NDC 55346-0418 Plak Smacker

NDC Product Code 55346-0418

NDC CODE: 55346-0418

Proprietary Name: Plak Smacker 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.

Product Characteristics

Flavor(s):
GRAPE (C73391 - GROOVY GRAPE)

NDC Code Structure

  • 55346 - Dental Technologies, Inc.

NDC 55346-0418-2

Package Description: 121.9 g in 1 TUBE

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Plak Smacker with NDC 55346-0418 is a product labeled by Dental Technologies, Inc.. The product's dosage form is and is administered via form.

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.

  • ASCORBIC ACID (UNII: PQ6CK8PD0R)
  • CARBOMER 934 (UNII: Z135WT9208)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • TROLAMINE (UNII: 9O3K93S3TK)

Product Labeler Information

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

Labeler Name: Dental Technologies, Inc.
Labeler Code: 55346
Start Marketing Date: 12-31-2007 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: 12-31-2019 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: I - INACTIVATED, the listing data was inactivated by the FDA. 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Plak Smacker Product Label Images

Plak Smacker 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 0.4%

Purpose

Anticavity

Uses

Helps aid in the prevention of dental cavities.

Warnings:

This is an anticavity fluoride preventive treatment gel, not a toothpaste.Read directions carefully before using.When using this product it may produce surface staining of the teeth. Adequate tooth brushing may prevent these stains which are not harmful to permanent and may be removed by your dentist.

Keep Out Of Reach Of Children.

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions:

  • Adults and children 6 years of age and 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 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

Do not use if the foil seal under the cap is torn, cut or missing.

Inactive Ingredients:

Ascorbic Acid, Carbomer, Citric Acid, Flavor, Glycerin, Triethanolamine

* Please review the disclaimer below.