Tom's® Children's Wild Blueberry Anticavity BLUE

Toms Childrens Wild Blueberry Anticavity BLUE by

Drug Labeling and Warnings

Toms Childrens Wild Blueberry Anticavity BLUE by is a Otc medication manufactured, distributed, or labeled by Tom's of Maine. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

TOMS CHILDRENS WILD BLUEBERRY ANTICAVITY BLUE- sodium monofluorophosphate cream 
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® Children's Wild Blueberry Anticavity BLUE

Drug Facts

Active ingredient

Sodium monofluorophosphate 0.76% (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

glycerin, water, calcium carbonate, hydrated silica, natural flavor, carrageenan, sodium lauryl sulfate, benzyl alcohol, Rebaudioside A.

Questions?

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

PRINCIPAL DISPLAY PANEL - 144 g Tube Label

SINCE 1970
Tom's®
OF MAINE

natural
children's

fluoride toothpaste
fights cavities
tastes great
dye free

wild blueberry
flavor

NET WT 5.1 OZ (144 g)

TOMS CHILDRENS WILD BLUEBERRY ANTICAVITY BLUE 
sodium monofluorophosphate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51009-913
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.0014 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
CALCIUM CARBONATE (UNII: H0G9379FGK)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
CARRAGEENAN (UNII: 5C69YCD2YJ)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
BENZYL ALCOHOL (UNII: LKG8494WBH)
REBAUDIOSIDE A (UNII: B3FUD0528F)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor	BLUEBERRY (Wild Blueberry)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51009-913-51	144 g in 1 TUBE; Type 0: Not a Combination Product	11/11/2020	03/18/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part355	11/11/2020	03/18/2023

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

Revised: 12/2022

Document Id: 1a8e44ef-8f92-4ac9-bc04-832576f1cb2a

34390-5

Set id: 76328789-5278-4498-9f23-2d7784e090b8

Version: 3

Effective Time: 20221216