GingiCaine Gel, Cotton Candy Flavor

GingiCaine Gel, Cotton Candy Flavor is an FDA-registered drug product whose active ingredient is GINGICAINE GEL, COTTON CANDY FLAVOR. It is labelled by Gingi-Pak a Division of the Belport taken by dental and marketed as a human otc drug product. Identifiers on file: NDC 10129-037, application M022, label effective 20260625. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing GINGICAINE GEL, COTTON CANDY FLAVOR are most often described in connection with: minor irritation, temporary relief, pain due, injury oral, mucous membrane, dental procedures, mouth gums, caused dentures. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

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

Dosage and Adminnstration 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.

Warnings 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

What is GingiCaine Gel, Cotton Candy Flavor used for?
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

Who makes GingiCaine Gel, Cotton Candy Flavor?
Gingi-Pak a Division of the Belport is the labeler of record for GingiCaine Gel, Cotton Candy Flavor.

What form does GingiCaine Gel, Cotton Candy Flavor come in?
administered by dental. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is GingiCaine Gel, Cotton Candy Flavor prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Has GingiCaine Gel, Cotton Candy Flavor been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.