Azelaicdrug info
azelaic acid 0.15 MG/MG Topical Gel
What it is used for
Azelaic acid gel, 15% is indicated for topical treatment of the inflammatory papules and pustules of mild to moderate rosacea. Limitations of Use 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. Azelaic acid gel, 15% is indicated for topical treatment of the inflammatory papules and pustules of mild to moderate rosacea. Limitations of Use Efficacy for treatment of erythema in rosacea in the absence of papules and pustules has not been evaluated.
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective December 23, 2021. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
Description
Azelaic Acid Gel, 15%, is a white to yellowish white opaque gel which contains azelaic acid, a naturally-occurring saturated dicarboxylic acid. It is for topical use. Chemically, azelaic acid is 1,7-heptanedicarboxylic acid. The molecular formula for azelaic acid is C 9 H 16 O 4. It has the following structure: Azelaic acid has a molecular weight of 188.22 g/mol. It is a white to off-white solid that is insoluble in water, toluene and heptane, but soluble in acetone, methanol, isopropyl alcohol and isopropyl acetate. Azelaic Acid Gel, 15% is a white to yellowish white opaque gel for topical use; each gram contains 0.15 gm azelaic acid (15% w/w) as the active ingredient in an aqueous gel base containing benzoic acid (as a preservative), carbomer homopolymer, disodium edetate, isopropyl myristate, polysorbate 80, propylene glycol, purified water and sodium hydroxide to adjust pH. azelaic- acid-chemical-structure
Text above is quoted in full from the FDA-approved drug label published by openFDA, effective December 23, 2021. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.
This page reproduces regulatory text for reference. It is not medical advice, and KenyRx is not a pharmacy or a prescriber. Talk to a doctor or pharmacist about whether a medicine is right for you.
See what it costs — price without insurance