TOMS WICKED FRESH COOL PEPPERMINT  FRESH BREATH / CAVITY PROTECTION- 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 Wicked Fresh® Cool Peppermint Toothpaste
fresh breath / cavity protection

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, xylitol, hydrated silica, natural flavor1, sodium lauryl sulfate, carrageenan, benzyl alcohol, Glycyrrhiza glabra (Licorice) root extract.

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
Toms's
OF MAINE

NOT TESTED ON
• ANIMALS •

NATURAL • WITH FLUORIDE

WICKED
FRESH!®

anticavity toothpaste

COOL PEPPERMINT

4.0 OZ (113 g)

CLINICALLY PROVEN
TO FRESHEN BREATH

FIGHTS CAVITIES

BLOCKS BAD BREATH

NO
ANIMAL TESTING,
ARTIFICIAL FLAVORS,
SWEETENERS OR DYES

PRINCIPAL DISPLAY PANEL - 113 g Tube Carton
TOMS WICKED FRESH COOL PEPPERMINT   FRESH BREATH / CAVITY PROTECTION
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51009-205
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.4 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
CALCIUM CARBONATE (UNII: H0G9379FGK)  
XYLITOL (UNII: VCQ006KQ1E)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
CARRAGEENAN (UNII: 5C69YCD2YJ)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
LICORICE (UNII: 61ZBX54883)  
Product Characteristics
ColorWHITE (Off white) Score    
ShapeSize
FlavorPEPPERMINT (Cool Peppermint) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51009-205-471 in 1 CARTON06/06/2014
1133 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:51009-205-401 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 FINALpart35508/08/2013
Labeler - Tom's of Maine, Inc. (052764354)

Revised: 10/2023
Document Id: 39836806-e9ee-491d-a493-d99223f68a05
Set id: 1c029b10-29b0-4131-9134-cebfca4328a3
Version: 5
Effective Time: 20231004
 
Tom's of Maine, Inc.