LONG-LASTING WICKED FRESH - COOL PEPPERMINT- sodium monofluorophosphate 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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natural care
Tom's
of Maine®

Drug Facts

Active ingredient

Sodium monofluorophosphate 0.76% (0.14% w/v fluoride ion)

Purpose

Anticavity

Use

aids in the prevention of dental 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

glycerin, water, hydrated silica, calcium carbonate, xylitol, natural flavors, sodium lauryl sulfate, Chondrus crispus (carrageenan), Glycyrrhiza uralensis (licorice) root extract.

Questions?

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

© 2009 Tom's of Maine, Inc., 302 Lafayette Ctr.,
Kennebunk, ME 04043 Made in U.S.A.

PRINCIPAL DISPLAY PANEL - 147.4g Box

cool peppermint

new!

natural
care
Tom's
of Maine®

LONG-LASTING
wicked fresh!

fresh breath anticavity toothpaste
with fluoride

NET WT 147.4g (5.2 OZ)

Principal Display Panel - 147.4g Box
LONG-LASTING WICKED FRESH - COOL PEPPERMINT 
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51009-146
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium monofluorophosphate (UNII: C810JCZ56Q) (Sodium cation - UNII:LYR4M0NH37) Sodium monofluorophosphate0.0076  g  in 1 g
Inactive Ingredients
Ingredient NameStrength
Glycerin (UNII: PDC6A3C0OX)  
Water (UNII: 059QF0KO0R)  
Calcium carbonate (UNII: H0G9379FGK)  
Xylitol (UNII: VCQ006KQ1E)  
Silicon Dioxide (UNII: ETJ7Z6XBU4)  
Carrageenan (UNII: 5C69YCD2YJ)  
Peppermint Oil (UNII: AV092KU4JH)  
Menthol (UNII: L7T10EIP3A)  
Sodium Lauryl Sulfate (UNII: 368GB5141J)  
Anise Seed (UNII: 21C2F5E8RE)  
Eucalyptus Oil (UNII: 2R04ONI662)  
Licorice (UNII: 61ZBX54883)  
Vanillin (UNII: CHI530446X)  
Cinnamyl Alcohol (UNII: SS8YOP444F)  
Clove oil (UNII: 578389D6D0)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorPEPPERMINT (Cool Peppermint) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51009-146-061 in 1 BOX
1147.4 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33511/30/2009
Labeler - Tom's of Maine, Inc. (052764354)
Establishment
NameAddressID/FEIBusiness Operations
Tom's of Maine, Inc.052764354MANUFACTURE

Revised: 11/2009
Document Id: 9ec12240-a65a-4f5d-8059-f33e5b283adc
Set id: 9a74262a-e532-4ce1-801a-99f0253940ba
Version: 1
Effective Time: 20091109
 
Tom's of Maine, Inc.