Voltaren

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Voltaren Recall

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Side Effects & Adverse Reactions

There is currently no warning information available for this product. We apologize for any inconvenience.

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Legal Issues

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FDA Safety Alerts

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Manufacturer Warnings

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FDA Labeling Changes

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Uses

Voltaren® 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.

•: Voltaren® Gel has not been evaluated for use on the spine, hip, or shoulder.

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History

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Other Information

Voltaren® Gel (diclofenac sodium topical gel) is a nonsteroidal anti-inflammatory drug (NSAID) for topical use only. It contains the active ingredient, diclofenac sodium, in an opaque, white gel base. Diclofenac sodium is a white to slightly yellow crystalline powder. Diclofenac sodium is a benzene–acetic acid derivative. The chemical name is 2-[(2,6-dichlorophenyl)amino]benzeneacetic acid, monosodium salt. The molecular weight is 318.14. Its molecular formula is C14H10C12NNaO2. It has the following structural formula:

Voltaren® Gel also contains carbomer homopolymer Type C, cocoyl caprylocaprate, fragrance, isopropyl alcohol, mineral oil, polyoxyl 20 cetostearyl ether, propylene glycol, purified water, and strong ammonia solution.

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Voltaren Manufacturers

Preferred Pharmaceuticals, Inc.

Voltaren | Preferred Pharmaceuticals, Inc.

2.1 Dosing Card [See the Medication Guide – Patient Instructions for Use]
The proper amount of Voltaren® Gel should be measured using the dosing card supplied in the drug product carton. The dosing card is made of polypropylene, like the tube cap containing Voltaren® Gel, but without the white colorant. The dosing card should be used for each application of drug product. The gel should be applied within the oblong area of the dosing card up to the 2 gram or 4 gram line (2 g for each elbow, wrist, or hand, and 4 g for each knee, ankle, or foot). The dosing card containing Voltaren® Gel can be used to apply the gel. The hands should then be used to gently rub the gel into the skin. After using the dosing card, hold with fingertips, rinse, and dry. It treatment site is the hands, patients should wait at least one (1) hour to wash their hands
2.2 Lower extremities, including the knees, ankles, and feet
Apply the gel (4 g) to the affected foot or knee or ankle, 4 times daily. Voltaren® Gel should be gently massaged into the skin ensuring application to the entire affected foot or knee or ankle. The entire foot includes the sole, top of the foot and the toes. Do not apply more than 16 g daily to any single joint of the lower extremities.
2.3 Upper extremities including the elbows, wrists and hands
Apply the gel (2 g) to the affected hand or elbow or wrist, 4 times daily. Voltaren® Gel should be gently massaged into the skin ensuring application to the entire affected hand or elbow or wrist. The entire hand includes the palm, back of the hands, and the fingers. Do not apply more than 8 g daily to any single joint of the upper extremities.

Total dose should not exceed 32 g per day, over all affected joints.
2.4 Special Precautions • Showering/bathing should be avoided for at least 1 hour after the application. Patient should wash his/her hands after use, unless the hands are the treated joint. If Voltaren® Gel is applied to the hand(s) for treatment; patient should not wash the treated hand(s) for at least 1 hour after the application.
• Voltaren® Gel should not be applied to open wounds.
• Contact of Voltaren® Gel with eyes and mucous membranes should be avoided.
• External heat and/or occlusive dressings should not be applied to treated joints.
• Exposure of the treated joint(s) to sunlight should be avoided.
• Voltaren® Gel should not be used concomitantly with sunscreens, cosmetics, lotions, moisturizers, insect repellants, or other topical medications on the same skin sites has not been evaluated.
• Concomitant use of Voltaren® Gel with oral non-steroidal anti-inflammatory drugs (NSAIDs) has not been evaluated, and may increase adverse NSAIDs effects.
• Wearing of clothing or gloves should be avoided for at least 10 minutes after applying Voltaren® Gel.

No Recall
Endo Pharmaceuticals, Inc.

Voltaren | Endo Pharmaceuticals Inc.

2.1 Dosing Card [See the patient Instructions for Use]
The dosing card can be found attached to the inside of the carton.

