Drug Catalog - Product Detail
VOLTAREN 1% GEL 100GM
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 63481-0684-47 | ENDO PHARMACEUTICALS | 100 | 1% | GEL |
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Description
11 DESCRIPTION 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 C 14 H 10 C l2 NNaO 2 . 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. Chemical Structure
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Voltaren® Gel is available in tubes containing 100 g of the topical gel in each tube. Physician samples are packaged in 20 g tubes. Each tube contains diclofenac sodium in a gel base (10 mg of diclofenac sodium per gram of gel or 1%). 20 g tube (physician's sample) NDC 63481-684-83 100 g tube NDC 63481-684-47 3 Pack (3 Tubes containing 100 g each) NDC 63481-684-03 5 Pack (5 Tubes containing 100 g each) NDC 63481-684-05 Storage Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [See USP Controlled Room Temperature] Keep from freezing.
Indications & Usage
1 INDICATIONS AND USAGE 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. Voltaren® Gel is a nonsteroidal 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 ) Voltaren® Gel was not evaluated for use on joints of the spine, hip, or shoulder. ( 14.1 )
Dosage and Administration
2 DOSAGE AND ADMINISTRATION Total dose should not exceed 32 g per day, overall affected joints. ( 2.3 ) Voltaren Gel should be measured onto the enclosed dosing card to the appropriate 2 g or 4 g designation. ( 2 ) Lower extremities: Apply the gel (4 g) to the affected area 4 times daily. Do not apply more than 16 g daily to any one affected joint of the lower extremities. ( 2.2 ) Upper extremities: Apply the gel (2 g) to the affected area 4 times daily. Do not apply more than 8 g daily to any one affected joint of the upper extremities. ( 2.3 ) 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.