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

ProSys Tube

res

PROSYS 5000 
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:66975-501
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE1.1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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    
ShapeSize
FlavorVANILLA (MINT) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66975-501-04112 g in 1 TUBE; Type 0: Not a Combination Product10/13/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other10/13/2023
Labeler - Benco Dental (015108087)
Registrant - Benco Dental (015108087)

Revised: 11/2023
Document Id: 4d1a3bcd-d558-4f5f-b669-ddcc6db32691
Set id: 63e92d01-0982-4a04-b2ef-8b1243f3d353
Version: 4
Effective Time: 20231102
 
Benco Dental