Drug Facts
Composition & Profile
Identifiers & Packaging
PRINCIPAL DISPLAY PANEL Carton Label - NDC 71205-747-00 Diclofenac Sodium Topical Gel, 1% (NSAID)- Arthritis pain reliever For external use only For daily Treatment of Arthritis Pain Anti-Inflammatory Net Wt 3.53 OZ (100 g) Container Label Diclofenac Sodium Topical Gel, 1% (NSAID)- Arthritis pain reliever For external use only For daily Treatment of Arthritis Pain Anti-Inflammatory Net Wt 3.53 OZ (100 g) Dosing Card Use Enclosed Dosing Card to Measure a Dose How to Use •For arthritis pain only •Use 4 times a day •May take up to 7 days to work for your arthritis pain •for use on no more than 2 body areas •Use up to 21 days unless directed by your doctor 71205-747-00
- PRINCIPAL DISPLAY PANEL Carton Label - NDC 71205-747-00 Diclofenac Sodium Topical Gel, 1% (NSAID)- Arthritis pain reliever For external use only For daily Treatment of Arthritis Pain Anti-Inflammatory Net Wt 3.53 OZ (100 g) Container Label Diclofenac Sodium Topical Gel, 1% (NSAID)- Arthritis pain reliever For external use only For daily Treatment of Arthritis Pain Anti-Inflammatory Net Wt 3.53 OZ (100 g) Dosing Card Use Enclosed Dosing Card to Measure a Dose How to Use •For arthritis pain only •Use 4 times a day •May take up to 7 days to work for your arthritis pain •for use on no more than 2 body areas •Use up to 21 days unless directed by your doctor 71205-747-00
Overview
Uses • for the temporary relief of arthritis pain ONLY in the following areas: o hand, wrist, elbow (upper body areas) o 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
Indications & Usage
Uses • for the temporary relief of arthritis pain ONLY in the following areas: o hand, wrist, elbow (upper body areas) o 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
Dosage & Administration
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 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% Arthritis Pain. The dosing card is re-usable.
Warnings & Precautions
Warnings 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.
Purpose
Purpose Arthritis pain reliever
Do Not Use
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
When Using
When using this product • avoid contact with eyes, nose, or mouth • if eye contact occurs, rinse thoroughly with water
Stop Use & Ask a Doctor
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 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
Keep Out of Reach of Children
Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away.
Storage & Handling
Other information • Store at 20-25 o C (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. Inactive ingredients Carbomer homopolymer Type C, cocoyl caprylocaprate, ispropyl alcohol, mineral oil, polyoxyl 20 cetostearyl ether, propylene glycol, purified water, strong ammonia solution. Question and comments 1-833-285-4151
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