FDA Label for Dentek Eugenol
View Indications, Usage & Precautions
Dentek Eugenol Product Label
The following document was submitted to the FDA by the labeler of this product Team Technologies, Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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
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
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