Tom's OF MAINE CAVITY PROTECTION fluoride toothpaste

Cavity Protection by

Drug Labeling and Warnings

Cavity Protection by is a Otc medication manufactured, distributed, or labeled by Tom's of Maine, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

CAVITY PROTECTION  WINTERMINT- 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
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)

Principal Display Panel - 133 g Carton
CAVITY PROTECTION   WINTERMINT
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 51009-111
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Monofluorophosphate (UNII: C810JCZ56Q) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion0.0076 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
Glycerin (UNII: PDC6A3C0OX)  
Water (UNII: 059QF0KO0R)  
Calcium carbonate (UNII: H0G9379FGK)  
Hydrated silica (UNII: Y6O7T4G8P9)  
Xylitol (UNII: VCQ006KQ1E)  
Carrageenan (UNII: 5C69YCD2YJ)  
Sodium lauryl sulfate (UNII: 368GB5141J)  
Methyl Salicylate (UNII: LAV5U5022Y)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorWINTERGREENImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 51009-111-471 in 1 CARTON02/14/201109/30/2014
1133 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35502/14/201109/30/2014
Labeler - Tom's of Maine, Inc. (052764354)

Revised: 9/2019
 
Tom's of Maine, Inc.