VEREGEN Ointment Ref.[11070] Active ingredients: Sinecatechins

Source: FDA, National Drug Code (US)  Revision Year: 2020 

Product description

Veregen (sinecatechins) Ointment, 15% is a botanical drug product for topical use. The drug substance in Veregen is sinecatechins, which is a partially purified fraction of the water extract of green tea leaves from Camellia sinensis (L.) O Kuntze, and is a mixture of catechins and other green tea components. Catechins constitute 85 to 95% (by weight) of the total drug substance which includes more than 55% of Epigallocatechin gallate (EGCg), other catechin derivatives such as Epicatechin (EC), Epigallocatechin (EGC), Epicatechin gallate (ECg), and some additional minor catechin derivatives i.e. Gallocatechin gallate (GCg), Gallocatechin (GC), Catechin gallate (Cg), and Catechin ©. In addition to the known catechin components, it also contains gallic acid, caffeine, and theobromine which together constitute about 2.5% of the drug substance. The remaining amount of the drug substance contains undefined botanical constituents derived from green tea leaves.

The structural formulae of catechins are shown below.

Each gram of the ointment contains 150 mg of sinecatechins in a water free ointment base consisting of isopropyl myristate, white petrolatum, cera alba (white wax), propylene glycol palmitostearate, and oleyl alcohol.

Dosage Forms and Strengths

Ointment, 15% w/w. Each gram of Veregen Ointment, 15% contains 150 mg of sinecatechins in a brown ointment base.

How Supplied

Veregen is a brown ointment and is supplied in an aluminum tube containing 15 grams (NDC # 10337-450-15) of ointment per tube or 30 grams (NDC # 10337-450-03) of ointment per tube.

Manufactured for: PharmaDerm, A division of Fougera Pharmaceuticals Inc., Melville, New York 11747

Manufactured by: C.P.M. ContractPharma GmbH., Frรผhlingstrasse 7 D-83620, Feldkirchen-Westerham, Germany

Drugs

Drug Countries
VEREGEN Canada, Estonia, Croatia, Lithuania, Netherlands, Romania, United States

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