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Full Prescribing Information

IMPORTANT SAFETY INFORMATION

FINACEA is for dermatologic use only, and not for ophthalmic, oral, or intravaginal use.
FINACEA is contraindicated in individuals with a history of hypersensitivity to propylene glycol or any other component of the formulation. In clinical trials, sensations of burning/stinging/tingling occurred in 29% of patients, and itching in 11%, regardless of the relationship to therapy. Continue reading below

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A quick, convenient routine to help you take control of managing the bumps, pimples and associated redness of your mild to moderate rosacea.
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About Rosacea - Do You Have Rosacea

If you think you might have rosacea, here are 5 questions to take with you to discuss with your dermatologist during your next visit. After answering these questions, click SUBMIT for some useful information about rosacea symptoms and a printer-friendly summary of your answers.


5 Questions to help you and your dermatologist tell if you have rosacea


1. Do you have any of the following on your face? Please check all that apply.

Bumps with black heads
Bumps with white heads
Bumps
Roughness
Redness on the nose
Redness on the cheeks
Redness on the entire face
Noticeable veins on your nose and cheeks

2. Do your eyes often feel irritated?

Yes   No

3. On a scale of 1 to 5, how bothered are you by the bumps, roughness or redness on your face?

1   2   3   4   5
(Very Little)                     (Very Much)

4. On a scale of 1 to 5, how often do you experience redness on your cheeks, nose or face?

1   2   3   4   5
(Never)                           (Frequently)

5. When does your skin get worse in terms of redness and bumps?

After having a meal with spicy food and red wine
After exercising
After eating tomatoes, spinach, or certain other fruits and vegetables
In extreme heat or extreme cold
After drinking hot beverages
When stressed


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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 is for dermatologic use only, and not for ophthalmic, oral, or intravaginal use. FINACEA is contraindicated in individuals with a history of hypersensitivity to propylene glycol or any other component of the formulation. In clinical trials, sensations of burning/stinging/tingling occurred in 29% of patients, and itching in 11%, regardless of the relationship to therapy. Post-marketing safety - Skin: facial burning and irritation; Eyes: iridocyclitis on accidental exposure to the eye. There have been isolated reports of hypopigmentation after use of azelaic acid. Since azelaic acid has not been well studied in patients with a dark complexion, these patients should be monitored for early signs of hypopigmentation.

Other than FINACEA, Intendis, Inc. (part of the Bayer group) does not promote or endorse any products or recommendations made by third parties. All products and brand names listed are the property and responsibility of their respective trademark and copyright holders.

Please see full prescribing information for FINACEA.

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.




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