GingiCaine Gel, Banana

Manufacturer
Gingi-Pak a Division of the Belport
Effective date
2026-06-25
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
monthly-update
Hydrated at
2026-07-17 21:36:40

Label at a glance#

ProductGingiCaine Gel
Active ingredientBENZOCAINE
Label structure12 sections

Indications and uses

For anesthesia of mucous membrane of oropharynx. Temporary relief of 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

Dosage and administration

Mucosa should be dried prior to application. Removal of excess saliva with cotton rolls or saliva ejectors will minimize dilution of the local anesthetic. Sterile cotton or gauze 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...

Storage and handling

DO NOT USE IF TAMPER-EVIDENT SLEEVE IS BROKEN. Avoid excessive heat above 40°C (104°F).

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzocaine 20% w/v

Inactive ingredient

INACTIVE INGREDIENT SECTION

polyethylene glycol 400, polyethylene glycol 3350, sodium saccharin, flavor, D&C Yellow #10

Allergy Alert and Contraindication

OTC - DO NOT USE SECTION

Do not use if you have a history of allergy to any “Caine” local anesthetics.

Avoid contact with eyes.

Keep out of reach of children.

If more than normal usage amount is accidentally swallowed, get medical help or contact a Poison Control Center immediately.

Do not exceed recommended dosage.

Stop use and ask a doctor if

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have severely traumatized, infected mucosal areas or areas of the posterior pharynx that might obstruct protective reflexes.

Purpose

OTC - PURPOSE SECTION

Oral Anesthetic

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

If more than normal usage amount is accidentally swallowed, get medical help or contact a Poison Control Center immediately.

Dosage and Administration

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 anesthetic.

Sterile cotton or gauze 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 minute and then spit out.

• Use up to 4 times a day or as directed by a dentist or doctor.

• This product is for adults and children 2 years of age and older.

Indications and Uses

INDICATIONS & USAGE SECTION

For anesthesia of mucous membrane of oropharynx.

Temporary relief of 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

Avoid excessive heat

STORAGE AND HANDLING SECTION

DO NOT USE IF TAMPER-EVIDENT SLEEVE IS BROKEN.

Avoid excessive heat above 40°C (104°F).

Warnings

WARNINGS SECTION

Do not use if you have a history of hypersensitivity to ester–type local anesthetics, not for use with teething or children under 2 years of age.

For topical use only

Use of this product may cause methemoglobinemia, a rare but serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. Consumers are advised to cease use and seek immediate medical attention if they or a child in their care develop:

• Pale, gray, or blue colored skin (cyanosis)

• Headache

• Rapid heart rate

• Shortness of breath • Dizziness or lightheadedness

• Fatigue or lack of energy

Sore throat is severe and more than 2 days

Fever, headache, rash, nausea, or vomiting develops

Mouth sores do not go away in 7 days

Irritation, pain, or redness worsens

GingiCaine Gel Banana label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Jar LabelJar LabelManufactured by: Gingi-Pak®, 4825 Camarillo, CA 93012 www.gingi-pak.com Gingicaine® Banana Topical Anesthetic Gel 20% Benzocaine Oral Anesthetic REF 20113 NDC 10129-035-03 1 oz.

Gingicaine Gel Banana-Hakusui

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Jar Label-JPJar Label-JP

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeCode 128(01)04548188180085GTIN-14: 04548188180085
GTIN-13: 4548188180085
EAN-13: 4548188180085
GTIN storage (14 digits): 04548188180085
Gingicaine Banana Jar Label-Hakusui JP.jpg

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
10129-035-012025-01-30C16284748780-1c7ccaba7-0e76-fd44-e053-dadaa90aa01bGingiCaine Gel, Banana
10129-035-012025-01-30C16284748780-1c7ccaba7-0e76-fd44-e053-dadaa90aa01bGingiCaine Gel, Banana
10129-035-032025-01-30C16284748780-1c7ccaba7-0e76-fd44-e053-dadaa90aa01bGingiCaine Gel, Banana
10129-035-032025-01-30C16284748780-1c7ccaba7-0e76-fd44-e053-dadaa90aa01bGingiCaine Gel, Banana
10129-035-052025-01-30C16284748780-1c7ccaba7-0e76-fd44-e053-dadaa90aa01bGingiCaine Gel, Banana
10129-035-052025-01-30C16284748780-1c7ccaba7-0e76-fd44-e053-dadaa90aa01bGingiCaine Gel, Banana
10129-035-012021-09-02C16284748780-1c7ccaba7-0e76-fd44-e053-dadaa90aa01bGingiCaine Gel, Banana
10129-035-012021-09-02C16284748780-1c7ccaba7-0e76-fd44-e053-dadaa90aa01bGingiCaine Gel, Banana
10129-035-032021-09-02C16284748780-1c7ccaba7-0e76-fd44-e053-dadaa90aa01bGingiCaine Gel, Banana
10129-035-032021-09-02C16284748780-1c7ccaba7-0e76-fd44-e053-dadaa90aa01bGingiCaine Gel, Banana
10129-035-052021-09-02C16284748780-1c7ccaba7-0e76-fd44-e053-dadaa90aa01bGingiCaine Gel, Banana
10129-035-052021-09-02C16284748780-1c7ccaba7-0e76-fd44-e053-dadaa90aa01bGingiCaine Gel, Banana
10129-035-012021-07-23C16284748780-1c7ccaba7-0e76-fd44-e053-dadaa90aa01bGingiCaine Gel, Banana
10129-035-012021-07-23C16284748780-1c7ccaba7-0e76-fd44-e053-dadaa90aa01bGingiCaine Gel, Banana
10129-035-032021-07-23C16284748780-1c7ccaba7-0e76-fd44-e053-dadaa90aa01bGingiCaine Gel, Banana
10129-035-032021-07-23C16284748780-1c7ccaba7-0e76-fd44-e053-dadaa90aa01bGingiCaine Gel, Banana
10129-035-052021-07-23C16284748780-1c7ccaba7-0e76-fd44-e053-dadaa90aa01bGingiCaine Gel, Banana
10129-035-052021-07-23C16284748780-1c7ccaba7-0e76-fd44-e053-dadaa90aa01bGingiCaine Gel, Banana

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
10129-03510129-035-03, 10129-035-05, 10129-035-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Source Document#

Source XML · Source PDF

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
32021-12-08full-release2026-05-31 23:45:30

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
GingiCaine GelGINGICAINE GEL BANANA FLAVORGingi-Pak a Division of the Belport62857d06-a829-4efa-e053-2991aa0a6d152026-06-25WarningsExact identifier
ndc (package): 10129-035-01
ndc (package): 10129-035-05
ndc (package): 10129-035-03
ndc (product): 10129-035
ndc11 (package): 10129003503
ndc11 (package): 10129003505
ndc11 (package): 10129003501
spl id: 551e4115-9355-7ef8-e063-6394a90a5bd5
spl set id: 62857d06-a829-4efa-e053-2991aa0a6d15

Reported adverse events (FAERS/openFDA)#

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