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Toms Wicked Cool Fluoride - Mild Mint fights cavities / strengthens enamel / freshens breath / dye free

Dosage form: paste, dentifrice
Ingredients: Sodium monofluorophosphate 1.4mg in 1g
Labeler: Tom's of Maine, Inc.
NDC Code: 51009-217

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.

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 flavor.


Peppermint oil and other natural flavor

Questions?

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

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 AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium monofluorophosphate (Fluoride ion) Fluoride ion1.4 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Glycerin 
Water 
Calcium carbonate 
Hydrated Silica 
Carrageenan 
Sodium Lauryl Sulfate 
Peppermint oil 
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorPEPPERMINTImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:51009-217-0121.2 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35504/01/2015
Labeler - Tom's of Maine, Inc. (052764354)
Establishment
NameAddressID/FEIOperations
Tom's of Maine, Inc.829517189MANUFACTURE(51009-217)
Establishment
NameAddressID/FEIOperations
Quality Packaging Specialists International, LLC825078165LABEL(51009-217), PACK(51009-217)

Revised: 03/2015
 
Tom's of Maine, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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