TOMS CHILDRENS  ANTICAVITY FLUORIDE- sodium fluoride gel, 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.

----------

Tom's Children's Gel Toothpaste
anticavity fluoride toothpaste

Drug Facts

Active ingredient

Sodium fluoride 0.24% (0.14% 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

glycerin, water, sorbitol, hydrated silica, propanediol, xylitol, benzyl alcohol, sodium lauryl sulfate, xanthan gum, natural flavor, carrageenan, Stevia rebaudiana extract.

Questions?

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

PRINCIPAL DISPLAY PANEL - 119 g Tube Label

New!

SINCE 1970
Tom's
OF MAINE

natural

children's
gel
anticavity
fluoride toothpaste

fights cavities
contains xylitol
dye free
clear gel

Fruitilicious™

NET WT 4.2 OZ (119 g)

PRINCIPAL DISPLAY PANEL - 119 g Tube Label
TOMS CHILDRENS   ANTICAVITY FLUORIDE
sodium fluoride gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51009-221
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.00243 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
SORBITOL (UNII: 506T60A25R)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
PROPANEDIOL (UNII: 5965N8W85T)  
XANTHAN GUM (UNII: TTV12P4NEE)  
XYLITOL (UNII: VCQ006KQ1E)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
CARRAGEENAN (UNII: 5C69YCD2YJ)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51009-221-42119 g in 1 TUBE; Type 0: Not a Combination Product01/15/201711/06/2021
2NDC:51009-221-51144 g in 1 TUBE; Type 0: Not a Combination Product12/15/201908/05/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35501/15/201708/05/2022
Labeler - Tom's of Maine, Inc. (052764354)

Revised: 12/2022
Document Id: 285288d7-4474-4bd4-89ba-c8ccc1b1094b
Set id: 237a6555-e8ac-4535-a426-13868d31bfa7
Version: 3
Effective Time: 20221219
 
Tom's of Maine, Inc.