Perrigo Diclofenac Sodium Topical Gel, 1% (NSAID) Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

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

Purpose

OTC - PURPOSE SECTION

Arthritis pain reliever

Uses

INDICATIONS & USAGE SECTION

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 7 days to work for arthritis pain; it is not for immediate relief. If no pain relief in 7 days, stop use.

Warnings

WARNINGS SECTION

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 nonprescription 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.

Directions

DOSAGE & ADMINISTRATION SECTION

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 4 times per day every day Do not use on more than 2 body areas at the same time Use ENCLOSED DOSING CARD to measure a 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 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% product. The dosing card is re-usable.

Other information

STORAGE AND HANDLING SECTION

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

INACTIVE INGREDIENT SECTION

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

Questions or comments ?

OTC - QUESTIONS SECTION

1-800-719-9260

Diclofenac Sodium Topical Gel, 1% (NSAID)

SPL UNCLASSIFIED SECTION

Arthritis Pain Reliever User Guide How to use Diclofenac Sodium Topical Gel, 1% with answers to frequently asked questions Quick Start How 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 a tube of Diclofenac Sodium Topical Gel, 1%: The first time you use a 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 4 times a 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 2 body areas from the following list: a hand, a wrist, an elbow, a foot, an ankle, a knee. Do not use on more than 2 body areas at once. Some examples include: Measuring the correct amount using the dosing card For each upper body area (a hand, a 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 a 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? Don’t worry! Call 1-800-719-9260 to get a free replacement. Applying Diclofenac Sodium Topical Gel, 1% Gently rub Diclofenac Sodium Topical Gel, 1% into the skin using your hand. Apply 4 times a day for best results. Do not use on more than 2 body areas at once. Apply only to clean, dry skin that doesn’t 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 1 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: showering or bathing for at least 1 hour after use exposing the treated area to sunlight or artificial light (such as in tanning booths) use in same area as other products applied to the skin applying a bandage over the treated area eye, nose, or mouth contact if eye contact occurs, rinse thoroughly with water Facts you need to know Important information about Diclofenac Sodium Topical Gel, 1% Do not use Diclofenac Sodium Topical Gel, 1%... 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 you are taking any other drug you are pregnant or breast-feeding It is especially important not to use this product during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Warnings to consider before use... Allergy alert Diclofenac may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: hives blisters asthma (wheezing) facial swelling skin reddening 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 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 nonprescription 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. 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%... use only as directed apply only to clean, dry skin that does not have any cuts, open wounds, infections or rashes do not apply in the same area as any other product used on the skin do not apply with external heat such as heating pad do not apply a bandage over the treated area do not get gel in eyes, nose or mouth store 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 a Poison Control Center right away (1-800-222-1222). Stop using Diclofenac Sodium Topical Gel, 1% 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 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 of side of body slurred speech Questions and Answers Answers to questions you may ask about Diclofenac Sodium Topical Gel, 1% Can I use Diclofenac Sodium Topical Gel, 1% 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 Diclofenac Sodium Topical Gel, 1% work for arthritis pain? Diclofenac Sodium Topical Gel, 1% 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 no pain relief in 7 days, stop use. What is Diclofenac Sodium Topical Gel, 1% used for? Diclofenac 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 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 o...

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