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IMPORTANT SAFETY INFORMATION

Warnings and Precautions

Skin Reactions: There have been isolated reports of hypopigmentation after use of azelaic acid. Because azelaic acid has not been well studied in patients with dark complexion, monitor these patients for early signs of hypopigmentation. continue reading below ▾

For US healthcare professionals only

Finacea® Foam for mild-to-moderate rosacea should be applied twice daily to the entire facial area

Finacea® Foam Facts

Important information about Finacea® Foam application and packaging

Application

Apply a thin layer twice a day

Instruct patients to apply Finacea® Foam twice daily (morning and evening) to the entire facial area (cheeks, chin, forehead, and nose)

Cosmetics may be applied after the application of Finacea® Foam has dried
  • For a single application, patient should dispense the smallest amount of foam necessary to adequately cover the affected area(s) with a thin layer
  • Shake well before use
  • Cosmetics may be applied after the application of Finacea® Foam has dried
  • Avoid the use of occlusive dressings or wrappings
  • Finacea® Foam should be used continuously over 12 weeks
    •   You should reassess patients if no improvement is observed upon completing 12 weeks of therapy
  • Not for oral, ophthalmic, or intravaginal use

Packaging facts

  • Finacea® Foam is a white to off-white emulsion supplied in a pressurized 50 g aluminum can
  • Store at 25°C (77°F); excursions permitted between 15–30°C (59–86°F)
  • WARNING: Flammable. Avoid fire, flame, or smoking during and immediately following application. Contents under pressure. Do not puncture or incinerate. Do not expose to heat or store at temperatures above 120°F (49°C)
Finacea® Foam should be applied twice daily at the same times each day

Reference: Finacea® (azelaic acid) Foam, 15% [package insert]. Whippany, NJ: Bayer HealthCare Pharmaceuticals Inc; 2015.

Important Safety Information

Warnings and Precautions

Skin Reactions: There have been isolated reports of hypopigmentation after use of azelaic acid. Because azelaic acid has not been well studied in patients with dark complexion, monitor these patients for early signs of hypopigmentation.

Eye and Mucous Membranes Irritation: Azelaic acid has been reported to cause irritation of the eyes. Avoid contact with the eyes, mouth, and other mucous membranes. If Finacea® Foam does come in contact with the eyes, wash the eyes with large amounts of water and consult a healthcare professional if eye irritation persists.

Flammability: The propellant in Finacea® Foam is flammable. Instruct the patient to avoid fire, flame, and smoking during and immediately following application. Do not puncture and/or incinerate the containers. Do not expose containers to heat and/or store at temperatures above 120°F (49°C).

Most Common Adverse Reactions

In clinical studies, the most frequently observed adverse reactions in ≥ 0.5% of subjects treated with Finacea® Foam included local site pain (6.2%), pruritus (2.5%), dryness (0.7%), and erythema (0.7%).

For Topical Use Only

Finacea® Foam is not for oral, ophthalmic, or intravaginal use.

Avoid the use of occlusive dressings or wrappings at the application site. Avoid use of alcoholic cleansers, tinctures and astringents, abrasives, and peeling agents.

Patients should be reassessed if no improvement is observed upon completing 12 weeks of therapy.

Indication

Finacea® (azelaic acid) Foam, 15% is indicated for topical treatment of the inflammatory papules and pustules of mild to moderate rosacea.

You are encouraged to report side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch, or call 1-800-FDA-1088 (1-800-332-1088).

For important risk and use information, see the full Prescribing Information.