ProSYS Sensitivity - Mint (OTC)

Manufacturer
Benco Dental
Effective date
2026-04-22
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:54:37

Label at a glance#

ProductPRO-SYS
Active ingredientPOTASSIUM NITRATE, SODIUM FLUORIDE
Label structure9 sections

Indications and uses

Helps protect against cavities

Dosage and administration

Adults and children 12 years of age and older: Apply at least a 1-inch strip of the product onto a soft bristle toothbrush. Brush teeth thoroughly for at least 1 minute twice a day (morning and evening), and not more than 3 times a day, or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Minimize swallowing. Spit out after brushing. Children under 12 years of age: Consult...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium Fluoride 0.24% w/w (0.15% w/v Fluoride Ion)

Potassium Nitrate 5%

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Sorbitol, Hydrated Silica, Water, Glycerin, PEG-12, Titanium Dioxide, Flavor, Sodium Lauryl Sulfate, Cellulose Gum, Sodium Benzoate, Disodium Phosphate, Sodium Saccharin

Purpose

OTC - PURPOSE SECTION

Anticavity Toothpaste

Uses

INDICATIONS & USAGE SECTION

Helps protect against cavities

Warnings

WARNINGS SECTION

Keep out of reach of children under 6 years of age. If you accidentally swallow more than used for brushing, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years of age and older:

  • Apply at least a 1-inch strip of the product onto a soft bristle toothbrush.
  • Brush teeth thoroughly for at least 1 minute twice a day (morning and evening), and not more than 3 times a day, or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Minimize swallowing. Spit out after brushing.

Children under 12 years of age:

  • Consult a dentist or doctor.

Questions or Comments?

OTC - QUESTIONS SECTION

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

1-800-462-3626

Keep out of reach of children under 6 years of age.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children under 6 years of age. If you accidentally swallow more than used for brushing, get medical help or contact a Poison Control Center right away.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRO-SYS®

PROFESSIONAL

ANTI-CAVITY FLUORIDE TOOTHPASTE

SENSITIVE

MINT, 0.85 OZ. (24G)

BENCO DENTAL

Tube1Tube1

PRO-SYS®

PROFESSIONAL

ANTI-CAVITY FLUORIDE TOOTHPASTE

SENSITIVE

MINT, 4.0 OZ. (113G)

BENCO DENTAL

Tube2Tube2

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeCode 396371-473PM5922 Rev000.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66975-780-01PRO-SYS113 g in 1 TUBEPASTE, DENTIFRICE1132
66975-780-02PRO-SYS24 g in 1 TUBEPASTE, DENTIFRICE242

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66975-78066975-780-01, 66975-780-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Source Document#

Source XML

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
PRO-SYSSENSITIVITY - MINT (OTC)Benco Dental4e46847e-8c1d-c988-e063-6394a90a8e502026-04-22WarningsExact identifier
ndc (package): 66975-780-01
ndc (package): 66975-780-02
ndc (product): 66975-780
ndc11 (package): 66975078002
ndc11 (package): 66975078001
spl id: 500d7c21-dc0f-a18a-e063-6394a90ab3ee
spl set id: 4e46847e-8c1d-c988-e063-6394a90a8e50

Reported adverse events (FAERS/openFDA)#

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