NicAzel Forte®

Suggested/Recommended/Usage/Directions

Dosage and Administration Usual adult dose is one or two tablets taken once or twice a day with or without food or as prescribed by a physician.

Suggested/Recommended/Usage/Directions

Dosage: Adults - One or two tablets taken once or twice a day with out without food or as prescribed by a physician.

Storage

Store between 15 degrees - 30 degrees Celsius (50 degrees - 86 degrees Fahrenheit).

Formula re: Contains

(Azerizin, zinc, pyridoxine, copper, folic acid)

Formulation re: Other

Description NicAzel FORTE tablets is a uniquely formulated dietary supplement for oral administration. Each green-colored, oval-shaped tablet is imprinted on one side with "EL510" and contains Azerizin, a proprietary blend of natural ingredients that combine demonstrated anti-inflammatory and antimicrobial properties, along with inhibiting effects on sebum production.

Formula re: Contains

Azerizin is a proprietary blend of Nicotinamide, Azelaic Acid, Quercetin and Curcumin.

Formulation re: Other

Use As a dietary supplement for inflammatory skin disorders, such as acne vulgaris or rosacea, and/or individuals who are deficient in or at risk of deficiency in one or more of the components in Nicazel FORTE Tablets.

Formulation re: Other

Made in the USA

Formulation re: Other

Green-colored, oval-shaped tablets embossed "EL510" on one side.

FDA Statement of Identity

Prescription Dietary Supplement

FDA Disclaimer Statement

These statements have not been evaluated by the Food and Drug Administration. These products are not intended to diagnose, treat, cure, or prevent any disease.

Brand IP Statement(s) re: (c), (TM), (SM)

Clinical Pharmacology Nicotinamide is a water-soluble component of the vitamin B complex group. In vivo, nicotinamide is incorporated into nicotinamide adenine dinucleotide (NAD) and nicotinamide adenine dinucleotide phosphate (NADP). NAD and NADPH function as coenzymes in a wide variety of enzymatic oxidation-reduction reactions essential for tissue respiration, lipid metabolism, and glycogenolysis. Nicotinamide has demonstrated anti-inflammatory actions that may be of benefit in patients with acne including, but not limited to, suppression of antigen-induced lymphocytic transformation and inhibition of 3'.5'- cyclic AMP phosphodiesterase. Nicotinamide has been demonstrated to block the inflammatory actions of iodides known to precipitate or exacerbate acne. Nicotinamide lacks the vasodilator, gastrointestinal, hepatic, and hypolipemic actions of nicolinic acid or niacin. As such, nicotinamide has been shown to produce the flushing, itching and burning sensations of the skin, as is commonly seen when large doses of nicotinic acid or niacin are administered orally. Azelaic acid is a dietary constituent (e.g., in whole grain cereals and animal products) that has been shown to possess antimicrobial activity against Propionibacterium acnes and Staphyloccoccus epidermidis. The antimicrobial action may be attributable to inhibition of microbial cellular protein synthesis. A normalization of keratinization leading to an anticomedonal effect of azelaic acid may also contribute to its topical use for treatment of acne vulgaris and rosacea. Quercetin is a polyphenolic substance and a member of the class of flavonoids called flavonols. Quercetin is widely distributed in the plant kingdom, with onions, apples, red wine. and green tea especially rich sources of the agent. Quercetin is an antioxidant htat inhibits lipid peroxidation. Its patent anti-inflammatory activity is at least in part accounted for by its inhibition of degranulation of mast cells, basophils and neutrophils, coupled with its modulation of the activity of the inflammatory mediator NF-kappa B. Quercetin has been reported to reduce inflammation in bath acne and rosacea. Curcumin is a polyphenolic substance principally found in the spices turmeric and ginger. Curcumin has been demonstrated to have antioxidant, anti-inflammatory, and antimicrobial activities, and has been clinically most widely evaluated for its purported anti-cancer and cancer chemopreventive properties. Curcumin has been widely employed in the management of acne vulgaris and rosacea, based on its significant inhibition of Propionibacterium acnes and its potent anti-inflammatory actions, which include inhibition of cyclooxygenase (COX) and lipoxygenase (LOX), reduction of the release of reactive oxygen species (ROS) by stimulated neutrophils, and its inhibition of the activation of proinflammatory cytokines. Pyridoxine or Vitamin B6 is a water soluble component of the vitamin B complex group, which in the form of the coenzyme pyridoxal 5' -phosphate, is involved in a wide range of biochemical reactions, and is present in a wide variety of food sources including meat, poultry, fish, eggs, starchy vegetables, and non-citrus fruits. Pyridoxine plays an active role in the immune system and supplementation to normal levels in individuals with even a marginal deficiency generally restores immune functions due to deficiency. Pyridoxine supplementation has been found helpful in the management of acne, particularly for women with premenstrual flares of acne. Zinc has been shown to inhibit the inflammatory polymorphonuclear leukocyte chemotaxis in acne patients. Zinc has also demonstrated an inhibitory effect on the lipase of three Propionibacterium species found in human pilosebaceous follicles. Patients with acne have been shown to have significantly lower serum zinc levels than matched healthy controls. Copper is an essential trace mineral in human nutrition. Although rare, copper deficiency has been induced by supplemental zinc therapy. Folic aid serves as an essential cofactor of the biosynthesis of thymidine and purine nucleotides required for normal cellular DNA synthesis. Deficiencies of folic acid have been demonstrated to occur in some cutaneous disorders.

General Statements: All Other Content

How Supplied 60 tablets 42783-510-60 4 tablets 42783-510-04 (physician sample size)

Brand IP Statement(s) re: (c), (TM), (SM)

U.S. Patent Pending 07/2015 Copyright 2015 Elorac, Inc. 140616-04

General Statements: All Other Content

42783-510-60

General Statements: All Other Content

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