SUPERSMILE- sodium monofluorophoshate 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, The Works

Active Ingredient:

Sodium Monofluorophosphate (0.14% w/v as 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 Poison Control center right away.

Directions:

Adults and children 2 years of age and 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, Calprox®, Citric Acid, Titanium Dioxide, Sodium Bicarbonate, Dicalcium Phosphate, Calcium Carbonate, Cellulose Gum, Flavor, Sodium Perborate, Magnesium Carbonate, Corn Starch, Sodium Lauryl Sulfoacetate, Sodium Saccharin.

Principal Display

supersmile

THE WORKS

All you need for a

whiter, healthier smile

MINT ON MINT

Powered by CALPROX®

to give you the whitest + cleanest teeth

without abrasion or sensitivity

whitening toothpaste

Contains Fluoride

Net wt. 8 oz / 227 g

supermile_mint_image.jpg

SUPERSMILE 
sodium monofluorophoshate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53567-0764
Route of AdministrationDENTAL, ORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.4 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
MINT (UNII: FV98Z8GITP)  
SODIUM LAURYL SULFOACETATE (UNII: D0Y70F2B9J)  
WATER (UNII: 059QF0KO0R)  
CALCIUM CARBONATE (UNII: H0G9379FGK)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBITOL (UNII: 506T60A25R)  
CALCIUM PEROXIDE (UNII: 7FRO2ENO91)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SODIUM PERBORATE TETRAHYDRATE (UNII: 822HSQ655R)  
STARCH, CORN (UNII: O8232NY3SJ)  
MAGNESIUM CARBONATE (UNII: 0E53J927NA)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53567-0764-1227 g in 1 TUBE; Type 0: Not a Combination Product08/11/2020
2NDC:53567-0764-240 g in 1 TUBE; Type 0: Not a Combination Product04/14/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35508/11/2020
Labeler - Robell Research, Inc. (155571656)

Revised: 4/2023
 
Robell Research, Inc.