1 INDICATIONS AND USAGE Diclofenac sodium is a non-steroidal anti-inflammatory drug indicated for the relief of the pain of osteoarthritis of joints amenable to topical treatment, such as the knees and those of the hands.

( 1 ) Diclofenac sodium topical gel was not evaluated for use on joints of the spine, hip, or shoulder.

( 14.1 ) Diclofenac sodium topical gel is indicated for the relief of the pain of osteoarthritis of joints amenable to topical treatment, such as the knees and those of the hands.

Diclofenac sodium topical gel has not been evaluated for use on the spine, hip, or shoulder.

INSTRUCTIONS FOR USE Diclofenac Sodium Topical Gel, 1% Important: Use the dosing card that is inside the diclofenac sodium topical gel carton to correctly measure each dose.

The dosing card is re-usable.

Do not throw the dosing card away.

Before you use diclofenac sodium topical gel for the first time, your healthcare provider or pharmacist should show you how to correctly measure your dose using the dosing card.

Read this Instructions for Use before you start using diclofenac sodium topical gel and each time you get a refill.

There may be new information.

This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

Your healthcare provider has prescribed diclofenac sodium topical gel to help relieve arthritis pain in some of your joints.

Diclofenac sodium topical gel may be used to treat arthritis pain in the arms (hands, wrists, and elbows) and in the legs (feet, ankles, and knees).

It is not known if diclofenac sodium topical gel is safe and effective if used on your spine, hips, or shoulders.

Use diclofenac sodium topical gel exactly how your healthcare provider prescribes it for you.

Do not apply diclofenac sodium topical gel anywhere other than where your healthcare provider tells you to.

Do not use more than a total of 32 grams of diclofenac sodium topical gel each day.

If you add up the amount of diclofenac sodium topical gel as directed by your healthcare provider, it should not be more than 32 grams in one day.

The dose for your hands, wrists, or elbows is 2 grams of diclofenac sodium topical gel each time you apply it.

Apply diclofenac sodium topical gel 4 times a day (a total of 8 grams each day).

Do not apply more than 8 grams each day to any one of your affected hands, wrists, or elbows.

Some examples of diclofenac sodium topical gel application include: If you use 2 grams of diclofenac sodium topical gel on one hand, 4 times a day, your total dose for one day is 8 grams.

If you use 4 grams of diclofenac sodium topical gel on one knee, 4 times a day, your total dose for one day is 16 grams.

Your total dose for one day, treating one hand and one knee, is 8 grams plus 16 grams, which equals 24 grams of diclofenac sodium topical gel.

Before you use a new tube of diclofenac sodium topical gel for the first time, open the foil seal that covers the tube opening by using the spiked top of the cap.

Remember to remove the dosing card from the carton to measure your dose (see Figure A).

Apply diclofenac sodium topical gel to clean, dry skin that does not have any cuts, open wounds, infections, or rashes.

Do not use heating pads or apply bandages to where you have applied diclofenac sodium topical gel.

Avoid exposing skin where you apply diclofenac sodium topical gel to sunlight and artificial light, such as tanning booths.

Do not use sunscreens, cosmetics, lotions, moisturizers, insect repellants, or other topical medicines on the same skin areas where you have applied diclofenac sodium topical gel.

Do not get diclofenac sodium topical gel in your eyes, nose, or mouth.

Diclofenac sodium topical gel is only to be used on your skin (topical use).

If you get diclofenac sodium topical gel in your eyes, rinse your eyes right away with water or saline.

Talk with your healthcare provider if eye irritation lasts for more than one hour.

What if I miss a dose? If you miss a dose of diclofenac sodium topical gel, continue with your next scheduled dose using the prescribed amount of diclofenac sodium topical gel.

Do not double the dose.

Applying 2 grams (2 g) of diclofenac sodium topical gel to hands, wrists, or elbows: Step 1.

