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IMPORTANT SAFETY INFORMATION

What should I tell my healthcare professional about CHANGES IN MY SKIN COLOR during use of Finacea® Foam?

Report abnormal changes in skin color to your healthcare professional. There have been isolated reports of loss of skin color (hypopigmentation) after the use of azelaic acid (the active ingredient in Finacea® Foam). If you have a dark complexion, your healthcare professional will monitor you for early signs of loss of skin color. continue reading below

For US audiences only

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

About Finacea® Foam

Now you know what to call your skin “problem.”

Your healthcare professional said it’s mild to moderate rosacea. The medical name for those raised spots is “inflammatory papules,” and the pimple-like bumps are “pustules.” But no matter what they’re called, you know you need treatment.

What is Finacea® Foam?

Finacea® Foam is a topical prescription medicine used to treat the inflammatory papules (raised spots) and pustules (pimple-like bumps) of mild to moderate rosacea.

  • The first and only prescription foam approved by the FDA for the treatment of rosacea
  • Finacea® Foam is a water-based (hydrophilic) foam that is light and airy
    • —   Not alcohol-based
    • —   Fragrance-free
  • Apply Finacea® Foam twice daily (morning and evening) to the entire facial area (cheeks, chin, forehead, and nose). For a single application, 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
  • Your healthcare professional will reassess your treatment if no improvement is observed upon completing 12 weeks of therapy
  • Not for oral, ophthalmic or intravaginal use

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

Smooth it on

Apply Finacea® Foam twice daily (morning and evening) to the entire facial area (cheeks, chin, forehead, and nose). For a single application, dispense the smallest amount of foam necessary to adequately cover the affected area(s) with a thin layer.

What should I tell my healthcare professional about CHANGES IN MY SKIN COLOR during use of Finacea® Foam?

Report abnormal changes in skin color to your healthcare professional. There have been isolated reports of loss of skin color (hypopigmentation) after the use of azelaic acid (the active ingredient in Finacea® Foam). If you have a dark complexion, your healthcare professional will monitor you for early signs of loss of skin color.

Ask your healthcare professional if Finacea® Foam could help you.

FIND A DERMATOLOGIST »

Understanding rosacea

What is rosacea?

Rosacea (roh-ZAY-sha) is a chronic condition that mostly affects the skin on your face.

Rosacea has many symptoms, including:

  • Raised spots and pimple-like bumps, sometimes with pus inside

Without treatment, the symptoms of rosacea may get worse.

underRosaceaImg1

Who gets rosacea?

Rosacea is common, especially in men and women with fair or light-colored skin. It often appears when you’re in your 30s or older. In an early stage, you might mistake rosacea for a sunburn and then ignore it. Rosacea doesn’t go away, and it can get worse without treatment.

It’s important to treat and manage rosacea as early as possible, before bumps and pimples get worse. Unfortunately, there’s no cure for rosacea, but many people have been able to manage it by avoiding triggers and using a prescription medication.

Common triggers

The following things may cause (“trigger”) rosacea flare-ups*:

  • Sun—time spent in the sun is a top trigger for flare-ups. Use daily sun protection! Ask your healthcare professional about a sunscreen that may be right for you
  • Strong wind; very cold or warm and humid conditions
  • Spicy food and drinks, and those that are hot in temperature (for example, hot coffee and tea)
  • Alcoholic drinks
  • Certain foods such as chocolate, cheese, sour cream, yogurt, vinegar, citrus fruits, tomatoes, and bananas
  • Stress and anxiety
  • Skin care products with alcohol, witch hazel, acetone, or fragrance

Use the “Rosacea Diary” from the National Rosacea Society (NRS), a free booklet to help you find and avoid your personal rosacea triggers.

*According to patient histories and a survey from the NRS.

Why is treatment important?

Rosacea doesn’t go away on its own—in fact, if left untreated, it may get worse as time goes on. If you think you have rosacea, talk to your healthcare professional as soon as possible.

  • Finacea® Foam is proven to help treat the inflammatory papules (raised spots) and pustules (pimple-like bumps) of mild to moderate rosacea
  • Finacea® Foam is a water-based (hydrophilic) foam that is light and airy
    • —   Not alcohol-based
    • —   Fragrance-free
  • Wash your hands right after you use Finacea® Foam
  • You can put on makeup and other cosmetics after Finacea® Foam dries on your skin. Consult your healthcare professional about cosmetics that are right for your skin
  • If allergic reactions occur, discontinue use and consult your physician

Finacea® Foam (azelaic acid ), 15% is proven to treat the inflammatory papules and pustules of mild to moderate rosacea

