Molecule
Diclofenac epolamine is a nonsteroidal anti-inflammatory drug indicated for the topical treatment of acute pain due to minor strains, sprains, and contusions in adults and pediatric patients 6 years and older. MedsAcross supplies Diclofenac epolamine for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% is indicated for the topical treatment of acute pain due to minor strains, sprains, and contusions in adults and pediatric patients 6 years and older. DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% is a nonsteroidal anti-inflammatory drug (NSAID), and is indicated for the topical treatment of acute pain due to minor strains, sprains, and contusions in adults and pediatric patients 6 years and older.
Source: US FDA prescribing information
Diclofenac has analgesic, anti-inflammatory, and antipyretic properties. The mechanism of action of diclofenac, like that of other NSAIDs, is not completely understood but involves inhibition of cyclooxygenase (COX-1 and COX-2). Diclofenac is a potent inhibitor of prostaglandin synthesis in vitro. Diclofenac concentrations reached during therapy have produced in vivo effects. Prostaglandins sensitize afferent nerves and potentiate the action of bradykinin in inducing pain in animal models. Prostaglandins are mediators of inflammation. Because diclofenac is an inhibitor of prostaglandin synthesis, its mode of action may be due to a decrease of prostaglandins in peripheral tissues.
Source: US FDA prescribing information
Use the lowest effective dosage for shortest duration consist with the individual patient treatment goals. The recommended dose of DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% for adults and pediatric patients 6 years and older is one topical system to the most painful area twice a day. DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% should not be applied to damaged or non-intact skin.
Source: US FDA prescribing information
DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% is contraindicated in the following patients: Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to diclofenac or any components of the drug product History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal, anaphylactic reactions to NSAIDs have been reported in such patients In the setting of coronary artery bypass graft (CABG) surgery DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% is contraindicated for use on non-intact or damaged skin resulting from any etiology, including exudative dermatitis, eczema, infection lesions, burns or wounds.
Source: US FDA prescribing information
Boxed warning: Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use. DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% is contraindicated in the setting of coronary artery bypass graft (CABG) surgery. Hepatotoxicity: Inform patients of warning signs and symptoms of hepatotoxicity. Discontinue if abnormal liver tests persist or worsen or if clinical signs and symptoms of liver disease develop. Hypertension: Patients taking some antihypertensive medications may have impaired response to these therapies when taking NSAIDs. Monitor blood pressure.
Source: US FDA prescribing information
The following adverse reactions are discussed in greater detail in other sections of the labeling: Cardiovascular Thrombotic Events GI Bleeding, Ulceration and Perforation Hepatotoxicity Hypertension Heart Failure and Edema Renal Toxicity and Hyperkalemia Anaphylactic Reactions Serious Skin Reactions Hematologic Toxicity The most common adverse reactions in DICLOFENAC EPOLAMINE TOPICAL SYSTEM and placebo-treated adult patients were pruritus (5% and 8%, respectively) and nausea (3% and 2%, respectively). The most common adverse reactions in DICLOFENAC EPOLAMINE TOPICAL SYSTEM 1.3% treated pediatric patients were headache (9%) and application site pruritus (7%)
Source: US FDA prescribing information
See Table 2 for clinically significant drug interactions with diclofenac. Table 2: Clinically Significant Drug Interactions with Diclofenac Drugs That Interfere with Hemostasis Clinical Impact: Diclofenac and anticoagulants such as warfarin have a synergistic effect on bleeding. The concomitant use of diclofenac and anticoagulants have an increased risk of serious bleeding compared to the use of either drug alone. Serotonin release by platelets plays an important role in hemostasis. Case-control and cohort epidemiological studies showed that concomitant use of drugs that interfere with serotonin reuptake and an NSAID may potentiate the risk of bleeding more than an NSAID alone.
Source: US FDA prescribing information
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).
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
4 presentations of Diclofenac epolamine, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Diclofenac epolamine 0.013 g transdermal systemTopicalGeneric name | — | US FDA | Available on request |
| Licart 0.013 g transdermal systemTopical | IBSA Pharma | US FDA | Available on request |
| Flector 0.013 g transdermal systemTopical | IBSA Pharma | US FDA | Available on request |
| Diclox Patch 30CT 0.013 g transdermal systemTopical | Injecta Medcial | US FDA | Available on request |
3 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 31 January 2007 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Yes, on request. MedsAcross lists 4 presentations of Diclofenac epolamine and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 3 brand names for Diclofenac epolamine, including Diclox Patch 30CT, Flector, Licart.
Yes. The US FDA first approved Diclofenac epolamine on 31 January 2007, according to Drugs@FDA.
No listed presentation of Diclofenac epolamine is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.