FDA.reportPublic FDA data

PRO-SYS TOOTHPASTE, MINT GEL

Manufacturer
Benco Dental
Effective date
2025-12-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:52:15

Label at a glance#

ProductPRO-SYS
Active ingredientSODIUM FLUORIDE
Label structure9 sections

Indications and uses

Helps protect against cavities

Dosage and administration

Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Children under 6 years of age: use a pea-sized amount and instruct in good brushing and rinsing habits to reduce swallowing. Supervise children as necessary until capable of using without supervision. Children under 2 years of age: Consult a dentist or doc...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Sorbitol, Hydrated Silica, Water, Glycerin, PEG 600, Sodium Lauryl Sulfate, Cellulose Gum, Flavor, Sodium Benzoate, Disodium Phosphate, Sodium Saccharin, Blue 1.

Purpose

OTC - PURPOSE SECTION

Acticavity 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 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Children under 6 years of age: use a pea-sized amount and instruct in good brushing and rinsing habits to reduce swallowing. Supervise children as necessary until capable of using without supervision. Children under 2 years of age: Consult a dentist or doctor.

Questions or Comments?

OTC - QUESTIONS SECTION

Distributed by Benco Dental

1-800-462-3626

Benco.com

295 CenterPoint Blvd, Pittston, PA 18640

www.PRO-SYS.com

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.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DENTIST RECOMMENDED

PRO-SYS®

PROFESSIONAL

FLUORIDE TOOTHGEL

MINT

0.85 OZ. (24G)

MADE IN USA

0.850.85

DENTIST RECOMMENDED

PRO-SYS®

PROFESSIONAL

FLUORIDE TOOTHGEL

MINT

4 OZ. (113.4G)

MADE IN USA

4.0 OZ4.0 OZ

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
416783sodium fluoride 0.24 % ToothpastePSN1
416783sodium fluoride 0.0024 MG/MG ToothpasteSCD1
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSY1
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY1
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY1

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130366975000255GTIN-13: 0366975000255
EAN-13: 0366975000255
GTIN-12: 366975000255
UPC-A: 366975000255
GTIN storage (14 digits): 00366975000255		PM5937 Rev000 25_BB_Pkg_PRO-SYS_Fluoride Toothgel_4 oz 4834-879_OUTLINES.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66975-700-01PRO-SYS113.4 g in 1 TUBEPASTE, DENTIFRICE113.41
66975-700-02PRO-SYS24 g in 1 TUBEPASTE, DENTIFRICE241

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
66975-70066975-700-01, 66975-700-02

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
POLYETHYLENE GLYCOL 600NL4J9F21N9IACT
BLUE 1H3R47K3TBDIACT
SODIUM LAURYL SULFATE368GB5141JIACT
SORBITOL506T60A25RIACT
HYDRATED SILICAY6O7T4G8P9IACT
DISODIUM PHOSPHATE22ADO53M6FIACT
SODIUM SACCHARINSB8ZUX40TYIACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIM
CELLULOSE GUMK679OBS311IACT
GLYCERINPDC6A3C0OXIACT

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-SYSSODIUM FLUORIDE AND POTASSIUM NITRATEBenco Dental4e470ba4-60bb-1815-e063-6294a90abacc2025-12-01WarningsExact identifier
ndc (package): 66975-700-02
ndc (package): 66975-700-01
ndc (product): 66975-700
ndc11 (package): 66975070001
ndc11 (package): 66975070002
spl id: 4e470bae-2cd0-1363-e063-6294a90a65ae
spl set id: 4e470ba4-60bb-1815-e063-6294a90abacc

Reported adverse events (FAERS/openFDA)#

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