Reduced raised spots and
pimple-like bumps

Finacea® Foam is proven to help treat the inflammatory papules (raised spots) and pustules (pimple-like bumps) of mild to moderate rosacea

  • At the end of 12 weeks, researchers evaluated the changes they saw in the people in the studies

In 2 clinical studies with 1,362 people, Finacea® Foam was shown to:

Reduce the number of raised spots and pimple-like bumps

  • In 2 clinical studies, Finacea® Foam reduced the number of raised spots and pimple-like bumps (also called papules and pustules) when compared with a foam without drug
    • —  Mean nominal changes in the number of raised spots and pimple-like bumps from baseline to end of 12-week treatment periods:
    •  Mean nominal changes in the number of raised spots and pimple-like bumps from baseline to end of 12-week treatment periods:

Provide superior success rates vs foam without drug

  • Researchers measured success by labeling results they observed after a person had at least a 2-step reduction from the way he or she looked when treatment started
  • In both 12-week studies with 1,362 people, researchers observed superior IGA success rates with Finacea® Foam vs the foam without drug at the end of treatment

In two 12-week studies with 1,362 people, Finacea® Foam demonstrated superior IGA success rates vs the foam without the drug at the end of treatment In two 12-week studies with 1,362 people, Finacea® Foam demonstrated superior IGA success rates vs the foam without the drug at the end of treatment

What is an IGA scale?

  • IGA (Investigator’s Global Assessment) scale is a scale of disease severity that is used in clinical studies to determine whether a person has achieved success over time
  • People who were considered to have “success” ranged from “Clear” to “Minimal” AND had at least a 2-step improvement. For example, they went from “Moderate” to “Minimal” on the IGA scale at the end of the studies
Investigator’s Global Assessment (IGA) scale is a scale of disease severity used in clinical trials

Success is defined as a score of “Clear” or “Minimal” with at least a 2-step reduction from baseline on a 5-point IGA. Graphic representation is for illustrative purposes only.

Finacea® Foam was tested in 2 vehicle-controlled studies

Vehicle-controlled means:

Some people in the studies received a foam (vehicle) without drug, while others received Finacea® Foam. This is a common way for researchers to study the effectiveness of medicines.

After 12 weeks of treatment with Finacea® Foam

View the results of one patient’s 12-week journey with Finacea® Foam (azelaic acid), 15% View the results of one patient’s 12-week journey with Finacea® Foam (azelaic acid), 15%

Actual photos of Finacea® Foam clinical-trial subjects. All patients may not exhibit the same results.

What should I tell my healthcare professional about CHANGES IN MY SKIN COLOR during use of Finacea® Foam?

Report abnormal changes in skin color to your healthcare professional. There have been isolated reports of loss of skin color (hypopigmentation) after the use of azelaic acid (the active ingredient in Finacea® Foam). If you have a dark complexion, your healthcare professional will monitor you for early signs of loss of skin color.

What are the MOST COMMON SIDE EFFECTS of Finacea® Foam?

Local site:

  • pain (described as burning, stinging, “pins and needles,” and/or tenderness)
  • itching
  • dryness
  • redness

Frequently asked questions (FAQs)
about Finacea® Foam

Important Safety Information

What should I tell my healthcare professional about CHANGES IN MY SKIN COLOR during use of Finacea® Foam?

Report abnormal changes in skin color to your healthcare professional. There have been isolated reports of loss of skin color (hypopigmentation) after the use of azelaic acid (the active ingredient in Finacea® Foam). If you have a dark complexion, your healthcare professional will monitor you for early signs of loss of skin color.

What should I AVOID when using Finacea® Foam?

  • Avoid contact with the eyes, mouth, and other mucous membranes. Azelaic acid has been reported to cause irritation of the eyes. If Finacea® Foam does come in contact with the eyes, wash the eyes with large amounts of water, and consult your healthcare professional if eye irritation persists.
  • 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). The propellant in Finacea® Foam is flammable.
  • Avoid the use of tight dressings or wrappings where you apply Finacea® Foam.
  • Avoid use of alcoholic cleansers, tinctures and astringents, abrasives, and peeling agents.

What SAFETY FACTS should I follow when applying Finacea® Foam?

  • Finacea® Foam is for topical use only.
  • Do not use in the mouth, eye, or vagina.

What are the MOST COMMON SIDE EFFECTS of Finacea® Foam?

Local site:

  • pain (described as burning, stinging, “pins and needles,” and/or tenderness)
  • itching
  • dryness
  • redness

Indication

What is Finacea® Foam used for?

Finacea® Foam is a topical prescription medicine used to treat the inflammatory papules (raised spots) and pustules (pimple-like bumps) of mild to moderate rosacea.

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

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