FINACEA® (azelaic acid) Gel, 15%, contains azelaic acid, a naturally occurring saturated dicarboxylic acid. Chemically, azelaic acid is 1,7-heptanedicarboxylic acid, with the molecular formula C₉H₁₆O₄, a molecular weight of 188.22, and the structural formula:

Azelaic acid is a white, odorless crystalline solid that is poorly soluble in water at 20°C (0.24%), but freely soluble in boiling water and in ethanol.

Each gram of FINACEA Gel, 15%, contains 0.15 gm azelaic acid (15% w/w) as the active ingredient in an aqueous gel base containing benzoic acid (as a preservative), disodium-EDTA, lecithin, medium-chain triglycerides, polyacrylic acid, polysorbate 80, propylene glycol, purified water, and sodium hydroxide to adjust pH.

This drug may cause urine to darken in color. This is harmless.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: unsteadiness, seizures, mental/mood changes (such as confusion), numbness/tingling of hands/feet, painful urination.

Tell your doctor immediately if any of these rare but very serious side effects occur: eye pain, severe/persistent headache, stiff/painful neck, sudden vision changes, sore throat, persistent fever, unusual bleeding/bruising, severe stomach pain, persistent nausea/vomiting.

Use of this medication for prolonged or repeated periods may result in oral thrush or a new vaginal yeast infection (oral or vaginal fungal infection). Contact your doctor if you notice white patches in your mouth, a change in vaginal discharge, or other new symptoms.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking metronidazole, tell your doctor or pharmacist if you are allergic to it; or to other nitroimidazoles such as tinidazole; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver problems, nervous system disorders (e.g., seizures), blood disorders, Crohn's disease.

Avoid alcoholic beverages while taking this medication and for at least 3 days after finishing this medicine because severe stomach upset, nausea, vomiting, headache and flushing may occur.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely.

The elderly may be at greater risk for side effects while using this drug.

Tell your doctor if you are pregnant before using this drug. It should not be used during the first 3 months of pregnancy and used only with caution during the last 6 months, unless your infection has not improved on other antibiotics.

This medication passes into breast milk. Discuss the risks and benefits with your doctor before breast-feeding.