CLEAN AND GENTLE  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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Tom's
OF MAINE
CLEAN & GENTLE
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, organic Aloe barbadensis (aloe) leaf juice, xylitol, Chondrus crispus (carrageenan), Acacia senegal (acacia) gum, glycyrrhizic acid, Mentha piperita (peppermint) oil.

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

CLEAN & GENTLE

SLS-free | anticavity | whitening | fresh breath
fluoride toothpaste

peppermint

NET WT 4.7 OZ (133 g)

Principal Display Panel - 133 g Carton
CLEAN AND GENTLE   PEPPERMINT
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51009-107
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)  
Peppermint Oil (UNII: AV092KU4JH)  
Glycyrrhizin (UNII: 6FO62043WK)  
Aloe Vera Leaf (UNII: ZY81Z83H0X)  
Product Characteristics
ColorWHITE (Off-white) Score    
ShapeSize
FlavorPEPPERMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51009-107-471 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: 9302cac5-ef68-484a-b3ee-d120b4be4587
Set id: a6764c10-dc6f-493f-9502-8a6564e04477
Version: 1
Effective Time: 20110214
 
Tom's of Maine, Inc.