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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SIMPLY WHITE®

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 flavors, xanthan gum, titanium dioxide, Chondrus crispus (carrageenan).

Questions?

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

© 2010 Tom's of Maine, Inc., 302 Lafayette Ctr., Kennebunk, ME 04043
Made in U.S.A.

PRINCIPAL DISPLAY PANEL - 133.2g Tube Carton

new!

SINCE 1970
Tom's
OF MAINE™

natural

SIMPLY WHITE®
whitening | cavity protection | fresh breath
fluoride toothpaste
clean mint

NET WT 133.2g (4.7 OZ)

Principal Display Panel - 133.2g Tube Carton
SIMPLY WHITE  CLEAN MINT
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51009-148
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium fluoride (UNII: 8ZYQ1474W7) (fluoride ion - UNII:Q80VPU408O) Sodium fluoride0.0024 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
Sorbitol (UNII: 506T60A25R)  
Water (UNII: 059QF0KO0R)  
Silicon Dioxide (UNII: ETJ7Z6XBU4)  
Glycerin (UNII: PDC6A3C0OX)  
Xylitol (UNII: VCQ006KQ1E)  
Sodium lauryl sulfate (UNII: 368GB5141J)  
Menthol (UNII: L7T10EIP3A)  
Xanthan gum (UNII: TTV12P4NEE)  
Peppermint oil (UNII: AV092KU4JH)  
Carrageenan (UNII: 5C69YCD2YJ)  
Spearmint oil (UNII: C3M81465G5)  
Titanium dioxide (UNII: 15FIX9V2JP)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorMINT (Clean Mint) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51009-148-471 in 1 CARTON
1133.2 g in 1 TUBE
2NDC:51009-148-011 in 1 CARTON
225 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35502/04/2011
Labeler - Tom's of Maine, Inc. (052764354)
Establishment
NameAddressID/FEIBusiness Operations
Tom's of Maine, Inc.052764354MANUFACTURE
Establishment
NameAddressID/FEIBusiness Operations
Colgate-Palmolive Canada, Inc.259157246MANUFACTURE

Revised: 2/2011
Document Id: 2aae47ad-fe31-4232-b786-bf5cf28f5fe0
Set id: 350597b0-c2a0-4d9a-89d3-4c5930f4909c
Version: 2
Effective Time: 20110203
 
Tom's of Maine, Inc.