THOMAS AND FRIENDS- sodium monofluorophosphate 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 Monofluorophosphate-0.76%

Purpose

Anticavity Toothpaste

Uses

Helps protect teeth against cavities.

Warning

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

KEEP OUT OF REACH OF CHILDREN.

Directions

Adults and children 6 years of age and older:

Inactive Ingredients

Sorbitol, Water, Silica, Sodium Lauryl Sulfate, Xylitol, Flavor, CMC Sodium Carboxymethyl Cellulose, Sodium Benzoate, Xanthan Gum, Saccharin Sodium, Rose Red

Other Information

Store at room temperature.

BUBBLE GUM

ANTICAVITY FLUORIDE TOOTHPASTE

Make brushing fun!®

QUESTIONS OR COMMENTS?

1-877-274-8358 (U.S.A.)

1-909-434-0911 (INTERNATIONAL)

ONTARIO, CA 91761

DESIGNED IN U.S.A.

MADE IN CHINA

DISTRIBUTED BY ASHTEL STUDIOS INC.

Packaging

image description

THOMAS AND FRIENDS 
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70108-017
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.76 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL (UNII: 506T60A25R)  
WATER (UNII: 059QF0KO0R)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
XYLITOL (UNII: VCQ006KQ1E)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
XANTHAN GUM (UNII: TTV12P4NEE)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
ROSE BENGAL SODIUM (UNII: 956575SN5L)  
Product Characteristics
ColorblueScore    
ShapeSize
FlavorBUBBLE GUMImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70108-017-01119 g in 1 TUBE; Type 0: Not a Combination Product08/16/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35508/16/2018
Labeler - Ashtel Studios, Inc. (148689180)

Revised: 8/2018
Document Id: eae6e252-ad98-4eb8-a485-db49cdb4e97b
Set id: 04475db4-5845-4198-beb6-0821b6193931
Version: 1
Effective Time: 20180817
 
Ashtel Studios, Inc.