May 3, 2016
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Finacea Gel




Indications
Dosage
How Supplied

INDICATIONS

FINACEA® (azelaic acid) Gel, 15% is indicated for topical treatment of the 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.

DOSAGE AND ADMINISTRATION

  • Apply and gently massage a thin layer of FINACEA Gel into the affected areas on the face twice daily (morning and evening).
  • Use only very mild soaps or soapless cleansing lotion before application of FINACEA Gel.
  • Cosmetics may be applied after the application of FINACEA Gel has dried.
  • Avoid the use of occlusive dressings or wrappings.
  • Instruct patients to avoid spicy foods, thermally hot foods and drinks, alcoholic beverages.
  • Patients should be reassessed if no improvement is observed upon completing 12 weeks of therapy.
  • Not for oral, ophthalmic or intravaginal use.

HOW SUPPLIED

Dosage Forms And Strengths

FINACEA (azelaic acid) Gel, 15% is a white to yellowish white opaque gel. Each gram of FINACEA Gel contains 0.15 gm of azelaic acid (15% w/w).

FINACEA (azelaic acid) Gel, 15% is a white to yellowish white opaque gel supplied in the following:

50 g tube (NDC 50419-825-02)
45 g pump (NDC 50419-825-03)

Storage And Handling

Discard the pump 8 weeks after opening.

Store at 25°C (77°F); excursions permitted between 15–30°C (59–86°F) [see USP Controlled Room Temperature].

Manufactured for: Bayer HealthCare Pharmaceuticals Inc. Whippany, NJ 07981. Revised: Apr 2015.

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 1/6/2016

Indications
Dosage
How Supplied

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