PEPPERMINT CHARCOAL ANTICAVITY PCFT6  GENTLY WHITENS TEETH / FIGHTS CAVITIES / SAFE FOR ENAMEL / SAFE FOR EVERYDAY USE- sodium fluoride 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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Peppermint Charcoal Anticavity PCFT6
gently whitens teeth / fights cavities / safe for enamel / safe for everyday use

Drug Facts

Active ingredient

Sodium fluoride 0.24% (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

hydrated silica, water, sorbitol, glycerin, xylitol, lauryl glucoside, sodium cocoyl glutamate, natural flavor1, benzyl alcohol, charcoal powder, xanthan gum, carrageenan, Rebaudioside A.

1
peppermint oil and other natural flavor

Questions?

1-800-FOR-TOMS (1-800-367-8667)

PRINCIPAL DISPLAY PANEL - 133 g Tube Carton

SINCE 1970
Tom's®
OF MAINE

natural
with fluoride | sls-free

ACTIVATED CHARCOAL

anticavity toothpaste

gently whitens teeth | fights cavities
safe for enamel | safe for everyday use

peppermint

with
plant-based
activated
charcoal

4.7 OZ (133 g)

PRINCIPAL DISPLAY PANEL - 133 g Tube Carton
PEPPERMINT CHARCOAL ANTICAVITY PCFT6   GENTLY WHITENS TEETH / FIGHTS CAVITIES / SAFE FOR ENAMEL / SAFE FOR EVERYDAY USE
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51009-900
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.0024 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
GLYCERIN (UNII: PDC6A3C0OX)  
XYLITOL (UNII: VCQ006KQ1E)  
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
ACTIVATED CHARCOAL (UNII: 2P3VWU3H10)  
XANTHAN GUM (UNII: TTV12P4NEE)  
CARRAGEENAN (UNII: 5C69YCD2YJ)  
REBAUDIOSIDE A (UNII: B3FUD0528F)  
Product Characteristics
ColorBLACKScore    
ShapeSize
FlavorPEPPERMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51009-900-471 in 1 CARTON12/18/2018
1133 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:51009-900-401 in 1 CARTON07/13/2020
2113 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35512/18/2018
Labeler - Tom's of Maine, Inc. (052764354)
Registrant - Tom's of Maine, Inc. (829517189)
Establishment
NameAddressID/FEIBusiness Operations
Tom's of Maine, Inc.829517189MANUFACTURE(51009-900)

Revised: 11/2019
Document Id: d2713fe9-5309-47d4-9992-ce6962eb7f0d
Set id: b9e6e455-8444-4805-89f1-ee9142f98e36
Version: 5
Effective Time: 20191108
 
Tom's of Maine, Inc.