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Pro-sys (Fluoridex Daily Defense Sensitivity) Package Insert

Status:
Prescription (Rx) Facts
Strength:
1.1 g/100 g, 5 g/100 g
Brand names:
Active ingredients:
Similar drugs:

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

Prescribing information (package insert) - Pro-sys

Indications and Usage

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

Inactive Ingredients

Sorbitol, Hydrated Silica, Water, Glycerin, PEG-12, Titanium Dioxide, Cocamidopropyl Betaine, Flavor, Cellulose Gum, Xylitol, Sodium Benzoate, Disodium Phosphate, Sodium Saccharin

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.

About this document

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

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

Drug information for Pro-sys

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Active ingredients Sodium fluoride 1.1 g/100 g, Potassium nitrate 5 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
1.1 g/100 g, 5 g/100 g – 113 g in 1 tube NDC 66975-779-01

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.