Active Ingredient
Eugenol 85%
Dentek Eugenol
FDA Label NDC 83062-400
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Iimed Medical Mexicana S. De R.l. De C.v. for the product Dentek Eugenol (NDC 83062-400). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, when using this product, do not use, stop use and ask a dentist or doctor if, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Toothache Relief Agent
Uses
For the temporary relief of throbbing, persisitent toothache due to a cavity. Visit Dentist within 48 hours of use.
Warnings
Allergy alert: do not use if you are allergic to eugenol (clove oil).
When Using This Product
- use only in teeth with persistent throbbing pain
- avoid touching tissuers other than tooth cavity
- DO NOT SWALLOW to avoid irritation
- avoid contact with eyes.
Do Not Use
- for more than 7 days
- more than the recommended dosage.
Stop Use And Ask A Dentist Or Doctor If
- irritation persists
- inflammation develops
- if fever and infection develop.
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
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
sesame oil
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.