The proper amount of VOLTAREN® GEL should be measured using the dosing card supplied in the drug product carton. The dosing card is made of clear polypropylene. The dosing card should be used for each application of drug product. The gel should be applied within the oblong area of the dosing card up to the 2 gram or 4 gram line (2 g for each elbow, wrist, or hand, and 4 g for each knee, ankle, or foot). The 2 g line is 2.25 inches long. The 4 g line is 4.5 inches long. The dosing card containing VOLTAREN® GEL can be used to apply the gel. The hands should then be used to gently rub the gel into the skin. After using the dosing card, hold with fingertips, rinse, and dry. If treatment site is the hands, patients should wait at least one (1) hour to wash their hands.
2.2 Lower extremities, including the knees, ankles, and feet
Apply the gel (4 g) to the affected foot or knee or ankle, 4 times daily. VOLTAREN® GEL should be gently massaged into the skin ensuring application to the entire affected foot or knee or ankle. The entire foot includes the sole, top of the foot and the toes. Do not apply more than 16 g daily to any single joint of the lower extremities.
2.3 Upper extremities including the elbows, wrists and hands
Apply the gel (2 g) to the affected hand or elbow or wrist, 4 times daily. VOLTAREN® GEL should be gently massaged into the skin ensuring application to the entire affected hand or elbow or wrist. The entire hand includes the palm, back of the hands, and the fingers. Do not apply more than 8 g daily to any single joint of the upper extremities.
Total dose should not exceed 32 g per day, over all affected joints.
2.4 Special Precautions • Showering/bathing should be avoided for at least 1 hour after the application. Patient should wash his/her hands after use, unless the hands are the treated joint. If VOLTAREN® GEL is applied to the hand(s) for treatment; patient should not wash the treated hand(s) for at least 1 hour after the application. • VOLTAREN® GEL should not be applied to open wounds. • Contact of VOLTAREN® GEL with eyes and mucous membranes should be avoided. • External heat and/or occlusive dressings should not be applied to treated joints. • Exposure of the treated joint(s) to sunlight should be avoided. • Avoid concomitant use of VOLTAREN® GEL on the treated skin with other topical products including sunscreens, cosmetics, lotions, moisturizers, insect repellants, or other topical medications [see Drug Interactions (7.9)]. • Concomitant use of VOLTAREN® GEL with oral non-steroidal anti-inflammatory drugs (NSAIDs) has not been evaluated, and may increase adverse NSAIDs effects.
Wearing of clothing or gloves should be avoided for at least 10 minutes after applying VOLTAREN® GEL.

No Recall
Stat Rx Usa Llc

Voltaren | Stat Rx Usa Llc

2.1 Dosing Card [See the Medication Guide – Patient Instructions for Use]
The proper amount of Voltaren® Gel should be measured using the dosing card supplied in the drug product carton. The dosing card is made of polypropylene, like the tube cap containing Voltaren® Gel, but without the white colorant. The dosing card should be used for each application of drug product. The gel should be applied within the oblong area of the dosing card up to the 2 gram or 4 gram line (2 g for each elbow, wrist, or hand, and 4 g for each knee, ankle, or foot). The dosing card containing Voltaren® Gel can be used to apply the gel. The hands should then be used to gently rub the gel into the skin. After using the dosing card, hold with fingertips, rinse, and dry. It treatment site is the hands, patients should wait at least one (1) hour to wash their hands
2.2 Lower extremities, including the knees, ankles, and feet
Apply the gel (4 g) to the affected foot or knee or ankle, 4 times daily. Voltaren® Gel should be gently massaged into the skin ensuring application to the entire affected foot or knee or ankle. The entire foot includes the sole, top of the foot and the toes. Do not apply more than 16 g daily to any single joint of the lower extremities.
2.3 Upper extremities including the elbows, wrists and hands
Apply the gel (2 g) to the affected hand or elbow or wrist, 4 times daily. Voltaren® Gel should be gently massaged into the skin ensuring application to the entire affected hand or elbow or wrist. The entire hand includes the palm, back of the hands, and the fingers. Do not apply more than 8 g daily to any single joint of the upper extremities.

