NicAzel (niacinamide 600 mg zinc 10 mg azelaic acid 5 mg pyridoxine 5 mg copper 1.5 mg folic acid 500 ug) Dailymed
Generic: nicotinamide, pyridoxine, zinc, copper, folic acid is used for the treatment of Dermatitis, Atopic Diaper Rash Eczema Skin Neoplasms Sunburn Wounds and Injuries Cafe-au-Lait Spots Acne Vulgaris Rosacea Nutritional and Metabolic Diseases Pregnancy Anemia, Aplastic Anemia, Megaloblastic Anemia, Pernicious Folic Acid Deficiency Neural Tube Defects Anemia, Iron-Deficiency Seizures Vitamin B 6 Deficiency Drug-Related Side Effects and Adverse Reactions Coronary Artery Disease Diarrhea Flatulence Flushing Hemorrhage Hypercholesterolemia Hypotension Liver Diseases Pellagra Peptic Ulcer Hypertriglyceridemia Peripheral Vascular Diseases
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Nicazel (nicotinamide, Zinc, Azelaic Acid, Pyridoxine, Copper, Folic Acid)
Prescription Only
Dietary Supplement
DESCRIPTION
Nicazel Tablets is a dietary supplement for oral administration. Each tablet is purple-colored, oval-shaped, and debossed with "EL501" on one side.
Ingredients:
Each oral tablet provides:
Nicotinamide (Vitamin B3).............600 mgZinc (Zinc Oxide)...........................10 mgAzelaic Acid....................................5 mgPyridoxine (Vitamin B6)...................5 mgCopper (Cupric Oxide)..................1.5 mgFolic Acid....................................500 mcg
Other Ingredients:
Microcrystalline cellulose, stearic acid, purple coating (polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, FD&C Blue no. 2, FD&C Red no. 40), silicon dioxide, magnesium stearate.
Health Claim Section
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 NADP 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 nicotinic acid or niacin. As such, nicotinamide has not 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 the 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 Staphylococcus 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 be also contributed 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 acid 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 & 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 NDC 42783-501-60
Store between 15°-30°C (59°-86°F).
Dosage & Administration Section
Manufactured forElorac, Inc.100 Fairway Drive, Ste. 134Vernon Hills, IL 60061Made in the USA
U.S. Patent Pending
02/2015©2015 Elorac, Inc.141609-3
Dosage:
Adults - One or two tablets taken once or twice a day with or without food or as prescribed by a physician.Store between 15o-30oC (59o-86oF).
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.
DOSAGE & ADMINISTRATION SECTION
Manufactured for:Elorac, Inc.Vernon Hills, IL 60061
Rev. 02/157164-2
Package Label.principal Display Panel
42783-501-60
NicAzel®(nicotinamide, zinc, azelaic acid, pyridoxine, copper, folic acid)
Dietary Supplement
Prescription Only 60 Tablets
DISCLAIMER:
"This tool does not provide medical advice, and is for informational and educational purposes only, and is not a substitute for professional medical advice, treatment or diagnosis. Call your doctor to receive medical advice. If you think you may have a medical emergency, please dial 911."
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"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."
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