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Supersmile by Robell Research, Inc.

Medically reviewed on May 23, 2018

Dosage form: paste, dentifrice
Ingredients: SODIUM MONOFLUOROPHOSPHATE 1.4mg in 1g
Labeler: Robell Research, Inc.
NDC Code: 53567-0738

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.

Extra White

Active ingredient:

Sodium Monofluorophosphate (0.14% w/v Fluoride Ion)

Purpose:

Anticavity toothpaste

Uses:

Aids in the prevention of dental cavities.

Warnings:

As with all fluoride toothpastes, 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.

Warnings:

As with all fluoride toothpastes, 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:

For the best results: Brush teeth thoroughly after each meal at least twice a day, or as directed by a dentist. Instruct children under six about good brushing and rinsing habits to minimize swallowing. Supervise children as necessary until capable of using without supervision. Under two years of age consult a dentist or a doctor before use.

Inactive ingredients:

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

Principal Display Panel

SPECIAL EDITION

supersmile®

extra white

triple mint

professional

whitening

toothpaste

Contains Fluoride

7 oz / 198.5 g

SUPERSMILE 
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53567-0738
Route of AdministrationDENTAL, ORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (FLUORIDE ION) FLUORIDE ION1.4 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID 
CARBOXYMETHYLCELLULOSE SODIUM 
SODIUM PERBORATE 
MAGNESIUM CARBONATE 
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE 
WATER 
CALCIUM PEROXIDE 
SORBITOL 
CALCIUM CARBONATE 
STARCH, CORN 
SODIUM LAURYL SULFOACETATE 
SACCHARIN SODIUM 
SODIUM BICARBONATE 
TITANIUM DIOXIDE 
Product Characteristics
Color    Score    
ShapeSize
FlavorMINT (Triple Mint) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:53567-0738-1198.4 g in 1 TUBE
2NDC:53567-0738-2198.4 g in 1 BOTTLE, PUMP
3NDC:53567-0738-370.8 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35511/04/2016
Labeler - Robell Research, Inc. (155571656)

 
Robell Research, Inc.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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