NicAzel

42783-501-60

(nicotinamide, zinc, azelaic acid, pyridoxine, copper, folic acid)

Dietary Supplement

Prescription only

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

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

Purple-colored, oval-shaped tablets debossed "EL501" on one side.

Please refer to package foldout for warnings and precautions.

Keep out of reach of children.

Description Nicazel Tablets is a dietary supplement for oral administration. Each table is purple-colored, oval-shaped, and debossed with "EL501" on one side.

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. 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. 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. 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.

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.

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 Tablets.

Warnings: As with any dietary supplement, if you are pregnant, nursing or taking medication, consult your doctor before use.

Nicazel Tablets is not formulated for use in children under 6 years of age.

Folic Acid is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin b12 is deficient.

Precautions Allergic sensitization has been reported rarely following oral administration of folic acid. Folic acid above 1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive.

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.

How Supplied 60 tablets 42783-501-60

Made in the USA

U.S. Patent Pending 02/2015 Copyright 2015 Elorac, Inc. 141609-3