Label: TOMS NATURAL FLUORIDE-FREE STRENGTH SENSITIVE WINTERMINT CLINICALLY PROVEN TO REDUCE PAINFUL SENSITIVITY / NO ARTIFICIAL DYES OR SWEETENERS- potassium nitrate paste, dentifrice
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Contains inactivated NDC Code(s)
NDC Code(s): 51009-214-40 - Packager: Tom's of Maine, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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.
Drug Label Information
Updated April 20, 2015
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Use
- Warnings
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Directions
- adults and children 12 years of age and older apply at least a 1-inch strip of the product onto a soft bristle toothbrush. Brush teeth thoroughly at least 1 minute twice a day (morning and evening) or as recommended by a dentist or physician. Make sure to brush all sensitive areas of the teeth.
- children under 12 years of age: consult a dentist or physician
- Inactive ingredients
- Questions?
- PRINCIPAL DISPLAY PANEL - 113 g Tube Carton
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INGREDIENTS AND APPEARANCE
TOMS NATURAL FLUORIDE-FREE STRENGTH SENSITIVE WINTERMINT CLINICALLY PROVEN TO REDUCE PAINFUL SENSITIVITY / NO ARTIFICIAL DYES OR SWEETENERS
potassium nitrate paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51009-214 Route of Administration DENTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE 0.05 g in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) XYLITOL (UNII: VCQ006KQ1E) GLYCERIN (UNII: PDC6A3C0OX) METHYL SALICYLATE (UNII: LAV5U5022Y) SODIUM LAURYL SULFATE (UNII: 368GB5141J) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) XANTHAN GUM (UNII: TTV12P4NEE) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color WHITE Score Shape Size Flavor MINT (Wintermint) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51009-214-40 1 in 1 CARTON 05/01/2015 1 113 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part356 05/01/2015 Labeler - Tom's of Maine, Inc. (052764354) Establishment Name Address ID/FEI Business Operations Tom's of Maine, Inc. 829517189 MANUFACTURE(51009-214)