Toms Childrens Anticavity Mouthwash Juicy Mint

Manufacturer
Tom's of Maine, Inc.
Effective date
2019-07-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:18:25

Label at a glance#

ProductToms Childrens Anticavity Mouthwash Juicy Mint
Active ingredientSodium Fluoride
Label structure10 sections

Dosage and administration

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 min...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each 10mL)

OTC - ACTIVE INGREDIENT SECTION

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

Purpose

OTC - PURPOSE SECTION

Anticavity

Use

INDICATIONS & USAGE SECTION

aids in the prevention of dental cavities

Warnings

WARNINGS SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

adults and children 6 years of age and olderuse 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 ageinstruct 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 ageconsult a dentist or physician

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions?

OTC - QUESTIONS SECTION

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

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label
PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51009-83951009-839-52

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
c0d90680-fb0c-4744-83f4-b2bc2ac08881c6cc19e1-64af-41a2-b011-35c82a20bb122019-07-18WarningsExact identifier
spl id: c0d90680-fb0c-4744-83f4-b2bc2ac08881
spl set id: c6cc19e1-64af-41a2-b011-35c82a20bb12

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.