NDC Code(s) : 53567-0722-2, 53567-0722-5
Packager : Robell Research, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

SupersmileSodium Monofluorophosphate PASTE, DENTIFRICE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53567-0722
Route of Administration DENTAL, ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM MONOFLUOROPHOSPHATE(UNII: C810JCZ56Q)
(FLUORIDE ION - UNII:Q80VPU408O) 		FLUORIDE ION1.4 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
SORBITOL(UNII: 506T60A25R)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE(UNII: O7TSZ97GEP)
SODIUM BICARBONATE(UNII: 8MDF5V39QO)
CALCIUM CARBONATE(UNII: H0G9379FGK)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
CARBOXYMETHYLCELLULOSE SODIUM(UNII: K679OBS311)
CALCIUM PEROXIDE(UNII: 7FRO2ENO91)
SODIUM PERBORATE(UNII: Y52BK1W96C)
STARCH, CORN(UNII: O8232NY3SJ)
MAGNESIUM CARBONATE(UNII: 0E53J927NA)
SODIUM LAURYL SULFOACETATE(UNII: D0Y70F2B9J)
METHYLPARABEN(UNII: A2I8C7HI9T)
SACCHARIN SODIUM(UNII: SB8ZUX40TY)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
Product Characteristics
Color Score
Shape Size
Flavor APPLE Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:53567-0722-21 in 1 BOX
1119 g in 1 TUBE
2NDC:53567-0722-514.2 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part355 01/01/2006

PRINCIPAL DISPLAY PANEL

supersmile®

GREEN APPLE

professional

whitening

toothpaste

Contains fluoride.

4.2 oz / 119 g

image description