TOMS NATURAL ENAMEL STRENGTH PEPPERMINT  STRENGTHENS ENAMEL / WHITENING / FIGHTS CAVITIES / FRESHENS BREATH / NO ARTIFICIAL DYES OR SWEETENERS- sodium fluoride 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® Natural Enamel Strength® Peppermint Toothpaste
strengthens enamel / whitening / fights cavities / freshens breath / no artificial dyes or sweeteners

Drug Facts

Active ingredient

Sodium fluoride 0.24% (0.15% 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

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

1
peppermint 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

ADA
Accepted
American
Dental
Association ®

with fluoride
natural

ENAMEL STRENGTH®

fluoride toothpaste

strengthens enamel | whitening
fights cavities | freshens breath
no artificial dyes or sweeteners

peppermint

NET WT 4.0 OZ (113 g)

PRINCIPAL DISPLAY PANEL - 113 g Tube Carton
TOMS NATURAL ENAMEL STRENGTH PEPPERMINT   STRENGTHENS ENAMEL / WHITENING / FIGHTS CAVITIES / FRESHENS BREATH / NO ARTIFICIAL DYES OR SWEETENERS
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51009-209
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.00243 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
GLYCERIN (UNII: PDC6A3C0OX)  
XYLITOL (UNII: VCQ006KQ1E)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
XANTHAN GUM (UNII: TTV12P4NEE)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
CARRAGEENAN (UNII: 5C69YCD2YJ)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorPEPPERMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51009-209-401 in 1 CARTON12/17/2014
1113 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35512/17/2014
Labeler - Tom's of Maine, Inc. (052764354)
Establishment
NameAddressID/FEIBusiness Operations
Tom's of Maine, Inc.829517189MANUFACTURE(51009-209)

Revised: 12/2014
Document Id: 0c78d933-6641-4a77-a0e6-3fd8fb78846c
Set id: 5d351cae-6ba5-446a-9f93-3e758103c50b
Version: 2
Effective Time: 20141204
 
Tom's of Maine, Inc.