Medication-info.com Search Menu

Prosys (Gelato sodium fluoride, Nafrinse) Package Insert

Status:
Prescription (Rx) Facts
Strength:
0.11 g/100 g
Brand names:
Active ingredient:
Similar drugs:

Source: FDA drug labeling via NLM DailyMed · About this document

Prescribing information (package insert) - Prosys

Inactive Ingredients

Water, Sorbitol, Hydrated Silica, Glycerin, PEG-12, Cellulose Gum, Xylitol, Monosodium Phosphate, Titanium Dioxide, Flavor, Sodium Saccharin, Tri-Calcium Phosphate

Indications

PRO-SYS Professional is a self-applied dentrifice for prevention of tooth decay, orthodontic decalcification and hypersensitivity.

Warnings

  • Do not swallow
  • For topical use only
  • As with all medications, keep out of reach of children

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.

Questions

For more information on the entire family of PRO-SYS oral care products, visit www.PRO-SYS.com

About this document

Source: FDA drug labeling via NLM DailyMed · View the label on DailyMed

Found a mistake? Write to us via the contact page.

The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Prosys

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Active ingredient Sodium fluoride 0.11 g/100 g
Dosage form Paste, dentifrice
Route Dental
Marketing status listed in the FDA NDC Directory
Company (applicant) Benco Dental
FDA approval UNAPPROVED DRUG OTHERUnapproved drug
Manufacturers 1 labelers list this drug on DailyMed
Packages (NDC)
Package
0.11 g/100 g – 113 g in 1 tube NDC 66975-782-01

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.