Diclofenac Sodium, Methyl Salicylate

Generic Name: diclofenac sodium, methyl salicylate

Over-the-Counter (OTC)

Brand Names:

Xiclofen

9. DESCRIPTION Xiclofen TM Ointment is a clear to white external ointment comprised of the active ingredient’s diclofenac sodium 1% and 5% methyl salicylate. Each tube is 85g (3 oz) which contains the active and inactive ingredient formulation. The outer unit box is imprinted with the Xiclofen TM Ointment logo. One tube and a package insert are included in each unit box.

Overview

Uses

1. INDICATIONS & USAGE Xiclofen TM Ointment is indicated in adults over the age of 12 years old for the treatment of signs and symptoms of osteoarthritis of the joints, and of acute and chronic pain in muscles and joints associated with muscle soreness, strains, sprains, arthritis, simple backache, muscle stiffness, and more.

Dosage

2. DOSAGE & ADMINISTRATION 2.1 General Dosing Instructions Use Xiclofen TM Ointment only on dry, intact (unbroken) skin. Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals. Avoid contact with eyes and mucous membranes. Avoid showering or bathing for at least 1 hour after application of Xiclofen TM Ointment. Avoid concomitant use of Xiclofen TM Ointment on the treated skin site with other external products, including sunscreens, cosmetics, lotions, moisturizers, insect repellants, or other external medications. Do not use combination therapy with diclofenac sodium and an oral NSAID unless the benefit outweighs the risk and conduct periodic assessments.

Interactions

6. DRUG INTERACTIONS Drugs That Interfere with Hemostasis Monitor patients with concomitant use of diclofenac sodium external with anticoagulants (e.g., warfarin), antiplatelet agents (e.g., aspirin), selective serotonin reuptake inhibitors (SSRIs), and serotonin norepinephrine reuptake inhibitors (SNRIs) for signs of bleeding. Aspirin Concomitant use of diclofenac sodium external and analgesic doses of aspirin is not generally recommended because of the increased risk of bleeding. ACE Inhibitors, Angiotensin Receptor Blockers, and Beta-Blockers When these drugs are administered concomitantly, patients should be adequately hydrated. Assess renal function at the beginning of the concomitant treatment.

Warnings

5. WARNINGS, PRECAUTIONS & ADVERSE REACTIONS 5.1 Risk of Serious Cardiovascular and Gastrointestinal Events Nonsteroidal anti-inflammatory drugs (NSAIDs) can cause an increased risk of serious cardiovascular (CV) 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. NSAIDs, including diclofenac, can lead to new onset of hypertension, or worsening of preexisting hypertension, either of which may contribute to the increased incidence of CV events. To minimize the potential risk for an adverse CV event in NSAID-treated patients, use the lowest effective dose for the shortest duration possible. 4. CONTRAINDICATIONS Xiclofen TM Ointment is contraindicated in patients with a known history of hypersensitivity to non-steroidal anti-inflammatory medications such as diclofenac sodium or methyl salicylate. History of asthma, urticaria, or allergic-type reactions after absorbing nonsteroidal anti-inflammatory drugs (NSAIDs) should also be considered.

Storage

12. HOW SUPPLIED / STORAGE & HANDLING 12.1 How Supplied Xiclofen TM Ointment is available as a unit box containing an 85g (3oz tube) and package insert. NDC 87063-056-85 (relabeled from NDC 83295-5050-1) 12.2 Storage Store unit box between 69 o -77 o F (20 o -25 o C). Excursions between 15 o -30 o C (59 o -86 o F) are allowed. Keep Xiclofen TM Ointment stored upright with the cap on.

Frequently Asked Questions

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Medical Disclaimer

This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.