sodium Topical Gel, 1%Use times day for best results.For example:Where to apply Diclofenac Sodium Topical Gel, 1%Diclofenac Sodium Topical Gel, 1% can be used on up to body areas from the following list: hand, wrist, an elbow, foot, an ankle, knee. Do not use on more than body areas at once.Some examples include:Measuring the correct amount using the dosing cardFor each upper body area (a hand, wrist, or an elbow): Squeeze gel from the tube equal to the length shown on the upper body section of the dosing card (2.25 inches).For each lower body area (a foot, an ankle, or knee): Squeeze gel from the tube equal to the length shown on the lower body section of the dosing card (4.5 inches).Lost Your Dosing Card Dont worryCall 1-800-719-9260 to get free replacement.Applying Diclofenac Sodium Topical Gel, 1%Gently rub Diclofenac Sodium Topical Gel, 1% into the skin using your hand. Apply times day for best results. Do not use on more than body areas at once.Apply only to clean, dry skin that doesnt have any cuts, open wounds, infections or rashes. Do not apply in the same area as any other medicines or products that are applied to the skin.After You Use Diclofenac Sodium Topical Gel, 1%Wash your hands after applying Diclofenac Sodium Topical Gel, 1%. If the treated area is the hands wait up to hour to wash the hands.Wash the dosing card with water. Store dosing card with your Diclofenac Sodium Topical Gel, 1% and keep out of reach of children.Wait ten minutes before covering the treated areas with clothes or gloves.Avoid:oshowering or bathing for at least hour after useoexposing the treated area to sunlight or artificial light (such as in tanning booths)ouse in same area as other products applied to the skinoapplying bandage over the treated areaoeye, nose, or mouth contactoif eye contact occurs, rinse thoroughly with waterFacts you need to knowImportant information about Diclofenac Sodium Topical Gel, 1%Do not use Diclofenac Sodium Topical Gel, 1%...oif you have ever had an allergic reaction to any other pain reliever or to fever reducerofor strains, sprains, bruises or sports injuries. This product has not been shown to work for these types of injuries.oright before or after heart surgeryoon more than body areas at the same timeoin the eyes, nose or mouth Ask doctor before use if...oyou have problems or serious side effects from taking pain relievers or fever reducersostomach bleeding warning applies to youoyou have history of stomach problems such as heartburnoyou have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had strokeoyou are taking diureticoyou are under age 18 years. It is not known if this drug works or is safe in children under age 18 years.Ask doctor or pharmacist before use if...oyou are under doctors care for any serious conditiono you are taking any other drugoyou are pregnant or breast-feedingIt is especially important not to use this product during the last months of pregnancy unless definitely directed to do so by doctor because it may cause problems in the unborn child or complications during delivery.Warnings to consider before use...Allergy alertDiclofenac may cause severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:ohivesoblistersoasthma (wheezing)ofacial swellingoskin reddeningoshockorashIf an allergic reaction occurs, stop use and seek medical help right away.Liver warningThis product contains diclofenac. Liver damage may occur if you applyomore or for longer time than directedowhen using other drugs containing diclofenacStomach bleeding warningThis product contains an NSAID, which may cause stomach bleeding. The chance is small but higher if youoare age 60 or olderohave had stomach ulcers or bleeding problemsotake blood thinning (anticoagulant) or steroid drugotake other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)ohave or more alcoholic drinks every day while using this productoapply more or for longer than directedHeart attack and stroke warningNSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. This can be fatal. The risk is higher if you use more than directed or for longer than directed.Follow these important guidelines when using Diclofenac Sodium Topical Gel, 1%...ouse only as directedoapply only to clean, dry skin that does not have any cuts, open wounds, infections or rashesodo not apply in the same area as any other product used on the skinodo not apply with external heat such as heating padodo not apply bandage over the treated areaodo not get gel in eyes, nose or mouthostore ENCLOSED DOSING CARD with your Diclofenac Sodium Topical Gel, 1%. The dosing card is re-usable.Keep out of reach of children.If swallowed, get medical help or contact Poison Control Center right away (1-800-222-1222).Stop using Diclofenac Sodium Topical Gel, 1% and ask doctor if...opain gets worse or lasts more than 21 daysoredness or swelling is present in the painful areaofever occursoskin irritation occursoany new symptoms appear. These could be signs of serious condition.oyou experience any of the following signs of stomach bleeding:ofeel faintohave bloody or black stoolsovomit bloodohave stomach pain that does not get betteroyou have symptoms of heart problems or stroke:ochest painotrouble breathingoleg swellingoweakness in one part of side of bodyoslurred speechQuestions and AnswersAnswers to questions you may ask about Diclofenac Sodium Topical Gel, 1%Can use Diclofenac Sodium Topical Gel, 1% for the immediate relief of pain like that associated with sprains, strains, bruises, or sports injuriesNo.Do not use for strains, sprains, bruises, or sports injuries. This product has not been shown to work for these types of injuries. Its intended only for the temporary relief of arthritis pain.How quickly will Diclofenac Sodium Topical Gel, 1% work for arthritis painDiclofenac Sodium Topical Gel, 1% may take up to days to work for your arthritis pain; it is not for immediate relief. With times-a-day use, you may start to feel relief within few days. You should feel significant pain relief within days of continuous use. If no pain relief in days, stop use.What is Diclofenac Sodium Topical Gel, 1% used forDiclofenac Sodium Topical