Total dose should not exceed 32 g per day, over all affected joints.
2.4 Special Precautions Showering/bathing should be avoided for at least 1 hour after the application. Patient should wash his/her hands after use, unless the hands are the treated joint. If Voltaren® Gel is applied to the hand(s) for treatment; patient should not wash the treated hand(s) for at least 1 hour after the application.
Voltaren® Gel should not be applied to open wounds.
Contact of Voltaren® Gel with eyes and mucous membranes should be avoided.
External heat and/or occlusive dressings should not be applied to treated joints.
Exposure of the treated joint(s) to sunlight should be avoided.
Voltaren® Gel should not be used concomitantly with sunscreens, cosmetics, lotions, moisturizers, insect repellants, or other topical medications on the same skin sites has not been evaluated.
Concomitant use of Voltaren® Gel with oral non-steroidal anti-inflammatory drugs (NSAIDs) has not been evaluated, and may increase adverse NSAIDs effects.
Wearing of clothing or gloves should be avoided for at least 10 minutes after applying Voltaren® Gel.

No Recall
Rebel Distributors Corp

Voltaren | Rebel Distributors Corp

2.1 Dosing Card [See the Medication Guide – Patient Instructions for Use]
The proper amount of Voltaren® Gel should be measured using the dosing card supplied in the drug product carton. The dosing card is made of polypropylene, like the tube cap containing Voltaren® Gel, but without the white colorant. The dosing card should be used for each application of drug product. The gel should be applied within the oblong area of the dosing card up to the 2 gram or 4 gram line (2 g for each elbow, wrist, or hand, and 4 g for each knee, ankle, or foot). The dosing card containing Voltaren® Gel can be used to apply the gel. The hands should then be used to gently rub the gel into the skin. After using the dosing card, hold with fingertips, rinse, and dry. It treatment site is the hands, patients should wait at least one (1) hour to wash their hands
2.2 Lower extremities, including the knees, ankles, and feet
Apply the gel (4 g) to the affected foot or knee or ankle, 4 times daily. Voltaren® Gel should be gently massaged into the skin ensuring application to the entire affected foot or knee or ankle. The entire foot includes the sole, top of the foot and the toes. Do not apply more than 16 g daily to any single joint of the lower extremities.
2.3 Upper extremities including the elbows, wrists and hands
Apply the gel (2 g) to the affected hand or elbow or wrist, 4 times daily. Voltaren® Gel should be gently massaged into the skin ensuring application to the entire affected hand or elbow or wrist. The entire hand includes the palm, back of the hands, and the fingers. Do not apply more than 8 g daily to any single joint of the upper extremities.

Total dose should not exceed 32 g per day, over all affected joints.
2.4 Special Precautions Showering/bathing should be avoided for at least 1 hour after the application. Patient should wash his/her hands after use, unless the hands are the treated joint. If Voltaren® Gel is applied to the hand(s) for treatment; patient should not wash the treated hand(s) for at least 1 hour after the application.
Voltaren® Gel should not be applied to open wounds.
Contact of Voltaren® Gel with eyes and mucous membranes should be avoided.
External heat and/or occlusive dressings should not be applied to treated joints.
Exposure of the treated joint(s) to sunlight should be avoided.
Voltaren® Gel should not be used concomitantly with sunscreens, cosmetics, lotions, moisturizers, insect repellants, or other topical medications on the same skin sites has not been evaluated.
Concomitant use of Voltaren® Gel with oral non-steroidal anti-inflammatory drugs (NSAIDs) has not been evaluated, and may increase adverse NSAIDs effects.
Wearing of clothing or gloves should be avoided for at least 10 minutes after applying Voltaren® Gel.

No Recall
Keltman Pharmaceuticals Inc.

Voltaren | Keltman Pharmaceuticals Inc.

2.1 Dosing Card [See the Medication Guide – Patient Instructions for Use]
The proper amount of Voltaren® Gel should be measured using the dosing card supplied in the drug product carton. The dosing card is made of polypropylene, like the tube cap containing Voltaren® Gel, but without the white colorant. The dosing card should be used for each application of drug product. The gel should be applied within the oblong area of the dosing card up to the 2 gram or 4 gram line (2 g for each elbow, wrist, or hand, and 4 g for each knee, ankle, or foot). The dosing card containing Voltaren® Gel can be used to apply the gel. The hands should then be used to gently rub the gel into the skin. After using the dosing card, hold with fingertips, rinse, and dry. It treatment site is the hands, patients should wait at least one (1) hour to wash their hands
2.2 Lower extremities, including the knees, ankles, and feet
Apply the gel (4 g) to the affected foot or knee or ankle, 4 times daily. Voltaren® Gel should be gently massaged into the skin ensuring application to the entire affected foot or knee or ankle. The entire foot includes the sole, top of the foot and the toes. Do not apply more than 16 g daily to any single joint of the lower extremities.
2.3 Upper extremities including the elbows, wrists and hands
Apply the gel (2 g) to the affected hand or elbow or wrist, 4 times daily. Voltaren® Gel should be gently massaged into the skin ensuring application to the entire affected hand or elbow or wrist. The entire hand includes the palm, back of the hands, and the fingers. Do not apply more than 8 g daily to any single joint of the upper extremities.

