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

water, sorbitol, hydrated silica, xylitol, glycerin, lauryl glucoside, disodium 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 - 113 g Tube Carton

THE ORIGINAL
Tom's
OF MAINE

NOT TESTED ON
• ANIMALS •

NATURAL • WITH FLUORIDE

ACTIVATED
CHARCOAL
anticavity toothpaste

WHITENS TEETH*

GENTLY REMOVES
SURFACE STAINS

PREVENTS CAVITIES

NO
ANIMAL TESTING, SLS,
ARTIFICIAL FLAVORS,
SWEETENERS OR DYES

PEPPERMINT

4.0 OZ (113 g)

PRINCIPAL DISPLAY PANEL - 113 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)  
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 CARTON09/30/2023
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)

Revised: 10/2023
Document Id: a6329472-22d4-4d85-9a3f-021a5486bd8e
Set id: b9e6e455-8444-4805-89f1-ee9142f98e36
Version: 7
Effective Time: 20231002
 
Tom's of Maine, Inc.