Your browser does not support JavaScript! SUPERSMILE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [ROBELL RESEARCH, INC.]
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SUPERSMILE (sodium monofluorophosphate) paste, dentifrice
[Robell Research, Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

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 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

image description

SUPERSMILE 
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:53567-0706
Route of AdministrationDENTAL, ORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (FLUORIDE ION) FLUORIDE ION1.4 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER 
SORBITOL 
DIBASIC CALCIUM PHOSPHATE DIHYDRATE 
SODIUM BICARBONATE 
CALCIUM CARBONATE 
TITANIUM DIOXIDE 
CARBOXYMETHYLCELLULOSE SODIUM 
CALCIUM PEROXIDE 
SODIUM PERBORATE 
STARCH, CORN 
MAGNESIUM CARBONATE 
SODIUM LAURYL SULFOACETATE 
METHYLPARABEN 
SACCHARIN SODIUM 
PROPYLPARABEN 
Product Characteristics
Color    Score    
ShapeSize
FlavorMINT (ORIGINAL MINT) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53567-0706-6227 g in 1 TUBE
2NDC:53567-0706-36.0 g in 1 TUBE
3NDC:53567-0706-514 g in 1 TUBE
4NDC:53567-0706-840 g in 1 TUBE
5NDC:53567-0706-21 in 1 BOX
5119 g in 1 TUBE
6NDC:53567-0706-11 in 1 BOX
650 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35501/01/2006
Labeler - Robell Research, Inc. (155571656)

Revised: 11/2012
 
Robell Research, Inc.

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