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

Toms Whole Care Spearmint by

Drug Labeling and Warnings

Toms Whole Care Spearmint by is a Otc medication manufactured, distributed, or labeled by Tom's of Maine, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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, carrageenan.

1 spearmint 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

spearmint gel

NET WT 4.7 OZ (133 g)

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51009-207
Route of Administration	DENTAL

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

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Hydrated Silica (UNII: Y6O7T4G8P9)
Sorbitol (UNII: 506T60A25R)
Xylitol (UNII: VCQ006KQ1E)
Glycerin (UNII: PDC6A3C0OX)
Sodium Lauryl Sulfate (UNII: 368GB5141J)
Spearmint Oil (UNII: C3M81465G5)
ZINC CITRATE TRIHYDRATE (UNII: GNM26GAX7R)
XANTHAN GUM (UNII: TTV12P4NEE)
Peppermint Oil (UNII: AV092KU4JH)
Carrageenan (UNII: 5C69YCD2YJ)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51009-207-47	1 in 1 CARTON	08/12/2014
1		133 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part355	08/12/2014

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

Establishment
Name	Address	ID/FEI	Business Operations
Tom's of Maine, Inc.		829517189	MANUFACTURE(51009-207)