THOMAS AND FRIENDS- sodium fluoride paste, dentifrice 
Ashtel Studios, 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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Thomas & Friends Toothpaste

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

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:

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

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

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)

Revised: 5/2018
Document Id: 001d6e32-4a6b-46ec-b5a8-65fc7b68413f
Set id: 16942293-8df7-4a28-82b0-6eb4c828dc4b
Version: 3
Effective Time: 20180516
 
Ashtel Studios, Inc.