Gel, 1% 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 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 Diclofenac Sodium Topical Gel, 1% workDiclofenac sodium, the medicine in Diclofenac Sodium Topical Gel, 1%, is nonsteroidal anti-inflammatory drug (NSAID). NSAIDs are used to treat pain from medical conditions such as arthritis. Diclofenac Sodium Topical Gel, 1% works similarly to oral NSAIDs like ibuprofen or naproxen by temporarily blocking the production of pain signaling chemicals called prostaglandins. However, when taking 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, 1% is absorbed in 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, 1% differ from prescription Diclofenac Sodium Topical Gel, 1%Over-the-counter Diclofenac Sodium Topical Gel, 1% is the same strength and formula as original full prescription strength Diclofenac Sodium Topical Gel, 1% but is available without prescription.Apply Diclofenac Sodium Topical Gel, 1% times day to ensure you get the full effect of the medicine.Can apply Diclofenac Sodium Topical Gel, 1% to upper and lower body areas at the same timeYes.You can use Diclofenac Sodium Topical Gel, 1% on up to body areas at the same time. The areas can include the foot, ankle, knee, hand, wrist, and elbow.Some correct examples include:Do not use Diclofenac Sodium Topical Gel, 1% on more than body areas at once.Can apply Diclofenac Sodium Topical Gel, 1% without measuring it out on the dosing card firstNo.Use the dosing card to make sure you are getting the correct amount of medicine.Can use Diclofenac Sodium Topical Gel, 1% on my spine, hips, or shouldersNo.The use of Diclofenac Sodium Topical Gel, 1% on the spine, hips, and shoulders has not been studied.Can take any other pain medications with Diclofenac Sodium Topical Gel, 1%Ask your doctor or pharmacist before using Diclofenac Sodium Topical Gel, 1% 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 take any other pain medications during the first days use Diclofenac Sodium Topical Gel, 1%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, 1%.How long can use Diclofenac Sodium Topical Gel, 1%Use Diclofenac Sodium Topical Gel, 1% times day every day for up to 21 days for treatment of arthritis pain or as directed by your doctor.Diclofenac Sodium Topical Gel, 1% 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, 1% into complete program to help manage your arthritis pain.What do do if get Diclofenac Sodium Topical Gel, 1% in my eyesIf eye contact occurs, rinse thoroughly with water and consult doctor if irritation lasts more than an hour.How do clean the dosing cardWash the dosing card with water, and store dosing card and tube out of reach of children.What if miss dose of Diclofenac Sodium Topical Gel, 1%If you forget to apply Diclofenac Sodium Topical Gel, 1% dont double your dose. Just apply the next dose as scheduled.How should store Diclofenac Sodium Topical Gel, 1%oStore at 20-25C (68-77F).oDo not freeze Diclofenac Sodium Topical Gel, 1%.oStore the dosing card with your Diclofenac Sodium Topical Gel, 1%.oKeep out of reach of children.Additional QuestionsCall 1-800-719-9260.Made in IsraelDistributed ByPerrigo(R)Allegan, MI 4901087A00 00 J1. oshowering or bathing for at least hour after use. oexposing the treated area to sunlight or artificial light (such as in tanning booths). ouse in same area as other products applied to the skin. oapplying bandage over the treated area. oeye, nose, or mouth contact. oif eye contact occurs, rinse thoroughly with water. oif you have ever had an allergic reaction to any other pain reliever or to fever reducer. ofor strains, sprains, bruises or sports injuries. This product has not been shown to work for these types of injuries.. oright before or after heart surgery. oon more than body areas at the same time. oin the eyes, nose or mouth oyou have problems or serious side effects from taking pain relievers or fever reducers. ostomach bleeding warning applies to you. oyou have history of stomach problems such as heartburn. oyou have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had stroke. oyou are taking diuretic. oyou are under age 18 years. It is not known if this drug works or is safe in children under age 18 years.. oyou are under doctors care for any serious condition. you are taking any other drug. oyou are pregnant or breast-feeding. ohives. oblisters. oasthma (wheezing). ofacial swelling. oskin reddening. oshock. orash. omore or for longer time than directed. owhen using other drugs containing diclofenac. oare age 60 or older. ohave had stomach ulcers or bleeding problems. otake blood thinning (anticoagulant) or steroid drug. otake other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others). ohave or more alcoholic drinks every day while using this product. oapply more or for longer than directed. ouse only as directed. oapply only to clean, dry skin that does not have any cuts, open wounds, infections or rashes. odo not apply in the same area as any other product used on the skin. odo not apply with external heat such as heating pad. odo not apply bandage over the treated area. odo not get gel in eyes, nose or mouth. ostore ENCLOSED DOSING CARD with your Diclofenac Sodium Topical Gel, 1%. The dosing card is re-usable.. opain gets worse or lasts more than 21 days. oredness or swelling is present in the painful area. ofever occurs. oskin irritation occurs. oany new symptoms appear. These could be signs of serious condition.. oyou experience any of the following signs of stomach bleeding:. ofeel faint. ohave bloody or black stools. ovomit blood. ohave stomach pain that does not get better. oyou have symptoms of heart problems or stroke:. ochest pain. otrouble breathing. oleg swelling. oweakness in one part of side of body. oslurred speech. oStore at 20-25C (68-77F).. oDo not freeze Diclofenac Sodium Topical Gel, 1%.. oStore the dosing card with your Diclofenac Sodium Topical Gel, 1%.. oKeep out of reach of children.. dicolfenac-image1. Image 2. Image 3. Image 4. Image 5. Image 6. diclofenac-graphic2. diclofenac-graphic3. Image 9. Image 10. diclofenac-graphic4. Image 12. Image 13. Image 14.

