TOMS WHOLE CARE PEPPERMINT FIGHTS CAVITIES / WHITENING / FRESH BREATH / HELPS FIGHT TARTAR- 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® Whole Care® Peppermint Gel
fights cavities | whitening | fresh breath | helps fight tartar

Drug Facts

Active ingredient

Sodium monofluorophosphate 0.76% (0.14% 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

water, hydrated silica, sorbitol, xylitol, glycerin, natural flavor1, sodium lauryl sulfate, zinc citrate, xanthan gum, benzyl alcohol, carrageenan.

1: peppermint oil and other natural flavor

Questions?

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

PRINCIPAL DISPLAY PANEL - 133 g Tube Carton

SINCE 1970
Tom's®
OF MAINE

with fluoride | natural

WHOLE CARE®

fluoride toothpaste
fights cavities | whitening | fresh breath | helps fight tartar
no artificial dyes or sweeteners

peppermint gel

NET WT 4.7 OZ (133 g)

Principal Display Panel - 133 g Tube Carton

TOMS WHOLE CARE PEPPERMINT FIGHTS CAVITIES / WHITENING / FRESH BREATH / HELPS FIGHT TARTAR
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:51009-208
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Sodium monofluorophosphate (UNII: C810JCZ56Q) (Fluoride ion - UNII:Q80VPU408O)	Fluoride ion	1.4 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)
Hydrated Silica (UNII: Y6O7T4G8P9)
Sorbitol (UNII: 506T60A25R)
Xylitol (UNII: VCQ006KQ1E)
Glycerin (UNII: PDC6A3C0OX)
Peppermint Oil (UNII: AV092KU4JH)
Sodium Lauryl Sulfate (UNII: 368GB5141J)
ZINC CITRATE TRIHYDRATE (UNII: GNM26GAX7R)
XANTHAN GUM (UNII: TTV12P4NEE)
BENZYL ALCOHOL (UNII: LKG8494WBH)
Carrageenan (UNII: 5C69YCD2YJ)

Product Characteristics
Color	WHITE (Off white)	Score
Shape		Size
Flavor	PEPPERMINT	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:51009-208-47	1 in 1 CARTON	08/11/2014	11/30/2015
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	08/11/2014	11/30/2015

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

Revised: 12/2018

Document Id: b6d2fa42-d784-4035-af61-5601105a215a

Set id: 8d2bcd6b-30f2-41c9-8a61-bd9b828023a0

Version: 2

Effective Time: 20181210

Tom's of Maine, Inc.

Tom's® Whole Care® Peppermint Gel fights cavities | whitening | fresh breath | helps fight tartar