June 25, 2016
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Finacea Gel

FINACEA®
(azelaic acid) Gel, 15%




DRUG DESCRIPTION

FINACEA (azelaic acid) Gel, 15%, is an aqueous gel which contains azelaic acid, a naturally-occurring saturated dicarboxylic acid. Chemically, azelaic acid is 1,7-heptanedicarboxylic acid. The molecular formula for azelaic acid is C9H16O4. It has the following structure:

FINACEA® (azelaic acid) Structural Formula Illustration

Azelaic acid has a molecular weight of 188.22. It is a white, odorless crystalline solid. It is poorly soluble in water at 20°C (0.24%) but freely soluble in boiling water and in ethanol.

FINACEA Gel is a white to yellowish white opaque gel for topical use; each gram contains 0.15 gm azelaic acid (15%w/w) 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.

What are the possible side effects of azelaic acid topical (Azelex, Finacea, Finacea Plus, Finevin)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have a serious side effect such as:

  • severe burning, stinging, or warmth;
  • severe itching or tingling;
  • severe redness, dryness, peeling, or other irritation; or
  • changes in skin color.

Less serious side effects are more likely, and you may have none at all.

This is not a...

Read All Potential Side Effects and See Pictures of Finacea Gel »

Last reviewed on RxList: 1/6/2016
This monograph has been modified to include the generic and brand name in many instances.

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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