TOMS TEETH AND GUM HEALTH- sodium fluoride 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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Tom's Teeth and Gum Health

Drug Facts

Active ingredient

Sodium fluoride 0.24% (0.15% 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 olderbrush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician
children 2 to 6 yearsuse only a pea-sized amount and supervise child's brushing and rinsing (to minimize swallowing)
children under 2 yearsask a dentist or physician

Inactive ingredients

water, sorbitol, hydrated silica, xylitol, glycerin, sodium chloride, sodium lauryl sulfate, zinc citrate, natural flavor, xanthan gum, carrageenan.

Questions?

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

PRINCIPAL DISPLAY PANEL - 113 g Tube Carton

Certified
B®
Corporation

NEW

THE ORIGINAL
Tom's
OF MAINE

NATURAL • WITH FLUORIDE

TEETH + GUM
HEALTH*
anticavity toothpaste

SOOTHING EXPERIENCE
DEEP CLEAN

pureactiv:
SOLUTIONS

COOL MINT

4.0 OZ (113 g)

PRINCIPAL DISPLAY PANEL - 113 g Tube Carton
TOMS TEETH AND GUM HEALTH 
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51009-918
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.1 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
XYLITOL (UNII: VCQ006KQ1E)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
ZINC CITRATE (UNII: K72I3DEX9B)  
XANTHAN GUM (UNII: TTV12P4NEE)  
CARRAGEENAN (UNII: 5C69YCD2YJ)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51009-918-401 in 1 CARTON11/30/202112/30/2025
1113 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35511/30/202112/30/2025
Labeler - Tom's of Maine, Inc. (052764354)
Registrant - Colgate-Palmolive Company (001344381)

Revised: 9/2023
Document Id: c6155179-c3ab-4bdf-a50b-4970a736737b
Set id: e4393409-5e7c-08b8-48fa-1c0408827917
Version: 3
Effective Time: 20230919
 
Tom's of Maine, Inc.