Sea Salt Anticavity SALT47

Manufacturer
Toms of Maine, Inc.
Effective date
2019-08-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:00:11

Label at a glance#

ProductSea Salt Anticavity SALT47 gently scrubs away surface stains / fights bad breath germs / strengthens enamel
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% (0.15% 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

water, sorbitol, hydrated silica, xylitol, glycerin, sodium chloride, sodium lauryl sulfate, zinc citrate, natural flavor1, xanthan gum, carrageenan.

1 peppermint oil and other natural flavor

Questions?

OTC - QUESTIONS SECTION

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

PRINCIPAL DISPLAY PANEL - 133 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

4.7 OZ (133 g)

SINCE 1970
Tom's®
OF MAINE

natural
with fluoride

SEA SALT

anticavity toothpaste

gently scrubs away surface stains
fights bad breath germs
strengthens enamel

refreshing mint

with
purified
sea salt

PRINCIPAL DISPLAY PANEL - 133 g Tube Carton
PRINCIPAL DISPLAY PANEL - 133 g Tube Carton

FDA-Initiated Inactive NDC Indexing#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51009-901SEA SALT ANTICAVITY SALT47 GENTLY SCRUBS AWAY SURFACE STAINS / FIGHTS BAD BREATH GERMS / STRENGTHENS ENAMEL (SODIUM FLUORIDE) PASTE, DENTIFRICE [TOMS OF MAINE, INC.]1Legacy NDC20190831_a743bb22-bf93-4d10-820a-0a43bd1cb1d7.zip

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
51009-90151009-901-47

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 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
8fad49ca-e8f0-4b1c-bf86-5b3c1e5b7168a743bb22-bf93-4d10-820a-0a43bd1cb1d72025-10-29WarningsExact identifier
spl set id: a743bb22-bf93-4d10-820a-0a43bd1cb1d7

Reported adverse events (FAERS/openFDA)#

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