Indications and uses
temporary relieves pain associated with the following mouth and gum irritations: • toothache • sore gums • canker sores • braces • minor dental procedures • dentures
Oral Pain Relief
- Manufacturer
- GERI-CARE PHARMACEUTICAL CORP
- Effective date
- 2023-10-31
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-05-31 23:58:34
Label at a glance#
ProductOral Pain Relief
Active ingredientBENZOCAINE
Label structure10 sections
Dosage and administration
• do not exceed recommended dosage • do not use for more than 7 days unless told to do so by a dentist or doctor • adults and children 2 years of age or older: apply to affected area up to 4 times daily or as directed by doctor/dentist • children between 2 and 12 years of age: adult supervision should be given in use of this product • children under 2 years of age: do not use
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
Active Ingredient
Benzocaine 20%
Purpose
Oral anesthetic
Uses
temporary relieves pain associated with the following mouth
and gum irritations: • toothache • sore gums • canker
sores • braces • minor dental procedures • dentures
Warnings
SPL UNCLASSIFIED SECTION
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 develops:
• 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. If a skin reaction occurs, stop use and seek medical help right away.
Do not use
• for teething
• in children under 2 years of age
• more than recommended
• for more than 7 days unless told to do so by a dentist or doctor
When using this product
• avoid contact with the eyes
Stop use and ask a doctor if
• sore mouth symptoms do not improve in 7 days
• irritation, pain, or redness persists or worsens
• swelling, rash or fever develops
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
• do not exceed recommended dosage
• do not use for more than 7 days unless told to do so by a dentist or doctor
• adults and children 2 years of age or older: apply to affected area up to 4 times daily or as directed by doctor/dentist
• children between 2 and 12 years of age: adult supervision should be given in use of this product
• children under 2 years of age: do not use
Other information
• do not use tube if it is cut prior to opening
• to open tube, cut open tip of tube on score mark with scissors
• store at a controlled room temperature 68º-77ºF (20º-25ºC)
Inactive ingredients
Flavor, PEG-6, PEG-8, PEG-32, PEG-75, Sodium Saccharin, Sorbic Acid
Questions or Comments?
1-800-540-3765
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| BENZOCAINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| 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 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 57896-139-05 | Oral Pain Relief | 14.2 g in 1 TUBE | GEL | 14.2 | 2 | |
| 57896-139-05 | Oral Pain Relief | 1 in 1 CARTON | GEL | 1 | 2 |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 57896-139-05 | GM - Gram | 57896-139 | 9ab79ac4-4a36-43ea-9c22-f85e9b28dce0 | 1 | 2022-03-09 |
Products#
Every source-derived product name is available through these pages.
- Oral Pain Relief
- BENZOCAINE
- POLYETHYLENE GLYCOL 300
- POLYETHYLENE GLYCOL 400
- POLYETHYLENE GLYCOL 1500
- POLYETHYLENE GLYCOL 3350
- SACCHARIN SODIUM
- SORBIC ACID
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 57896-139 | 57896-139-05 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| POLYETHYLENE GLYCOL 300 | 5655G9Y8AQ | IACT |
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| POLYETHYLENE GLYCOL 1500 | 1212Z7S33A | IACT |
| POLYETHYLENE GLYCOL 3350 | G2M7P15E5P | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| SORBIC ACID | X045WJ989B | IACT |
| BENZOCAINE | U3RSY48JW5 | ACTIB |
Source Document#
openFDA label cross-check#
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 |
|---|---|---|---|---|---|---|
| Oral Pain Relief | BENZOCAINE | GERI-CARE PHARMACEUTICAL CORP | d294a39e-55f4-272d-e053-2995a90ab7f7 | 2023-10-31 | Warnings | 57896-139-05 57896-139 57896013905 0904e5d4-6c9c-156d-e063-6294a90a4a7d d294a39e-55f4-272d-e053-2995a90ab7f7 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.