Remove the dosing card that is attached inside the diclofenac sodium topical gel carton.

Use the dosing card to correctly measure each dose of diclofenac sodium topical gel.

To measure the correct amount of diclofenac sodium topical gel, place the dosing card on a flat surface so that you can read the print.

If the print is backwards, flip dosing card over (see Figure A).

If you lose or misplace your dosing card, you can ask your pharmacist for a new one or call 1-866-604-3268.

Ask your healthcare provider or pharmacist to show you how to correctly measure your dose of diclofenac sodium topical gel while you are waiting to receive your new dosing card.

Step 2.

Squeeze diclofenac sodium topical gel onto the dosing card evenly, up to the 2 g line (a 2.25 inch length of gel).

Make sure that the gel covers the 2 g area of the dosing card (see Figure B).

Put the cap back on the tube of diclofenac sodium topical gel.

Ask your healthcare provider or pharmacist if you are not sure how to correctly measure your dose of diclofenac sodium topical gel.

Step 3.

Apply the gel to your hand, wrist, or elbow.

You can use the dosing card to apply the gel (see Figure C).

Then, use your hands to gently rub the gel into the skin (see Figure D).

Do not share your dosing card with another person.

Make sure to cover the entire affected hand, wrist, or elbow with the gel.

Remember that the hand includes the palm of your hand, the top of your hand, and your fingers.

Step 4.

After using the dosing card, hold end with fingertips, rinse and dry.

Store the dosing card until next use.

Do not shower or bathe for at least 1 hour after applying diclofenac sodium topical gel.

Do not wash your treated hands for at least 1 hour after applying the diclofenac sodium topical gel.

Step 5.

After applying diclofenac sodium topical gel, wait 10 minutes before covering the treated skin with gloves or clothing.

Applying 4 grams (4 g) of diclofenac sodium topical gel to feet, ankles, or knees: Step 1.

Refer to Step 1 above.

Step 2.

Squeeze diclofenac sodium topical gel onto the dosing card evenly up to the 4 g line (a 4.5 inch length of gel), making sure the gel covers the 4 g area of the dosing card (see Figure E).

Put the cap back on the tube of diclofenac sodium topical gel.

Ask your healthcare provider or pharmacist if you are not sure how to correctly measure your dose of diclofenac sodium topical gel.

Step 3.

Apply diclofenac sodium topical gel to your foot, ankle, or knee.

You can use the dosing card to apply the gel (see Figure F).

Then, use your hands to gently rub the gel into the skin (see Figure G).

Do not share your dosing card with another person.

Make sure to cover your entire foot, ankle, or knee area with the gel.

For example, cover the skin above, below, inside and outside the knee cap.

Remember that the foot includes the sole of your foot, the top of your foot, and your toes.

Refer to Steps 4 and 5 above.

Wash your hands after applying diclofenac sodium topical gel to your foot, ankle, or knee.

What are the ingredients in diclofenac sodium topical gel? Active ingredient: diclofenac sodium, USP Inactive ingredients: carbomer homopolymer Type C, cocoyl caprylocaprate, fragrance, isopropyl alcohol, mineral oil, polyoxyl 20 cetostearyl ether, propylene glycol, purified water, and strong ammonia solution.

How should I store diclofenac sodium topical gel? ● Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F).

● Do not freeze diclofenac sodium topical gel.

● Store the dosing card with your diclofenac sodium topical gel.

Keep diclofenac sodium topical gel, the dosing card, and all medicines out of the reach of children.

This Medication Guide and Instructions for Use have been approved by the U.S.

Food and Drug Administration.

Manufactured by: Cipla Ltd.

Verna Goa, India Manufactured for: Cipla USA, Inc.

