LONG-LASTING WICKED FRESH - COOL PEPPERMINT- sodium monofluorophosphate paste, dentifrice 
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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Tom's
OF MAINE™
WICKED FRESH!™
fluoride toothpaste

Drug Facts

Active ingredient

Sodium monofluorophosphate 0.76% (0.14% 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

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

Questions?

1-800-FOR-TOMS (1-800-367-8667) M - F 8:30 a.m. - 5:30 p.m. ET

PRINCIPAL DISPLAY PANEL - 133 g Carton

SINCE 1970
Tom's
OF MAINE™

long-lasting | natural

WICKED FRESH!™

cavity protection | fresh breath

fluoride toothpaste

cool peppermint

NET WT 4.7 OZ (133 g)

Principal Display Panel - 133 g Carton

PRINCIPAL DISPLAY PANEL - 133 g Carton

SINCE 1970
Tom's
OF MAINE™

long-lasting | natural

WICKED FRESH!™

cavity protection | fresh breath

fluoride toothpaste

spearmint ice

NET WT 4.7 OZ (133 g)

Principal Display Panel - 133 g Carton
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) (Fluoride Ion - UNII:Q80VPU408O) Sodium monofluorophosphate.0076 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
Glycerin (UNII: PDC6A3C0OX)  
Water (UNII: 059QF0KO0R)  
Calcium carbonate (UNII: H0G9379FGK)  
Xylitol (UNII: VCQ006KQ1E)  
Hydrated Silica (UNII: Y6O7T4G8P9)  
Carrageenan (UNII: 5C69YCD2YJ)  
Sodium Lauryl Sulfate (UNII: 368GB5141J)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorPEPPERMINT (Cool Peppermint) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51009-146-471 in 1 CARTON
1133 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35505/06/2011
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) Sodium monofluorophosphate.0076 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
Glycerin (UNII: PDC6A3C0OX)  
Water (UNII: 059QF0KO0R)  
Calcium carbonate (UNII: H0G9379FGK)  
Xylitol (UNII: VCQ006KQ1E)  
Hydrated Silica (UNII: Y6O7T4G8P9)  
Carrageenan (UNII: 5C69YCD2YJ)  
Sodium Lauryl Sulfate (UNII: 368GB5141J)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorSPEARMINT (Spearmint Ice) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51009-145-471 in 1 CARTON
1133 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35505/06/2011
Labeler - Tom's of Maine, Inc. (052764354)
Establishment
NameAddressID/FEIBusiness Operations
Tom's of Maine, Inc.052764354MANUFACTURE

Revised: 5/2011
Document Id: 380e2556-177d-4937-b2d1-7e3f8f819c80
Set id: 9d334e5b-4879-4195-96aa-9bb8df26712b
Version: 1
Effective Time: 20110509
 
Tom's of Maine, Inc.