Total dose should not exceed 32 g per day, over all affected joints.
2.4 Special Precautions Showering/bathing should be avoided for at least 1 hour after the application. Patient should wash his/her hands after use, unless the hands are the treated joint. If Voltaren® Gel is applied to the hand(s) for treatment; patient should not wash the treated hand(s) for at least 1 hour after the application.
Voltaren® Gel should not be applied to open wounds.
Contact of Voltaren® Gel with eyes and mucous membranes should be avoided.
External heat and/or occlusive dressings should not be applied to treated joints.
Exposure of the treated joint(s) to sunlight should be avoided.
Voltaren® Gel should not be used concomitantly with sunscreens, cosmetics, lotions, moisturizers, insect repellants, or other topical medications on the same skin sites has not been evaluated.
Concomitant use of Voltaren® Gel with oral non-steroidal anti-inflammatory drugs (NSAIDs) has not been evaluated, and may increase adverse NSAIDs effects.
Wearing of clothing or gloves should be avoided for at least 10 minutes after applying Voltaren® Gel.

No Recall
Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc

Voltaren | Lake Erie Medical & Surgical Supply Dba Quality Care Products Llc

2.1 Dosing Card [See the Medication Guide – Patient Instructions for Use]
The proper amount of Voltaren® Gel should be measured using the dosing card supplied in the drug product carton. The dosing card is made of polypropylene, like the tube cap containing Voltaren® Gel, but without the white colorant. The dosing card should be used for each application of drug product. The gel should be applied within the oblong area of the dosing card up to the 2 gram or 4 gram line (2 g for each elbow, wrist, or hand, and 4 g for each knee, ankle, or foot). The dosing card containing Voltaren® Gel can be used to apply the gel. The hands should then be used to gently rub the gel into the skin. After using the dosing card, hold with fingertips, rinse, and dry. It treatment site is the hands, patients should wait at least one (1) hour to wash their hands
2.2 Lower extremities, including the knees, ankles, and feet
Apply the gel (4 g) to the affected foot or knee or ankle, 4 times daily. Voltaren® Gel should be gently massaged into the skin ensuring application to the entire affected foot or knee or ankle. The entire foot includes the sole, top of the foot and the toes. Do not apply more than 16 g daily to any single joint of the lower extremities.
2.3 Upper extremities including the elbows, wrists and hands
Apply the gel (2 g) to the affected hand or elbow or wrist, 4 times daily. Voltaren® Gel should be gently massaged into the skin ensuring application to the entire affected hand or elbow or wrist. The entire hand includes the palm, back of the hands, and the fingers. Do not apply more than 8 g daily to any single joint of the upper extremities.

Total dose should not exceed 32 g per day, over all affected joints.
2.4 Special Precautions Showering/bathing should be avoided for at least 1 hour after the application. Patient should wash his/her hands after use, unless the hands are the treated joint. If Voltaren® Gel is applied to the hand(s) for treatment; patient should not wash the treated hand(s) for at least 1 hour after the application.
Voltaren® Gel should not be applied to open wounds.
Contact of Voltaren® Gel with eyes and mucous membranes should be avoided.
External heat and/or occlusive dressings should not be applied to treated joints.
Exposure of the treated joint(s) to sunlight should be avoided.
Voltaren® Gel should not be used concomitantly with sunscreens, cosmetics, lotions, moisturizers, insect repellants, or other topical medications on the same skin sites has not been evaluated.
Concomitant use of Voltaren® Gel with oral non-steroidal anti-inflammatory drugs (NSAIDs) has not been evaluated, and may increase adverse NSAIDs effects.
Wearing of clothing or gloves should be avoided for at least 10 minutes after applying Voltaren® Gel.

No Recall
Physicians Total Care, Inc.

Voltaren | Physicians Total Care, Inc.

