FDA.reportPublic FDA data

GingiCaine Fusion

Manufacturer
Gingi-Pak a Division of the Belport | Jeff Nichols
Effective date
2021-12-07
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:45:30

Label at a glance#

ProductGingiCaine Fusion
Active ingredientBENZOCAINE
Label structure20 sections

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Active ingredientActive ingredient

Purpose

OTC - PURPOSE SECTION

PurposePurpose

Allergy Alert

OTC - DO NOT USE SECTION

Allergy alterAllergy alter

Consult a doctor

OTC - ASK DOCTOR SECTION

Consult a doctorConsult a doctor

Avoid Excessive heat

STORAGE AND HANDLING SECTION

Avoid excessive heatAvoid excessive heat

Caution

OTHER SAFETY INFORMATION

CautionCaution

Contraindications

CONTRAINDICATIONS SECTION

ContraindicationsContraindications

Directions for Use

INSTRUCTIONS FOR USE SECTION

Directions for useDirections for use

Dosage & Administration

DOSAGE & ADMINISTRATION SECTION

Dosage and AdministrationDosage and Administration

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Inactive ingredientsInactive ingredients

Indications

INDICATIONS & USAGE SECTION

IndicationsIndications

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of childrenKeep out of reach of children

Overdosage

OVERDOSAGE SECTION

OverdoseOverdose

Precautions

OTC - DO NOT USE SECTION

PrecautionsPrecautions

Temper Evident Statement

STORAGE AND HANDLING SECTION

Temper Evident StatementTemper Evident Statement

Uses

INDICATIONS & USAGE SECTION

UsesUses

Warnings

WARNINGS SECTION

WarningsWarnings

Description

DESCRIPTION SECTION

DescriptionDescription

RECENT MAJOR CHANGES SECTION

  • Indications section was NOT modified and remains the same as the previous label
  • Contraindications section was modified, such that the statement "do not use product for teething or in infants and children younger than 2" was added. This change was made effective on 12/07/2021.
  • Caution section was modified, such that the previous statement was replaced with "store between 15 C (59 F) and 40 C (104 F).
  • Uses section was madified, such that the statement "Reduces discomfort during healing process of mucous membrane," was added to pervious statement, effective 12/07/2021
  • Warning section was modified, such that the defenition of methemoglobinemia is added to the statement, effective 12/07/2021.
  • Jar Box_Strawberry, Jar Box_Vanilla, Jar Label_Strawberry, Jar label_Vanilla, Syringe_Strawberry, and Syringe_Vanilla sections were all updated with new label corrections, effective 12/07/2021

Principal Display

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Jar label_vanillaJar label_vanilla

Jar box_vanillaJar box_vanilla

Syringe_VanillaSyringe_Vanilla

Jar label_strawberryJar label_strawberry

Jar box_strawberryJar box_strawberry

Sryringe_StrawberrySryringe_Strawberry

box packagebox package

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
4d7a96d5-8256-4268-9a6c-25ea66d321feProduct name120180814
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
10129-040-012023-01-30C16284748780-1c7ccaba7-1212-fd44-e053-dadaa90aa01bGingiCaine Fusion
10129-040-202023-01-30C16284748780-1c7ccaba7-1212-fd44-e053-dadaa90aa01bGingiCaine Fusion
10129-041-012023-01-30C16284748780-1c7ccaba7-1212-fd44-e053-dadaa90aa01bGingiCaine Fusion
10129-041-202023-01-30C16284748780-1c7ccaba7-1212-fd44-e053-dadaa90aa01bGingiCaine Fusion
10129-040-012021-09-02C16284748780-1c7ccaba7-1212-fd44-e053-dadaa90aa01bGingiCaine Fusion
10129-040-202021-09-02C16284748780-1c7ccaba7-1212-fd44-e053-dadaa90aa01bGingiCaine Fusion
10129-041-012021-09-02C16284748780-1c7ccaba7-1212-fd44-e053-dadaa90aa01bGingiCaine Fusion
10129-041-202021-09-02C16284748780-1c7ccaba7-1212-fd44-e053-dadaa90aa01bGingiCaine Fusion
10129-040-012021-07-23C16284748780-1c7ccaba7-1212-fd44-e053-dadaa90aa01bGingiCaine Fusion
10129-040-202021-07-23C16284748780-1c7ccaba7-1212-fd44-e053-dadaa90aa01bGingiCaine Fusion
10129-041-012021-07-23C16284748780-1c7ccaba7-1212-fd44-e053-dadaa90aa01bGingiCaine Fusion
10129-041-202021-07-23C16284748780-1c7ccaba7-1212-fd44-e053-dadaa90aa01bGingiCaine Fusion

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10129-040-01GingiCaine Fusion14 g in 1 JARGEL142
10129-040-20GingiCaine Fusion1.2 g in 1 SYRINGE, PLASTICGEL1.22
10129-040-20GingiCaine Fusion20 in 1 BOXGEL202
10129-041-01GingiCaine Fusion14 g in 1 JARGEL142
10129-041-20GingiCaine Fusion20 in 1 BOXGEL202
10129-041-20GingiCaine Fusion1.2 g in 1 SYRINGE, PLASTICGEL1.22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10129-040GINGICAINE FUSION (BENZOCAINE) GEL [GINGI-PAK A DIVISION OF THE BELPORT]2Legacy NDC, 3 package rows20211209_a1f3c4d4-048c-7c3c-e053-2995a90a1b35.zip
10129-041GINGICAINE FUSION (BENZOCAINE) GEL [GINGI-PAK A DIVISION OF THE BELPORT]2Legacy NDC, 3 package rows20211209_a1f3c4d4-048c-7c3c-e053-2995a90a1b35.zip

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
10129-04010129-040-01, 10129-040-20
10129-04110129-041-01, 10129-041-20

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYETHYLENE GLYCOL 3350G2M7P15E5PIACT
CANNABIDIOL19GBJ60SN5IACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
BENZOCAINEU3RSY48JW5ACTIB
POTASSIUM SODIUM SACCHARATE73U34YC90UIACT
POLYETHYLENE GLYCOL 3350G2M7P15E5PIACT
CANNABIDIOL19GBJ60SN5IACT
POTASSIUM SODIUM SACCHARATE73U34YC90UIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
BENZOCAINEU3RSY48JW5ACTIB

Source Document#

Source XML

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
d292edc9-652b-b62d-e053-2995a90a635ca1f3c4d4-048c-7c3c-e053-2995a90a1b352021-12-07WarningsExact identifier
spl id: d292edc9-652b-b62d-e053-2995a90a635c
spl set id: a1f3c4d4-048c-7c3c-e053-2995a90a1b35

Reported adverse events (FAERS/openFDA)#

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