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#

ProductPrime-Gel
Active ingredientBENZOCAINE
Label structure12 sections

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

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 77794-018-017NDC 77794-018-017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
238910benzocaine 20 % Oral GelPSN3
238910benzocaine 0.2 MG/MG Oral GelSCD3
238910benzocaine 20 % (180-220 MG per 1 GM) Oral GelSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BENZOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
77794-018-002021-07-23C16284748780-1c7ccaba7-2073-fd44-e053-dadaa90aa01bab6ef479-2567-0cf2-e053-2a95a90a272a
77794-018-002021-07-23C16284748780-1c7ccaba7-2073-fd44-e053-dadaa90aa01bab6ef479-2567-0cf2-e053-2a95a90a272a

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77794-018-00Prime-Gel24 in 1 BOX, UNIT-DOSEGEL243
77794-018-17Prime-Gel29.6 g in 1 BOTTLEGEL29.63

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77794-01877794-018-17, 77794-018-00

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22021-04-30full-release2026-05-31 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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
419cfbd9-6cad-03c1-e063-6294a90a2784ab6ef479-2567-0cf2-e053-2a95a90a272a2025-10-20WarningsExact identifier
spl id: 419cfbd9-6cad-03c1-e063-6294a90a2784
spl set id: ab6ef479-2567-0cf2-e053-2a95a90a272a

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.