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Supersmile

ROBELL RESEARCH, INC.

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active Ingredient:

Sodium Monoflurophosphate

(0.14% w/v Fluoride Ion)

Purpose:

Anticavity toothpaste

Uses:

Aids in the prevention of dental cavities.

Warnings:

As with all fluoride toothpastes,

If you accidentally swallow more than used for brushing, get medical help or call a Poison Control Center right away.

Directions:

For best results: Brush teeth thoroughly after each meal, at least twice a day, or as directed by a dentist. 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 Phoshate 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

Created by,

​DR. ​IRWIN SMIGEL

​World Renowned

Father of Aesthetic

Dentistry

For best results, place a pearlsize drop of Whitening Toothpaste on a DRY toothbrush and brush in a circular motion for two minutes twice daily.

Three month supply (when used as directed)

​Whitens ​- Calprox® safely lifts surface stains, maintains and enhances the vibrancy of professionally bleached teeth, and restores bonding, caps, veneers and dentures to their original whiteness.

​Freshens ​- Lasting germicidal protection.

​Strengthens - ​Remineralizes tooth enamel.

​Protects ​- Fluoride prevents cavities.

​Safely ​- No harsh abrasives, no sensitivity.

STORE IN A COOL PLACE. RECYCLABLE

DETERMINE YOUR SMILE CARE NEEDS WITH A PERSONALIZED PROFILE AT WWW.SUPERSMILE.COM

QUESTIONS: 1-800-784-SMILE or INFO@SUPERSMILE.COM

© Robell Research, Inc., New York, NY 10022 Made in USA

Principal Display Panel

supersmile®

ORIGINAL MINT

professional

whitening

toothpaste

Contains fluoride.

4.2 oz / 119 g

Supersmile

Supersmile

Sodium Monofluorophosphate PASTE, DENTIFRICE

Product Information

Product Type Human otc drug label Item Code (Source) NDC:53567-0706
Route of Administration DENTAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
SODIUM MONOFLUOROPHOSPHATE FLUORIDE ION 1.4 mg

Inactive Ingredients

Ingredient Name Strength
water
sorbitol
DIBASIC CALCIUM PHOSPHATE DIHYDRATE
SODIUM BICARBONATE
CALCIUM CARBONATE
titanium dioxide
CARBOXYMETHYLCELLULOSE SODIUM
CALCIUM PEROXIDE
SODIUM PERBORATE
STARCH, CORN
MAGNESIUM CARBONATE
sodium lauryl sulfoacetate
METHYLPARABEN
saccharin sodium
PROPYLPARABEN

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:53567-0706-6 227 in 1 TUBE
2 NDC:53567-0706-3 6.0 in 1 TUBE
3 NDC:53567-0706-5 14 in 1 TUBE
4 NDC:53567-0706-8 40 in 1 TUBE
5 119 in 1 TUBE
6 50 in 1 TUBE
7 NDC:53567-0706-1 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part355 2006-01-01


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