FDA Label for Eugenol Toothache Medication
View Indications, Usage & Precautions
Eugenol Toothache Medication 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, 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
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