Leading the way to safer medication
 Crosscheck  Recommender

AMELUZ Gel (2021)

Active ingredients: Aminolevulinic acid

Product 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-oxo-pentanoic acid hydrochloride, molecular weight is 167.59 and molecular formula is C5H9NO3·HCl.

The structural formula of aminolevulinic acid hydrochloride is represented below:

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.

Dosage Forms and Strengths

Each gram of AMELUZ gel, 10% contains 100 mg of aminolevulinic acid hydrochloride (equivalent to 78 mg of aminolevulinic acid).

How supplied

AMELUZ (aminolevulinic acid hydrochloride) gel, 10% is a white-to-yellowish gel. The drug product is supplied in an aluminum tube with a white, high density polyethylene (HDPE) screw cap. Each tube contains 2 g of gel.

NDC 70621-101-01 2 g tube
NDC 70621-101-10 Cardbox containing one 2 g tube
NDC 70621-101-20 Cardbox containing ten 2 g tubes

Manufacturer: Biofrontera Pharma GmbH

Distributed by: Biofrontera Inc., 120 Presidential Way, Suite 330, Woburn, MA 01801, USA