Otc - Active Ingredient
Active Ingredient Eugenol 85%
Dentek Eugenol
FDA Label NDC 67659-400
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Team Technologies, Inc for the product Dentek Eugenol (NDC 67659-400). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - when using, otc - do not use, otc - stop use, otc - 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
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
Warnings
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 . 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.
Outer Retail Package Label - Dentek Dental First Aid Kit
Front And Back Of Card (250566d Usdfak 102615 2)
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