NATURAL FLUORIDE FRESH MINT  CAVITY PROTECTION WHITENING FRESH BREATH- 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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Natural Fluoride Toothpaste, Fresh Mint
cavity protection / whitening / fresh breath

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, carrageenan.


1
Peppermint oil and other natural flavor

Questions?

1-800-FOR-TOMS (1-800-367-8667) M - F 8:30 a.m. - 5 p.m. ET

PRINCIPAL DISPLAY PANEL - 85 g Tube

SINCE 1970
Tom's®
OF MAINE

natural
fluoride
TOOTHPASTE
cavity protection | whitening | fresh breath

fresh mint

NET WT 3 OZ (85 g)

Principal Display Panel
NATURAL FLUORIDE FRESH MINT   CAVITY PROTECTION WHITENING FRESH BREATH
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51009-238
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE0.00243 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL (UNII: 506T60A25R)  
WATER (UNII: 059QF0KO0R)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
GLYCERIN (UNII: PDC6A3C0OX)  
XYLITOL (UNII: VCQ006KQ1E)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
XANTHAN GUM (UNII: TTV12P4NEE)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
CARRAGEENAN (UNII: 5C69YCD2YJ)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorMINT (Fresh Mint) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51009-238-5985 g in 1 TUBE; Type 0: Not a Combination Product09/01/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35509/01/2012
Labeler - Tom's of Maine, Inc. (052764354)

Revised: 12/2022
Document Id: ad655c58-f689-42bd-95b1-974980ba633b
Set id: fce5e8b5-34f8-4a45-a662-82c903419809
Version: 3
Effective Time: 20221213
 
Tom's of Maine, Inc.