BARBIE- 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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Barbie Anticavity Fluoride Toothpaste

Drug Facts

Active Ingredients

Sodium Monofluorophosphate 0.76%

Purpose

Anticavity Toothpaste

Uses

Helps protect teeth and roots 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 2 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 FLAVOR

HELPS PREVENT CAVITIES!

ANTICAVITY FLUORIDE TOOTHPASTE

Alcohol & Sugar Free

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

Barbienw

BARBIE 
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70108-016
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
Color    Score    
ShapeSize
FlavorBUBBLE GUMImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70108-016-01119 g in 1 TUBE; Type 0: Not a Combination Product07/25/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35507/25/2018
Labeler - Ashtel Studios, Inc. (148689180)

Revised: 7/2018
Document Id: 5b0cc7f5-47ab-46cb-9207-c29f98d5de54
Set id: 210676d8-bbb9-4bd0-8fa3-9d12dbf21649
Version: 1
Effective Time: 20180727
 
Ashtel Studios, Inc.