GingiCaine Gel, Cotton Candy

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 21:36:44

Label at a glance#

ProductGingiCaine Gel, Cotton Candy Flavor
Active ingredientBENZOCAINE
Label structure11 sections

Indications and uses

For the temporary relief of pain due to: • Minor irritation or injury of oral mucous membrane • Minor dental procedures • Minor irritation of mouth or gums caused by dentures or orthodontic appliances

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#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Benzocaine 20% w/v

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Polyethylene glycol 400, polyethylene glycol 3350, sodium saccharin, flavor, FD&C Red #40

Ask a doctor (pharmacist) before use if

OTC - ASK DOCTOR SECTION

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

Allergy Alert and Contraindications

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.

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 Adminnstration

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

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).

Warnings

WARNINGS SECTION

For topical use only.

Methemoglobinemia warning Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in the blood. Symptoms may occur within minutes to 1–2 hours after use and include: • Pale, gray, or blue‑colored skin, lips, and nail beds • Shortness of breath • Fatigue or lack of energy

Stop use and ask a doctor if: • Sore throat is severe and more than 2 days • Fever, headache, rash, nausea, or vomiting occur • Mouth does not heal within 7 days • Irritation, pain, or redness worsens

Indications and Uses

INDICATIONS & USAGE SECTION

For the temporary relief of pain due to: • Minor irritation or injury of oral mucous membrane • Minor dental procedures • Minor irritation of mouth or gums caused by dentures or orthodontic appliances

GingiCaine Gel, Cotton Candy Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Jar LabelJar Label

Manufactured by: Gingi-Pak®, 4825 Camarillo, CA 93012 www.gingi-pak.com Gingicaine® Cotton Candy Topical Anesthetic Gel 20% Benzocaine Oral Anesthetic REF 20119 NDC 10129-037-01 1 oz.

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#

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10129-03710129-037-01, 10129-037-05

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
22021-12-08full-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.

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GingiCaine Gel, Cotton Candy FlavorGINGICAINE GEL, COTTON CANDY FLAVORGingi-Pak a Division of the Belport628515a5-175f-ac2c-e053-2991aa0a19ce2026-06-25WarningsExact identifier
ndc (package): 10129-037-01
ndc (package): 10129-037-05
ndc (product): 10129-037
ndc11 (package): 10129003701
ndc11 (package): 10129003705
spl id: 55203a5d-d7c7-a5e1-e063-6294a90a20e2
spl set id: 628515a5-175f-ac2c-e053-2991aa0a19ce

Reported adverse events (FAERS/openFDA)#

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