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.

----------

Supersmile - Mandarin Mint

Active Ingredient:

Sodium Monoflurophosphate (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.

Directions:

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

Principal Display Panel

supersmile®

with the whitening power of Calprox®

MANDARIN MINT

professional

whitening

toothpaste

Contains fluoride.

4.2 oz / 119 g

mandarin_mint

SUPERSMILE 
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53567-0972
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
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
CALCIUM CARBONATE (UNII: H0G9379FGK)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
CALCIUM PEROXIDE (UNII: 7FRO2ENO91)  
SODIUM PERBORATE TETRAHYDRATE (UNII: 822HSQ655R)  
STARCH, CORN (UNII: O8232NY3SJ)  
MAGNESIUM CARBONATE (UNII: 0E53J927NA)  
SODIUM LAURYL SULFOACETATE (UNII: D0Y70F2B9J)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
Product Characteristics
Color    Score    
ShapeSize
FlavorORANGE (MANDARIN MINT) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53567-0972-31 in 1 BOX07/14/2014
1119 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:53567-0972-414.2 g in 1 TUBE; Type 0: Not a Combination Product07/14/2014
3NDC:53567-0972-840 g in 1 TUBE; Type 0: Not a Combination Product07/14/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35507/14/2014
Labeler - Robell Research, Inc. (155571656)

Revised: 4/2019
 
Robell Research, Inc.