Tom's OF MAINE CAVITY PROTECTION fluoride toothpaste

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.

----------

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 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 years	use only a pea-sized amount and supervise child's brushing and rinsing (to minimize swallowing)
children under 2 years	ask 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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51009-111
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Sodium Monofluorophosphate (UNII: C810JCZ56Q) (Fluoride Ion - UNII:Q80VPU408O)	Fluoride Ion	0.0076 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
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
Color	WHITE	Score
Shape		Size
Flavor	WINTERGREEN	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 51009-111-47	1 in 1 CARTON	02/14/2011	09/30/2014
1		133 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part355	02/14/2011	09/30/2014

Labeler - Tom's of Maine, Inc. (052764354)

Revised: 9/2019

Document Id: 0c84fc5f-738c-4b71-8141-466d866f2f4f

Set id: fbf0c1c7-105e-4f98-8875-0d19f4ac8214

Version: 2

Effective Time: 20190906

Tom's of Maine, Inc.