FDA.reportPublic FDA data

PRO-SYS TOOTHPASTE, BUBBLEGUM 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 01:52:16

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, Red 40, Red 33.

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

BUBBLE GUM

0.85 OZ. (24G)

MADE IN USA

0.850.85

DENTIST RECOMMENDED

PRO-SYS® kids

PROFESSIONAL

FLUORIDE TOOTHGEL

BUBBLE GUM

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-130366975000262GTIN-13: 0366975000262
EAN-13: 0366975000262
GTIN-12: 366975000262
UPC-A: 366975000262
GTIN storage (14 digits): 00366975000262		PM5939 Rev000 25_BB_Pkg_PRO-SYS_Fluoride Toothgel_4 oz 4834-888_OUTLINES.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66975-720-01PRO-SYS113.4 g in 1 TUBEPASTE, DENTIFRICE113.41
66975-720-02PRO-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
66975-72066975-720-01, 66975-720-02

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
RED 40WZB9127XOAIACT
POLYETHYLENE GLYCOL 600NL4J9F21N9IACT
SODIUM LAURYL SULFATE368GB5141JIACT
SORBITOL506T60A25RIACT
HYDRATED SILICAY6O7T4G8P9IACT
DISODIUM PHOSPHATE22ADO53M6FIACT
SODIUM SACCHARINSB8ZUX40TYIACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
CELLULOSE GUMK679OBS311IACT
GLYCERINPDC6A3C0OXIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIM
RED 339DBA0SBB0LIACT

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 FLUORIDEBenco Dental4e539cb2-bcbd-95fc-e063-6294a90a21212025-12-01WarningsExact identifier
ndc (package): 66975-720-02
ndc (package): 66975-720-01
ndc (product): 66975-720
ndc11 (package): 66975072001
ndc11 (package): 66975072002
spl id: 4e53a23c-7977-632d-e063-6394a90a7ae6
spl set id: 4e539cb2-bcbd-95fc-e063-6294a90a2121

Reported adverse events (FAERS/openFDA)#

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