ABOUT
RHOFADE® CREAM

RHOFADE® cream helped reduce persistent facial redness due to  rosacea in adults on Day 29  through 12 hours (assessed at  hours 3, 6, 9, and 12).

Before and After Images

At hours 3, 6, 9, and 12 on Day 29 of clinical trials, results were seen in 12% to 18% of adult patients using RHOFADE® cream vs 5% to 9% using vehicle. The most common side effects at the application site include: dermatitis, worsening of rosacea pimples, itching, redness, and pain. These are not all  the possible side effects of RHOFADE® cream. Individual results may vary.

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INDICATIONS AND USAGE

RHOFADE® (oxymetazoline hydrochloride, 1%) cream is an alpha1A adrenoceptor agonist indicated for the topical treatment of persistent facial erythema associated with rosacea in adults.

WARNINGS AND PRECAUTIONS

  • Alpha-adrenergic agonists as a class may impact blood pressure. Advise patients with cardiovascular disease, orthostatic hypotension, and/or uncontrolled hypertension or hypotension to seek medical care if their condition worsens.
  • Use with caution in patients with cerebral or coronary insufficiency, Raynaud's phenomenon, thromboangiitis obliterans, scleroderma, or Sjögren's syndrome and advise patients to seek medical care if signs and symptoms of potentiation of vascular insufficiency develop.
  • Advise patients to seek immediate medical care if signs and symptoms of acute narrow-angle glaucoma develop.

ADVERSE REACTIONS

Most common adverse reactions (incidence ≥ 1%) are application site dermatitis, worsening inflammatory lesions of rosacea, application site pruritis, application site erythema, and application site pain.

MEDICAL INFORMATION and ADVERSE DRUG EVENTS REPORTING

To report a suspected adverse reaction from one of our products, please contact Mayne Pharma at 1-844-825-8500 or the FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.

For more information, please see full Prescribing Information and Patient Information Leaflet.




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