Tom's™ OF MAINE

Drug Labeling and Warnings

Drug Details [pdf]

ANTICAVITY JUICY MINT- sodium fluoride rinse 
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™
OF MAINE

Drug Facts

Active ingredient (in each 10mL)

Sodium fluoride 0.0442%

Purpose

Anticavity

Use

aids in the prevention of dental cavities

Warnings

Keep out of reach of children under 6 years of age.

• If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 6 years of age and older:

• Use once a day after brushing your teeth with toothpaste
• Remove cap, fill to 10 ml mark
• Vigorously swish 10 ml of rinse between your teeth for 1 minute and then spit out
• Do not swallow the rinse
• Do not eat or drink for 30 min. after rinsing
• Instruct children under 12 yrs. of age in good rinsing habits (to minimize swallowing)
• Supervise children as necessary until capable of using without supervision.

Children under 6 years of age: Consult a dentist or doctor.

Inactive ingredients

water, glycerin, organic Aloe barbadensis leaf juice, xylitol, sodium phosphate, propanediol, natural flavor, benzoic acid, menthol

Questions?

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

M - F 8:30 a.m. - 5:30 p.m. ET

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

new!

SINCE 1970
Tom's™
OF MAINE

ADA
Accepted
American
Dental
Association ®

alcohol-free
natural

ANTICAVITY

strong cavity protection
for a healthy smile

fluoride rinse

juicy mint

473 mL (16 FL OZ)

IMPORTANT: Read
directions for proper use

ANTICAVITY  JUICY MINT
sodium fluoride rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51009-001
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O)	Sodium Fluoride	0.46277 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Glycerin (UNII: PDC6A3C0OX)
Xylitol (UNII: VCQ006KQ1E)
Sodium Phosphate (UNII: SE337SVY37)
Propanediol (UNII: 5965N8W85T)
Benzoic Acid (UNII: 8SKN0B0MIM)
Aloe Vera Leaf (UNII: ZY81Z83H0X)
Menthol, Unspecified Form (UNII: L7T10EIP3A)
MINT (UNII: FV98Z8GITP)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT (Fruity-Mint)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51009-001-16	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/30/2010	01/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	08/30/2010	01/01/2017

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

Revised: 9/2019

Document Id: 8f0bd2e7-66bf-4135-ae26-10644646adef

34390-5

Set id: 669c8bab-9fb1-421d-8d50-7c648961691a

Version: 2

Effective Time: 20190904