"Young children have died or become seriously ill from accidental exposure to a skin patch containing fentanyl, a powerful pain reliever. As a result of this, the Food and Drug Administration (FDA) is issuing a Drug Safety Communication to warn pa"...
Flector® Patch is indicated for the topical treatment of acute pain due to minor strains, sprains, and contusions.
DOSAGE AND ADMINISTRATION
The recommended dose of Flector Patch (diclofenac epolamine topical patch) is one (1) patch to the most painful area twice a day.
- Patients should be informed that, if Flector Patch (diclofenac epolamine topical patch) begins to peel-off, the edges of the patch may be taped down. If problems with adhesion persist, patients may overlay the patch with a mesh netting sleeve, where appropriate (e.g. to secure patches applied to ankles, knees, or elbows). The mesh netting sleeve (e.g. Curad® Hold Tite™, Surgilast® Tubular Elastic Dressing) must allow air to pass through and not be occlusive (non-breathable).
- Do not apply Flector Patch (diclofenac epolamine topical patch) to non-intact or damaged skin resulting from any etiology e.g. exudative dermatitis, eczema, infected lesion, burns or wounds.
- Do not wear a Flector Patch (diclofenac epolamine topical patch) when bathing or showering.
- Wash your hands after applying, handling or removing the patch.
- Avoid eye contact.
Dosage Forms and Strengths
Patch (10 x 14 cm) containing 180 mg of diclofenac epolamine, embossed with "FLECTOR PATCH < DICLOFENAC EPOLAMINE TOPICAL PATCH > 1.3%"
The Flector Patch (diclofenac epolamine topical patch) is supplied in resealable envelopes, each containing 5 patches (10 cm x 14 cm), with 6 envelopes per box (NDC 60793-411-30). Each individual patch is embossed with "FLECTOR PATCH < DICLOFENAC EPOLAMINE TOPICAL PATCH > 1.3%".
- Each patch contains 180 mg of diclofenac epolamine in an aqueous base (13 mg of active per gram of adhesive or 1.3%).
- The product is intended for topical use only.
- Keep out of reach of children and pets.
- ENVELOPES SHOULD BE SEALED AT ALL TIMES WHEN NOT IN USE.
- Curad® Hold Tite™ is a trademark of Medline Industries, Inc., and Surgilast® Tubular Elastic Dressing is a trademark of Derma Sciences, Inc.
Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].
Distributed by: King Pharmaceuticals Inc. 501 Fifth Street, Bristol TN 37620 USA. Manufactured for: IBSA Institut Biochimique SA, CH-6903 Lugano, Switzerland Manufactured by: Teikoku Seiyaku Co., Ltd., Sanbonmatsu, Kagawa 769-2695 Japan. Version November, 2010
Last reviewed on RxList: 3/18/2011
This monograph has been modified to include the generic and brand name in many instances.
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