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. 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®

with the whitening power of Calprox®

GREEN APPLE

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: 53567-0971
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
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
CALCIUM CARBONATE (UNII: H0G9379FGK)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
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)

Product Characteristics
Color		Score
Shape		Size
Flavor	APPLE (Green Apple)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53567-0971-3	1 in 1 BOX	02/19/2014
1		119 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 53567-0971-4	14.2 g in 1 TUBE; Type 0: Not a Combination Product	02/19/2014
3	NDC: 53567-0971-8	40 g in 1 TUBE; Type 0: Not a Combination Product	02/19/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	01/01/2014

Labeler - Robell Research, Inc. (155571656)