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
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
DO NOT USE IF TAMPER-EVIDENT SLEEVE IS BROKEN. Storage information: Avoid excessive heat above 40°C (104°F).
Benzocaine 20% w/v
Polyethylene glycol 400, polyethylene glycol 3350, sodium saccharin, flavor, FD&C Red #40
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.
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.
Oral Anesthetic
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.
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.
DO NOT USE IF TAMPER-EVIDENT SLEEVE IS BROKEN. Storage information: Avoid excessive heat above 40°C (104°F).
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
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
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.
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 362d7abb-94e6-4c60-9a58-266894157713 | Product name | 1 | 20231023 |
| 816b97af-edc5-4060-aff1-b814bdbcad50 | Product name | 1 | 20190415 |
| 419aab54-5d5a-4146-9453-026d4a9991be | Product name | 2 | 20170525 |
| 89dac932-b90a-4410-9ab1-84c53e57de25 | Product name | 1 | 20150316 |
| d723478e-ad4a-ec23-6bd7-cfe33e1e3840 | Product name | 1 | 20140508 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 10129-037 | 10129-037-01, 10129-037-05 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| BENZOCAINE | U3RSY48JW5 | ACTIB |
| POLYETHYLENE GLYCOL 3350 | G2M7P15E5P | IACT |
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| POTASSIUM SODIUM SACCHARATE | 73U34YC90U | IACT |
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 2 | 2021-12-08 | full-release | 2026-05-31 23:45:30 |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| GingiCaine Gel, Cotton Candy Flavor | GINGICAINE GEL, COTTON CANDY FLAVOR | Gingi-Pak a Division of the Belport | 628515a5-175f-ac2c-e053-2991aa0a19ce | 2026-06-25 | Warnings | 10129-037-01 10129-037-05 10129-037 10129003701 10129003705 55203a5d-d7c7-a5e1-e063-6294a90a20e2 628515a5-175f-ac2c-e053-2991aa0a19ce |
Adverse event summaries are temporarily unavailable. Other product information remains available.