TOMS SIMPLY WHITE FLUORIDE CLEAN MINT  WHITENING / CAVITY PROTECTION- 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® Simply White™ Fluoride Clean Mint Toothpaste
whitening / cavity protection

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 the 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 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, sodium hydroxide.

1
Peppermint oil and other natural flavor

Questions?

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

PRINCIPAL DISPLAY PANEL - 25 g Tube Free Sample Card

PRINCIPAL DISPLAY PANEL - 25 g Tube Free Sample Card
TOMS SIMPLY WHITE FLUORIDE CLEAN MINT   WHITENING / CAVITY PROTECTION
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51009-216
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
Silicon dioxide (UNII: ETJ7Z6XBU4)  
Water (UNII: 059QF0KO0R)  
Sorbitol (UNII: 506T60A25R)  
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)  
Sodium hydroxide (UNII: 55X04QC32I)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorPEPPERMINT (Clean Mint) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51009-216-0125 g in 1 TUBE; Type 0: Not a Combination Product04/01/201503/31/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35504/01/201503/31/2016
Labeler - Tom's of Maine, Inc. (052764354)

Revised: 12/2018
Document Id: 27847f9b-dc76-4476-b60b-4ae8635bf52c
Set id: 2e6b3d76-56d7-4913-998d-523ea147d32e
Version: 2
Effective Time: 20181210
 
Tom's of Maine, Inc.