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Supersmile by Robell Research, Inc.

Medically reviewed on December 1, 2017

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.

Drug Facts

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. For children 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

Supersmile®

with the whitening power of Calprox®

ROSEWATER MINT

professional

whitening

toothpaste

Contains fluoride.

4.2 oz / 119 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
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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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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