FLECTOR Patch Ref.[27463] Active ingredients: Diclofenac

Source: FDA, National Drug Code (US)  Revision Year: 2020 

Product description

FLECTOR PATCH (diclofenac epolamine patch) is a nonsteroidal anti-inflammatory drug, available for topical application. FLECTOR PATCH is a 10 cm × 14 cm patch comprised of an adhesive material containing 1.3% diclofenac epolamine which is applied to a non-woven polyester felt backing and covered with a polypropylene film release liner. The release liner is removed prior to topical application to the skin.

The chemical name of diclofenac epolamine is 2-[(2,6-dichlorophenyl) amino]benzeneacetic acid, (2-(pyrrolidin-1-yl) ethanol salt, with a molecular formula of C20H24Cl2N2O3, and molecular weight 411.3, an n-octanol/water partition coefficient of 8 at pH 8.5, and the following chemical structure:

Each adhesive patch contains 180 mg of diclofenac epolamine (13 mg per gram adhesive) in an aqueous base. It also contains the following inactive ingredients: 1,3-butylene glycol, dihydroxyaluminum aminoacetate, disodium edetate, D-sorbitol, fragrance (Dalin PH), gelatin, kaolin, methylparaben, polysorbate 80, povidone, propylene glycol, propylparaben, sodium carboxymethylcellulose, sodium polyacrylate, tartaric acid, titanium dioxide, and purified water.

Dosage Forms and Strengths

FLECTOR (diclofenac epolamine) Patch (10 × 14 cm) containing 180 mg of diclofenac epolamine, embossed with FLECTOR PATCH <DICLOFENAC EPOLAMINE TOPICAL PATCH> 1.3%.
How Supplied

The FLECTOR PATCHis supplied in resealable envelopes, each containing 5 patches (10 cm × 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.

Distributor: Pfizer Inc, New York, NY 10017

Manufacturer: Altergon Italia Srl, Zona Industriale ASI, Morra de Sanctis, Avellino 83040, Italy (ITA)

Manufactured for: IBSA Institut Biochimique SA, CH-6903 Lugano, Switzerland

Drugs

Drug Countries
FLECTOR Austria, Cyprus, Spain, France, Hong Kong, Ireland, Poland, Tunisia, Turkey, United Kingdom, United States
 
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