TOMS CHILDRENS ANTICAVITY MOUTHWASH JUICY MINT- sodium fluoride rinse

Toms Childrens Anticavity Mouthwash Juicy Mint by

Drug Labeling and Warnings

Toms Childrens Anticavity Mouthwash Juicy Mint by is a Otc medication manufactured, distributed, or labeled by Tom's of Maine, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

Active ingredient (in each 10mL)

Sodium fluoride 0.04% (0.02% w/v fluoride ion)

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 a toothpaste. Remove cap, fill to 10 mL mark. Vigorously swish 10 milliliters of rinse between your teeth for 1 minute and then spit out. Do not swallow the rinse. Do not eat or drink for 30 minutes after rinsing.
• children 6 years to under 12 years of age: instruct children under 12 years 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 physician

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)

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Dist. by Tom's of Maine, Inc., Kennebunk, ME 04043 U.S.A.

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

new look
same great taste

SINCE 1970
Tom's
OF MAINE®

ADA
Accepted
American
Dental
Association ®

alcohol-free | natural

children's anticavity

fluoride rinse

strong cavity protection
for a healthy smile

tastes great

dye free

juicy mint

16 FL OZ (473 mL)

P9897335

IMPORTANT: Read
directions for proper use

INGREDIENTS AND APPEARANCE

TOMS CHILDRENS ANTICAVITY MOUTHWASH JUICY MINT 
sodium fluoride rinse

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51009-839
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O)	Fluoride Ion	0.2 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PROPANEDIOL (UNII: 5965N8W85T)
XYLITOL (UNII: VCQ006KQ1E)
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)
BENZOIC ACID (UNII: 8SKN0B0MIM)
Aloe Vera Leaf (UNII: ZY81Z83H0X)
LEVOMENTHOL (UNII: BZ1R15MTK7)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51009-839-52	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/26/2017	10/15/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part355	05/26/2017	10/15/2021

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