NDC 48783-500 Enamelon Preventive Treatment

Stannous Fluoride

NDC Product Code 48783-500

NDC 48783-500-40

Package Description: 1 TUBE in 1 CARTON > 113 g in 1 TUBE

NDC Product Information

Enamelon Preventive Treatment with NDC 48783-500 is a a human over the counter drug product labeled by Premier Dental Products Company. The generic name of Enamelon Preventive Treatment is stannous fluoride. The product's dosage form is gel and is administered via dental form.

Labeler Name: Premier Dental Products Company

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

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.

Enamelon Preventive Treatment 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.

  • STANNOUS FLUORIDE .004 g/g

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.

  • ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
  • CALCIUM SULFATE (UNII: WAT0DDB505)
  • CALCIUM/SODIUM MALEATE METHYL VINYL ETHER COPOLYMER (1000000 MW, 1900 MPA.S AT 11%) (UNII: 5216H1HX5F)
  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • LAUROYL SARCOSINE (UNII: LIJ19P3L6F)
  • SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)
  • POLOXAMER 407 (UNII: TUF2IVW3M2)
  • POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)

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.

Product Labeler Information

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

Labeler Name: Premier Dental Products Company
Labeler Code: 48783
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: 01-01-2014 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: 12-31-2021 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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Enamelon Preventive Treatment Product Label Images

Enamelon Preventive Treatment 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

Stannous fluoride 0.40% (0.15% w/v fluoride ion)

Purpose

Anticavity/Sensitivity Relief/Antigingivitis

Uses

  • Aids in the prevention of cavitiesBuilds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contactHelps prevent gingivitisHelps interfere with the harmful effects of plaque associated with gingivitis

Warnings

Keep out of the reach of children.

Directions

Adults and children 6 years of age or older: Use once a day after brushing your teeth with a toothpaste. Apply the gel to your teeth and brush thoroughly. Allow the gel to remain on your teeth for 1 minute and then spit out. Do not swallow the gel. Do not rinse, eat or drink for 30 minutes after brushing. Instruct children under 12 years of age in the use of this product (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 6 years of age: Consult a dentist or doctor.

Other Information

  • This is an anticavity/fluoride preventive treatment gel, not a toothpaste. Read directions carefully before using. Products containing stannous fluoride may produce surface staining of the teeth. Adequate toothbrushing may prevent these stains which are not harmful or permanent and may be removed by your dentist.Do not use if foil seal is broken or missingKeep tightly closed when not in useStore at controlled room temperature

Inactive Ingredients

Acesulfame K, calcium/sodium maleate methyl vinyl ether copolymer, calcium sulfate, cocamidopropyl betaine, dimethicone, flavors, glycerin, lauroyl-sarcosine, monosodium phosphate, poloxamer 407, polyethylene glycol, silica, sucralose

Other

  • United States Patent Numbers: US 5,993,784, US 5,711,936, US 5,651,959 and other patents pending. Made in U.S.A.Ultramulsion® is a registered trademark of WhiteHill Oral Technologies, Inc.Clinically Proven Active Ingredient for Anticavity, Antigingivitis and Sensitive TeethRelieves the discomfort of dry mouth tissuesNon-irritating to patients with dry mouthOptimized with calcium and phosphate ionsNo Sodium Lauryl Sulfate (SLS), No Gluten, No Dyes​Distributed by:Premier® Dental Products Company, Plymouth Meeting, PA 19462www.premusa.com Part # 9007285 www.enamelon.comNDC 48783-500-40 021665 Rev4 SP

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