TOMS WICKED COOL FLUORIDE - MILD MINT  FIGHTS CAVITIES / STRENGTHENS ENAMEL / FRESHENS BREATH / DYE FREE- 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 Cool!® Fluoride Toothpaste - Mild Mint
fights cavities / strengthens enamel / freshens breath / dye free

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 the 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 older:brush 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, carrageenan, sodium lauryl sulfate, natural flavor1.

1
Peppermint oil and other natural flavor

Questions?

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

PRINCIPAL DISPLAY PANEL - 21.2 g Tube Free Sample Card

PRINCIPAL DISPLAY PANEL - 21.2 g Tube Free Sample Card
TOMS WICKED COOL FLUORIDE - MILD MINT   FIGHTS CAVITIES / STRENGTHENS ENAMEL / FRESHENS BREATH / DYE FREE
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51009-217
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)  
Hydrated Silica (UNII: Y6O7T4G8P9)  
Carrageenan (UNII: 5C69YCD2YJ)  
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:51009-217-0121.2 g in 1 TUBE; Type 0: Not a Combination Product04/01/201505/31/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35504/01/201505/31/2016
Labeler - Tom's of Maine, Inc. (052764354)

Revised: 12/2018
Document Id: ae21c57b-8a93-40ca-9ccf-96ec8781bf9e
Set id: f493d638-8759-41c8-84d4-8ac2eeebe3c8
Version: 2
Effective Time: 20181210
 
Tom's of Maine, Inc.