Label: SUPERSMILE PROFESSIONAL WHITENING- sodium monofluorophosphate paste, dentifrice
- NDC Code(s): 53567-6044-2
- Packager: Robell Research, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
NOTE: Most over the counter (OTC) are not reviewed and approved by the 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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- Active Ingredient:
Sodium Monofluorophosphate (0.14% w/v Fluoride Ion)Close
Aids in the prevention of dental cavities.Close
As with all fluoride toothpastes,Close
- KEEP OUT OF REACH OF CHILDREN
children under 6 years old.Close
For best results: Brush teeth thoroughly after each meal, at least twice a day, or as directed by a dentist.Close
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 Phosphate 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
1-800 -784 -SMILEClose
- INGREDIENTS AND APPEARANCE
SUPERSMILE PROFESSIONAL WHITENING
toothpaste paste, dentifrice
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:53567-6044 Route of Administration DENTAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM MONOFLUOROPHOSPHATE (MONOFLUOROPHOSPHATE ION) MONOFLUOROPHOSPHATE ION 0.83 g in 100 g Inactive Ingredients Ingredient Name Strength WATER CALCIUM PEROXIDE SODIUM PERBORATE SODIUM BICARBONATE CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS CALCIUM CARBONATE MAGNESIUM CARBONATE STARCH, CORN SACCHARIN METHYLPARABEN PROPYLPARABEN TITANIUM DIOXIDE CARBOXYMETHYLCELLULOSE SODIUM SODIUM LAURYL SULFOACETATE Product Characteristics Color Score Shape Size Flavor MINT Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53567-6044-2 227 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part355 06/28/2011 Labeler - Robell Research, Inc. (155571656) Registrant - Loranmead (126440440) Establishment Name Address ID/FEI Business Operations Lornamead 126440440 manufacture(53567-6044), pack(53567-6044)