Label: TOMS WHOLE CARE WINTERMINT FIGHTS CAVITIES / WHITENING / FRESH BREATH / HELPS FIGHT TARTAR / NO ARTIFICIAL DYES OR SWEETENERS- sodium monofluorophosphate paste, dentifrice
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Contains inactivated NDC Code(s)
NDC Code(s): 51009-212-47 - Packager: Tom's of Maine, 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.
Drug Label Information
Updated February 13, 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 2 years of age and older brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician children 2 to 6 years use only a pea-sized amount and supervise child's brushing and rinsing (to minimize swallowing) children under 2 years ask a dentist or physician - Inactive ingredients
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- PRINCIPAL DISPLAY PANEL - 133 g Tube Carton
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INGREDIENTS AND APPEARANCE
TOMS WHOLE CARE WINTERMINT FIGHTS CAVITIES / WHITENING / FRESH BREATH / HELPS FIGHT TARTAR / NO ARTIFICIAL DYES OR SWEETENERS
sodium monofluorophosphate paste, dentifriceProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51009-212 Route of Administration DENTAL 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) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SORBITOL (UNII: 506T60A25R) XYLITOL (UNII: VCQ006KQ1E) GLYCERIN (UNII: PDC6A3C0OX) METHYL SALICYLATE (UNII: LAV5U5022Y) SODIUM LAURYL SULFATE (UNII: 368GB5141J) ZINC CITRATE (UNII: K72I3DEX9B) XANTHAN GUM (UNII: TTV12P4NEE) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) CARRAGEENAN (UNII: 5C69YCD2YJ) Product Characteristics Color WHITE (Off White) Score Shape Size Flavor WINTERGREEN (Wintermint) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51009-212-47 1 in 1 CARTON 03/01/2015 1 133 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 FINAL part355 03/01/2015 Labeler - Tom's of Maine, Inc. (052764354) Establishment Name Address ID/FEI Business Operations Tom's of Maine, Inc. 829517189 MANUFACTURE(51009-212)