10 Independence Boulevard, Suite 300 Warren NJ 07059 Revised: 10/2020 image description image description

6 ADVERSE REACTIONS Most common adverse reactions (incidence >2% of patients treated with diclofenac sodium and greater than placebo) are application site reactions, including dermatitis.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Cipla Limited at 1-866-604-3268 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

The following adverse reactions are discussed in greater detail in other sections of the labeling: Cardiovascular Thrombotic Events [ see Warnings and Precautions ( 5.1 ) ] GI Bleeding, Ulceration and Perforation [ see Warnings and Precautions ( 5.2 ) ] Hepatotoxicity [ see Warnings and Precautions ( 5.3 ) ] Hypertension [ see Warnings and Precautions ( 5.4 ) ] Heart Failure and Edema [ see Warnings and Precautions ( 5.5 ) ] Renal Toxicity and Hyperkalemia [ see Warnings and Precautions ( 5.6 ) ] Anaphylactic Reactions [ see Warnings and Precautions ( 5.7 ) ] Serious Skin Reactions [ see Warnings and Precautions ( 5.9 ) ] Hematologic Toxicity [ see Warnings and Precautions ( 5.11 ) ] 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.

During clinical development, 913 patients were exposed to diclofenac sodium topical gel in randomized, double-blind, multicenter, vehicle-controlled, parallel-group studies in osteoarthritis of the superficial joints of the extremities.

Of these, 513 patients received diclofenac sodium topical gel for osteoarthritis of the knee and 400 were treated for osteoarthritis of the hand.

Additionally, 583 patients were exposed to diclofenac sodium topical gel in an uncontrolled, open-label, long-term safety trial in osteoarthritis of the knee.

Of these, 355 patients were treated for osteoarthritis of 1 knee and 228 were treated for osteoarthritis of both knees.

Duration of exposure ranged from 8 to 12 weeks for the placebo-controlled studies, and up to 12 months for the open-label safety trial.

Short-Term Placebo-Controlled Trials: Adverse reactions observed in at least 1% of patients treated with diclofenac sodium topical gel: Non-serious adverse reactions that were reported during the short-term placebo-controlled studies comparing diclofenac sodium topical gel and placebo (vehicle gel) over study periods of 8 to 12 weeks (16 g per day), were application site reactions.

These were the only adverse reactions that occurred in >1% of treated patients with a greater frequency in the diclofenac sodium topical gel group (7%) than the placebo group (2%).

Table 1 lists the types of application site reactions reported.

Application site dermatitis was the most frequent type of application site reaction and was reported by 4% of patients treated with diclofenac sodium topical gel, compared to 1% of placebo patients.

Table 1.

Non-serious Application Site Adverse Reactions (≥1% Diclofenac Sodium Patients) –Short-term Controlled Trials † Preferred Term according to MedDRA 9.1.

Diclofenac sodium topical gel Placebo (vehicle) N=913 N=876 Adverse Reaction † N (%) N (%) Any application site reaction 62 (7) 19 (2) Application site dermatitis 32 (4) 6 (<1) Application site pruritus 7 (<1) 1 (<1) Application site erythema 6 (<1) 3 (<1) Application site paresthesia 5 (<1) 3 (<1) Application site dryness 4 (<1) 3 (<1) Application site vesicles 3 (<1) 0 Application site irritation 2 (<1) 0 Application site papules 1 (<1) 0 In the placebo-controlled trials, the discontinuation rate due to adverse reactions was 5% for patients treated with diclofenac sodium topical gel, and 3% for patients in the placebo group.

Application site reactions, including application site dermatitis, were the most frequent reason for treatment discontinuation.

Long-Term Open-Label Safety Trial: In the open-label, long-term safety study, distribution of adverse reactions was similar to that in the placebo-controlled studies.

In this study, where patients were treated for up to 1 year with diclofenac sodium topical gel up to 32 g per day, application site dermatitis was observed in 11% of patients.

Adverse reactions that led to the discontinuation of the study drug were experienced in 12% of patients.

The most common adverse reaction that led to discontinuation of the study was application site dermatitis, which was experienced by 6% of patients.