natural care Tom's of Maine®

Drug Labeling and Warnings

Drug Details [pdf]

LONG-LASTING WICKED FRESH - SPEARMINT ICE- 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.

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natural care
Tom's
of Maine®

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, sodium lauryl sulfate, natural flavors, Chondrus crispus (carrageenan), Glycyrrhiza uralensis (licorice) root extract.

Questions?

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

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

PRINCIPAL DISPLAY PANEL - 147.4g Box

spearmint ice

new!

natural
care
Tom's
of Maine®

LONG-LASTING
wicked fresh!

fresh breath anticavity toothpaste
with fluoride

NET WT 147.4g (5.2 OZ)

LONG-LASTING WICKED FRESH - SPEARMINT ICE 
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51009-145
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sodium monofluorophosphate (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	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)
Spearmint Oil (UNII: C3M81465G5)
Peppermint Oil (UNII: AV092KU4JH)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
Sodium Lauryl Sulfate (UNII: 368GB5141J)
Anise (UNII: 21C2F5E8RE)
Eucalyptus Oil (UNII: 2R04ONI662)
Glycyrrhizin (UNII: 6FO62043WK)
Licorice (UNII: 61ZBX54883)
Vanillin (UNII: CHI530446X)
Clove oil (UNII: 578389D6D0)
Cinnamyl Alcohol (UNII: SS8YOP444F)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor	SPEARMINT (Spearmint Ice)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51009-145-06	1 in 1 BOX	11/30/2009	06/05/2014
1		147.4 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	11/30/2009	06/05/2014

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

Revised: 9/2019

Document Id: 13c17ec2-efe3-4390-bd30-8a210aad74b8

34390-5

Set id: 075d7863-4c69-4096-af1c-b6f0c0247fb9

Version: 2

Effective Time: 20190906