Label: SUPERSMILE- sodium monofluorophosphate paste, dentifrice
- NDC Code(s): 53567-0722-2, 53567-0722-5
- Packager: Robell Research, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Updated November 12, 2012
If you are a consumer or patient please visit this version.
- Active Ingredient:
(0.14% w/v Fluoride Ion)Close
Aids in the prevention of dental cavities.Close
- As with all fluoride toothpastes, 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.Close
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.Close
- 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 ParabenClose
- SPL UNCLASSIFIED SECTION
Father of Aesthetic
For best results, place a pearl size 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 USAClose
- Principal Display Panel
4.2 oz / 119 g
- INGREDIENTS AND APPEARANCE
sodium monofluorophosphate paste, dentifrice
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53567-0722 Route of Administration DENTAL, ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 1.4 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 (Green Apple) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53567-0722-2 1 in 1 BOX 1 119 g in 1 TUBE 2 NDC:53567-0722-5 14.2 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 Labeler - Robell Research, Inc. (155571656)