SUPERSMILE- sodium monofluorophosphate paste, dentifrice

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]

Active ingredient:

Sodium Monofluorophosphate (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.

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 the 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. For children under two years of age, consult a dentist or a doctor before use.

Inactive ingredients:

Water, Sorbitol, Dicalcium Phosphate 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®

JASMINE GREEN TEA MINT

professional

whitening

toothpaste

Contains fluoride.

4.2 oz / 119 g

INGREDIENTS AND APPEARANCE

SUPERSMILE 
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53567-0747
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)
SODIUM PERBORATE TETRAHYDRATE (UNII: 822HSQ655R)
MAGNESIUM CARBONATE (UNII: 0E53J927NA)
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)
WATER (UNII: 059QF0KO0R)
CALCIUM PEROXIDE (UNII: 7FRO2ENO91)
SORBITOL (UNII: 506T60A25R)
CALCIUM CARBONATE (UNII: H0G9379FGK)
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM LAURYL SULFOACETATE (UNII: D0Y70F2B9J)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT (Jazmine Green Tea Mint)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53567-0747-3	1 in 1 BOX	05/01/2017
1		119 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 53567-0747-2	227 g in 1 TUBE; Type 0: Not a Combination Product	03/06/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	05/01/2017

Labeler - Robell Research, Inc. (155571656)