Otc - Active Ingredient
Active Ingredient Eugenol 85%
Eugenol Toothache Medication
FDA Label NDC 67659-415
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 Eugenol Toothache Medication (NDC 67659-415). 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, persistent toothache due to a cavity. Visit Dentist within 48 hours of use.
Warnings
Warnings
For 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
Directions
Adults 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
Package Label.Principal Display Panel
Kit Package Label (250686b Card Sm3)
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