ULTRACARE ANESTHETIC GEL- benzocaine gel
The Bellport Company, Inc. dba Gingi-Pak
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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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.
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
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
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.
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.
ULTRACARE ANESTHETIC GEL
benzocaine gel |
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Labeler - The Bellport Company, Inc. dba Gingi-Pak (008480121) |
Registrant - Jeff Nichols (008480121) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
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The Bellport Company, Inc. dba Gingi-Pak | 008480121 | manufacture(10129-071) |