Label: SENSITIVE FLUORIDE-FREE - WINTERMINT- potassium nitrate paste, dentifrice
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Contains inactivated NDC Code(s)
NDC Code(s): 51009-197-04 - 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 September 12, 2019
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- SPL UNCLASSIFIED SECTION
- Active ingredients
- 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
SENSITIVE FLUORIDE-FREE - WINTERMINT
potassium nitrate paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51009-197 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 sorbitol (UNII: 506T60A25R) hydrated silica (UNII: Y6O7T4G8P9) xylitol (UNII: VCQ006KQ1E) glycerin (UNII: PDC6A3C0OX) water (UNII: 059QF0KO0R) cocamidopropyl betaine (UNII: 5OCF3O11KX) sodium lauryl sulfate (UNII: 368GB5141J) xanthan gum (UNII: TTV12P4NEE) peppermint oil (UNII: AV092KU4JH) titanium dioxide (UNII: 15FIX9V2JP) spearmint oil (UNII: C3M81465G5) menthol, unspecified form (UNII: L7T10EIP3A) glycyrrhizin (UNII: 6FO62043WK) star anise oil (UNII: 6RXP35EIRE) methyl salicylate (UNII: LAV5U5022Y) aloe vera leaf (UNII: ZY81Z83H0X) Product Characteristics Color WHITE Score Shape Size Flavor WINTERGREEN (Wintermint) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51009-197-04 1 in 1 CARTON 09/01/2009 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 09/01/2009 Labeler - Tom's of Maine, Inc. (052764354) Establishment Name Address ID/FEI Business Operations Tom's of Maine, Inc. 829517189 MANUFACTURE(51009-197)