Natural Prebiotic Spearmint SPBT4

Manufacturer
Tom's of Maine, Inc.
Effective date
2022-12-19
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:43:43

Label at a glance#

ProductNatural Prebiotic Peppermint PPBT4
Active ingredientSODIUM FLUORIDE
Label structure11 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

Drugs 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, glycerin, xylitol, inulin, sodium lauryl sulfate, zinc citrate, natural flavor, xanthan gum, benzyl alcohol, carrageenan.

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 - 113 g Tube Carton - Peppermint

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

new

SINCE 1970
Tom's
OF MAINE®

PREBIOTIC
FLUORIDE TOOTHPASTE

HELPS SUPPORT GOOD BACTERIA
TO MAINTAIN HEALTHY BALANCE*

  • fights cavities
  • whitens teeth
  • strengthens enamel
  • fights tartar buildup
  • freshens breath

PEPPERMINT

4 OZ (113 g)

PRINCIPAL DISPLAY PANEL - 113 g Tube Carton - Peppermint
PRINCIPAL DISPLAY PANEL - 113 g Tube Carton - Peppermint

PRINCIPAL DISPLAY PANEL - 113 g Tube Carton - Spearmint

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

new

SINCE 1970
Tom's
OF MAINE®

NATURAL
PREBIOTIC
FLUORIDE TOOTHPASTE

HELPS SUPPORT GOOD BACTERIA
TO MAINTAIN HEALTHY BALANCE*

  • fights cavities
  • whitens teeth
  • strengthens enamel
  • fights tartar buildup
  • freshens breath

SPEARMINT

4 OZ (113 g)

PRINCIPAL DISPLAY PANEL - 113 g Tube Carton - Spearmint
PRINCIPAL DISPLAY PANEL - 113 g Tube Carton - Spearmint

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51009-90351009-903-04
51009-90451009-904-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 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
d76bf1d9-7f2a-4775-af83-c4992e1f35b71864b3c6-c826-43e1-a749-745a2e1acf222023-01-13WarningsExact identifier
spl set id: 1864b3c6-c826-43e1-a749-745a2e1acf22

Reported adverse events (FAERS/openFDA)#

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