Diclofenac Sodium and Menthol, Methyl salicylate
Drug Details
- Generic Name
- Diclofenac Sodium and Menthol, Methyl salicylate
- Brand Names
- Fenovar, Varophen, Torvex, Orthaphen, Orthrexo
- Application Number
- ANDA202027
- Sponsor
- V2 Pharma, LLC
- NDC Codes
- 5
- Dosage Forms
- KIT
- Routes
- N/A
- Active Ingredients
- N/A
Indications and Usage
1 INDICATIONS AND USAGE Diclofenac sodium topical solution is indicated for the treatment of signs and symptoms of osteoarthritis of the knee(s). Diclofenac sodium topical solution is a nonsteroidal anti-inflammatory drug indicated for the treatment of signs and symptoms of osteoarthritis of the knee(s). ( 1 )
For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains.
Warnings
For external use only Do not use: On wounds or damaged skin With a heating pad On a child under 12 years of age with arthritis-like conditions Ask a doctor before use if you haveredness over the affected area When using this product Avoid contact with eyes Do not bandage tightly Stop use and ask a doctor if Condition worsens or symptoms persist for more than 7 days Symptoms clear up and occur again within a few days Excessive skin irritation occurs