BLUE SAVE THE ANIMALS- sodium monofluorophosphate cream 
Tom's of Maine, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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BLUE Save the Animals

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 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

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)

PRINCIPAL DISPLAY PANEL - 144 g Tube Label
BLUE SAVE THE ANIMALS 
sodium monofluorophosphate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51009-916
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.4 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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
ColorWHITEScore    
ShapeSize
FlavorBLUEBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51009-916-51144 g in 1 TUBE; Type 0: Not a Combination Product06/30/202112/30/2025
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35506/30/202112/30/2025
Labeler - Tom's of Maine, Inc. (052764354)
Registrant - Coglate-Palmolive Company (068693167)

Revised: 9/2023
Document Id: c152bbb7-13b6-4f0a-9f99-1f0356b57e87
Set id: 1c84fb97-5d7a-4def-b0dd-0bf993d49a42
Version: 4
Effective Time: 20230919
 
Tom's of Maine, Inc.