TOMS LUMINOUS WHITE FLUORIDE CLEAN MINT  CAVITY PROTECTION / WHITENING- sodium fluoride paste, dentifrice 
Tom's of Maine, Inc.

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Tom's Luminous White Fluoride Clean Mint
cavity protection / whitening

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 older: brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician. children 2 to 6 years: use only a pea-sized amount and supervise child's brushing and rinsing (to minimize swallowing). children under 2 years: ask a dentist or physician.

inactive ingredients

water, hydrated silica, glycerin, sorbitol, xylitol, sodium lauryl sulfate, natural flavor1, xanthan gum, carrageenan, titanium dioxide.

1
peppermint oil and other natural flavor

PRINCIPAL DISPLAY PANEL - 113 g Tube Label

THE ORIGINAL
Tom's
OF MAINE

BEAUTIFUL SMILE.
BEAUTIFUL PLANET.

LUMINOUS
WHITE

4.0 OZ (113 g)

PRINCIPAL DISPLAY PANEL - 113 g Tube Label
TOMS LUMINOUS WHITE FLUORIDE CLEAN MINT   CAVITY PROTECTION / WHITENING
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51009-218
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.00243 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
SORBITOL (UNII: 506T60A25R)  
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
FlavorPEPPERMINT (Clean Mint) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51009-218-751 in 1 CARTON10/20/201712/29/2023
121 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:51009-218-401 in 1 CARTON11/13/2018
2113 g in 1 TUBE; Type 0: Not a Combination Product
3NDC:51009-218-2121 g in 1 TUBE; Type 0: Not a Combination Product07/25/201811/03/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph drugM02112/01/2015
Labeler - Tom's of Maine, Inc. (052764354)
Registrant - Tom's of Maine, Inc. (829517189)

Revised: 10/2023
Document Id: a293b163-41ec-4bec-a923-f54de9c5e2c0
Set id: 7d0bc7be-da6e-4c24-9be9-8a0b40f27960
Version: 7
Effective Time: 20231026
 
Tom's of Maine, Inc.