TOMS CAVITY PROTECTION SPEARMINT FIGHTS CAVITIES FRESH BREATH- sodium monofluorophosphate paste, dentifrice

Toms Cavity Protection Spearmint by

Drug Labeling and Warnings

Toms Cavity Protection 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% (0.16% 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

calcium carbonate, water, glycerin, xylitol, sodium lauryl sulfate, natural flavor1, carrageenan, sodium bicarbonate, benzyl alcohol.

1 spearmint oil and other natural flavor

Questions?

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

PRINCIPAL DISPLAY PANEL - 155.9 g Tube Carton

SINCE 1970
Tom's
OF MAINE®

natural

CAVITY PROTECTION

fluoride toothpaste
fights cavities | fresh breath
no artificial dyes or sweeteners

spearmint

NET WT 5.5 OZ (155.9 g)

INGREDIENTS AND APPEARANCE

TOMS CAVITY PROTECTION SPEARMINT   FIGHTS CAVITIES FRESH BREATH
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51009-210
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
Calcium carbonate (UNII: H0G9379FGK)
Water (UNII: 059QF0KO0R)
Glycerin (UNII: PDC6A3C0OX)
Xylitol (UNII: VCQ006KQ1E)
Sodium Lauryl Sulfate (UNII: 368GB5141J)
Carrageenan (UNII: 5C69YCD2YJ)
Spearmint Oil (UNII: C3M81465G5)
Sodium Bicarbonate (UNII: 8MDF5V39QO)
BENZYL ALCOHOL (UNII: LKG8494WBH)
Peppermint oil (UNII: AV092KU4JH)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51009-210-55	1 in 1 CARTON	12/31/2014
1		155.9 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	12/31/2014

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

Establishment
Name	Address	ID/FEI	Business Operations
Tom's of Maine, Inc.		829517189	MANUFACTURE(51009-210)