FDA.reportPublic FDA data

Tom's Children's Gel Toothpaste anticavity fluoride toothpaste

Manufacturer
Tom's of Maine, Inc.
Effective date
2016-11-15
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:42:15

Label at a glance#

ProductToms Childrens anticavity fluoride
Active ingredientSODIUM FLUORIDE
Label structure9 sections

Dosage and administration

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium fluoride 0.24% (0.14% w/v fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anticavity

Use

INDICATIONS & USAGE SECTION

helps protect against 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 brushing is accidentally swallowed, get medical help or dial (412) 390-3381 right away (Poison Control Center).

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 2 years of age and olderbrush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician.
children 2 to 6 yearsuse only a pea-sized amount and supervise child's brushing and rinsing (to minimize swallowing)
children under 2 yearsask a dentist or physician

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerin, water, sorbitol, hydrated silica, propanediol, xylitol, benzyl alcohol, sodium lauryl sulfate, xanthan gum, natural flavor, carrageenan, Stevia rebaudiana extract.

Questions?

OTC - QUESTIONS SECTION

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

PRINCIPAL DISPLAY PANEL - 119 g Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

New!

SINCE 1970
Tom's
OF MAINE

natural

children's
gel
anticavity
fluoride toothpaste

fights cavities
contains xylitol
dye free
clear gel

Fruitilicious™

NET WT 4.2 OZ (119 g)

PRINCIPAL DISPLAY PANEL - 119 g Tube Label
PRINCIPAL DISPLAY PANEL - 119 g Tube Label

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51009-22151009-221-42, 51009-221-51

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM FLUORIDE8ZYQ1474W7ACTIM
GLYCERINPDC6A3C0OXIACT
SORBITOL506T60A25RIACT
BENZYL ALCOHOLLKG8494WBHIACT
PROPANEDIOL5965N8W85TIACT
XANTHAN GUMTTV12P4NEEIACT
XYLITOLVCQ006KQ1EIACT
HYDRATED SILICAY6O7T4G8P9IACT
CARRAGEENAN5C69YCD2YJIACT
SODIUM LAURYL SULFATE368GB5141JIACT
STEVIA REBAUDIUNA LEAF6TC6NN0876IACT
WATER059QF0KO0RIACT

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
285288d7-4474-4bd4-89ba-c8ccc1b1094b237a6555-e8ac-4535-a426-13868d31bfa72022-12-19WarningsExact identifier
spl set id: 237a6555-e8ac-4535-a426-13868d31bfa7

Reported adverse events (FAERS/openFDA)#

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