Prosys - Benco Dental

Manufacturer
Benco Dental
Effective date
2026-02-01
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:16:03

Label at a glance#

ProductProsys
Active ingredientSODIUM FLUORIDE
Label structure6 sections

Dosage and administration

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 ...

Label contents#

Full prescribing information#

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

Indications

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

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

Directions: Use as Directed

DOSAGE & ADMINISTRATION SECTION

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

OTC - QUESTIONS SECTION

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

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dentist Recommended

PRO-SYS

Professional

Anti-Cavity Fluoride Toothpaste

Vanilla Mint 4 oz. (113g) RX ONLY

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DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
392038sodium fluoride 1.1 % ToothpastePSN2
392038sodium fluoride 0.011 MG/MG ToothpasteSCD2
392038sodium fluoride 1.1 % (fluoride ion 0.5 % ) ToothpasteSY2
392038sodium fluoride 1.1 % Dental GelSY2

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeCode 394710-501PM5941 Rev000.jpg, PM5940 Rev000.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66975-782-01Prosys113 g in 1 TUBEPASTE, DENTIFRICE1132

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66975-78266975-782-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12026-02-01legacy-cache2026-08-01 20:32:54

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Prosys1.1% SODIUM FLUORIDEBenco Dental4e6c48c6-bce2-aa33-e063-6394a90a96592026-02-01WarningsExact identifier
ndc (package): 66975-782-01
ndc (product): 66975-782
ndc11 (package): 66975078201
spl id: 500d9ff5-0091-fc40-e063-6394a90a8810
spl set id: 4e6c48c6-bce2-aa33-e063-6394a90a9659

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.