STORAGE AND HANDLING SECTION.

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

WARNINGS SECTION.

Warnings For external use onlyAllergy alert: Diclofenac may cause severe allergic reaction, especially in people allergic to aspirin.Symptoms may include:ohivesoasthma (wheezing)oskin reddeningoblistersofacial swellingoshockorashIf an allergic reaction occurs, stop use and seek medical help right away.Liver warning: This product contains diclofenac. Liver damage may occur if you applyomore or for longer time than directedowhen using other drugs containing diclofenacStomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is small but higher if youoare age 60 or olderohave had stomach ulcers or bleeding problemsotake blood thinning (anticoagulant) or steroid drugotake other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)ohave or more alcoholic drinks every day while using this productoapply more or for longer than directedHeart 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.. ohives. oasthma (wheezing). oskin reddening. oblisters. ofacial swelling. oshock. orash. omore or for longer time than directed. owhen using other drugs containing diclofenac. oare age 60 or older. ohave had stomach ulcers or bleeding problems. otake blood thinning (anticoagulant) or steroid drug. otake other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others). ohave or more alcoholic drinks every day while using this product. oapply more or for longer than directed. Do not use oif you have ever had an allergic reaction to any other pain reliever or to fever reducerofor strains, sprains, bruises or sports injuries. This product has not been shown to work for these types of injuries.oright before or after heart surgeryoon more than body areas at the same timeoin the eyes, nose or mouth. oif you have ever had an allergic reaction to any other pain reliever or to fever reducer. ofor strains, sprains, bruises or sports injuries. This product has not been shown to work for these types of injuries.. oright before or after heart surgery. oon more than body areas at the same time. oin the eyes, nose or mouth. Ask doctor before use if oyou have problems or serious side effects from taking pain relievers or fever reducersostomach bleeding warning applies to youoyou have history of stomach problems, such as heartburnoyou have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had strokeoyou are taking diureticoyou are under age 18 years. It is not known if this drug works or is safe in children under age 18 years.. oyou have problems or serious side effects from taking pain relievers or fever reducers. ostomach bleeding warning applies to you. oyou have history of stomach problems, such as heartburn. oyou have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had stroke. oyou are taking diuretic. oyou are under age 18 years. It is not known if this drug works or is safe in children under age 18 years.. Ask doctor or pharmacist before use if you are ounder doctors care for any serious conditionotaking any other drug. ounder doctors care for any serious condition. otaking any other drug. When using this product oavoid contact with eyes, nose, or mouthoif eye contact occurs, rinse thoroughly with water. oavoid contact with eyes, nose, or mouth. oif eye contact occurs, rinse thoroughly with water. Stop use and ask doctor if opain gets worse or lasts more than 21 daysoredness or swelling is present in the painful areaofever occursoskin irritation occursoany new symptoms appear. These could be signs of serious condition.oyou experience any of the following signs of stomach bleeding:ofeel faintohave bloody or black stoolsovomit bloodohave stomach pain that does not get betteroyou have symptoms of heart problems or stroke:ochest painotrouble breathingoleg swellingoweakness in one part or side of bodyoslurred speech. opain gets worse or lasts more than 21 days. oredness or swelling is present in the painful area. ofever occurs. oskin irritation occurs. oany new symptoms appear. These could be signs of serious condition.. oyou experience any of the following signs of stomach bleeding:. ofeel faint. ohave bloody or black stools. ovomit blood. ohave stomach pain that does not get better. oyou have symptoms of heart problems or stroke:. ochest pain. otrouble breathing. oleg swelling. oweakness in one part or side of body. oslurred speech. If pregnant or breast-feeding, ask health professional before use. It is especially important not to use this product during the last months of pregnancy unless definitely directed to do so by 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 Poison Control Center right away (1-800-222-1222).