DOSAGE & ADMINISTRATION SECTION.

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. Daily Per Dose For your arthritis pain:Use times per day every dayDo not use on more than body areas at the same time Use ENCLOSED DOSING CARD to measure dose For each upper body area (hand, wrist, or elbow) Squeeze out 2.25 inches (2 grams)For each lower body area (foot, ankle, or knee) Squeeze out 4.5 inches (4 grams) Read the enclosed User Guide for complete instructions:use only as directeddo not use more than directed or for longer than directedapply only to clean, dry skin that does not have any cuts, open wounds, infections, or rashesdo not apply in same areas as any other productdo not apply with external heat such as heating paddo not apply bandage over the treated areastore ENCLOSED DOSING CARD with your Diclofenac Sodium Topical Gel, 1%. The dosing card is re-usable.. Use times per day every day. Do not use on more than body areas at the same time. For each upper body area (hand, wrist, or elbow) Squeeze out 2.25 inches (2 grams). For each lower body area (foot, ankle, or knee) Squeeze out 4.5 inches (4 grams) 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 areas as any other product. do not apply with external heat such as heating pad. do not apply bandage over the treated area. store ENCLOSED DOSING CARD with your Diclofenac Sodium Topical Gel, 1%. 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. for the temporary relief of arthritis pain ONLY in the following areas:hand, wrist, elbow (upper body areas) foot, ankle, knee (lower body areas) this 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. for the temporary relief of arthritis pain ONLY in the following areas:hand, wrist, elbow (upper body areas) foot, ankle, knee (lower body areas) hand, wrist, elbow (upper body areas) foot, ankle, knee (lower body areas). this 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. you have problems or serious side effects from taking pain relievers or fever reducersstomach bleeding warning applies to you you have history of stomach problems, such as heartburnyou have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had strokeyou are taking diureticyou are under the age of 18 years. It is not known if this drug works or is safe in children under the age of 18 years. you have problems or serious side effects from taking pain relievers or fever reducers. stomach bleeding warning applies to you you have history of stomach problems, such as heartburn. you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had stroke. you are taking diuretic. you are under the age of 18 years. It is not known if this drug works or is safe in children under the age of 18 years.

OTC - ASK DOCTOR/PHARMACIST SECTION.

Ask doctor or pharmacist before use if. under doctors care for any serious conditiontaking any other drug under doctors care for any serious condition. taking any other drug.

OTC - DO NOT USE SECTION.

Do not use. if you have ever had an allergic reaction to any other pain reliever or to fever reducerfor strains, sprains, bruises or sports injuries. This product has not been shown to work for these types of injuries.right before or after heart surgeryon more than body areas at the same timein the eyes, nose, or mouth if you have ever had an allergic reaction to any other pain reliever or to 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 body areas at the same time. in 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 (1-800-222-1222) right away.

OTC - PREGNANCY OR BREAST FEEDING SECTION.

If pregnant or breast-feeding,. ask health professional before use. It is especially important to not 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. Call 1-800-645-2158.

OTC - STOP USE SECTION.

Stop use and ask doctor if. pain gets worse or lasts more than 21 daysredness or swelling is present in the painful areafever occursskin irritation occursany new symptoms appear. These could be signs of 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 of side of bodyslurred speech 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 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 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 paintrouble breathingleg swellingweakness in one part of side of bodyslurred speech chest pain. trouble breathing. leg swelling. weakness in one part of side of body. slurred speech.

OTC - WHEN USING SECTION.

When using this product. avoid contact with eyes, nose, or mouthif eye contact occurs, rinse thoroughly with water avoid contact with eyes, nose, or mouth. if eye contact occurs, rinse thoroughly with water.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

Principal Display Panel. +Compare to the active ingredient in Voltaren(R) Topical GelDiclofenac sodium topical gel, 1% (NSAID) Arthritis pain relieverOriginal prescription strength Medicated gel clinically proven to relieve arthritis pain For daily treatment of arthritis pain Anti-inflammatory For external use only+This product is not manufactured or distributed by GSK Consumer Healthcare, distributor of Voltaren(R) Topical Gel.Distributed by: RUGBY LABORATORIES, 17177 Laurel Park Drve, Suite 233, Livonia, MI 48152.

SPL UNCLASSIFIED SECTION.

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

WARNINGS SECTION.

Warnings. For external use only.Allergy alert: Diclofenac may cause severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:hivesasthma (wheezing)skin reddeningblistersfacial swellingshockrashIf 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 longer time than directedwhen 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 you:are age 60 or olderhave had stomach ulcers or bleeding problemstake blood thinning (anticoagulant) or steroid drugtake other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)have or more alcoholic drinks every day while using this productapply 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.. hives. asthma (wheezing). skin reddening. blisters. facial swelling. shock. rash. more or for longer time than directed. when using other drugs containing diclofenac. are age 60 or older. have had stomach ulcers or bleeding problems. take blood thinning (anticoagulant) or steroid drug. take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others). have or more alcoholic drinks every day while using this product. apply more or for longer than directed Do not use. if you have ever had an allergic reaction to any other pain reliever or to fever reducerfor strains, sprains, bruises or sports injuries. This product has not been shown to work for these types of injuries.right before or after heart surgeryon more than body areas at the same timein the eyes, nose, or mouth if you have ever had an allergic reaction to any other pain reliever or to 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 body areas at the same time. in the eyes, nose, or mouth Ask doctor before use if. you have problems or serious side effects from taking pain relievers or fever reducersstomach bleeding warning applies to you you have history of stomach problems, such as heartburnyou have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had strokeyou are taking diureticyou are under the age of 18 years. It is not known if this drug works or is safe in children under the age of 18 years. you have problems or serious side effects from taking pain relievers or fever reducers. stomach bleeding warning applies to you you have history of stomach problems, such as heartburn. you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had stroke. you are taking diuretic. you are under the age of 18 years. It is not known if this drug works or is safe in children under the age of 18 years. Ask doctor or pharmacist before use if. under doctors care for any serious conditiontaking any other drug under doctors care for any serious condition. taking any other drug When using this product. avoid contact with eyes, nose, or mouthif eye contact occurs, rinse thoroughly with water avoid contact with eyes, nose, or mouth. if eye contact occurs, rinse thoroughly with water Stop use and ask doctor if. pain gets worse or lasts more than 21 daysredness or swelling is present in the painful areafever occursskin irritation occursany new symptoms appear. These could be signs of 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 of side of bodyslurred speech 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 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 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 paintrouble breathingleg swellingweakness in one part of side of bodyslurred speech chest pain. trouble breathing. leg swelling. weakness in one part of side of body. slurred speech. If pregnant or breast-feeding,. ask health professional before use. It is especially important to not 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 (1-800-222-1222) right away.

SPL MEDGUIDE SECTION.

Medguide. Use enclosed dosing card to measure doseDiclofenac Sodium Topical Gel, 1%(NSAID) arthritis pain relieverUpper body dose: 2.25 inches long (2 grams)Lower body dose: 4.5 inches long (4 grams)Dosing Card (NOT ACTUAL SIZE)Read product User Guide before useNot for immediate pain reliefHow to useFor arthritis pain onlyUse times dayMay take up to days to work for your arthritis painFor use on no more than body areasUse up to 21 days unless directed by doctor. For arthritis pain only. Use times day. May take up to days to work for your arthritis pain. For use on no more than body areas. Use up to 21 days unless directed by doctor.