Source: FDA, National Drug Code (US) Revision Year: 2020
AKLIEF Cream for topical administration contains 0.005% (50 mcg/g) trifarotene. Trifarotene is a terphenyl acid derivative and is a retinoid. The chemical name of trifarotene is 3"-tert-Butyl-4'-(2-hydroxy-ethoxy)-4"-pyrrolidin-1-yl-[1,1',3',1"]terphenyl-4- carboxylic acid. Trifarotene has the molecular formula of C29H33NO4, the molecular weight of 459.58, and the following structural formula:
Trifarotene is a white to off-white to slightly yellow powder with the melting point of 245°C. It is practically insoluble in water with pKa1 of 5.69 and pKa2 of 4.55.
AKLIEF (trifarotene) Cream 0.005% contains the following inactive ingredients: allantoin, copolymer of acrylamide and sodium acryloyldimethyltaurate, dispersion 40% in isohexadecane, cyclomethicone, 5% ethanol, medium-chain triglycerides, phenoxyethanol, propylene glycol, purified water.
| Dosage Forms and Strengths |
|---|
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Cream: 0.005%. Each gram of AKLIEF Cream contains 50 mcg of trifarotene in a white cream. |
| How Supplied |
|---|
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AKLIEF Cream, 0.005% is provided as a white cream supplied in the following packaging configurations with corresponding NDC numbers:
|
| Drug | Countries | |
|---|---|---|
| AKLIEF | Canada, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Malta, Netherlands, Poland, Romania, United States |
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