TOMS BAKING SODA CAVITY PROTECTION PEPPERMINT  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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Tom's Baking Soda Cavity Protection Peppermint 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, sodium bicarbonate, xylitol, sodium lauryl sulfate, natural flavor1, carrageenan, benzyl alcohol.


1
peppermint 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
®

baking soda | natural

CAVITY PROTECTION

fluoride toothpaste
fights cavities | fresh breath
no artificial dyes or sweeteners

peppermint

NET WT 5.5 OZ (155.9 g)

Principal Display Panel - 155.9 g Tube Carton
TOMS BAKING SODA CAVITY PROTECTION PEPPERMINT   FIGHTS CAVITIES / FRESH BREATH
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51009-211
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)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
XYLITOL (UNII: VCQ006KQ1E)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
CARRAGEENAN (UNII: 5C69YCD2YJ)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
Product Characteristics
ColorWHITE (Chalk white) Score    
ShapeSize
FlavorPEPPERMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51009-211-551 in 1 CARTON12/31/201412/02/2021
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 FINALpart35512/31/201412/02/2021
Labeler - Tom's of Maine, Inc. (052764354)

Revised: 12/2022
 
Tom's of Maine, Inc.