Label: NICAZEL- nicotinamide, pyridoxine, zinc, copper, folic acid tablet, coated

  • Category: DIETARY SUPPLEMENT
  • DEA Schedule: None
  • Marketing Status: Dietary Supplement

Drug Label Information

Updated November 12, 2015

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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.

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  • Ingredients:

    Each oral tablet provides:

    Nicotinamide (Vitamin B3).............600 mg
    Zinc (Zinc Oxide)...........................10 mg
    Azelaic Acid....................................5 mg
    Pyridoxine (Vitamin B6)...................5 mg
    Copper (Cupric Oxide)..................1.5 mg
    Folic Acid....................................500 mcg

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  • 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.

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  • HEALTH CLAIM

    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.

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  • 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.

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  • 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.

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  • 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.

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  • 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.

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  • HOW SUPPLIED

    60 tablets NDC 42783-501-60

    Store between 15°-30°C (59°-86°F).

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  • DOSAGE & ADMINISTRATION

    Manufactured for
    Elorac, Inc.
    100 Fairway Drive, Ste. 134
    Vernon Hills, IL 60061
    Made in the USA

    U.S. Patent Pending

    02/2015
    ©2015 Elorac, Inc.
    141609-3

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  • 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.

    Manufactured for:
    Elorac, Inc.
    Vernon Hills, IL 60061

    Rev. 02/15
    7164-2

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  • PRINCIPAL DISPLAY PANEL

    42783-501-60

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

    Dietary Supplement

    Prescription Only
    60 Tablets

    label-nicazel.jpg

    fold-out-nicazel.jpg

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  • INGREDIENTS AND APPEARANCE
    NICAZEL 
    nicotinamide, pyridoxine, zinc, copper, folic acid tablet, coated
    Product Information
    Product Type DIETARY SUPPLEMENT Item Code (Source) NHRIC:42783-501
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE 600 mg
    ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS) ZINC 10 mg
    AZELAIC ACID (UNII: F2VW3D43YT) (AZELAIC ACID - UNII:F2VW3D43YT) AZELAIC ACID 5 mg
    PYRIDOXINE (UNII: KV2JZ1BI6Z) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE 5 mg
    COPPER (UNII: 789U1901C5) (COPPER - UNII:789U1901C5) COPPER 1.5 mg
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID 500 ug
    Inactive Ingredients
    Ingredient Name Strength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    TALC (UNII: 7SEV7J4R1U)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NHRIC:42783-501-60 60 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    dietary supplement 10/15/2010
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving % Daily Value
    color
    shape
    size (solid drugs) 19 mm
    scoring 1
    imprint
    Labeler - Elorac, Inc (832590009)
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