SILLY STRAWBERRY ANTICAVITY - BFT51 MRT- sodium monofluorophosphate paste, dentifrice 
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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Silly Strawberry Anticavity - BFT51 MRT

Drug Facts

Active ingredient

Sodium monofluorophosphate 0.76% (0.13% 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 flavor1, carrageenan, sodium lauryl sulfate


1
strawberry juice and other natural flavor

Questions?

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

PRINCIPAL DISPLAY PANEL - 144 g Tube Label

Original
Formula

SINCE 1970
Tom's
OF MAINE®

ADA
Accepted
American
Dental
Association ®

natural

children's

fluoride toothpaste

fights cavities

tastes great

dye free

silly strawberry

NET WT 5.1 OZ (144 g)

PRINCIPAL DISPLAY PANEL - 144 g Tube Label
SILLY STRAWBERRY ANTICAVITY - BFT51 MRT 
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51009-910
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.0014 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
CARRAGEENAN (UNII: 5C69YCD2YJ)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
CALCIUM CARBONATE (UNII: H0G9379FGK)  
STRAWBERRY (UNII: 4J2TY8Y81V)  
LEMON JUICE (UNII: AGN709ANTJ)  
MANGO JUICE (UNII: IU6I1JNV24)  
ORANGE JUICE (UNII: 5A9KE2L9L3)  
PINEAPPLE JUICE (UNII: O4KOG0B1KC)  
STRAWBERRY JUICE (UNII: U8NS58UGW0)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorSTRAWBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51009-910-51144 g in 1 TUBE; Type 0: Not a Combination Product11/15/2019
2NDC:51009-910-101 in 1 CARTON01/14/2013
221 g in 1 TUBE; Type 0: Not a Combination Product
3NDC:51009-910-42119 g in 1 TUBE; Type 0: Not a Combination Product08/16/2010
4NDC:51009-910-522 in 1 CARTON11/04/202001/29/2023
4144 g in 1 TUBE; Type 0: Not a Combination Product
5NDC:51009-910-0121 g in 1 TUBE; Type 0: Not a Combination Product04/01/201503/30/2020
6NDC:51009-910-533 in 1 CARTON02/15/202203/21/2024
6150 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35508/15/2010
Labeler - Tom's of Maine, Inc. (052764354)
Establishment
NameAddressID/FEIBusiness Operations
Team Technologies, Inc079527756PACK(51009-910)

Revised: 9/2023
Document Id: 5774a5b9-5f2a-4121-bb71-a1800da988b1
Set id: e36ceb7a-9a29-41d8-8d08-a859e515f1f5
Version: 9
Effective Time: 20230919
 
Tom's of Maine, Inc.