TOMS NATURAL ANTICAVITY PEPPERMINT  FIGHTS CAVITIES FRESHENS BREATH STRENGTHENS ENAMEL- 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 Anticavity Peppermint

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®

New!

Super Value!

natural
Anticavity
fluoride toothpaste

fights cavities
freshens breath
strengthens enamel

NET WT
4 OZ (113g)

peppermint

PRINCIPAL DISPLAY PANEL - 113 g Tube Carton
TOMS NATURAL ANTICAVITY PEPPERMINT   FIGHTS CAVITIES FRESHENS BREATH STRENGTHENS ENAMEL
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51009-198
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:51009-198-401 in 1 CARTON
1113 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35501/01/2014
Labeler - Tom's of Maine, Inc. (052764354)
Establishment
NameAddressID/FEIBusiness Operations
Tom's of Maine, Inc.829517189MANUFACTURE(51009-198)

Revised: 1/2014
Document Id: ca0bfc99-fb07-418a-a697-d627885a7107
Set id: 300f7808-9dd3-47d9-9406-7daeb7a0d7b6
Version: 1
Effective Time: 20140116
 
Tom's of Maine, Inc.