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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Drug Facts

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, Sodium Saccharin

Created by,

​DR.​IRWIN SMIGEL

​World Renowned

Father of Aesthetic

Dentistry

For best results, place a pearlsize 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, and 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

© Robell Research, Inc., New York, NY 10022 Made in USA

Principal Display Panel

supersmile®

ORIGINAL MINT

professional

whitening

toothpaste

Contains fluoride.

4.2 oz / 119 g

Original_Mint

SUPERSMILE 
sodium monofluorophosphate paste, dentifrice
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:53567-0706
Route of Administration DENTAL, ORAL DEA Schedule     
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 (UNII: Y52BK1W96C)  
STARCH, CORN (UNII: O8232NY3SJ)  
MAGNESIUM CARBONATE (UNII: 0E53J927NA)  
SODIUM LAURYL SULFOACETATE (UNII: D0Y70F2B9J)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
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:53567-0706-6 227 g in 1 TUBE
2 NDC:53567-0706-3 6 g in 1 TUBE
3 NDC:53567-0706-5 14 g in 1 TUBE
4 NDC:53567-0706-8 40 g in 1 TUBE
5 NDC:53567-0706-2 1 in 1 BOX
5 119 g in 1 TUBE
6 NDC:53567-0706-1 1 in 1 BOX
6 50 g in 1 TUBE
Image of Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part355 01/01/2006
Labeler - Robell Research, Inc. (155571656)

Revised: 3/2015
Document Id: 111ab2ca-9ebd-3f32-e054-00144ff8d46c
Set id: 87489290-c2de-4fee-97b5-3639374e0eeb
Version: 8
Effective Time: 20150312
 
Robell Research, Inc.