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ProSys 5000 Prescribing Information

Package insert / product label
Generic name: sodium fluoride
Dosage form: paste, dentifrice
Drug class: Mouth and throat products

Medically reviewed by Drugs.com. Last updated on Nov 5, 2023.

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)