Toms® Cavity Protection Spearmint Toothpaste Fights cavities | Fresh Breath

Drug Labeling and Warnings

Drug Details [pdf]

TOMS CAVITY PROTECTION SPEARMINT  FIGHTS CAVITIES / FRESH BREATH- 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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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 flavor1, carrageenan, sodium bicarbonate.


  • 1 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)

    PRINCIPAL DISPLAY PANEL - 155.9 Tube Carton
    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 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
    Calcium carbonate (UNII: H0G9379FGK)  
    Water (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    Xylitol (UNII: VCQ006KQ1E)  
    Sodium Lauryl Sulfate (UNII: 368GB5141J)  
    Carrageenan (UNII: 5C69YCD2YJ)  
    Spearmint Oil (UNII: C3M81465G5)  
    Sodium Bicarbonate (UNII: 8MDF5V39QO)  
    Peppermint oil (UNII: AV092KU4JH)  
    Product Characteristics
    ColorWHITE (Chalk white) Score    
    ShapeSize
    FlavorSPEARMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 51009-199-551 in 1 CARTON02/20/201311/30/2014
    1155.9 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35502/20/201311/30/2014
    Labeler - Tom's of Maine, Inc. (052764354)

    Revised: 9/2019
     

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