NDC 67659-415 Eugenol Toothache Medication

NDC Product Code 67659-415

NDC 67659-415-21

Package Description: 1 VIAL, GLASS in 1 KIT > 3.7 mL in 1 VIAL, GLASS (67659-415-23)

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

NDC Product Information

Eugenol Toothache Medication with NDC 67659-415 is a product labeled by Team Technologies, Inc. The generic name of Eugenol Toothache Medication 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.

Eugenol Toothache Medication Product Label Images

Eugenol Toothache Medication 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, persistent toothache due to a cavity. Visit Dentist within 48 hours of use.

Warnings

WarningsFor external use only.



Allergy 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



. 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 dose

Otc - Stop Use

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



. inflammation develops



. 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

DirectionsAdults and children 2 to 12 years of age and older: Rinse tooth with water to remove any food particles from the cavity. Moisten a cotton pellet with 1 or 2 drops of medication and using the tweezer, place in the cavity for approximately 1 minute. Avoid touching tissues other than the tooth cavity



. Apply the dose not more than four times daily or as directed by a dentist or physician.



Children 2 to 12 years of age: should be supervised in the use of this product.Children under 2 years of age: use only under the advice of a dentist or physician.

Other Safety Information

Other information. Do not purchase if package has been opened.



. Store at 46 - 90



o F.



. Cap tightly to avoid evaporation.



. toothaches and open cavities indicate serious problems which need prompt attention by a dentist.

Inactive Ingredient

Inactive ingredient sesame oil

* Please review the disclaimer below.