Rx Item-Finacea 15% Foam 50Gm By Bayer Pharma

FINACEA FOAM- azelaic acid aerosol, foam
Bayer HealthCare Pharmaceuticals Inc.

1 INDICATIONS AND USAGE

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

2 DOSAGE AND ADMINISTRATION

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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.
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Shake well before use.
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Cosmetics may be applied after the application of Finacea Foam has dried.
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Avoid the use of occlusive dressings or wrappings.
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Finacea Foam should be used continuously over 12 weeks.
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Reassess patients if no improvement is observed upon completing 12 weeks of therapy.
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Not for oral, ophthalmic or intravaginal use.
3 DOSAGE FORMS AND STRENGTHS



Each gram of Finacea (azelaic acid) Foam contains 0.15 g of azelaic acid (15% w/w) in a white to off-white foam.

4 CONTRAINDICATIONS

None.

5 WARNINGS AND PRECAUTIONS

5.1 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.

5.2 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 physician if eye irritation persists.

5.3 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).

RX ITEM-Finacea 15% Foam 50Gm By Bayer P
NDC 50419-0829-01 UPC/GTIN No.3-50419-82901-4 Mfg.Part No.82901

Finacea 15% Foam 50Gm By Bayer Pharma
BRAND: FINACEA NDC: 50419-0829-01,50419082901 UPC: 3-50419-82901-4,350419829014 Bayer Hc Pharma

AZELAIC ACID TOPICAL FOAM
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