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DermacinRx Lexitral
  • Professionals
  • FDA PI

DermacinRx Lexitral

Generic name:diclofenac sodium, capsaicin
Dosage form: kit
Drug class:Topical non-steroidal anti-inflammatories

Medically reviewed by Drugs.com. Last updated on Mar 1, 2022.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. Read further information about unapproved drugs.

DermacinRx® Lexitral™ PharmaPak II contains:

Diclofenac Sodium Topical Solution (1.5% w/w, 150 mL) and Penetral™ Cream (Capsaicin 0.025%, 8 fl oz / 237 mL).

THESE PRODUCTS ARE INTENDED ONLY FOR USE AS DESCRIBED.

The individual products contained in this package should not be used alone or in combination for other purposes. The information described in this labeling concerns only the use of these products as indicated in this administration package.

WARNING: CARDIOVASCULAR AND GASTROINTESTINAL RISK

Cardiovascular Risk

  • Nonsteroidal anti-inflammatory drugs (NSAIDs) may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk [see Warnings and Precautions (5.1)].
  • Diclofenac sodium topical solution is contraindicated in the perioperative setting of coronary artery bypass graft (CABG) surgery [see Contraindications (4)] .

Gastrointestinal Risk

  • NSAIDs cause an increased risk of serious gastrointesti..