EUGENOL: 20 Adverse Event Reports & Safety Profile
Healthy Teeth & Gums — The Probiotic Way
ProDentim: 3.5 billion good bacteria for a healthier mouth. No chemicals.
Drug Class: Allergens [CS] · Route: TOPICAL · Manufacturer: The Mentholatum Company · HUMAN OTC DRUG · FDA Label: Available
First Report: 20160301 · Latest Report: 20200107
What Are the Most Common EUGENOL Side Effects?
All EUGENOL Side Effects by Frequency
Who Reports EUGENOL Side Effects? Age & Gender Data
Gender: 65.0% female, 35.0% male. Average age: 34.2 years. Most reports from: US. View detailed demographics →
Is EUGENOL Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2016 | 2 | 0 | 0 |
| 2017 | 7 | 0 | 0 |
| 2018 | 7 | 0 | 0 |
| 2019 | 2 | 0 | 0 |
| 2020 | 1 | 0 | 0 |
What Is EUGENOL Used For?
| Indication | Reports |
|---|---|
| Toothache | 15 |
Other Drugs in Same Class: Allergens [CS]
Official FDA Label for EUGENOL
Official prescribing information from the FDA-approved drug label.
FDA Approved Uses (Indications)
Uses temporarily relieves throbbing, persistent toothache due to a cavity until a dentist can be seen
Dosage & Administration
Directions rinse tooth with water to remove any food particles from the cavity using tweezers, immerse cotton pellet in medication to prevent dripping , squeeze gently between fingers to remove excess liquid place pellet in tooth cavity for one minute without touching surrounding tissues , then remove supervise children using this product adults and children 12 years and over: use up to 4 times daily or as directed by a dentist or doctor children under 12 years: ask a dentist or doctor
Warnings
Warnings For external use only 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 tissues other than tooth cavity. Contact with lips or mucous membranes can cause burning, swelling, or irritation. DO NOT SWALLOW to avoid irritation do not use for more than 7 days do not exceed recommended dosage Stop use and ask a dentist or doctor if irritation persists, inflammation develops, or if fever and infection develop See a dentist as soon as possible whether or not the pain is relieved. Toothaches and open cavities indicate serious problems that need prompt attention by a dentist.
Active Ingredient
Active Ingredient Eugenol 1.2%
Inactive Ingredients
Inactive Ingredients: Ammonium Glycyrrhizate, Flavor, PEG-400, PEG-3350, Sodium Saccharin Dihydrate, Sorbic Acid