Outer Package Card Labeling
Labeling For Complete Kit (Walgreens Toothache 111815)
Walgreens Natural Eugenol/toothache Medication
FDA Label NDC 60630-608
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Dentek Oral Care, Inc. for the product Walgreens Natural Eugenol/toothache Medication (NDC 60630-608). 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 outer package card labeling, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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).
When using this product:
. use only in teeth with pesistent, throbbing pain
. avoid touching tissues other than tooth cavity
. 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.
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 years of age and older Rinse the tooth with water to remove any food particles from the cavity.
Moisten a cotton pellet with 1 to 2 drops of Eugenol and 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 under 12 years ask a dentist or doctor.
Inactive Ingredient
Inactive Ingredient: sesame oil
Otc - Questions
Questions or comments? 1-888-811-6188
* Please review the disclaimer below.
