Your browser does not support JavaScript! SUPERSMILE PROFESSIONAL WHITENING (FLUORIDE) PASTE, DENTIFRICE [ROBELL RESEARCH, INC.]
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SUPERSMILE PROFESSIONAL WHITENING (fluoride) 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 Monofluorophosphate (0.14% w/v Fluoride Ion)

Purpose:

Anticavity toothpaste

Uses:

Aids in the prevention of dental cavities.

Warnings:

As with all fluoride toothpastes,

children under 6 years old.

Directions:

For best results: Brush teeth thoroughly after each meal, at least twice a day, or as directed by a dentist.

Directions:

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 Phosphate 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

Questions:

1-800 -784 -SMILE

Tube Label

Tube Label

SUPERSMILE PROFESSIONAL  WHITENING
fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53567-0101
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (FLUORIDE ION) FLUORIDE ION0.76 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER 
CALCIUM PEROXIDE 
SODIUM PERBORATE 
SODIUM BICARBONATE 
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS 
CALCIUM CARBONATE 
MAGNESIUM CARBONATE 
STARCH, CORN 
SACCHARIN 
METHYLPARABEN 
PROPYLPARABEN 
TITANIUM DIOXIDE 
CARBOXYMETHYLCELLULOSE SODIUM 
SODIUM LAURYL SULFOACETATE 
Product Characteristics
Color    Score    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:53567-0101-6227 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35506/28/2011
Labeler - ROBELL RESEARCH, INC. (155571656)
Registrant - Lornamead (126440440)
Establishment
NameAddressID/FEIBusiness Operations
Lornamead126440440manufacture(53567-0101), pack(53567-0101)

Revised: 10/2012
Document Id: e123425c-cbac-47c2-b511-b07c4b14dee5
Set id: 43e5e8f9-1bb1-4154-b6a3-36af8c870c4d
Version: 7
Effective Time: 20121003
 
ROBELL RESEARCH, INC.

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