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Tri-Zel Tablets

Pronunciation

Generic Name: nicotinamide, azelaic acid, zinc, pyridoxine, copper, folic acid
Dosage Form: tablet

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.

Rx only

Tri-zel (nicotinamide, azelaic acid, zinc, pyridoxine, copper, folic acid) Dietary Supplement

As a dietary supplement for patients with acne vulgaris, rosacea, or other inflammatory skin disorders who are deficient in or at risk of deficiency in one or more of the components in Tri-Zel Tablets.

Tri-Zel Tablets is a dietary supplement for oral administration. Each tablet is purple colored, oval-shaped, and embossed with “R194” on one side.

​SUPPLEMENT FACTS

Each oral tablet provides:

Nicotinamide (Vitamin B3)……… 600 mg

Azelaic Acid……………………………. 5 mg

Zinc (Zinc Oxide)……………………. 10 mg

Pyridoxine (Vitamin B6)…………. 5 mg

Copper (Cupric Oxide)……………. 1.5 mg

Folic Acid……………………………….. 500 mcg

OTHER INGREDIENTS

Microcrystalline cellulose, starch, purple coating (polyvinyl alcohol, macrogol/PEG, talc, titanium dioxide, FD&C Red #40, FD&C Blue #2), silicon dioxide, magnesium stearate.

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.

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 also contribute to its clinical activity.

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.

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. This product is not intended to diagnose, treat, cure, or prevent any disease.

Warnings

As with any dietary supplement, if you are pregnant, nursing or taking medication, consult your doctor before use. Tri-Zel Tablets is not formulated for use in children under 6 years of age.

Folic acid above 1 mg daily may obscure pernicious anemia (hematologic remission may occur, while neurological manifestations remain progressive).

Precautions

Allergic sensitization has been reported rarely, following oral administration of folic acid.

Tri-Zel Tablets 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 NDC 49908-194-60

Store at 20ºC to 25ºC (68ºF to 77ºF), excursions permitted between 15ºC and 30ºC (between 59ºF and 86ºF). Brief exposure to temperatures up to 40ºC (104ºF) may be tolerated provided the mean kinetic temperature does not exceed 25ºC (77ºF); however, such exposure should be minimized.

Manufactured for:

Rochester Pharmaceuticals

Rochester, NY 14624

1-866-458-1772

www.RochesterPharm.com

834979

10/12

LABEL PANEL

 

 

 

 

TRI-ZEL 
nicotinamide, azelaic acid, zinc, pyridoxine, copper, folic acid tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49908-194
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NIACINAMIDE (NIACINAMIDE) NIACINAMIDE 600 mg
AZELAIC ACID (AZELAIC ACID) AZELAIC ACID 5 mg
ZINC OXIDE (ZINC CATION) ZINC CATION 10 mg
PYRIDOXINE (PYRIDOXINE) PYRIDOXINE 5 mg
CUPRIC OXIDE (CUPRIC CATION) CUPRIC CATION 1.5 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID 500 ug
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE  
STARCH, CORN  
POLYVINYL ALCOHOL  
POLYETHYLENE GLYCOLS  
TALC  
TITANIUM DIOXIDE  
FD&C RED NO. 40  
FD&C BLUE NO. 2  
SILICON DIOXIDE  
MAGNESIUM STEARATE  
Product Characteristics
Color purple Score no score
Shape OVAL Size 19mm
Flavor Imprint Code R194
Contains         
Packaging
# Item Code Package Description
1 NDC:49908-194-60 60 TABLET in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 09/10/2012
Labeler - Rochester Pharmaceuticals (069874500)
Revised: 08/2013
 
Rochester Pharmaceuticals



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