LONG-LASTING WICKED FRESH - COOL PEPPERMINT- sodium monofluorophosphate paste, dentifrice

Long-Lasting Wicked Fresh - Cool Peppermint by

Drug Labeling and Warnings

Long-Lasting 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% (0.14% w/v fluoride ion)

Purpose

Anticavity

Use

aids in the prevention of dental cavities.

Warnings

Keep out of the 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, hydrated silica, calcium carbonate, xylitol, natural flavors, sodium lauryl sulfate, Chondrus crispus (carrageenan), Glycyrrhiza uralensis (licorice) root extract.

Questions?

1-800-FOR-TOMS  M-F 8:30 a.m.-5 p.m. ET

SPL UNCLASSIFIED SECTION

© 2009 Tom's of Maine, Inc., 302 Lafayette Ctr.,
Kennebunk, ME 04043 Made in U.S.A.

PRINCIPAL DISPLAY PANEL - 147.4g Box

cool peppermint

new!

natural
care
Tom's
of Maine®

LONG-LASTING
wicked fresh!

fresh breath anticavity toothpaste
with fluoride

NET WT 147.4g (5.2 OZ)

INGREDIENTS AND APPEARANCE

LONG-LASTING WICKED FRESH - COOL PEPPERMINT 
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51009-146
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sodium monofluorophosphate (UNII: C810JCZ56Q) (Sodium cation - UNII:LYR4M0NH37)	Sodium monofluorophosphate	0.0076  g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Glycerin (UNII: PDC6A3C0OX)
Water (UNII: 059QF0KO0R)
Calcium carbonate (UNII: H0G9379FGK)
Xylitol (UNII: VCQ006KQ1E)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Carrageenan (UNII: 5C69YCD2YJ)
Peppermint Oil (UNII: AV092KU4JH)
Menthol (UNII: L7T10EIP3A)
Sodium Lauryl Sulfate (UNII: 368GB5141J)
Anise Seed (UNII: 21C2F5E8RE)
Eucalyptus Oil (UNII: 2R04ONI662)
Licorice (UNII: 61ZBX54883)
Vanillin (UNII: CHI530446X)
Cinnamyl Alcohol (UNII: SS8YOP444F)
Clove oil (UNII: 578389D6D0)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51009-146-06	1 in 1 BOX
1		147.4 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part335	11/30/2009

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

Establishment
Name	Address	ID/FEI	Business Operations
Tom's of Maine, Inc.		052764354	MANUFACTURE