OTC - ACTIVE INGREDIENT SECTION
Active Ingredient Eugenol 85%
Active Ingredient Eugenol 85%
Purpose Toothache Relief Agent
Uses For the temporary relief of throbbing, persistent toothache due to a cavity. Visit Dentist within 48 hours of use.
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 . DO NOT SWALLOW to avoid irritation . avoid contact with eyes
Do not use. For more than 7 days . more than the recommended dose
Stop use and ask a dentist or doctor if. irritation persists . inflammation develops . fever and infection develop
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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 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 sesame oil
| Class | Version | Type | Effective |
|---|---|---|---|
| EUGENOL Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 67659-415-21 | 2023-01-30 | C162847 | 48780-1 | 9d75b9d0-1fed-f424-e053-dadaa90a57ce | CVS TOOTHACHE RELIEF & REPAIR KIT (Prestige) |
| 67659-415-21 | 2021-12-28 | C162847 | 48780-1 | 9d75b9d0-1fed-f424-e053-dadaa90a57ce | CVS TOOTHACHE RELIEF & REPAIR KIT (Prestige) |
| 67659-415-21 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-1fed-f424-e053-dadaa90a57ce | CVS TOOTHACHE RELIEF & REPAIR KIT (Prestige) |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 67659-415-21 | Eugenol Toothache Medication | 1 in 1 KIT | LIQUID | 1 | 2 | |
| 67659-415-23 | Eugenol Toothache Medication | 3.7 mL in 1 VIAL, GLASS | LIQUID | 3.7 | 2 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 67659-415 | 67659-415-23, 67659-415-21 |
| 60630-686 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| SESAME OIL | QX10HYY4QV | IACT |
| EUGENOL | 3T8H1794QW | ACTIB |
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| d43835d4-30ed-1b0f-e053-2995a90aa367 | 3afd5a15-02ee-27d3-e054-00144ff88e88 | 2021-12-28 | Warnings | d43835d4-30ed-1b0f-e053-2995a90aa367 3afd5a15-02ee-27d3-e054-00144ff88e88 |
Adverse event summaries are temporarily unavailable. Other product information remains available.