GingiCaine Gel, Pina Colada

GingiCaine Gel, Pina Colada is an FDA-registered drug product whose active ingredient is GINGICAINE GEL, PINA COLADA 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 10129-033, application M022, label effective 20260629. 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, PINA COLADA FLAVOR are most often described in connection with: anesthesia mucous, membrane oropharynx, temporary relief, pain discomfort, caused minor, dental procedures, gum injury, canker sores. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

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 Adminstration 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.

Warnings 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 Methemoglobinemia warning 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 Stop use and ask a doctor if (signs of toxicity) • 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

What is GingiCaine Gel, Pina Colada used for?
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

Who makes GingiCaine Gel, Pina Colada?
Gingi-Pak a Division of the Belport is the labeler of record for GingiCaine Gel, Pina Colada.

What form does GingiCaine Gel, Pina Colada 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, Pina Colada 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, Pina Colada 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.