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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Cinnamon with Paraben

Active Ingredient:

Sodium Monoflurophosphate

(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.

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, Methyl Paraben, Sodium Saccharin, Propyl Paraben

Created by,

DR.IRWIN SMIGEL

World Renowned

Father of Aesthetic

Dentistry

For best results, place a pearl size drop of Whitening Toothpaste on a DRY toothbrush and brush in a circular motion for two minutes twice daily.

Three month supply (when used as directed)

Whitens - Calprox® safely lifts surface stains, maintains and enhances the vibrancy of professionally bleached teeth, restores bonding, caps, veneers and dentures to their original whiteness.

Freshens - Lasting germicidal protection.

Strengthens - Remineralizes tooth enamel.

Protects - Fluoride prevents cavities.

Safely - No harsh abrasives, no sensitivity.

STORE IN A COOL PLACE. RECYCLABLE

DETERMINE YOUR SMILE CARE NEEDS WITH A PERSONALIZED PROFILE AT WWW.SUPERSMILE.COM

QUESTIONS: 1-800-784-SMILE or INFO@SUPERSMILE.COM

Principal Display Panel

supersmile®

CINNAMON

professional

whitening

toothpaste

Contains fluoride.

4.2 oz / 119 g

image description

SUPERSMILE
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:53567-0717
Route of Administration	DENTAL, ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.4 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
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 (UNII: Y52BK1W96C)
STARCH, CORN (UNII: O8232NY3SJ)
MAGNESIUM CARBONATE (UNII: 0E53J927NA)
SODIUM LAURYL SULFOACETATE (UNII: D0Y70F2B9J)
METHYLPARABEN (UNII: A2I8C7HI9T)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Product Characteristics
Color		Score
Shape		Size
Flavor	CINNAMON (Cinnamon)	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:53567-0717-2	1 in 1 BOX	01/01/2006	05/31/2015
1		119 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC:53567-0717-5	14.2 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2006	05/31/2015

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	01/01/2006	05/31/2015

Labeler - Robell Research, Inc. (155571656)

Revised: 8/2018

Document Id: 72f22668-ca91-4a09-e053-2991aa0a60a6

Set id: 9b4829b5-c5f8-4fc9-b280-040d6d80b0c9

Version: 3

Effective Time: 20180808

Robell Research, Inc.