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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Tom's® Whole Care® Spearmint Gel
fights cavities | whitening | fresh breath | helps fight tartar

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, carrageenan.


1
spearmint 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

spearmint gel

NET WT 4.7 OZ (133 g)

Principal Display Panel - 133 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:51009-207
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)  
Hydrated Silica (UNII: Y6O7T4G8P9)  
Sorbitol (UNII: 506T60A25R)  
Xylitol (UNII: VCQ006KQ1E)  
Glycerin (UNII: PDC6A3C0OX)  
Sodium Lauryl Sulfate (UNII: 368GB5141J)  
Spearmint Oil (UNII: C3M81465G5)  
ZINC CITRATE TRIHYDRATE (UNII: GNM26GAX7R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Peppermint Oil (UNII: AV092KU4JH)  
Carrageenan (UNII: 5C69YCD2YJ)  
Product Characteristics
ColorWHITE (Off white) Score    
ShapeSize
FlavorSPEARMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51009-207-471 in 1 CARTON08/12/2014
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 FINALpart35508/12/2014
Labeler - Tom's of Maine, Inc. (052764354)
Establishment
NameAddressID/FEIBusiness Operations
Tom's of Maine, Inc.829517189MANUFACTURE(51009-207)

Revised: 9/2019
Document Id: 61845078-4ca9-4887-8bfa-5c2af3a8eaa9
Set id: 30417c17-27c5-4b3d-8501-b900f6c8185b
Version: 2
Effective Time: 20190913
 
Tom's of Maine, Inc.