NDC 73343-002 Fluoride Gel

Sodium Fluoride

NDC Product Code 73343-002

NDC CODE: 73343-002

Proprietary Name: Fluoride Gel 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

  • 73343 - Yangzhou Tracey Daily Chemical Plastic Co., Ltd.

NDC 73343-002-01

Package Description: 1 TUBE in 1 BOX > 43 g in 1 TUBE

NDC Product Information

Fluoride Gel with NDC 73343-002 is a a human over the counter drug product labeled by Yangzhou Tracey Daily Chemical Plastic Co., Ltd.. The generic name of Fluoride Gel is sodium fluoride. The product's dosage form is paste and is administered via dental form.

Labeler Name: Yangzhou Tracey Daily Chemical Plastic Co., Ltd.

Dosage Form: Paste - A semisolid3 dosage form, containing a large proportion (20 – 50%) of solids finely dispersed in a fatty vehicle. This dosage form is generally for external application to the skin or mucous membranes.

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.

Fluoride Gel 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 .22 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.

  • CARBOCYSTEINE LYSINE MONOHYDRATE (UNII: QA5ZP9OL3E)
  • SORBITOL (UNII: 506T60A25R)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • METHYL PARAOXON (UNII: UE1A2XL95H)
  • PROPYLPARABEN SODIUM (UNII: 625NNB0G9N)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM SILICATE (UNII: IJF18F77L3)
  • POTASSIUM SODIUM SACCHARATE (UNII: 73U34YC90U)

Administration Route(s)

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

  • Dental - Administration to a tooth or teeth.
  • Dental - Administration to a tooth or teeth.

Product Labeler Information

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

Labeler Name: Yangzhou Tracey Daily Chemical Plastic Co., Ltd.
Labeler Code: 73343
FDA Application Number: part356 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 NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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: 10-14-2019 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: 12-31-2020 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’.

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Information for Patients

Fluoride

Fluoride is pronounced as (floor' ide)

Why is fluoride medication prescribed?
Fluoride is used to prevent tooth decay. It is taken up by teeth and helps to strengthen teeth, resist acid, and block the cavity-forming action of bacteria. Fluoride usu...
[Read More]

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Fluoride Gel Product Label Images

Fluoride Gel 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 Ingredients

Sodium Fluoride 0.22%(0.1 w/v Fluoride ion)

Purpose

Anticavity

Uses

Helps protect against cavities.

Warnings

Keep out of the reach of children under 6 years of age.if more than used for brushing is accidently swallowed,get medical help or contact a Poison Control Center immediately.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Directions

Adults and children 2years of age and older:Brush teeth thoroughly,preferably after each meal or at least twice a day,or as directed by a dentist or a physician.Children 2-6 years:Use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)Children under 2 years:Ask a dentist or a physician.

Inactive Ingredient

Sorbitol,Silica,methyl Paraben Sodium,Propyl Paraben Sodium ,Flavour ,Sodium Saccharin,Treated Water,SCMC,Sodium Lauryl Sulfate

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