TOMS WHOLE CARE WINTERMINT  FIGHTS CAVITIES / WHITENING / FRESH BREATH / HELPS FIGHT TARTAR / NO ARTIFICIAL DYES OR SWEETENERS- sodium monofluorophosphate paste, dentifrice 
Tom's of Maine, Inc.

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.

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Toms® Whole Care® Wintermint Toothpaste
fights cavities / whitening / fresh breath / helps fight tartar / no artificial dyes or sweeteners

Drug Facts

Active ingredient

Sodium monofluorophosphate 0.76% (0.14% w/v fluoride ion)

Purpose

Anticavity

Use

helps protect against cavities

Warnings

Keep out of reach of children under 6 years of age.

If more than used for brushing is accidentally swallowed, get medical help or dial (412) 390-3381 right away (Poison Control Center).

Directions

adults and children 2 years of age and olderbrush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician
children 2 to 6 yearsuse only a pea-sized amount and supervise child's brushing and rinsing (to minimize swallowing)
children under 2 yearsask a dentist or physician

Inactive ingredients

water, hydrated silica, sorbitol, xylitol, glycerin, natural flavor1, sodium lauryl sulfate, zinc citrate, xanthan gum, titanium dioxide, carrageenan.

1
wintergreen oil and other natural flavor

Questions?

1-800-FOR-TOMS (1-800-367-8667)

PRINCIPAL DISPLAY PANEL - 133 g Tube Carton

SINCE 1970
Tom's®
OF MAINE

with fluoride | natural

WHOLE CARE®

fluoride toothpaste
fights cavities | whitening | fresh breath | helps fight tartar
no artificial dyes or sweeteners

wintermint

NET WT 4.7 OZ (133 g)

Principal Display Panel - 133 g Tube Carton
TOMS WHOLE CARE WINTERMINT   FIGHTS CAVITIES / WHITENING / FRESH BREATH / HELPS FIGHT TARTAR / NO ARTIFICIAL DYES OR SWEETENERS
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51009-212
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.4 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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
ColorWHITE (Off White) Score    
ShapeSize
FlavorWINTERGREEN (Wintermint) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51009-212-471 in 1 CARTON03/01/2015
1133 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35503/01/2015
Labeler - Tom's of Maine, Inc. (052764354)
Establishment
NameAddressID/FEIBusiness Operations
Tom's of Maine, Inc.829517189MANUFACTURE(51009-212)

Revised: 2/2015
Document Id: a7b9fd75-129a-4272-87b9-b560e804b749
Set id: 3ecfc085-0d5b-4d92-9306-c0f45a5c0971
Version: 2
Effective Time: 20150213
 
Tom's of Maine, Inc.