Supersmile by Robell Research, Inc. Supersmile, The Works

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 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

SUPERSMILE 
sodium monofluorophoshate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53567-0764
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
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53567-0764-1	227 g in 1 TUBE; Type 0: Not a Combination Product	08/11/2020
2	NDC: 53567-0764-2	40 g in 1 TUBE; Type 0: Not a Combination Product	04/14/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	08/11/2020

Labeler - Robell Research, Inc. (155571656)

Revised: 4/2023

Document Id: fa294e89-fa52-d98e-e053-6294a90ab4e9

34390-5

Set id: ac9c2232-e741-793a-e053-2995a90a61df

Version: 3

Effective Time: 20230425