FINACEA® (azelaic acid), Gel 15% is the first and only gel approved by the FDA to treat the bumps and pimples and associated redness * of mild to moderate rosacea.
#1 dermatologist-prescribed topical brand for the treatment of mild to moderate rosacea.
Rosacea is a chronic condition that primarily affects the facial skin, usually causing flushing and redness. Although an estimated 16 million Americans have the condition, only a small percentage of those affected are aware of it. There are different theories about the progression of the disease. In most people rosacea is cyclic: it may flare up for a period of weeks to months and then signs and symptoms lessen for a while before flaring up again.
Rosacea usually affects people between 30 and 50 years of age. While more women than men are diagnosed with rosacea, the symptoms tend to be more severe in men.
Unfortunately, there is no cure for rosacea. Complying with medical treatment and avoiding things that trigger rosacea symptoms may, however, help control rosacea symptoms in the long term.
INDICATIONS & USAGE
FINACEA® is indicated for topical treatment of inflammatory papules and pustules of mild to moderate rosacea.
*Although some reduction of erythema which was present in patients with papules and pustules of rosacea occurred in clinical studies, efficacy for treatment of erythema in rosacea in the absence of papules and pustules has not been evaluated.
IMPORTANT SAFETY INFORMATION
FINACEA® (azelaic acid) Gel, 15% is contraindicated in individuals with a history of hypersensitivity to propylene glycol or any other components of the formulation. There have been isolated reports of hypopigmentation after use of azelaic acid. Since azelaic acid has not been well studied in patients with dark complexion, these patients should be monitored for early signs of hypopigmentation. FINACEA® and its vehicle caused irritant reactions at the application site in human dermal safety studies. Skin irritation (e.g. pruritus, burning or stinging) may occur during use with FINACEA®, usually during the first few weeks of treatment. If sensitivity or severe irritation develops and/or persists during use with FINACEA®, discontinue use and institute appropriate therapy.
In clinical trials with FINACEA®, the most common local adverse events (AE’s) (inclusive of mild, moderate and severe categories) were: burning/stinging/tingling (29%), pruritus (11%), scaling/dry skin/xerosis (8%) and erythema/irritation (4%). Contact dermatitis, edema and acne were observed at frequencies of 1% or less. Rarely reported AE’s included: worsening of asthma, vitiligo depigmentation, small depigmented spots, hypertrichosis, reddening (signs of keratosis pilaris) and exacerbation of recurrent herpes labialis. Post-marketing safety information: Skin (facial burning and irritation); Eyes (iridocyclitis on accidental exposure with FINACEA® to the eyes). To report SUSPECTED ADVERSE REACTIONS, contact Bayer HealthCare at 1-866-463-3634 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
FINACEA® is for topical use only. It is not for ophthalmic, oral or intravaginal use. In case of accidental eye exposure, wash eyes with large amounts of water and consult a physician if eye irritation persists. Wash hands following application of FINACEA®.