Supersmile by Robell Research, Inc. Supersmile - Refreshmint

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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Supersmile - Refreshmint

Active Ingredient:

Sodium Monofluorophosphate (0.14% w/v Fluoride Ion)

Purpose:

Anticavity toothpaste

Uses:

Aids in the prevention of dental cavities.

Warning:

Keep out of reach of children under 6 years old. If more than used for brushing is accidentally swallowed, get medical help or contact a 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 about 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.

Ingredients:

Water, Sorbitol, Calprox®, Citric Acid, Dicalcium Phosphate, Sodium Bicarbonate, Titanium Dioxide, Cellulose Gum, Flavor, Sodium Perborate, Magnesium Carbonate, Corn Starch, Sodium Lauryl Sulfoacetate, Sodium Saccharin.

supersmile extra white

refreshmint

professional

extra

whitening

toothpaste

contains fluoride

Net wt. 7 oz / 198.5g

SUPERSMILE 
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53567-0777
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
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM LAURYL SULFOACETATE (UNII: D0Y70F2B9J)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CALCIUM PEROXIDE (UNII: 7FRO2ENO91)
WATER (UNII: 059QF0KO0R)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
MINT (UNII: FV98Z8GITP)
SORBITOL (UNII: 506T60A25R)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
MAGNESIUM CARBONATE (UNII: 0E53J927NA)
SODIUM PERBORATE TETRAHYDRATE (UNII: 822HSQ655R)
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)
CALCIUM CARBONATE (UNII: H0G9379FGK)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53567-0777-1	198.5 g in 1 TUBE; Type 0: Not a Combination Product	09/05/2023
2	NDC: 53567-0777-2	70.8 g in 1 TUBE; Type 0: Not a Combination Product	09/05/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	09/05/2023

Labeler - Robell Research, Inc. (155571656)

Revised: 8/2023

Document Id: 04381812-d9ad-3583-e063-6294a90a2c68

34390-5

Set id: 04381812-d9ac-3583-e063-6294a90a2c68

Version: 1

Effective Time: 20230831