Barbie Anticavity Fluoride Toothpaste

Barbie Anticavity Fluoride by

Drug Labeling and Warnings

Barbie Anticavity Fluoride by is a Otc medication manufactured, distributed, or labeled by Sunstar Americas, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

----------

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

BARBIE ANTICAVITY FLUORIDE 
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52376-047
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.24 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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
Color	pink	Score
Shape		Size
Flavor	BUBBLE GUM	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52376-047-12	119 g in 1 TUBE; Type 0: Not a Combination Product	01/22/2021	11/04/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	01/22/2021	11/04/2022

Labeler - Sunstar Americas, Inc. (025066358)

Establishment
Name	Address	ID/FEI	Business Operations
Sunstar Americas, Inc.		025066358	manufacture(52376-047)

Revised: 11/2022

Document Id: ecac4d0c-b7f9-e3aa-e053-2a95a90a5ccf

34390-5

Set id: 548add55-3a4d-4823-b74d-f663e35edf9b

Version: 2

Effective Time: 20221104