Indications and uses
Temporarily relieves pain caused by: toothache, dental work, minor irritation or injury of the mouth and gums, canker sores, cheek bites, gum sores, and denture irritation.
Temporarily relieves pain caused by: toothache, dental work, minor irritation or injury of the mouth and gums, canker sores, cheek bites, gum sores, and denture irritation.
Adults and children 2 years and older: dry affected area and apply medication undiluted. Use up to 4 times daily, but not more than every two hours, or as directed by a dentist or doctor. Consult a dentist or doctor for use on children under 2 years of age Children under 12 years of age should be supervised in the use of this product
Benzocaine 20%
Oral Pain Reliever
Temporarily relieves pain caused by: toothache, dental work, minor irritation or injury of the mouth and gums, canker sores, cheek bites, gum sores, and denture irritation.
For oral use only. Avoid contact with eyes.
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 due to the possibility of anaphylactic shock.
When using this product
Do not use for more than 7 days unless directed by a dentist or doctor. If sore mouth symptoms do not improve in 7 days; if irritation, pain or redness persists or worsens; or if swelling, rash, fever or other allergic reaction develops, see your doctor or dentist promptly. Do not exceed recommended dosage.
Keep out of reach of children
If more than used for pain relief is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Adults and children 2 years and older: dry affected area and apply medication undiluted. Use up to 4 times daily, but not more than every two hours, or as directed by a dentist or doctor.
Consult a dentist or doctor for use on children under 2 years of age
Children under 12 years of age should be supervised in the use of this product
Do not use if packet is torn, cut, or opened
Store at room temperature, 15º to 30ºC (59º to 86ºF)
Avoid contact with eyes
PEG 400, PEG 3350, peppermint oil, sodium saccharin, sorbic acid
Keep out of Reach of Children
| 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 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 44224-0102-0 | 2023-01-30 | C162847 | 48780-1 | f386c649-c6d6-0266-e053-dadaa90a7c1a | Adventure Medical Kits Dental Medic |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 44224-0102-0 | Adventure Medical Kits Dental Medic | 1 in 1 BAG | KIT | 1 | 1 | |
| 61010-8100-2 | Adventure Medical Kits Dental Medic | 0.5 g in 1 PACKET | LIQUID | 2 g in .5 | 200 mg in 1g | 1 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 44224-0102 | ADVENTURE MEDICAL KITS DENTAL MEDIC (BENZOCAINE) KIT [TENDER CORPORATION] | 1 | Legacy NDC, 2 package rows | 20170327_4adc9c0d-9ef2-281b-e054-00144ff8d46c.zip |
| 61010-8100 | ADVENTURE MEDICAL KITS DENTAL MEDIC (BENZOCAINE) KIT [TENDER CORPORATION] | 1 | Current NDC, Legacy NDC | 20170327_4adc9c0d-9ef2-281b-e054-00144ff8d46c.zip |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 44224-0102 | 44224-0102-0 |
| 61010-8100 | 61010-8100-2 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| PEPPERMINT OIL | AV092KU4JH | IACT |
| BENZOCAINE | U3RSY48JW5 | ACTIB |
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| POLYETHYLENE GLYCOL 3350 | G2M7P15E5P | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| SORBIC ACID | X045WJ989B | IACT |
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 |
|---|---|---|---|---|---|---|
| Pain Relief | BENZOCAINE | Safetec of America, Inc. | de84e598-d047-4fae-b2ed-155a3788bc6f | 2024-02-16 | Warnings | 61010-8100-2 61010-8100 61010810002 |
| 4adc9c0d-9ef3-281b-e054-00144ff8d46c | 4adc9c0d-9ef2-281b-e054-00144ff8d46c | 2017-03-16 | Warnings | 4adc9c0d-9ef3-281b-e054-00144ff8d46c 4adc9c0d-9ef2-281b-e054-00144ff8d46c |
Adverse event summaries are temporarily unavailable. Other product information remains available.