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Toms Whole Care Peppermint fights cavities / whitening / fresh breath / helps fight tartar

Dosage form: paste, dentifrice
Ingredients: Sodium monofluorophosphate 1.4mg in 1g
Labeler: Tom's of Maine, Inc.
NDC Code: 51009-208

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.

Tom's® Whole Care® Peppermint 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 flavor, sodium lauryl sulfate, zinc citrate, xanthan gum, benzyl alcohol, carrageenan.


peppermint 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

peppermint gel

NET WT 4.7 OZ (133 g)

TOMS WHOLE CARE PEPPERMINT   FIGHTS CAVITIES / WHITENING / FRESH BREATH / HELPS FIGHT TARTAR
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51009-208
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium monofluorophosphate (Fluoride ion) Fluoride ion1.4 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Water 
Hydrated Silica 
Sorbitol 
Xylitol 
Glycerin 
Peppermint Oil 
Sodium Lauryl Sulfate 
ZINC CITRATE TRIHYDRATE 
XANTHAN GUM 
BENZYL ALCOHOL 
Carrageenan 
Product Characteristics
ColorWHITE (Off white) Score    
ShapeSize
FlavorPEPPERMINTImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:51009-208-471 TUBE in 1 CARTON
1133 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35508/11/2014
Labeler - Tom's of Maine, Inc. (052764354)
Establishment
NameAddressID/FEIOperations
Tom's of Maine, Inc.829517189MANUFACTURE(51009-208)

Revised: 08/2014
 
Tom's of Maine, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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