Gingicaine Gel, Strawberry

Manufacturer
Gingi-Pak a Division of the Belport
Effective date
2026-05-01
Label type
HUMAN OTC DRUG LABEL
Version
13
Source
monthly-update
Hydrated at
2026-07-17 21:36:09

Label at a glance#

ProductGingicaine Gel Strawberry
Active ingredientBENZOCAINE
Label structure14 sections

Indications and uses

For anesthesia of mucous membrane of oropharynx. Temporarily relieves pain or discomfort caused by minor dental procedures, orthodontic appliances, teething, canker sores, cold sores, fever blisters, minor injury of the mouth or gums, and 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...

Storage and handling

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

Label contents#

Full prescribing information#

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 daily or as directed by a dentist or doctor.

• Do not exceed recommended dosage.

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

• Children under 2 years of age should consult a dentist or a doctor.

Precaution Section

WARNINGS SECTION

Dentists should avoid application to severely traumatized, infected mucosal areas or areas of the posterior pharynx that might obtund protective reflexes. Local anesthetics should be used with caution in patients with known drug sensitivities, particularly those known to be allergic to ester-type anesthetics (procaine, benzocaine, tetracaine). Dentists should avoid contact with all local anesthetics to avoid possible sensitization.

Indications and usage section

INDICATIONS & USAGE SECTION

For anesthesia of mucous membrane of oropharynx.

Temporarily relieves pain or discomfort caused by minor dental procedures, orthodontic appliances, teething, canker sores, cold sores, fever blisters, minor injury of the mouth or gums, and irritations caused by dentures or orthodontic appliances.

Active Ingredient - Benzocaine, 20%

OTC - ACTIVE INGREDIENT SECTION

Benzocaine 20% w/v

Warnings

WARNINGS SECTION

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

Do not use in children under 2 years of age.

Consult a doctor promptly

OTC - ASK DOCTOR SECTION

If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting. If mouth sore does not go away within 10 days. If irritation, pain, or redness persists or worsens.

Do not use

OTC - DO NOT USE SECTION

Do not use if you have a history of allergy to any "caine" local anesthetics or FD&C Red #40. Do not use for teething or in children under 2 years of age.

Avoid excessive heat

STORAGE AND HANDLING SECTION

DO NOT USE IF TAMPER-EVIDENT SLEEVE IS BROKEN.

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Polyethylene glycol 400, propylene glycol 3350, saccharin, flavor, FD&C Red #40.

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.

Strawberry Label USA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Jar LabelJar Label

GingiCaine Gel Syringe label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Syringe LabelSyringe Label

GingiCAINE in Syringe Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Syringe BoxSyringe Box

