NDC 67659-400 Dentek Eugenol

NDC Product Code 67659-400

NDC 67659-400-21

Package Description: 1 VIAL, GLASS in 1 KIT > 3.5 mL in 1 VIAL, GLASS (67659-400-20)

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

NDC Product Information

Dentek Eugenol with NDC 67659-400 is a product labeled by Team Technologies, Inc. The generic name of Dentek Eugenol is . The product's dosage form is and is administered via form.

Labeler Name: Team Technologies, Inc

Dosage Form: -

Product Type: 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.

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.

  • SESAME OIL (UNII: QX10HYY4QV)

Product Labeler Information

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

Labeler Name: Team Technologies, Inc
Labeler Code: 67659
Start Marketing Date: 07-01-2015 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 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.

Dentek Eugenol Product Label Images

Dentek Eugenol 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

Otc - Active Ingredient

Active Ingredient Eugenol 85%

Otc - Purpose

Purpose Toothache Relief Agent

Indications & Usage

Uses For the temporary relief of throbbing, persisitent toothache due to a cavity. Visit Dentist within 48 hours of use.

Warnings

WarningsAllergy alert: do not use if you are allergic to eugenol (clove oil).

Otc - When Using

When using this product:. use only in teeth with persistent, throbbing pain



. avoid touching tissuers othere than tooth cavity



. DO NOT



SWALLOW to avoid irritation



. avoid contact with eyes.

Otc - Do Not Use

Do not use: . for more than 7 days



. more than the recommended dosage.

Otc - Stop Use

Stop use and ask a dentist or doctor if: . irritation persists



. inflammation develops



. if fever and infection develop.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Dosage & Administration

Directions Adults and children 12 year of age and older: Rinse the tooth with water to remove any food particles from the cavity. Moisten a cotton swab with Eugenol and place in the cavity for approximately 1 minute. Avoid touching tissue other than the tooth cavity. Apply the dose not more than four times daily or as directed by dentist or physician.



Adults and children 12 years and older use up to 4 times daily or as directed by a dentist or doctor.



Children under 12 years ask a dentist or doctor.

Inactive Ingredient

Inactive ingredient: sesame oil

Other Safety Information

Other information Do not purchase if package has been opened. Store at 68-77



o F. Cap tightly to avoid evaporation.

* Please review the disclaimer below.