Active Ingredient
Benzocaine 20% w/v
Ultracare Anesthetic Gel
FDA Label NDC 10129-071
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by The Bellport Company, Inc. Dba Gingi-pak for the product Ultracare Anesthetic Gel (NDC 10129-071). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, warnings, otc - ask doctor, otc - ask doctor/pharmacist, methemoglobinemia warning, otc - do not use, otc - keep out of reach of children, overdosage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Warnings
For external use only.
Otc - Ask Doctor
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
Otc - Ask Doctor/Pharmacist
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
Otc - Do Not Use
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.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Overdosage
If more than normal usage amount if accidentally swallowed, get medical help or contact a Poison Control Center immediately. Do not exceed recommended dosage.
Purpose
Oral Anesthetic
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
Indications
Anesthesia of mucous membrane of oropharynx. Minimizes the pain of ulcers, needle puncture, deep scaling procedures, and the application of matrix bands. Also an aid in the taking of impressions or intraoral radiographs of patients with an excessive gag reflexes.
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.
Inactive Ingredients
Polyethylene Glycol 400 (PEG 400) NF, Polyethylene Glycol 3350 (3550) NF, Sodium Saccharin, natural and artificial flavors.
Storage
Avoid excessive heat above 40C (104F).
Net content 1oz. (30 grams)
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