Supersmile

Manufacturer
Robell Research, Inc.
Effective date
2023-07-12
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:28:44

Label at a glance#

ProductSupersmile
Active ingredientSODIUM MONOFLUOROPHOSPHATE
Label structure8 sections

Indications and uses

Aids in the prevention of dental 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. Instruct children under 6 years of age about good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 2 years of age: Consult a dentist or doctor.

Label contents#

Full prescribing information#

Active Ingredient:

OTC - ACTIVE INGREDIENT SECTION

Sodium Monofluorophosphate (0.14% w/v Fluoride Ion)

Purpose:

OTC - PURPOSE SECTION

Anticavity

Uses:

INDICATIONS & USAGE SECTION

Aids in the prevention of dental cavities

Keep out of reach of children under 6 years old.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If you accidentally swallow more than used for brushing, get medical help or call 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. Instruct children under 6 years of age about good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 2 years of age: Consult a dentist or doctor.

Ingredients:

INACTIVE INGREDIENT SECTION

Water, Sorbitol, Calprox®, Citric Acid, Titanium Dioxide, Sodium Bicarbonate, Dicalcium Phoshate, Calcium Carbonate, Cellulose Gum, Flavor, Sodium Perborate, Magnesium Carbonate, Corn Starch, Sodium Lauryl Sulfoacetate, Sodium Saccharin.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

supersmile

THE WORKS

All you need for a

whiter, healthier smile

TROPICAL MINT

Powered by CALPROX®

to give you the whitest + cleanest teeth

without abrasion or sensitivity.

whitening toothpaste

Contains Fluoride

Net wt. 8 oz / 227 g

Supersmile_Tropical_Mint.jpgSupersmile_Tropical_Mint.jpg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

supersmile

SASSY MINT

THE WORKS

whitening

toothpaste +

activator

Powered by CALPROX®

Contains Fluoride

Net Wt. 7 oz / 198.5g

sassy_mint.jpgsassy_mint.jpg

Products#

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

DailyMed product names page 1 of 2 · 43 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53567-077253567-0772-1, 53567-0772-2, 53567-0772-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 40 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
004a06c1-0406-b41b-e063-6294a90a698fdc616ea2-ca09-62ae-e053-2995a90ad8e32023-07-12WarningsExact identifier
spl id: 004a06c1-0406-b41b-e063-6294a90a698f
spl set id: dc616ea2-ca09-62ae-e053-2995a90ad8e3

Reported adverse events (FAERS/openFDA)#

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