2.1 Dosing Card [See the Medication Guide – Patient Instructions for Use]
The proper amount of Voltaren® Gel should be measured using the dosing card supplied in the drug product carton. The dosing card is made of polypropylene, like the tube cap containing Voltaren® Gel, but without the white colorant. The dosing card should be used for each application of drug product. The gel should be applied within the oblong area of the dosing card up to the 2 gram or 4 gram line (2 g for each elbow, wrist, or hand, and 4 g for each knee, ankle, or foot). The dosing card containing Voltaren® Gel can be used to apply the gel. The hands should then be used to gently rub the gel into the skin. After using the dosing card, hold with fingertips, rinse, and dry. It treatment site is the hands, patients should wait at least one (1) hour to wash their hands
2.2 Lower extremities, including the knees, ankles, and feet
Apply the gel (4 g) to the affected foot or knee or ankle, 4 times daily. Voltaren® Gel should be gently massaged into the skin ensuring application to the entire affected foot or knee or ankle. The entire foot includes the sole, top of the foot and the toes. Do not apply more than 16 g daily to any single joint of the lower extremities.
2.3 Upper extremities including the elbows, wrists and hands
Apply the gel (2 g) to the affected hand or elbow or wrist, 4 times daily. Voltaren® Gel should be gently massaged into the skin ensuring application to the entire affected hand or elbow or wrist. The entire hand includes the palm, back of the hands, and the fingers. Do not apply more than 8 g daily to any single joint of the upper extremities.

Total dose should not exceed 32 g per day, over all affected joints.
2.4 Special Precautions Showering/bathing should be avoided for at least 1 hour after the application. Patient should wash his/her hands after use, unless the hands are the treated joint. If Voltaren® Gel is applied to the hand(s) for treatment; patient should not wash the treated hand(s) for at least 1 hour after the application.
Voltaren® Gel should not be applied to open wounds.
Contact of Voltaren® Gel with eyes and mucous membranes should be avoided.
External heat and/or occlusive dressings should not be applied to treated joints.
Exposure of the treated joint(s) to sunlight should be avoided.
Voltaren® Gel should not be used concomitantly with sunscreens, cosmetics, lotions, moisturizers, insect repellants, or other topical medications on the same skin sites has not been evaluated.
Concomitant use of Voltaren® Gel with oral non-steroidal anti-inflammatory drugs (NSAIDs) has not been evaluated, and may increase adverse NSAIDs effects.
Wearing of clothing or gloves should be avoided for at least 10 minutes after applying Voltaren® Gel.

No Recall
Stat Rx Usa Llc

Voltaren | Stat Rx Usa Llc

2.1 Dosing Card [See the Medication Guide – Patient Instructions for Use]
The proper amount of Voltaren® Gel should be measured using the dosing cards supplied in the drug product carton. One dosing card should be used for each application of drug product. The gel should be applied within the oblong area of the dosing card up to the 2 gram or 4 gram line (2 g for each elbow, wrist, or hand, and 4 g for each knee, ankle, or foot). The dosing card containing Voltaren® Gel can be used to apply the gel.
2.2 Lower extremities, including the knees, ankles, and feet
Apply the gel (4 g) to the affected foot or knee or ankle, 4 times daily. Voltaren® Gel should be gently massaged into the skin ensuring application to the entire affected foot or knee or ankle. The entire foot includes the sole, top of the foot and the toes. Do not apply more than 16 g daily to any single joint of the lower extremities.
2.3 Upper extremities including the elbows, wrists and hands
Apply the gel (2 g) to the affected hand or elbow or wrist, 4 times daily. Voltaren® Gel should be gently massaged into the skin ensuring application to the entire affected hand or elbow or wrist. The entire hand includes the palm, back of the hands, and the fingers. Do not apply more than 8 g daily to any single joint of the upper extremities.

Total dose should not exceed 32 g per day, over all affected joints.
2.4 Special Precautions
• Showering/bathing should be avoided for at least 1 hour after the application. Patient should wash his/her hands after use, unless the hands are the treated joint. If Voltaren® Gel is applied to the hand(s) for treatment, patient should not wash the treated hand(s) for at least 1 hour after the application.

• Voltaren® Gel should not be applied to open wounds.

• Contact of Voltaren® Gel with eyes and mucous membranes should be avoided.

• External heat and/or occlusive dressings should not be applied to treated joints.

• Exposure of the treated joint(s) to sunlight should be avoided.

• Voltaren® Gel should not be used concomitantly with sunscreens, cosmetics, lotions, moisturizers, insect repellants, or other topical medications on the same skin sites has not been evaluated.

