Supersmile

Manufacturer
Robell Research, Inc.
Effective date
2021-11-29
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:25:44

Label at a glance#

ProductSupersmile
Active ingredientSODIUM MONOFLUOROPHOSPHATE
Label structure10 sections

Indications and uses

Aids in the prevention of dental cavities.

Dosage and administration

Adults and children 2 years of age or 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 in 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.

Storage and handling

STORE AT ROOM TEMPERATURE

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children under 6 years old. 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 or 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 in 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.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

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

STORAGE AND HANDLING SECTION

STORE AT ROOM TEMPERATURE

OTC - QUESTIONS SECTION

Want more Supersmile? Stop by to see the full collection: supersmile.com 1-800-784-SMILE ©Robell Research, Inc., New York, NY 10065 Made in USA

Manufactured for Robell Research, Inc.

SPL UNCLASSIFIED SECTION

Created by Dr. Irwin Smigel

World Renowned

Father of Aesthetic

Dentistry

Supersmile Professional Whitening Toothpaste,

fortified with CALPROX®:

Whitens teeth without sensitivity

cleans breath

inhibits plaque

fights cavities with fluoride

works on all dental restorations

freshens breath

replaced your regular toothpaste

No need to change any of your habits -

eat, drink without fear of stains.

Directions: Place a pearl-sized drop of Professional

Whitening Toothpaste on a DRY toothbrush and brush

in a circular motion for 2 minutes 2x a day.

Free of: parabens, sulfates (SLS + SLES), silica, charcoal,

triclosan, harsh bleaching agents, BPA and animal by-products.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

supersmile®

WILD MINT

professional

whitening

toothpaste

Powered by CALPROX®

contains fluoride

Net. wt. 8 oz / 227 g

Supersmile_wild_image.jpgSupersmile_wild_image.jpg

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
53567-076953567-0769-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 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
d1f064a8-2b95-a7b7-e053-2a95a90ac653d175e1b4-ea93-8db9-e053-2a95a90a1ceb2021-11-29WarningsExact identifier
spl id: d1f064a8-2b95-a7b7-e053-2a95a90ac653
spl set id: d175e1b4-ea93-8db9-e053-2a95a90a1ceb

Reported adverse events (FAERS/openFDA)#

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