Label: SILLY STRAWBERRY ANTICAVITY - BFT51 MRT- sodium monofluorophosphate paste, dentifrice

  • NDC Code(s): 51009-910-01, 51009-910-10, 51009-910-42, 51009-910-51, view more
    51009-910-52, 51009-910-53
  • Packager: Tom's of Maine, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated September 19, 2023

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  • SPL UNCLASSIFIED SECTION

    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
  • INGREDIENTS AND APPEARANCE
    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)
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