Carefully consider the potential benefits and risks of Flector® Patch and other treatment options before deciding to use Flector® Patch. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).

Flector® Patch is indicated for the topical treatment of acute pain due to minor strains, sprains, and contusions.

Carefully consider the potential benefits and risks of Flector® Patch and other treatment options before deciding to use Flector® Patch. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).

The recommended dose of Flector® Patch is one (1) patch to the most painful area twice a day.

Flector® patch should not be applied to damaged or non-intact skin.

Flector® patch should not be worn when bathing or showering.

HANDLING AND DISPOSAL

Patients and caregivers should wash their hands after applying, handling or removing the patch. Eye contact should be avoided.

Flector® Patch is supplied in resealable envelopes, each containing 5 patches (10 cm x 14 cm), with one or two envelopes per box (NDC 64032-xxx-xx). Each individual patch is embossed with “Diclofenac Epolamine 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.
• The ENVELOPES SHOULD BE SEALED AT ALL TIMES WHEN NOT IN USE.
• Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature].

Manufacturer: Teikoku Seiyaku Co., Ltd., Sanbonmatsu, Kagawa 769-2695, Japan Distributor:
FDA rev date: 1/31/2007

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