Supersmile by Robell Research, Inc.

Supersmile by

Drug Labeling and Warnings

Supersmile by is a Otc medication manufactured, distributed, or labeled by Robell Research, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

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Active Ingredient:

Sodium Monofluorophosphate (0.14% w/v Fluoride Ion)

Purpose:

Anticavity toothpaste.

Uses:

Aids in the prevention of dental cavities.

Warnings:

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

supersmile

PEPPY MINT

professional

whitening

toothpaste

powered by Calprox®

with fluoride

Net wt. 1.4 oz / 40 g

SUPERSMILE 
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53567-0776
Route of Administration	DENTAL, ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.4 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CALCIUM PEROXIDE (UNII: 7FRO2ENO91)
SORBITOL (UNII: 506T60A25R)
CALCIUM BICARBONATE (UNII: 7PRA4BLM2L)
SODIUM PERBORATE TETRAHYDRATE (UNII: 822HSQ655R)
SODIUM LAURYL SULFOACETATE (UNII: D0Y70F2B9J)
MAGNESIUM CARBONATE (UNII: 0E53J927NA)
WATER (UNII: 059QF0KO0R)
STARCH, CORN (UNII: O8232NY3SJ)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
MINT (UNII: FV98Z8GITP)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT (Peppy Mint)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53567-0776-1	40 g in 1 TUBE; Type 0: Not a Combination Product	08/21/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	08/21/2023

Labeler - Robell Research, Inc. (155571656)

Revised: 8/2023

Document Id: 0396f36a-75dd-eff8-e063-6294a90a7790

34390-5

Set id: 0396f36a-75dc-eff8-e063-6294a90a7790

Version: 1

Effective Time: 20230823