BLUE SAVE THE ANIMALS- sodium monofluorophosphate cream

BLUE Save the Animals by

Drug Labeling and Warnings

BLUE Save the Animals by is a Otc medication manufactured, distributed, or labeled by Tom's of Maine, Inc., Coglate-Palmolive Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Sodium monofluorophosphate 0.76% (0.14% w/v fluoride ion)

Purpose

Anticavity

Use

helps protect against cavities

Warnings

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

• 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

Inactive ingredients

glycerin, water, calcium carbonate, hydrated silica, natural flavor, carrageenan, sodium lauryl sulfate, benzyl alcohol, Rebaudioside A.

Questions?

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

PRINCIPAL DISPLAY PANEL - 144 g Tube Label

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)

INGREDIENTS AND APPEARANCE

BLUE SAVE THE ANIMALS 
sodium monofluorophosphate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51009-916
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1.4 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
CALCIUM CARBONATE (UNII: H0G9379FGK)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
CARRAGEENAN (UNII: 5C69YCD2YJ)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
BENZYL ALCOHOL (UNII: LKG8494WBH)
REBAUDIOSIDE A (UNII: B3FUD0528F)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor	BLUEBERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51009-916-51	144 g in 1 TUBE; Type 0: Not a Combination Product	06/30/2021	12/30/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH DRUG	M021	06/30/2021	12/30/2025

Labeler - Tom's of Maine, Inc. (052764354)

Registrant - Coglate-Palmolive Company (068693167)