CAVITY PROTECTION  PEPPERMINT WITH BAKING SODA- sodium monofluorophosphate paste, dentifrice 
CAVITY PROTECTION  SPEARMINT- 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
CAVITY PROTECTION
fluoride toothpaste

Drug Facts

Active ingredient

Sodium monofluorophosphate 0.76% (0.15% 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

calcium carbonate, water, glycerin, sodium bicarbonate, Chondrus crispus (carrageenan), Mentha piperita (peppermint) oil, xylitol, sodium lauryl sulfate.

Questions?

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

PRINCIPAL DISPLAY PANEL - 155.9 g Carton

SINCE 1970
Tom's
OF MAINE™

baking soda ∣ natural

CAVITY PROTECTION

fights cavities ∣ fresh breath

fluoride toothpaste

peppermint

ADA
Accepted
American
Dental
Association ®

NET WT 5.5 OZ (155.9 g)

Principal Display Panel - 155.9 g Carton

PRINCIPAL DISPLAY PANEL - 155.9 g Carton

SINCE 1970
Tom's
OF MAINE™

natural

CAVITY PROTECTION

fights cavities ∣ fresh breath

fluoride toothpaste

spearmint

ADA
Accepted
American
Dental
Association ®

NET WT 5.5 OZ (155.9 g)

Principal Display Panel - 155.9 g Carton
CAVITY PROTECTION   PEPPERMINT WITH BAKING SODA
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51009-120
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
Calcium carbonate (UNII: H0G9379FGK)  
Glycerin (UNII: PDC6A3C0OX)  
Water (UNII: 059QF0KO0R)  
Sodium Bicarbonate (UNII: 8MDF5V39QO)  
Carrageenan (UNII: 5C69YCD2YJ)  
Xylitol (UNII: VCQ006KQ1E)  
Sodium Lauryl Sulfate (UNII: 368GB5141J)  
Peppermint oil (UNII: AV092KU4JH)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorPEPPERMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51009-120-551 in 1 CARTON
1155.9 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35502/14/2011
CAVITY PROTECTION   SPEARMINT
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51009-116
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
Calcium carbonate (UNII: H0G9379FGK)  
Glycerin (UNII: PDC6A3C0OX)  
Water (UNII: 059QF0KO0R)  
Xylitol (UNII: VCQ006KQ1E)  
Carrageenan (UNII: 5C69YCD2YJ)  
Sodium Lauryl Sulfate (UNII: 368GB5141J)  
Spearmint Oil (UNII: C3M81465G5)  
Peppermint oil (UNII: AV092KU4JH)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorSPEARMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51009-116-551 in 1 CARTON
1155.9 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: 5/2011
Document Id: 873dc868-9a54-452c-ae24-e090e8464a05
Set id: f1cba5ce-852e-424a-b274-4a514505156b
Version: 2
Effective Time: 20110510
 
Tom's of Maine, Inc.