TOMS WHOLE CARE SPEARMINT  FIGHTS CAVITIES WHITENING FRESH BREATH HELPS FIGHT TARTAR- 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® Spearmint Toothpaste

Drug Facts

Active ingredient

Sodium monofluorophosphate 0.76% (0.13% 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

glycerin, water, calcium carbonate, hydrated silica, xylitol, natural flavor1, sodium lauryl sulfate, carrageenan, zinc citrate, sodium bicarbonate, benzyl alcohol.


1
spearmint oil and other natural flavor

Questions?

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

PRINCIPAL DISPLAY PANEL - 113 g Tube Carton

SINCE 1970
Tom's
OF MAINE®

with fluoride | natural

WHOLE CARE®

anticavity toothpaste

6 BENEFITS

fights cavities | promotes remineralization
whitens teeth* | fights tartar buildup
freshens breath | strengthens enamel

4.0 OZ (113 g)

spearmint

Principal Display Panel - 113 g Tube Carton
TOMS WHOLE CARE SPEARMINT   FIGHTS CAVITIES WHITENING FRESH BREATH HELPS FIGHT TARTAR
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51009-203
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
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
CALCIUM CARBONATE (UNII: H0G9379FGK)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
XYLITOL (UNII: VCQ006KQ1E)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SPEARMINT OIL (UNII: C3M81465G5)  
CARRAGEENAN (UNII: 5C69YCD2YJ)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
ZINC CITRATE (UNII: K72I3DEX9B)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
Product Characteristics
ColorWHITE (Off white) Score    
ShapeSize
FlavorSPEARMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51009-203-471 in 1 CARTON06/06/201403/05/2021
1133 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:51009-203-041 in 1 CARTON11/15/2018
2113 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35506/06/2014
Labeler - Tom's of Maine, Inc. (052764354)

Revised: 12/2022
Document Id: 4c8f86d3-419b-4465-872e-af7c99dc8d79
Set id: ebb62015-0027-459a-a9cf-56b640f9f456
Version: 4
Effective Time: 20221206
 
Tom's of Maine, Inc.