WHOLE CARE  CINNAMON CLOVE- sodium monofluorophosphate paste, dentifrice 
WHOLE CARE  PEPPERMINT- sodium monofluorophosphate paste, dentifrice 
WHOLE CARE  SPEARMINT- sodium monofluorophosphate paste, dentifrice 
WHOLE CARE  WINTERMINT- 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
WHOLE CARE
fluoride toothpaste

Drug Facts

Active ingredient

Sodium monofluorophosphate 0.76% (0.13% 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, calcium carbonate, hydrated silica, xylitol, Chondrus crispus (carrageenan), sodium lauryl sulfate, sodium bicarbonate, zinc citrate, Cinnamomum cassia (cinnamon) leaf oil and other natural flavors.

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™

with fluoride | natural

WHOLE CARE®

fights cavities | whitening | fresh breath | helps fight tartar
fluoride toothpaste

cinnamon clove

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™

with fluoride | natural

WHOLE CARE®

fights cavities | whitening | fresh breath | helps fight tartar
fluoride toothpaste

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™

with fluoride | natural

WHOLE CARE®

fights cavities | whitening | fresh breath | helps fight tartar
fluoride toothpaste

spearmint

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™

with fluoride | natural

WHOLE CARE®

fights cavities | whitening | fresh breath | helps fight tartar
fluoride toothpaste

wintermint

NET WT 4.7 OZ (133 g)

Principal Display Panel - 133 g Carton
WHOLE CARE   CINNAMON CLOVE
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51009-100
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium monofluorophosphate (UNII: C810JCZ56Q) (fluoride ion - UNII:Q80VPU408O) Sodium monofluorophosphate0.0076 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
Glycerin (UNII: PDC6A3C0OX)  
Water (UNII: 059QF0KO0R)  
Calcium carbonate (UNII: H0G9379FGK)  
Hydrated Silica (UNII: Y6O7T4G8P9)  
Xylitol (UNII: VCQ006KQ1E)  
Carrageenan (UNII: 5C69YCD2YJ)  
Zinc citrate (UNII: K72I3DEX9B)  
Sodium Lauryl Sulfate (UNII: 368GB5141J)  
Cinnamon leaf oil (UNII: S92U8SQ71V)  
Clove oil (UNII: 578389D6D0)  
Clove stem oil (UNII: 9368YZM9M4)  
Product Characteristics
ColorWHITE (off-white) Score    
ShapeSize
FlavorCINNAMON (Cinnamon-Clove) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51009-100-471 in 1 CARTON
1133 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35502/14/2011
WHOLE CARE   PEPPERMINT
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51009-104
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium monofluorophosphate (UNII: C810JCZ56Q) (fluoride ion - UNII:Q80VPU408O) Sodium monofluorophosphate0.0076 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
Glycerin (UNII: PDC6A3C0OX)  
Water (UNII: 059QF0KO0R)  
Calcium carbonate (UNII: H0G9379FGK)  
Hydrated Silica (UNII: Y6O7T4G8P9)  
Xylitol (UNII: VCQ006KQ1E)  
Carrageenan (UNII: 5C69YCD2YJ)  
Zinc citrate (UNII: K72I3DEX9B)  
Sodium Lauryl Sulfate (UNII: 368GB5141J)  
Peppermint Oil (UNII: AV092KU4JH)  
Product Characteristics
ColorWHITE (off-white) Score    
ShapeSize
FlavorPEPPERMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51009-104-471 in 1 CARTON
1133 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35502/14/2011
WHOLE CARE   SPEARMINT
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51009-105
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium monofluorophosphate (UNII: C810JCZ56Q) (fluoride ion - UNII:Q80VPU408O) Sodium monofluorophosphate0.0076 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
Glycerin (UNII: PDC6A3C0OX)  
Water (UNII: 059QF0KO0R)  
Calcium carbonate (UNII: H0G9379FGK)  
Hydrated Silica (UNII: Y6O7T4G8P9)  
Xylitol (UNII: VCQ006KQ1E)  
Carrageenan (UNII: 5C69YCD2YJ)  
Zinc citrate (UNII: K72I3DEX9B)  
Sodium Lauryl Sulfate (UNII: 368GB5141J)  
Spearmint Oil (UNII: C3M81465G5)  
Peppermint Oil (UNII: AV092KU4JH)  
Product Characteristics
ColorWHITE (off-white) Score    
ShapeSize
FlavorSPEARMINT (Spearmint Ice) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51009-105-471 in 1 CARTON
1133 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35502/14/2011
WHOLE CARE   WINTERMINT
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51009-106
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium monofluorophosphate (UNII: C810JCZ56Q) (fluoride ion - UNII:Q80VPU408O) Sodium monofluorophosphate0.0076 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
Glycerin (UNII: PDC6A3C0OX)  
Water (UNII: 059QF0KO0R)  
Calcium carbonate (UNII: H0G9379FGK)  
Hydrated Silica (UNII: Y6O7T4G8P9)  
Xylitol (UNII: VCQ006KQ1E)  
Carrageenan (UNII: 5C69YCD2YJ)  
Zinc citrate (UNII: K72I3DEX9B)  
Sodium Lauryl Sulfate (UNII: 368GB5141J)  
Methyl salicylate (UNII: LAV5U5022Y)  
Peppermint Oil (UNII: AV092KU4JH)  
Product Characteristics
ColorWHITE (off-white) Score    
ShapeSize
FlavorMINT (Wintermint) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51009-106-471 in 1 CARTON
1133 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35502/14/2011
Labeler - Tom's of Maine, Inc. (052764354)
Establishment
NameAddressID/FEIBusiness Operations
Tom's of Maine, Inc.052764354MANUFACTURE

Revised: 2/2011
Document Id: 3452f64a-225d-428c-95d3-df5bd9c8d826
Set id: 7f20f8a0-75f9-4365-b00a-a53c6a35b448
Version: 1
Effective Time: 20110211
 
Tom's of Maine, Inc.