SUPERSMILE PROFESSIONAL WHITENING- 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 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 Type HUMAN OTC DRUG Item Code (Source) NDC:53567-6044
Route of Administration DENTAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (MONOFLUOROPHOSPHATE ION - UNII:4964UZ79MI) MONOFLUOROPHOSPHATE ION 0.83 g  in 100 g
Inactive Ingredients
Ingredient Name Strength
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     
Shape Size
Flavor MINT Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:53567-6044-2 227 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part355 06/28/2011
Labeler - Robell Research, Inc. (155571656)
Registrant - Loranmead (126440440)
Establishment
Name Address ID/FEI Business Operations
Lornamead 126440440 manufacture(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.