Supersmile Professional Whitening (Toothpaste) Paste, Dentifrice [Robell Research, Inc.] -

SUPERSMILE PROFESSIONAL WHITENING (TOOTHPASTE) PASTE, DENTIFRICE [ROBELL RESEARCH, INC.]
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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
PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SUPERSMILE PROFESSIONAL WHITENING
toothpaste paste, dentifrice

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (MONOFLUOROPHOSPHATE ION - UNII:4964UZ79MI)	MONOFLUOROPHOSPHATE ION	0.83 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:53567-6044-2	227 g in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	06/28/2011

Labeler - Robell Research, Inc. (155571656)

Registrant - Loranmead (126440440)

Name	Address	ID/FEI	Business Operations
Establishment
Lornamead		126440440	manufacture(53567-6044) , pack(53567-6044)

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