ProSys 5000 by Benco Dental ProSys 5000

ProSys 5000 by

Drug Labeling and Warnings

ProSys 5000 by is a Prescription medication manufactured, distributed, or labeled by Benco Dental. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PROSYS 5000- sodium fluoride paste, dentifrice 
Benco Dental

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.

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ProSys 5000

DRUG FACTS

Active Ingredient
1.1% Neutral Sodium Fluoride

Inactive Ingredients:Filtered Water, Sorbitol, Hydrated Silica,
Glycerin, PEG, Carboxymethylcellulose, Xylitol, Monosodium
Phosphate,Titanium Dioxide, Mint, Sodium Saccharin,
Tri-Calcium Phosphate.

Indications
PRO-SYS Professional is a self-applied dentifrice 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.

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

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 5000 
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 66975-501
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	1.1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)
XYLITOL (UNII: VCQ006KQ1E)
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
MINT (UNII: FV98Z8GITP)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
TRICALCIUM PHOSPHATE (UNII: K4C08XP666)

Product Characteristics
Color		Score
Shape		Size
Flavor	VANILLA (MINT)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66975-501-04	112 g in 1 TUBE; Type 0: Not a Combination Product	10/13/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		10/13/2023	12/11/2025

Labeler - Benco Dental (015108087)

Registrant - Benco Dental (015108087)

Revised: 12/2025

Document Id: b8d7c92e-e2b7-4064-970f-fe7a96deb467

34391-3

Set id: 63e92d01-0982-4a04-b2ef-8b1243f3d353

Version: 6

Effective Time: 20251211

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