DermaNIC

DERMANIC- niacinamide, inositol niacinate, niacin, chromium nicotinate, folic acid, hydroxocobalamin, ferrous cysteine glycinate and acetylcysteine zinc tablet
Allegis Pharmaceuticals, LLC

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

PRESCRIPTION (Rx )-DIETARY SUPPLEMENT
MULTIPHASIC TABLETS

PRODUCT CODE: ++ 28595-500-60

DESCRIPTION

DermaNIC™ is an orally administered, folate-containing prescription (Rx ) dietary supplement for the clinical dietary management of suboptimal niacin and zinc levels associated with acne and/or acne therapy. DermaNIC™ may be administered as adjunctive niacin-folate therapy to provide a protective effect in reducing the risk of hyperhomocysteinemia and/or pellegra in patients undergoing acne therapy or may be administered as monotherapy for patients who are in need of advanced niacin and zinc supplementation as determined by a licensed medical practitioner.2,3,20,22,23 DermaNIC™ is not a drug, but may be prescribed along with acne medications for concomitant care.3 The ultimate goal of acne treatment is to address as many of the pathogenic factors of acne as possible while minimizing side effects.

DermaNIC™ is formulated with niacin and zinc, which support healthful methylation biochemistry and have anti-inflammatory effects via preservation of intracellular coenzyme homeostasis.21 Furthermore, natural ingredients have been added to DermaNIC™ that combine anti-inflammatory and antimicrobial properties along with inhibiting effects on sebum production.22,24-26 Lastly, antibiotic use, which is common in acne patients, can lower the levels of B vitamins that are essential for methylation biochemistry.18 Specifically, studies have shown that acne patients on isotretinoin therapy have decreased folate levels and increased levels of homocysteine.19

INGREDIENTS *:
Supplement Facts
Serving Size: 1 Multiphasic Tablet Servings Per Container: 60
Amount Per Tablet % DV
*
Daily Values not established for patients with unique nutritional needs who are in need of supplementation as directed by a licensed medical practitioner.
% Daily Value (DV) for Adults and Children Four or More Years of Age.
Quadracin™ is a proprietary vitamin B3 blend consisting of four forms of niacin — nicotinic acid, nicotinamide (niacinamide), chromium polynicotinate and inositol nicotinate.
§
CitraFolic® is a controlled-release form of folic acid that is pH-specific using citrates as buffers to achieve optimal absorption for targeted-GI at the proximal jejunum AND in order to meet USP requirements for folic acid dissolution and disintegration; it is patent pending. CitraFolic® uses only DMF-approved manufacturers of folic acid.
AminoFerr® as ferrous glycine cysteinate, also known as FERROUS CYSTEINE GLYCINATE, and has the Unique Ingredient Identifier (UNII) code 8B4OP7RK5N. AminoFerr® is a proprietary ingredient containing pure chelates without interfering ions -resulting in high solubility and absorption; it is the only pure amino acid iron chelate supplement on the market, and is protected under US Patent No. 7,341,708.
#
Zinc-NACx® as zinc n-acetyl-l-cysteine also known as ACETYLCYSTEINE ZINC, and has the UNII code LP811J9FA1. Zinc-NACx® is a patent pending amino-acid derivative chelate of zinc; It uses the proprietary NACx® -technology — which is the world’s first amino-acid derivative chelate. It was co-developed by Via Naturally, LLC and Viva Pharmaceuticals (Richmond, BC, Canada).
Þ
Daily Value not established ~Approximate value
Niacin (moiety) from Quadracin™ 760 mg 3800%
moiety comprised of - 498 mg from nicotinamide (niacinamide)
260 mg from inositol nicotinate
1.5 mg from nicotinic acid
0.5 mg from chromium polynicotinate
Folic Acid, USP as CitraFolic® § [from controlled-release citrated-pteroylmonoglutamic acid] 500 mcg 125%
Cobalamin (hydroxocobalamin) 15 mcg 250%
Iron (elemental) as AminoFerr® [from ferrous glycine cysteinate] 1.5 mg 8%
Zinc as Zinc-NACx® # [from zinc n-acetyl-l-cysteine] 20 mg 133%
Chromium [from chromium polynicotinate] ~70 mcg 58%
Inositol [from inositol nicotinate] ~68 mg Þ
N-acetyl-l-cysteine [from zinc n-acetyl-l-cysteine] 49.5 mg Þ

OTHER INGREDIENTS

Coating (FD&C Yellow No. 6 Lake, FD&C Blue No. 2 Lake, hydroxypropyl methylcellulose, polyethylene glycol, polyvinyl alcohol, titanium dioxide, talc), croscarmellose sodium, magnesium stearate, microcrystalline cellulose, piperine 1, pregelatinized starch, silicified microcrystalline cellulose, silicon dioxide, stearic acid.…. [and other ancillary ingredients 2 as needed to ensure product stability]

This product contains FD&C Yellow #6 Lake.


1
Bioavailability enhancer piperine as BioPerine® is a registered trademark of Sabinsa Corporation, Piscataway, NJ. Protected and manufactured under US Patent Nos. 5,536,506, 5,744,161, 5,972,382; and 6,054,585.
2
Since additives, preservatives, bioavailability enhancers, colors and/or flavors of natural origin, etc. are preferred over synthetics, it may be the case that product color, appearance and/or taste may vary slightly over time; and it may be necessary to substitute excipients during the manufacturing process as needed to preserve product appearance and continuity in order to avoid confusion in the marketplace and ensure the highest therapeutic target, safety and quality.
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