Indications and uses
Reduce pain or discomfort caused by minor dental procedures • minor gum injury • canker sores • sore throat • minor mouth or gum irritations caused by dentures or orthodontic appliances.
UltraCare, Bubblegum
- Manufacturer
- The Belport Company, Inc. DBA Gingi-Pak
- Effective date
- 2025-01-29
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- monthly-update
- Hydrated at
- 2026-07-17 21:36:35
Label at a glance#
ProductUltraCare Anesthetic Gel
Active ingredientBENZOCAINE
Label structure12 sections
Label contents#
Full prescribing information#
Uses
Reduce pain or discomfort caused by minor dental procedures • minor gum injury • canker sores • sore throat • minor mouth or gum irritations caused by dentures or orthodontic appliances.
ADVERSE REACTIONS SECTION
OTC - ACTIVE INGREDIENT SECTION
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
OTC - DO NOT USE SECTION
Do not use in patients with history of hypersensitivity to any ester-type local anesthetics.
Do not use the product for teething or in infants and children younger than 2 years.
DO NOT USE IF TAMPER EVIDENT SLEEVE IS BROKEN.
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask doctor (pharmacist) before use if you have severely traumatized, infected mucosal areas or areas of the posterior pharnx that might obtund protective reflexes. Stop use and ask doctor if sore throat is severe for more than 2 days, fever, headache, rash, nausea, or vomiting develops, mouth sore does not go away within 10 days, irritation, pain or redness worsens.
DOSAGE & ADMINISTRATION SECTION
Mucosa should be dried prior to application. Removal of excess saliva with cotton rolls or saliva ejectors will minimize dilution of the local anethestic. Sterile cotton or gause should be used in applying anesthetic to mucosa. Care must be taken to avoid cross contamination between patients. Total dose should not exceed the amount required for anesthesia. Apply to the affected area. Remain in place for at least 1 minutes and then spit. Use up to 4 times daily or as directed by dentist or doctor. Do not exceed recommended dosage. This product is for adults and children 2 years or age and older. Children under 2 years of age should consult a dentist or a doctor.
INACTIVE INGREDIENT SECTION
The inactive ingredients in UltraCare bubblegum are polyethylene glycol 400 (PEG 400) NF, Polyethylene Glycol 3350 (3350) NF, Sodium Saccharin, artificial Flavor, FD$C Red #40.
WARNINGS SECTION
SAFE HANDLING WARNING SECTION
Do Not Use
Do not use in patients with history of hypersensitivity to any ester-type local anesthetics.
Do not use the product for teething or in infants and children younger than 2 years.
DO NOT USE IF TAMPER EVIDENT SLEEVE IS BROKEN.
Ultracare Bubble Gum Jar Label
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 |
Products#
Every source-derived product name is available through these pages.
- UltraCare Anesthetic Gel
- Benzocaine
- POLYETHYLENE GLYCOL 3350
- POLYETHYLENE GLYCOL 400
- POTASSIUM SODIUM SACCHARATE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 10129-072 | 10129-072-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| POLYETHYLENE GLYCOL 3350 | G2M7P15E5P | IACT |
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| BENZOCAINE | U3RSY48JW5 | ACTIB |
| POTASSIUM SODIUM SACCHARATE | 73U34YC90U | IACT |
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 1 | 2024-03-20 | full-release | 2026-06-01 00:10:17 |
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 |
|---|---|---|---|---|---|---|
| UltraCare Anesthetic Gel | BENZOCAINE | The Belport Company, Inc. DBA Gingi-Pak | 142062ca-6f8f-78d2-e063-6294a90a19d8 | 2025-01-29 | Warnings, Adverse reactions | 10129-072-01 10129-072 10129007201 2ce05104-05bd-3ff9-e063-6394a90a51b9 142062ca-6f8f-78d2-e063-6294a90a19d8 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.