Prime-Gel
- Manufacturer
- Prime Dental Manufacturing, Inc.
- Effective date
- 2025-10-20
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-06-01 01:39:38
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
DOSAGE & ADMINISTRATION SECTION
Use for Oral mucosal use only, as directed by dentist. For the temporary relief of pain due to minor dental procedures.
Do not use for more than 7 days unless directed by a dentist or doctor.
See drug facts.
List of Inactive Ingredients
Flavoring, PEG3350, PEG400, sodium saccharin, water. may contain blue#, green #5, red #3, red #28, red#40, yellow #5 as color additives.
INDICATIONS & USAGE SECTION
Use: for Oral mucosal use only, as directed by dentist. For the temporary relief of pain due to minor dental procedures.
Indications/Directions: Apply only amount needed to the oral mucosa to prevent or relieve pain.
See drug facts.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach section.
See drug facts:
OTC - PURPOSE SECTION
Purpose: Oral Anesthetic.
See drug facts.
OTC - ACTIVE INGREDIENT SECTION
Active Ingridient: Benzocaine 0.2 g (200mg) per gram.
See drug facts.
WARNINGS AND PRECAUTIONS SECTION
Warnings
Allergy Alert: Do not use on patients with a history of allergies to local anesthetics such as benzocaine or other "caine" anesthetics.
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; irritation, pain, or redness persists or worsens; or if swelling, rash or fever develops, see your dentist or doctor promptly.
When using this product avoid contact with eyes. If contact occures, flush with water.
Stop use and consult a health care practitioner if the following symptoms appear: weakness, confusion, headache, difficulty breathing, and/or pale, grey or blue colored skin, as these may be signs of methemoglobinemia, a rare disorder, which may appear up to 2 hours after use.
Do not exceed recommended dosage. If more than used for pain is accidentally swaloowed, get medical help or contact a posion control center immediately.
If pregnant or breast feeding, ask a health care proffesional before use.
Keep out of reach of children.
OTC - QUESTIONS SECTION
Contact 773-283-2914
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast feeding ask a health care professional before use.
OTC - ASK DOCTOR/PHARMACIST SECTION
Stop use and consult a health care practitioner if the following symptoms appear: weakness, confusion, headache, difficulty breathing, and/or pale, grey or blue colored skin, as these may be signs of methemoglobinemia, a rare disorder, which may appear up to 2 hours after use.
WARNINGS SECTION
Warnings
Allergy Alert: Do not use on patients with a history of allergies to local anesthetics such as benzocaine or other "caine" anesthetics.
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; irritation, pain, or redness persists or worsens; or if swelling, rash or fever develops, see your dentist or doctor promptly.
When using this product avoid contact with eyes. If contact occures, flush with water.
Stop use and consult a health care practitioner if the following symptoms appear: weakness, confusion, headache, difficulty breathing, and/or pale, grey or blue colored skin, as these may be signs of methemoglobinemia, a rare disorder, which may appear up to 2 hours after use.
Do not exceed recommended dosage. If more than used for pain is accidentally swaloowed, get medical help or contact a posion control center immediately.
If pregnant or breast feeding, ask a health care proffesional before use.
Keep out of reach of children.
Package Labelling
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 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 77794-018-00 | 2021-07-23 | C162847 | 48780-1 | c7ccaba7-2073-fd44-e053-dadaa90aa01b | ab6ef479-2567-0cf2-e053-2a95a90a272a |
| 77794-018-00 | 2021-07-23 | C162847 | 48780-1 | c7ccaba7-2073-fd44-e053-dadaa90aa01b | ab6ef479-2567-0cf2-e053-2a95a90a272a |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 77794-018-00 | Prime-Gel | 24 in 1 BOX, UNIT-DOSE | GEL | 24 | 3 | |
| 77794-018-17 | Prime-Gel | 29.6 g in 1 BOTTLE | GEL | 29.6 | 3 |
Products#
Every source-derived product name is available through these pages.
- Prime-Gel
- Benzocaine
- POLYETHYLENE GLYCOL 400
- HC RED NO. 3
- SACCHARIN
- POLYETHYLENE GLYCOL 3350
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 77794-018 | 77794-018-17, 77794-018-00 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| HC RED NO. 3 | 51CPX7M1SQ | IACT |
| SACCHARIN | FST467XS7D | IACT |
| BENZOCAINE | U3RSY48JW5 | ACTIB |
| POLYETHYLENE GLYCOL 3350 | G2M7P15E5P | IACT |
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 2 | 2021-04-30 | full-release | 2026-05-31 23:40:07 |
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 |
|---|---|---|---|---|---|---|
| 419cfbd9-6cad-03c1-e063-6294a90a2784 | ab6ef479-2567-0cf2-e053-2a95a90a272a | 2025-10-20 | Warnings | 419cfbd9-6cad-03c1-e063-6294a90a2784 ab6ef479-2567-0cf2-e053-2a95a90a272a |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
