Label: THOMAS AND FRIENDS- sodium fluoride paste, dentifrice

  • 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 May 16, 2018

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  • Drug Facts

  • Active Ingredients

    Sodium Fluoride 0.243% (0.15% w/v Fluoride Ion)

  • Purpose

    Anticavity Toothpaste

  • Uses

    Helps protect teeth against cavities.

  • Warning

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

    If more than used for brushing is accidently swallowed, seek professional assistance or contact a Poison Control Center immediately.

  • Directions

    Adults and children 6 years of age and older:

    • Brush teeth thoroughly after meals or at least twice a day. Use directed by a dentist.
    • Do not swallow.
    • To minimize swallowing, use a pea-sized amount in children under 6 years of age.
    • Supervise children’s brushing until good brushing habit are established.
    • Children under 2 years of age: Ask a dentist.
  • Inactive Ingredients

    Sorbitol, Silica, Aqua, PEG-32, Xylitol, Sodium Lauryl Sulphate, Flavor, Cellulose Gum, Benzyl Alcohol, Sodium Benzoate, Sodium Saccharin, Trisodium Phosphate, FD&C Blue #1, FD&C Red #40.

  • Other Information

    Store at room temperature.

  • QUESTIONS

    QUESTIONS? COMMENTS? / COMMENTAIRES?
    1-877-274-8358 (U.S.A.)
    1-909-434-0911 (INTERNATIONAL)
    1-888-635-5337 (CANADA)

  • SPL UNCLASSIFIED SECTION

    BUBBLE GUM GOMME À BULLES

    ANTICAVITY FLUORIDE TOOTHPASTE DENTIFRICE ANTICARIE AU FLUORURE

    make brushing fun!®

    For more oral care information,
    visit us at / Pour d’autres
    renseignements, visitez:
    www.brushbuddies.com

    DISTR. BY/PAR NORTHERN NATIONAL
    SALES INC. TORONTO, ON, M9M 1M7

    C.No. DNH/COS/DNH/52

    ©2017 HIT Entertainment Limited. HIT and the HIT logo are trademarks of HIT Entertainment Limited.

    © 2017 Gullane (Thomas) Limited.

  • Packaging

    image description

  • INGREDIENTS AND APPEARANCE
    THOMAS AND FRIENDS 
    sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70108-015
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION243 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    SORBITOL (UNII: 506T60A25R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    WATER (UNII: 059QF0KO0R)  
    POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)  
    XYLITOL (UNII: VCQ006KQ1E)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS (UNII: SX01TZO3QZ)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70108-015-01100 mL in 1 TUBE; Type 0: Not a Combination Product05/09/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35505/09/2018
    Labeler - Ashtel Studios, Inc. (148689180)
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