SIMPLY WHITE  CLEAN MINT- 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
OF MAINE
SIMPLY WHITE®
fluoride toothpaste
clean mint

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

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

1
peppermint oil and other natural flavor

Questions?

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

PRINCIPAL DISPLAY PANEL - 113 g Tube Carton

THE ORIGINAL
Tom's
OF MAINE

ADA
Accepted
American
Dental
Association ®

NATURAL • WITH FLUORIDE

SIMPLY
WHITE®

anticavity toothpaste

CLEAN MINT

4.0 OZ (113 g)

CLINICALLY PROVEN
WHITENING

REMINERALIZES ENAMEL

PREVENTS CAVITIES

NO
ANIMAL TESTING,
ARTIFICIAL FLAVORS,
SWEETENERS OR DYES

PRINCIPAL DISPLAY PANEL - 113 g Tube Carton
SIMPLY WHITE   CLEAN MINT
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51009-248
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)  
XANTHAN GUM (UNII: TTV12P4NEE)  
CARRAGEENAN (UNII: 5C69YCD2YJ)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorMINT (Clean Mint) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51009-248-471 in 1 CARTON08/29/2011
1133 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:51009-248-401 in 1 CARTON09/30/2023
2113 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35508/29/2011
Labeler - Tom's of Maine, Inc. (052764354)

Revised: 10/2023
Document Id: 63a0c641-c741-47d2-9c57-8c5ecaf2b3b3
Set id: 204a3eec-3d91-456d-bc15-51363f25e711
Version: 4
Effective Time: 20231003
 
Tom's of Maine, Inc.