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Ameluz

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Ameluz

AMELUZ®
(aminolevulinic acid hydrochloride) Gel

DRUG DESCRIPTION

AMELUZ (aminolevulinic acid hydrochloride) gel, 10% for topical use is a non-sterile white-to-yellowish gel. The gel formulation contains a nanoemulsion.

Aminolevulinic acid, a porphyrin precursor, is a white to off-white crystalline solid. It is readily soluble in water, methanol, and dimethylformamide. Its chemical name is 5-amino-4-oxopentanoic acid hydrochloride, molecular weight is 167.59 and molecular formula is C5H9NO3•HCl . The structural formula of aminolevulinic acid hydrochloride is represented below:

AMELUZ® (aminolevulinic acid hydrochloride)  Structural Formula Illustration

Each gram of AMELUZ contains 100 mg of aminolevulinic acid hydrochloride (equivalent to 78 mg aminolevulinic acid) as the active ingredient and the following inactive ingredients: xanthan gum, soybean phosphatidylcholine, polysorbate 80, medium-chain triglycerides, isopropyl alcohol, dibasic sodium phosphate, monobasic sodium phosphate, propylene glycol, sodium benzoate and purified water.

Last reviewed on RxList: 5/18/2016
This monograph has been modified to include the generic and brand name in many instances.

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