BARBIE ANTICAVITY FLUORIDE- sodium fluoride paste, dentifrice 
Sunstar Americas, 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 ingredient

Sodium fluoride 0.24%

(0.14% w/v fluoride ion)

Purpose

Anticavity

Use

helps in the prevention of dental 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 contact a Poison Control Center right away.

Directions

Unscrew cap and remove foil seal. Once cap is screwed back into place, flip it open and apply a thin strip of toothpaste to the toothbrush.

adults and children 2 years of
age and older 		brush teeth thoroughly, preferably after each meal or at least twice a day, or
use as directed by a dentist or physician
children under 6 years of age Instruct in good brushing and rinsing habits (to minimize swallowing).
Supervise children as necessary until capable of using without supervision
children under 2 years of age  ask a dentist or physician

Inactive ingredients:

Sorbitol, Hydrated silica, Purified water, Glycerin, Xylitol, Xanthan gum, Potassium acesulfame, Sodium lauryl sulfate, Flavor, Cellulose gum, Trisodium phosphate, Sodium hydroxide, D&C Red No. 28

Manufactured by: © Sunstar Americas, Inc. 301 East Central Rd., Schaumburg, IL 60195 U.S.A. 1-888-777-3101 GUMbrand.com
© 2020 Mattel. All Rights Reserved. BARBIE™ and associated trademarks are owned by and used under license from Mattel. Made in USA

Packaging

image description

BARBIE ANTICAVITY FLUORIDE 
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52376-047
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.24 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL (UNII: 506T60A25R)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
XYLITOL (UNII: VCQ006KQ1E)  
XANTHAN GUM (UNII: TTV12P4NEE)  
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS (UNII: SX01TZO3QZ)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
D&C RED NO. 28 (UNII: 767IP0Y5NH)  
Product Characteristics
ColorpinkScore    
ShapeSize
FlavorBUBBLE GUMImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52376-047-12119 g in 1 TUBE; Type 0: Not a Combination Product01/22/202111/04/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35501/22/202111/04/2022
Labeler - Sunstar Americas, Inc. (025066358)
Establishment
NameAddressID/FEIBusiness Operations
Sunstar Americas, Inc.025066358manufacture(52376-047)

Revised: 11/2022
Document Id: ecac4d0c-b7f9-e3aa-e053-2a95a90a5ccf
Set id: 548add55-3a4d-4823-b74d-f663e35edf9b
Version: 2
Effective Time: 20221104
 
Sunstar Americas, Inc.