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 as fluoride ion)

Purpose:

Anticavity.

Uses:

Aids in the prevention of 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.

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. Under two years of age consult a dentist or doctor before use.

Inactive Ingredients:

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

Principal Display

supersmile®

extra white

lotus peach mintea

professional

extra

whitening

toothpaste

Contains Fluoride

7 oz / 198.5 g

INGREDIENTS AND APPEARANCE

SUPERSMILE 
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53567-0760
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
SODIUM PERBORATE TETRAHYDRATE (UNII: 822HSQ655R)
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)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
MAGNESIUM CARBONATE (UNII: 0E53J927NA)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53567-0760-1	198.5 g in 1 TUBE; Type 0: Not a Combination Product	04/15/2019
2	NDC: 53567-0760-2	70.8 g in 1 TUBE; Type 0: Not a Combination Product	04/15/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	04/15/2019

Labeler - Robell Research, Inc. (155571656)