SUPERSMILE- 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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Supersmile - Original Mint

Active Ingredient:

Sodium Monoflurophosphate

(0.14% w/v Fluoride Ion)

Purpose:

Anticavity toothpaste

Uses:

Aids in the prevention of dental cavities.

Warnings:

Keep out of reach of children under 6 years old. If you accidentally swallow more than used for brushing, get medical help or call a Poison Control Center right away.

Directions:

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. Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 2 years of age: Consult a dentist or a doctor.

Inactive Ingredients:

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

Principal Display Panel

supersmile®

ORIGINAL MINT

professional

whitening

toothpaste

contains fluoride.

Net wt. 4.2 oz / 119 g

supersmile_originalmint_image

SUPERSMILE
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:53567-0552
Route of Administration	ORAL, DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.4 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
CALCIUM PEROXIDE (UNII: 7FRO2ENO91)
SODIUM PERBORATE TETRAHYDRATE (UNII: 822HSQ655R)
STARCH, CORN (UNII: O8232NY3SJ)
MAGNESIUM CARBONATE (UNII: 0E53J927NA)
SODIUM LAURYL SULFOACETATE (UNII: D0Y70F2B9J)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
MINT (UNII: FV98Z8GITP)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
CALCIUM CARBONATE (UNII: H0G9379FGK)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT (ORIGINAL MINT)	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:53567-0552-3	6 g in 1 TUBE; Type 0: Not a Combination Product	05/01/2013
2	NDC:53567-0552-2	1 in 1 BOX	05/01/2013
2		119 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC:53567-0552-1	1 in 1 BOX	05/01/2013
3		40 g in 1 TUBE; Type 1: Convenience Kit of Co-Package
4	NDC:53567-0552-8	227 g in 1 TUBE; Type 0: Not a Combination Product	03/06/2018
5	NDC:53567-0552-4	70.8 g in 1 TUBE; Type 0: Not a Combination Product	12/11/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	05/01/2013

Labeler - Robell Research, Inc. (155571656)

Revised: 8/2022

Document Id: e6fe1aee-a52a-e008-e053-2a95a90af202

Set id: 87489290-c2de-4fee-97b5-3639374e0eeb

Version: 14

Effective Time: 20220824

Robell Research, Inc.