• Concomitant use of Voltaren® Gel with oral non-steroidal anti-inflammatory drugs (NSAIDs) has not been evaluated, and may increase adverse NSAIDs effects.

• Wearing of clothing or gloves should be avoided for at least 10 minutes after applying Voltaren® Gel.

No Recall
Unit Dose Services

Voltaren | Unit Dose Services

2.1 Dosing Card [See the Medication Guide – Patient Instructions for Use]
The proper amount of Voltaren® Gel should be measured using the dosing card supplied in the drug product carton. The dosing card is made of polypropylene, like the tube cap containing Voltaren® Gel, but without the white colorant. The dosing card should be used for each application of drug product. The gel should be applied within the oblong area of the dosing card up to the 2 gram or 4 gram line (2 g for each elbow, wrist, or hand, and 4 g for each knee, ankle, or foot). The dosing card containing Voltaren® Gel can be used to apply the gel. The hands should then be used to gently rub the gel into the skin. After using the dosing card, hold with fingertips, rinse, and dry. It treatment site is the hands, patients should wait at least one (1) hour to wash their hands
2.2 Lower extremities, including the knees, ankles, and feet
Apply the gel (4 g) to the affected foot or knee or ankle, 4 times daily. Voltaren® Gel should be gently massaged into the skin ensuring application to the entire affected foot or knee or ankle. The entire foot includes the sole, top of the foot and the toes. Do not apply more than 16 g daily to any single joint of the lower extremities.
2.3 Upper extremities including the elbows, wrists and hands
Apply the gel (2 g) to the affected hand or elbow or wrist, 4 times daily. Voltaren® Gel should be gently massaged into the skin ensuring application to the entire affected hand or elbow or wrist. The entire hand includes the palm, back of the hands, and the fingers. Do not apply more than 8 g daily to any single joint of the upper extremities.

Total dose should not exceed 32 g per day, over all affected joints.
2.4 Special Precautions Showering/bathing should be avoided for at least 1 hour after the application. Patient should wash his/her hands after use, unless the hands are the treated joint. If Voltaren® Gel is applied to the hand(s) for treatment; patient should not wash the treated hand(s) for at least 1 hour after the application.
Voltaren® Gel should not be applied to open wounds.
Contact of Voltaren® Gel with eyes and mucous membranes should be avoided.
External heat and/or occlusive dressings should not be applied to treated joints.
Exposure of the treated joint(s) to sunlight should be avoided.
Voltaren® Gel should not be used concomitantly with sunscreens, cosmetics, lotions, moisturizers, insect repellants, or other topical medications on the same skin sites has not been evaluated.
Concomitant use of Voltaren® Gel with oral non-steroidal anti-inflammatory drugs (NSAIDs) has not been evaluated, and may increase adverse NSAIDs effects.
Wearing of clothing or gloves should be avoided for at least 10 minutes after applying Voltaren® Gel.

No Recall
Novartis Pharmaceutical Corporation

Voltaren | Novartis Pharmaceutical Corporation

Cataract Surgery
One drop of Voltaren Ophthalmic should be applied to the affected eye, 4 times daily beginning 24 hours after cataract surgery and continuing throughout the first 2 weeks of the postoperative period.
Corneal Refractive Surgery
One or two drops of Voltaren Ophthalmic should be applied to the operative eye within the hour prior to corneal refractive surgery. Within 15 minutes after surgery, one or two drops should be applied to the operative eye and continued 4 times daily for up to 3 days.

No Recall
Clinical Solutions Wholesale

Voltaren | Clinical Solutions Wholesale

2.1 Dosing Card [See the Medication Guide – Patient Instructions for Use]
The proper amount of Voltaren® Gel should be measured using the dosing card supplied in the drug product carton. The dosing card is made of polypropylene, like the tube cap containing Voltaren® Gel, but without the white colorant. The dosing card should be used for each application of drug product. The gel should be applied within the oblong area of the dosing card up to the 2 gram or 4 gram line (2 g for each elbow, wrist, or hand, and 4 g for each knee, ankle, or foot). The dosing card containing Voltaren® Gel can be used to apply the gel. The hands should then be used to gently rub the gel into the skin. After using the dosing card, hold with fingertips, rinse, and dry. It treatment site is the hands, patients should wait at least one (1) hour to wash their hands
2.2 Lower extremities, including the knees, ankles, and feet
Apply the gel (4 g) to the affected foot or knee or ankle, 4 times daily. Voltaren® Gel should be gently massaged into the skin ensuring application to the entire affected foot or knee or ankle. The entire foot includes the sole, top of the foot and the toes. Do not apply more than 16 g daily to any single joint of the lower extremities.
2.3 Upper extremities including the elbows, wrists and hands
Apply the gel (2 g) to the affected hand or elbow or wrist, 4 times daily. Voltaren® Gel should be gently massaged into the skin ensuring application to the entire affected hand or elbow or wrist. The entire hand includes the palm, back of the hands, and the fingers. Do not apply more than 8 g daily to any single joint of the upper extremities.

