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Toms Cavity Protection Spearmint Fights cavities / Fresh Breath

Medically reviewed on June 26, 2017

Dosage form: paste, dentifrice
Ingredients: Sodium Monofluorophosphate 1.4mg in 1g
Labeler: Tom's of Maine, Inc.
NDC Code: 51009-199

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.

Toms® Cavity Protection Spearmint Toothpaste
Fights cavities | Fresh Breath

Drug Facts

Active ingredient

Sodium monofluorophosphate 0.76% (0.16% 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

calcium carbonate, water, glycerin, xylitol, sodium lauryl sulfate, natural flavor, carrageenan, sodium bicarbonate.


spearmint oil and other natural flavor

Questions?

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

PRINCIPAL DISPLAY PANEL - 155.9 g Tube Carton

SINCE 1970
Tom's
OF MAINE
®

natural

CAVITY PROTECTION

fluoride toothpaste
fights cavities | fresh breath

spearmint

ADA
Accepted
American
Dental
Association ®

NET WT 5.5 OZ (155.9 g)

TOMS CAVITY PROTECTION SPEARMINT   FIGHTS CAVITIES / FRESH BREATH
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51009-199
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
Calcium carbonate 
Water 
Glycerin 
Xylitol 
Sodium Lauryl Sulfate 
Carrageenan 
Spearmint Oil 
Sodium Bicarbonate 
Peppermint oil 
Product Characteristics
ColorWHITE (Chalk white) Score    
ShapeSize
FlavorSPEARMINTImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:51009-199-551 TUBE in 1 CARTON
1155.9 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35502/20/2013
Labeler - Tom's of Maine, Inc. (052764354)
Establishment
NameAddressID/FEIOperations
Tom's of Maine, Inc.829517189MANUFACTURE(51009-199)

 
Tom's of Maine, Inc.

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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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