UltraCare Anesthetic Gel

UltraCare Anesthetic Gel is an FDA-registered drug product whose active ingredient is BENZOCAINE. It is labelled by The Bellport Company, Inc. dba Gingi-Pak taken by dental and marketed as a human otc drug product. Identifiers on file: NDC 10129-071, application M022, label effective 20260626. It is one of 70 FDA drug label records sharing the active ingredient BENZOCAINE. 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 BENZOCAINE are most often described in connection with: reduce pain, discomfort caused, minor dental, gum injury, canker sores, sore throat, dentures orthodontic. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses Reduce 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 applicances

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 amout required for anethesia. - Apply to the affected area. - Remain in place for at least 1 minute and then spit. - Use up to 4 times daily or as directed by a dentist or doctor. - Do not exceed recommended dosage. - This product is for adultsand children 2 years of age and older. - Chidlren under 2 years of age should consult a dentist or a doctor.

Warnings For external use only. Stop use and ask a doctor if - Sore throat is severe and more than 2 days - Fever, headache, rash, nausea, or vomiting develops - Mouth sore does not go away within 10 days - Irritation, pain or redness worsens 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. Methemoglobinemia warning Use of this product may cause methemoglobinemia, a rare but serious condition that must be treated prompltly because it reduces the amount of oxygen carried in blood. Cease use and seek immediate medical attention if one of the following symptoms develops: -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 patients with history of hypersensitivity to any ester-type local anesthetics. Do not use the product for teething or in infants and children younger than 2 years. Do not use if you have history of allergy to any "caine" local anesthetics. Avoid contact with eyes. Keep out of reach of children. If more than normal usage amount if accidentally swallowed, get medical help or contact a Poison Control Center immediately. Do not exceed recommended dosage.

FDA lists 70 drug label records with BENZOCAINE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

What is UltraCare Anesthetic Gel used for?
Uses Reduce 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 applicances

Who makes UltraCare Anesthetic Gel?
The Bellport Company, Inc. dba Gingi-Pak is the labeler of record for UltraCare Anesthetic Gel. 70 FDA label records share the active ingredient BENZOCAINE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does UltraCare Anesthetic Gel 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 UltraCare Anesthetic Gel 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.

Are there other products containing BENZOCAINE?
Yes. 70 FDA drug label records list BENZOCAINE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has UltraCare Anesthetic Gel 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.