Total dose should not exceed 32 g per day, over all affected joints.
2.4 Special Precautions • Showering/bathing should be avoided for at least 1 hour after the application. Patient should wash his/her hands after use, unless the hands are the treated joint. If Voltaren® Gel is applied to the hand(s) for treatment; patient should not wash the treated hand(s) for at least 1 hour after the application.
• Voltaren® Gel should not be applied to open wounds.
• Contact of Voltaren® Gel with eyes and mucous membranes should be avoided.
• External heat and/or occlusive dressings should not be applied to treated joints.
• Exposure of the treated joint(s) to sunlight should be avoided.
• Voltaren® Gel should not be used concomitantly with sunscreens, cosmetics, lotions, moisturizers, insect repellants, or other topical medications on the same skin sites has not been evaluated.
• Concomitant use of Voltaren® Gel with oral non-steroidal anti-inflammatory drugs (NSAIDs) has not been evaluated, and may increase adverse NSAIDs effects.
• Wearing of clothing or gloves should be avoided for at least 10 minutes after applying Voltaren® Gel.

No Recall
Bryant Ranch Prepack

Voltaren | Bryant Ranch Prepack

2.1 Dosing Card [See the Medication Guide – Patient Instructions for Use]
The proper amount of Voltaren® Gel should be measured using the dosing card supplied in the drug product carton. The dosing card is made of polypropylene, like the tube cap containing Voltaren® Gel, but without the white colorant. The dosing card should be used for each application of drug product. The gel should be applied within the oblong area of the dosing card up to the 2 gram or 4 gram line (2 g for each elbow, wrist, or hand, and 4 g for each knee, ankle, or foot). The dosing card containing Voltaren® Gel can be used to apply the gel. The hands should then be used to gently rub the gel into the skin. After using the dosing card, hold with fingertips, rinse, and dry. It treatment site is the hands, patients should wait at least one (1) hour to wash their hands
2.2 Lower extremities, including the knees, ankles, and feet
Apply the gel (4 g) to the affected foot or knee or ankle, 4 times daily. Voltaren® Gel should be gently massaged into the skin ensuring application to the entire affected foot or knee or ankle. The entire foot includes the sole, top of the foot and the toes. Do not apply more than 16 g daily to any single joint of the lower extremities.
2.3 Upper extremities including the elbows, wrists and hands
Apply the gel (2 g) to the affected hand or elbow or wrist, 4 times daily. Voltaren® Gel should be gently massaged into the skin ensuring application to the entire affected hand or elbow or wrist. The entire hand includes the palm, back of the hands, and the fingers. Do not apply more than 8 g daily to any single joint of the upper extremities.

Total dose should not exceed 32 g per day, over all affected joints.
2.4 Special Precautions Showering/bathing should be avoided for at least 1 hour after the application. Patient should wash his/her hands after use, unless the hands are the treated joint. If Voltaren® Gel is applied to the hand(s) for treatment; patient should not wash the treated hand(s) for at least 1 hour after the application.
Voltaren® Gel should not be applied to open wounds.
Contact of Voltaren® Gel with eyes and mucous membranes should be avoided.
External heat and/or occlusive dressings should not be applied to treated joints.
Exposure of the treated joint(s) to sunlight should be avoided.
Voltaren® Gel should not be used concomitantly with sunscreens, cosmetics, lotions, moisturizers, insect repellants, or other topical medications on the same skin sites has not been evaluated.
Concomitant use of Voltaren® Gel with oral non-steroidal anti-inflammatory drugs (NSAIDs) has not been evaluated, and may increase adverse NSAIDs effects.
Wearing of clothing or gloves should be avoided for at least 10 minutes after applying Voltaren® Gel.

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