Tom's Kids Grape Save the Animals

Toms Kids Grape Save the Animals by

Drug Labeling and Warnings

Toms Kids Grape Save the Animals by is a Otc medication manufactured, distributed, or labeled by Tom's of Maine, Inc., Coglate-Palmolive Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

TOMS KIDS GRAPE SAVE THE ANIMALS- 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.

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Tom's Kids Grape Save the Animals

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 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

water, glycerin, sorbitol, hydrated silica, propanediol, xylitol, benzyl alcohol, sodium lauryl sulfate, xanthan gum, natural flavor, carrageenan, Rebaudioside A .

Questions?

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

PRINCIPAL DISPLAY PANEL - 144 g Tube Label

NEW!

THE ORIGINAL
Tom's
OF MAINE

HELP SAVE THE ANIMALS

10%
PROFITS
TO WWF*

NATURAL WITH FLUORIDE

grape flavor

anticavity gel toothpaste

WWF®

fights
cavities

dye free

NET WT 5.1 OZ (144 g)

TOMS KIDS GRAPE SAVE THE ANIMALS 
sodium fluoride gel, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51009-915
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	1.4 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
SORBITOL (UNII: 506T60A25R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
PROPANEDIOL (UNII: 5965N8W85T)
XYLITOL (UNII: VCQ006KQ1E)
BENZYL ALCOHOL (UNII: LKG8494WBH)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
XANTHAN GUM (UNII: TTV12P4NEE)
CARRAGEENAN (UNII: 5C69YCD2YJ)
REBAUDIOSIDE A (UNII: B3FUD0528F)

Product Characteristics
Color	BROWN (clear gel with tan tinge)	Score
Shape		Size
Flavor	GRAPE (fruit)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51009-915-51	144 g in 1 TUBE; Type 0: Not a Combination Product	06/30/2021	10/15/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part355	06/30/2021	10/15/2023

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

Registrant - Coglate-Palmolive Company (068693167)

Revised: 12/2022

Document Id: a2bd404d-3beb-4a43-b5a3-976f4034204e

34390-5

Set id: 55e62c08-3347-4373-9b76-feb7a255c9d8

Version: 3

Effective Time: 20221215