SUPERSMILE PROFESSIONAL WHITENING- toothpaste 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 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

SUPERSMILE PROFESSIONAL  WHITENING
toothpaste paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53567-6044
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (MONOFLUOROPHOSPHATE ION - UNII:4964UZ79MI) MONOFLUOROPHOSPHATE ION0.83 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CALCIUM PEROXIDE (UNII: 7FRO2ENO91)  
SODIUM PERBORATE (UNII: Y52BK1W96C)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
CALCIUM CARBONATE (UNII: H0G9379FGK)  
MAGNESIUM CARBONATE (UNII: 0E53J927NA)  
STARCH, CORN (UNII: O8232NY3SJ)  
SACCHARIN (UNII: FST467XS7D)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
SODIUM LAURYL SULFOACETATE (UNII: D0Y70F2B9J)  
Product Characteristics
Color    Score    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53567-6044-2227 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 - Loranmead (126440440)
Establishment
NameAddressID/FEIBusiness Operations
Lornamead126440440manufacture(53567-6044) , pack(53567-6044)

Revised: 10/2012
Document Id: 1d9c0c38-cbc7-4aef-b188-ecc3898bb42d
Set id: 6313d26c-aa25-45c8-845a-a560bccc57c5
Version: 4
Effective Time: 20121003
 
Robell Research, Inc.