NDC 52376-047 Barbie Anticavity Fluoride

Sodium Fluoride

NDC Product Code 52376-047

NDC CODE: 52376-047

Proprietary Name: Barbie Anticavity Fluoride What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Sodium Fluoride What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is used to prevent cavities. It makes teeth stronger and more resistant to decay caused by acid and bacteria. Talk to your dentist or doctor about the benefits and risks of this product. This medication is not recommended for use in infants less than 6 months of age. This medication is not recommended for use in areas where the fluoride content in the water supply is greater than 0.6 parts per million. See Notes section for more information.

NDC Code Structure

  • 52376 - Sunstar Americas, Inc.

NDC 52376-047-12

Package Description: 119 g in 1 TUBE

NDC Product Information

Barbie Anticavity Fluoride with NDC 52376-047 is a a human over the counter drug product labeled by Sunstar Americas, Inc.. The generic name of Barbie Anticavity Fluoride is sodium fluoride. The product's dosage form is paste, dentifrice and is administered via oral form.

Labeler Name: Sunstar Americas, Inc.

Dosage Form: Paste, Dentifrice - A paste formulation intended to clean and/or polish the teeth, and which may contain certain additional agents.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Barbie Anticavity Fluoride Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • SODIUM FLUORIDE .24 g/100g

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • 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)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Sunstar Americas, Inc.
Labeler Code: 52376
FDA Application Number: part355 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 01-22-2021 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2022 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Barbie Anticavity Fluoride Product Label Images

Barbie Anticavity Fluoride Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

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.

Warnings

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

* Please review the disclaimer below.