TOMS WICKED FRESH COOL PEPPERMINT FRESH BREATH / CAVITY PROTECTION- sodium monofluorophosphate paste, dentifrice

Toms Wicked Fresh Cool Peppermint by

Drug Labeling and Warnings

Toms Wicked Fresh Cool Peppermint 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% (0.13% 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, xylitol, hydrated silica, sodium lauryl sulfate, natural flavor1, carrageenan, benzyl alcohol, Glycyrrhiza uralensis (licorice) root extract.

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®

clinically proven | natural

WICKED FRESH!®

fluoride toothpaste
fresh breath | cavity protection
no artificial dyes or sweeteners

cool peppermint

NET WT 4.7 OZ (133 g)

INGREDIENTS AND APPEARANCE

TOMS WICKED FRESH COOL PEPPERMINT   FRESH BREATH / CAVITY PROTECTION
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51009-205
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
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
CALCIUM CARBONATE (UNII: H0G9379FGK)
XYLITOL (UNII: VCQ006KQ1E)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
CARRAGEENAN (UNII: 5C69YCD2YJ)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
PEPPERMINT OIL (UNII: AV092KU4JH)
BENZYL ALCOHOL (UNII: LKG8494WBH)
STAR ANISE OIL (UNII: 6RXP35EIRE)
EUCALYPTUS OIL (UNII: 2R04ONI662)
LICORICE (UNII: 61ZBX54883)
VANILLIN (UNII: CHI530446X)
CLOVE OIL (UNII: 578389D6D0)
CINNAMALDEHYDE (UNII: SR60A3XG0F)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51009-205-47	1 in 1 CARTON	06/06/2014
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	08/08/2013

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

Establishment
Name	Address	ID/FEI	Business Operations
Tom's of Maine, Inc.		829517189	MANUFACTURE(51009-205)