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 Monoflurophosphate

(0.14% w/v Fluoride Ion)

Purpose:

Anticavity toothpaste

Uses:

Aids in the prevention of dental cavities.

Warnings:

KEEP OUT OF REACH OF CHILDREN

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. For children 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®

ORIGINAL MINT

the whitening power of Calprox®

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: 53567-0552
Route of Administration	ORAL, DENTAL

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)
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)
MINT (UNII: FV98Z8GITP)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
CALCIUM CARBONATE (UNII: H0G9379FGK)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53567-0552-3	6 g in 1 TUBE; Type 0: Not a Combination Product	05/01/2013
2	NDC: 53567-0552-2	1 in 1 BOX	05/01/2013
2		119 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 53567-0552-1	1 in 1 BOX	05/01/2013
3		40 g in 1 TUBE; Type 1: Convenience Kit of Co-Package
4	NDC: 53567-0552-8	227 g in 1 TUBE; Type 0: Not a Combination Product	03/06/2018
5	NDC: 53567-0552-4	70.8 g in 1 TUBE; Type 0: Not a Combination Product	12/11/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	05/01/2013

Labeler - Robell Research, Inc. (155571656)