SUPERSMILE PROFESSIONAL WHITENING- fluoride paste, dentifrice

SuperSmile Professional by

Drug Labeling and Warnings

SuperSmile Professional by is a Otc medication manufactured, distributed, or labeled by ROBELL RESEARCH, INC., Lornamead. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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,

KEEP OUT OF REACH OF CHILDREN

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

INGREDIENTS AND APPEARANCE

SUPERSMILE PROFESSIONAL  WHITENING
fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53567-0101
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.76 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: 53567-0101-6	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 - Lornamead (126440440)

Establishment
Name	Address	ID/FEI	Business Operations
Lornamead		126440440	manufacture(53567-0101) , pack(53567-0101)