TOMS LUMINOUS WHITE - SPEARMINT  FIGHTS CAVITIES WHITENING- 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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Tom's Luminous White™ Toothpaste - Spearmint
fights cavities | 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 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, glycerin, sorbitol, xylitol, sodium lauryl sulfate, natural flavor1, xanthan gum, titanium dioxide, carrageenan.

1
spearmint oil and other natural flavor

Questions?

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

PRINCIPAL DISPLAY PANEL - 133 g Tube Carton

New!

SINCE 1970
Tom's
OF MAINE®

with fluoride | natural

LUMINOUS WHITE™

anticavity fluoride toothpaste

Safe for Enamel
Clinically proven whitening technology
Helps prevent tartar build-up*

spearmint

NET WT
4.7 OZ (133 g)

PRINCIPAL DISPLAY PANEL - 133 g Tube Carton
TOMS LUMINOUS WHITE - SPEARMINT   FIGHTS CAVITIES WHITENING
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51009-220
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
WATER (UNII: 059QF0KO0R)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
SORBITOL (UNII: 506T60A25R)  
XYLITOL (UNII: VCQ006KQ1E)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SPEARMINT OIL (UNII: C3M81465G5)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
XANTHAN GUM (UNII: TTV12P4NEE)  
CARRAGEENAN (UNII: 5C69YCD2YJ)  
Product Characteristics
ColorWHITE (Nearly white) Score    
ShapeSize
FlavorSPEARMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51009-220-471 in 1 CARTON12/01/201612/11/2020
1133 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35512/01/201612/11/2020
Labeler - Tom's of Maine, Inc. (052764354)

Revised: 12/2022
Document Id: b98973e5-53b2-4e95-80dd-ef8e9f5ef29a
Set id: 7079e5ed-b797-4c0e-982e-023d3117f916
Version: 2
Effective Time: 20221219
 
Tom's of Maine, Inc.