Supersmile by Robell Research, Inc. Supersmile - Wild Mint

Supersmile by

Drug Labeling and Warnings

Supersmile by is a Otc medication manufactured, distributed, or labeled by Robell Research, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SUPERSMILE- sodium monofluorophosphate paste, dentifrice 
Robell Research, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Supersmile - Wild Mint

Active Ingredient

Sodium Monofluorophosphate (0.14% w/v Fluoride Ion)

Purpose

Anticavity

Uses:

Aids in the prevention of dental cavities.

Warnings:

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:

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:

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.

STORE AT ROOM TEMPERATURE

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.

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.

supersmile®

WILD MINT

professional

whitening

toothpaste

Powered by CALPROX®

contains fluoride

Net. wt. 8 oz / 227 g

SUPERSMILE 
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53567-0769
Route of Administration	DENTAL, ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.4 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SODIUM PERBORATE TETRAHYDRATE (UNII: 822HSQ655R)
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM LAURYL SULFOACETATE (UNII: D0Y70F2B9J)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
MINT (UNII: FV98Z8GITP)
MAGNESIUM CARBONATE (UNII: 0E53J927NA)
CALCIUM PEROXIDE (UNII: 7FRO2ENO91)
CALCIUM BICARBONATE (UNII: 7PRA4BLM2L)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT (Wild Mint)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53567-0769-1	227 g in 1 TUBE; Type 0: Not a Combination Product	11/23/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	11/23/2021

Labeler - Robell Research, Inc. (155571656)

Revised: 11/2021

Document Id: d1f064a8-2b95-a7b7-e053-2a95a90ac653

34390-5

Set id: d175e1b4-ea93-8db9-e053-2a95a90a1ceb

Version: 2

Effective Time: 20211129