LONG-LASTING WICKED FRESH - SPEARMINT ICE- 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, sodium lauryl sulfate, natural flavors, 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

spearmint ice

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 - SPEARMINT ICE 
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51009-145
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium monofluorophosphate (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.0076  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)  
Spearmint Oil (UNII: C3M81465G5)  
Peppermint Oil (UNII: AV092KU4JH)  
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
Sodium Lauryl Sulfate (UNII: 368GB5141J)  
Anise (UNII: 21C2F5E8RE)  
Eucalyptus Oil (UNII: 2R04ONI662)  
Glycyrrhizin (UNII: 6FO62043WK)  
Licorice (UNII: 61ZBX54883)  
Vanillin (UNII: CHI530446X)  
Clove oil (UNII: 578389D6D0)  
Cinnamyl Alcohol (UNII: SS8YOP444F)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorSPEARMINT (Spearmint Ice) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51009-145-061 in 1 BOX11/30/200906/05/2014
1147.4 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35511/30/200906/05/2014
Labeler - Tom's of Maine, Inc. (052764354)

Revised: 9/2019
Document Id: 13c17ec2-efe3-4390-bd30-8a210aad74b8
Set id: 075d7863-4c69-4096-af1c-b6f0c0247fb9
Version: 2
Effective Time: 20190906
 
Tom's of Maine, Inc.