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
10129-036-012026-01-29C16284748780-1c7ccaba7-194d-fd44-e053-dadaa90aa01bGingicaine Gel, Strawberry
10129-036-012026-01-29C16284748780-1c7ccaba7-194d-fd44-e053-dadaa90aa01bGingicaine Gel, Strawberry
10129-036-042026-01-29C16284748780-1c7ccaba7-194d-fd44-e053-dadaa90aa01bGingicaine Gel, Strawberry
10129-036-042026-01-29C16284748780-1c7ccaba7-194d-fd44-e053-dadaa90aa01bGingicaine Gel, Strawberry
10129-036-052026-01-29C16284748780-1c7ccaba7-194d-fd44-e053-dadaa90aa01bGingicaine Gel, Strawberry
10129-036-052026-01-29C16284748780-1c7ccaba7-194d-fd44-e053-dadaa90aa01bGingicaine Gel, Strawberry
10129-036-012024-03-06C16284748780-1c7ccaba7-194d-fd44-e053-dadaa90aa01bGingicaine Gel, Strawberry
10129-036-012024-03-06C16284748780-1c7ccaba7-194d-fd44-e053-dadaa90aa01bGingicaine Gel, Strawberry
10129-036-042024-03-06C16284748780-1c7ccaba7-194d-fd44-e053-dadaa90aa01bGingicaine Gel, Strawberry
10129-036-042024-03-06C16284748780-1c7ccaba7-194d-fd44-e053-dadaa90aa01bGingicaine Gel, Strawberry
10129-036-052024-03-06C16284748780-1c7ccaba7-194d-fd44-e053-dadaa90aa01bGingicaine Gel, Strawberry
10129-036-052024-03-06C16284748780-1c7ccaba7-194d-fd44-e053-dadaa90aa01bGingicaine Gel, Strawberry
10129-036-012023-01-30C16284748780-1c7ccaba7-194d-fd44-e053-dadaa90aa01bGingicaine Gel, Strawberry
10129-036-012023-01-30C16284748780-1c7ccaba7-194d-fd44-e053-dadaa90aa01bGingicaine Gel, Strawberry
10129-036-042023-01-30C16284748780-1c7ccaba7-194d-fd44-e053-dadaa90aa01bGingicaine Gel, Strawberry
10129-036-042023-01-30C16284748780-1c7ccaba7-194d-fd44-e053-dadaa90aa01bGingicaine Gel, Strawberry
10129-036-052023-01-30C16284748780-1c7ccaba7-194d-fd44-e053-dadaa90aa01bGingicaine Gel, Strawberry
10129-036-052023-01-30C16284748780-1c7ccaba7-194d-fd44-e053-dadaa90aa01bGingicaine Gel, Strawberry
10129-036-012021-09-02C16284748780-1c7ccaba7-194d-fd44-e053-dadaa90aa01bGingicaine Gel, Strawberry
10129-036-012021-09-02C16284748780-1c7ccaba7-194d-fd44-e053-dadaa90aa01bGingicaine Gel, Strawberry
10129-036-042021-09-02C16284748780-1c7ccaba7-194d-fd44-e053-dadaa90aa01bGingicaine Gel, Strawberry
10129-036-042021-09-02C16284748780-1c7ccaba7-194d-fd44-e053-dadaa90aa01bGingicaine Gel, Strawberry
10129-036-052021-09-02C16284748780-1c7ccaba7-194d-fd44-e053-dadaa90aa01bGingicaine Gel, Strawberry
10129-036-052021-09-02C16284748780-1c7ccaba7-194d-fd44-e053-dadaa90aa01bGingicaine Gel, Strawberry
10129-036-012021-07-23C16284748780-1c7ccaba7-194d-fd44-e053-dadaa90aa01bGingicaine Gel, Strawberry
10129-036-012021-07-23C16284748780-1c7ccaba7-194d-fd44-e053-dadaa90aa01bGingicaine Gel, Strawberry
10129-036-042021-07-23C16284748780-1c7ccaba7-194d-fd44-e053-dadaa90aa01bGingicaine Gel, Strawberry
10129-036-042021-07-23C16284748780-1c7ccaba7-194d-fd44-e053-dadaa90aa01bGingicaine Gel, Strawberry
10129-036-052021-07-23C16284748780-1c7ccaba7-194d-fd44-e053-dadaa90aa01bGingicaine Gel, Strawberry
10129-036-052021-07-23C16284748780-1c7ccaba7-194d-fd44-e053-dadaa90aa01bGingicaine Gel, Strawberry

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
10129-03610129-036-01, 10129-036-04, 10129-036-05

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

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
122023-12-27full-release2026-06-01 00:09:31

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 Gel StrawberryGINGICAINE GEL STRAWBERRY FLAVORGingi-Pak a Division of the Belport2fd37612-a28b-3aa1-e054-00144ff8d46c2026-05-01WarningsExact identifier
ndc (package): 10129-036-05
ndc (package): 10129-036-04
ndc (package): 10129-036-01
ndc (product): 10129-036
ndc11 (package): 10129003605
ndc11 (package): 10129003604
ndc11 (package): 10129003601
spl id: 50cb6dbf-74de-4f3a-e063-6394a90a21bb
spl set id: 2fd37612-a28b-3aa1-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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