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Prosys 5000 - Medication Information

Product NDC Code 66975-501
Drug Name

Prosys 5000

Type Brand
Active Ingredients
Sodium fluoride 1.1 g/100g
Route ORAL
Dosage Form PASTE, DENTIFRICE
RxCUI drug identifier 392038
Labeler Name Benco Dental
Packages
Package NDC Code Description
66975-501-04 112 g in 1 tube (66975-501-04)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
DRUG FACTS Active Ingredient 1.1% Neutral Sodium Fluoride

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
Directions: Use As Directed This prescription dentifrice is recommended for adults and pediatric patients six years and older. • Apply a thin ribbon of PRO-SYS Professional along the length of the toothbrush no more than "pea size" total dose. Brush for two minutes. • After brushing: ADULTS-Expectorate; do not eat or drink for 30 minutes. CHILDREN SIX YEARS OF AGE OR OLDER-Expectorate and rinse mouth with water. • Use at bedtime in place of your regular toothpaste or as directed by your dental professional.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive Ingredients: Filtered Water, Sorbitol, Hydrated Silica, Glycerin, PEG, Carboxymethylcellulose, Xylitol, Monosodium Phosphate,Titanium Dioxide, Mint, Sodium Saccharin, Tri-Calcium Phosphate.

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
Indications PRO-SYS Professional is a self-applied dentifrice for - prevention of tooth decay, orthodontic decalcification - and hypersensitivity

Spl product data elements

Usually a list of ingredients in a drug product.
ProSys 5000 SODIUM FLUORIDE SODIUM FLUORIDE FLUORIDE ION WATER SORBITOL HYDRATED SILICA GLYCERIN POLYETHYLENE GLYCOL, UNSPECIFIED CARBOXYMETHYLCELLULOSE XYLITOL SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM TITANIUM DIOXIDE MINT SACCHARIN SODIUM TRICALCIUM PHOSPHATE MINT

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
Package Label - ProSys 5000 DENTIST RECOMMENDED PRO-SYS PROFESSIONAL ANTI-CAVITY FLUORIDE TOOTHPASTE VANILLA MINT 4 OZ. RX ONLY [4710-501] WWW.PRO-SYS.COM Distributed by BencoDental 800.GO.BENCO • benco.com 295 CentralPoint Blvd., Pittston, PA 18640 res ProSys Tube

Other safety information

Information about safe use and handling of the product that may not have been specified in another field.
For more information on the entire family of PRO-SYS oral care products, visit www.PRO-SYS.com.

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
Warnings • Do not swallow • For topical use only • As with all medications, keep out of reach of children

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API