OTC - ACTIVE INGREDIENT SECTION
Benzocaine 10% . . . Oral pain reliever
Menthol 0.25% . . . Oral pain reliever
Benzocaine 10% . . . Oral pain reliever
Menthol 0.25% . . . Oral pain reliever
for the temporary relief of pain due to toothaches
Methemoglobinemia warning: use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develop: * pale, gray, or blue colored skin (cyanosis) * headache * rapid heart rate * shortness of breath * dizziness or lightheadedness * fatigue or lack of energy
Allergy alert: do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other "caine" anesthetics
Do not use * more than directed * for more than 7 days unless told to do so by a dentist or doctor * for teething * in children under 2 years of age
Stop use and ask a doctor if * swelling, rash or fever develops * iffitation, pain or redness persists or worsens * symptoms do not improve in 7 days * allergic reaction occurs
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
carefully remove gel cushion from blister. Gently mold with fingers until soft. Apply to the affected tooth/gum area and gently press for 5-10 seconds to mold for a comfortable fit. Gel cushion will stay in place and dissolve slowly in mouth. Adults and children 12 years of age and older: use up to 3 times daily or as directed by a dentist or doctor. Children under 12 years of age: ask a dentist or doctor. Children under 2 years of age: do not use
Do not use if blister card is broken. This preparation is intended for use in cases of toothache, only as a temporary expedient until a dentist can be consulted. Do not use continuously. These toothache cushions are designed to completely dissolve in place. Store at room temperature 15-30°C (59-86°F)
cellulose gum, flavor, polyethylene glycol
| Class | Version | Type | Effective |
|---|---|---|---|
| BENZOCAINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 362d7abb-94e6-4c60-9a58-266894157713 | Product name | 1 | 20231023 |
| 816b97af-edc5-4060-aff1-b814bdbcad50 | Product name | 1 | 20190415 |
| 419aab54-5d5a-4146-9453-026d4a9991be | Product name | 2 | 20170525 |
| 89dac932-b90a-4410-9ab1-84c53e57de25 | Product name | 1 | 20150316 |
| d723478e-ad4a-ec23-6bd7-cfe33e1e3840 | Product name | 1 | 20140508 |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 11822-1616-9 | Toothache and Gum Relief Cushions | 0.5 g in 1 BLISTER PACK | DRESSING | 0.5 | 6 | |
| 11822-1616-9 | Toothache and Gum Relief Cushions | 8 in 1 CARTON | DRESSING | 8 | 6 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 11822-1616 | 11822-1616-9 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| POLYETHYLENE GLYCOL 3350 | G2M7P15E5P | IACT |
| CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM | K679OBS311 | IACT |
| MENTHOL | L7T10EIP3A | ACTIB |
| BENZOCAINE | U3RSY48JW5 | 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 |
|---|---|---|---|---|---|---|
| Toothache and Gum Relief Cushions | BENZOCAINE | Rite Aid | 9970d485-0b78-1438-e053-2995a90ad32c | 2025-11-21 | Warnings | 11822-1616-9 11822-1616 11822161609 441ec368-d742-cc10-e063-6394a90a6c66 9970d485-0b78-1438-e053-2995a90ad32c |
Adverse event summaries are temporarily unavailable. Other product information remains available.