SUPERSMILE PROFESSIONAL WHITENING TP ORIGINAL MINT- sodium monofluorophosphate paste, dentifrice

Supersmile by

Drug Labeling and Warnings

Supersmile by is a Otc medication manufactured, distributed, or labeled by Robell Research, Inc, Lornamead, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Sodium Monoflurophosphate 0.79% (0.14% w/v Fluoride Ion) .................... Anticavity

INACTIVE INGREDIENT

Water, Sorbitol, Dicalcium Phosphate, Calcium Carbonate, Sodium Bicarbonate, Titanium Dioxide, Cellulose Gum, Calprox®, Sodium Perborate, Corn Starch, Flavor, Magnesium Carbonate, Sodium Lauryl Sulfoacetate, Sodium Saccharin

PURPOSE

Aids in the prevention of dental cavities

WARNINGS

Keep out of reach of children under 6 years old. If you accedentally swallow more than used for brushing, get medical help or call a Posion control center rigth away.

INDICATIONS & USAGE

Place a pearl-sized drop of Whitening toothpaste on a dry toothbrush and brush in a circular motion for 2 minutes, 2x a day.

DOSAGE & ADMINISTRATION

Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Instruc children under 6 years of age in good brushing and rinsing habots (to minimize swallowing). Supervise children as necessary until capable of using wihtout supervision. Children under 2 years of age: Consult a dentist or doctor.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children under 6 years old. If you accedentally swallow more than used for brushing, get medical help or call a Posion control center rigth away.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SUPERSMILE  PROFESSIONAL WHITENING TP ORIGINAL MINT
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53567-0033
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.14 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SODIUM PERBORATE TETRAHYDRATE (UNII: 822HSQ655R)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
MAGNESIUM CARBONATE (UNII: 0E53J927NA)
STARCH, CORN (UNII: O8232NY3SJ)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM LAURYL SULFOACETATE (UNII: D0Y70F2B9J)
CALCIUM CARBONATE (UNII: H0G9379FGK)
CALCIUM PEROXIDE (UNII: 7FRO2ENO91)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)

Product Characteristics
Color	white (Opaque White)	Score
Shape		Size
Flavor	PEPPERMINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53567-0033-1	40 g in 1 TUBE; Type 0: Not a Combination Product	10/15/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M021	10/15/2024

Labeler - Robell Research, Inc (155571656)

Registrant - Lornamead, Inc (080046418)

Establishment
Name	Address	ID/FEI	Business Operations
Lornamead, Inc		080046418	manufacture(53567-0033) , pack(53567-0033)