BLUE Save the Animals

Manufacturer
Tom's of Maine, Inc. | Coglate-Palmolive Company
Effective date
2024-11-18
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 20:49:10

Label at a glance#

ProductBLUE Save the Animals
Active ingredientSODIUM MONOFLUOROPHOSPHATE
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 monofluorophosphate 0.76% (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, calcium carbonate, hydrated silica, natural flavor, carrageenan, sodium lauryl sulfate, benzyl alcohol, Rebaudioside A.

Questions?

OTC - QUESTIONS SECTION

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

PRINCIPAL DISPLAY PANEL - 144 g Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NEW!

THE ORIGINAL
Tom's
OF MAINE

HELP SAVE THE ANIMALS

10%
PROFITS
TO WWF*

NATURAL • WITH FLUORIDE

blueberry flavor

anticavity toothpaste

WWF®

fights
cavities

dye free

NET WT 5.1 OZ (144 g)

PRINCIPAL DISPLAY PANEL - 144 g Tube Label
PRINCIPAL DISPLAY PANEL - 144 g Tube Label

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51009-916BLUE SAVE THE ANIMALS (SODIUM MONOFLUOROPHOSPHATE) CREAM [TOM'S OF MAINE, INC.]5Legacy NDC20241120_1c84fb97-5d7a-4def-b0dd-0bf993d49a42.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51009-91651009-916-51

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
04293744-8d61-4079-8ee9-c5c91d2bb3231c84fb97-5d7a-4def-b0dd-0bf993d49a422024-11-18WarningsExact identifier
spl id: 04293744-8d61-4079-8ee9-c5c91d2bb323
spl set id: 1c84fb97-5d7a-4def-b0dd-0bf993d49a42

Reported adverse events (FAERS/openFDA)#

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