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Cavity Protection Wintermint

Dosage form: paste, dentifrice
Ingredients: Sodium Monofluorophosphate 0.0076g in 1g
Labeler: Tom's of Maine, Inc.
NDC Code: 51009-111

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
OF MAINE
CAVITY PROTECTION
fluoride toothpaste

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, hydrated silica, xylitol, Chondrus crispus (carrageenan), Gaultheria procumbens (wintergreen) leaf oil and other natural flavors, sodium lauryl sulfate.

Questions?

1-800-FOR-TOMS (1-800-367-8667) M - F 8:30 a.m. - 5:30 p.m. ET

PRINCIPAL DISPLAY PANEL - 133 g Carton

SINCE 1970
Tom's
OF MAINE

natural

CAVITY PROTECTION

fights cavities ∣ fresh breath

fluoride toothpaste

wintermint

ADA
Accepted

American
Dental
Association ®

NET WT 4.7 OZ (133 g)

CAVITY PROTECTION   WINTERMINT
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51009-111
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Monofluorophosphate (Fluoride Ion) Sodium Monofluorophosphate0.0076 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
Glycerin 
Water 
Calcium carbonate 
Hydrated silica 
Xylitol 
Carrageenan 
Sodium lauryl sulfate 
Methyl Salicylate 
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorWINTERGREENImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:51009-111-471 TUBE (TUBE) in 1 CARTON
1133 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35502/14/2011
Labeler - Tom's of Maine, Inc. (052764354)
Establishment
NameAddressID/FEIOperations
Tom's of Maine, Inc.052764354MANUFACTURE

 
Tom's of Maine, Inc.

Medically reviewed on Feb 14, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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