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Supersmile by Robell Research, Inc.

Dosage form: paste, dentifrice
Ingredients: SODIUM MONOFLUOROPHOSPHATE 1.4mg in 1g
Labeler: Robell Research, Inc.
NDC Code: 53567-0748

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.

Supersmile Rosewater

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

Principal Display Panel

Supersmile®

ROSEWATER MINT

professional

whitening

toothpaste

powered by Calprox®

with fluoride.

Net wt. 4.2 oz / 119 g

SUPERSMILE 
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53567-0748
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
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 (Rosewater Mint) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:53567-0748-21 TUBE in 1 BOX
1119 g in 1 TUBE
2NDC:53567-0748-3227 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35505/01/2017
Labeler - Robell Research, Inc. (155571656)

 
Robell Research, Inc.

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Medically reviewed on Jul 16, 2018

Further information

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

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