Voltaren (Page 7 of 7)

Instructions for Use

VOLTAREN® GEL (diclofenac sodium)

Important: Use the dosing card that is inside the VOLTAREN® GEL carton to correctly measure each dose. The dosing card is re-usable. Do not throw the dosing card away. Before you use VOLTAREN® 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 VOLTAREN® 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 VOLTAREN® GEL to help relieve arthritis pain in some of your joints. VOLTAREN® 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 VOLTAREN® GEL is safe and effective if used on your spine, hips, or shoulders.

Use VOLTAREN® GEL exactly how your healthcare provider prescribes it for you. Do not apply VOLTAREN® GEL anywhere other than where your doctor tells you to.
Do not use more than a total of 32 grams of VOLTAREN® GEL each day. If you add up the amount of VOLTAREN® 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 VOLTAREN® GEL each time you apply it.

Apply VOLTAREN® 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.

The dose for your feet, ankles, or knees is 4 grams of VOLTAREN® GEL each time you apply it.

Apply VOLTAREN® GEL 4 times a day (a total of 16 grams each day). Do not apply more than 16 grams each day to any one of your affected knees, ankles, or feet.

Some examples of VOLTAREN® GEL applications include:

If you use 2 grams of VOLTAREN® GEL on one hand, 4 times a day, your total dose for one day is 8 grams
If you use 4 grams of VOLTAREN® 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 VOLTAREN® GEL.
Dosing Card
(click image for full-size original)

Figure A

Before you use a new tube of VOLTAREN® 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 VOLTAREN® GEL to clean, dry skin that does not have any cuts, infections or rashes.
Do not use heating pads or apply bandages where you have applied VOLTAREN® GEL.
Avoid exposing skin where you apply VOLTAREN® 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 VOLTAREN® GEL.
Do not get VOLTAREN® GEL in your eyes, nose, or mouth. VOLTAREN® GEL is only to be used on your skin (topical use). If you get VOLTAREN® 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 VOLTAREN® GEL, continue with your next scheduled dose using the prescribed amount of VOLTAREN® GEL. Do not double the dose.

Applying 2 grams (2 g) of VOLTAREN® GEL to hands, wrists, or elbows:

Step 1. Remove the dosing card that is attached inside the VOLTAREN® GEL carton. Use the dosing card to correctly measure each dose of VOLTAREN® GEL. To measure the correct amount of VOLTAREN® 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 1-800-398-5876. Ask your healthcare provider or pharmacist to show you how to correctly measure your dose of VOLTAREN® GEL while you are waiting to receive your new dosing card.

Step 2. Squeeze VOLTAREN® 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 entire 2 gram area of the dosing card (See Figure B). Put the cap back on the tube of VOLTAREN® GEL. Ask your healthcare provider or pharmacist if you are not sure how to correctly measure your dose of VOLTAREN® 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 VOLTAREN® GEL. Do not wash your treated hands for at least 1 hour after applying the VOLTAREN® GEL.

Step 5. After applying VOLTAREN® GEL, wait 10 minutes before covering the treated skin with gloves or clothing.

Figures B-C-D
(click image for full-size original)

Applying 4 grams (4 g) of VOLTAREN® GEL to feet, ankles, or knees:

Step 1. Refer to Step 1 above.

Step 2. Squeeze VOLTAREN® 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 VOLTAREN® GEL. Ask your healthcare provider or pharmacist if you are not sure how to correctly measure your dose of VOLTAREN® GEL.

Step 3. Apply VOLTAREN® 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 VOLTAREN® GEL to your foot, ankle, or knee.

Figures E F G
(click image for full-size original)

What are the ingredients in VOLTAREN® GEL?Active ingredient: diclofenac sodium

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 VOLTAREN® GEL? Store at 20°C to 25°C (68°F to 77°F). Do not freeze VOLTAREN® GEL. Store the dosing card with your VOLTAREN® GEL.

Keep VOLTAREN® 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.

Marketed by:

Endo Pharmaceuticals Inc., Malvern, PA 19355

Manufactured by:

Novartis Pharma Produktions GmbH,

Wehr, Germany for

Sandoz Inc., Princeton, NJ 08540

Relabeled by:

Proficient Rx, LP

Thousand Oaks, CA 91320

Revised: November 2014

63187-582-00
(click image for full-size original)
VOLTAREN diclofenac sodium gel
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63187-582(NDC:63481-684)
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DICLOFENAC SODIUM (DICLOFENAC) DICLOFENAC SODIUM 10 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
AMMONIA
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)
COCO-CAPRYLATE/CAPRATE
ISOPROPYL ALCOHOL
MINERAL OIL
POLYOXYL 20 CETOSTEARYL ETHER
PROPYLENE GLYCOL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63187-582-00 1 TUBE in 1 CARTON contains a TUBE
1 100 g in 1 TUBE This package is contained within the CARTON (63187-582-00)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022122 10/17/2007
Labeler — Proficient Rx LP (079196022)
Establishment
Name Address ID/FEI Operations
Proficient Rx LP 079196022 REPACK (63187-582), RELABEL (63187-582)

Revised: 01/2021 Proficient Rx LP

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