What Is This Dental Gel?
It is a compounded topical anesthetic gel that combines lidocaine, prilocaine, tetracaine, and phenylephrine. Dental professionals apply it to the surface of the gums and oral tissues to reduce discomfort before certain procedures. It is prepared by prescription for an individual patient and is intended for professional use.
How the Ingredients Work
The Local Anesthetics — Lidocaine, Prilocaine, Tetracaine
These block sodium channels in nearby nerve endings, interrupting pain signals where the gel is applied. Lidocaine and prilocaine are amide-type anesthetics; tetracaine is an ester-type. Combining them produces surface (soft-tissue) numbing; pulpal (deep tooth) anesthesia should not be expected from this type of topical. ResearchGate
Phenylephrine — the Vasoconstrictor
Phenylephrine is added to narrow nearby blood vessels, which helps keep the anesthetic in the treatment area, reduce systemic absorption, improve the anesthetic effect, and help control bleeding. Contemporary OB/GYN
What Is It Used For?
Dentists, periodontists, and dental hygienists apply it to the gums or oral mucosa for procedures such as scaling and root planing, periodontal probing, and placing orthodontic appliances. This type of gel typically has an onset of about one minute and a short duration, and has shown efficacy for controlling pain during scaling and root planing and periodontal probing. ResearchGate
Is It Safe? Important Safety Information
Because it combines several anesthetics, a compounded gel can be far more concentrated than over-the-counter products, and these agents have a low therapeutic index. Key points for the treating professional: Sage Journals
- Methemoglobinemia. Acquired methemoglobinemia — a serious condition that reduces the blood's ability to carry oxygen — is associated mainly with prilocaine and benzocaine, and the FDA has issued a warning about compounded topical anesthetics and this risk. This gel contains prilocaine and is contraindicated in patients at risk for methemoglobinemia. PubMed
- Allergies. It contains both amide and ester anesthetics, so it is contraindicated in patients with amide or ester (PABA) anesthetic allergies.
- Single-patient use. Compounded anesthetics are meant for an individual patient by prescription and should not be used as an office-wide stock drug; misuse and serious reactions have prompted FDA regulatory action. Bayview Pharmacy
- Professional responsibility. Patient selection, dose limits, application, and monitoring are the treating dental professional's responsibility.
Quality and Compliance
Mixwell Compounding Pharmacy prepares this gel in our purpose-built, USP <795>-compliant lab to the prescriber's exact strengths, dispensed only with a valid prescription for an individual patient. Mixwell is a non-sterile pharmacy and does not prepare sterile products or injectables. Compounded medications are not reviewed or approved by the FDA. Nothing here promises a specific result, and compounded preparations are not presented as superior to commercially available products.
References
- American Academy of Pediatric Dentistry. Use of Local Anesthesia for Pediatric Dental Patients. AAPD Oral Health Policies and Recommendations.
- Petersilka GJ, Arweiler NB, Otto J, Wittig T. Non-interventional study on application of lidocaine gel 2% during scaling and root planing and professional mechanical plaque removal. Clin Oral Investig. 2018. doi:10.1007/s00784-018-2468-0.
- Update on Dental Topical Anesthetics. Decisions in Dentistry. 2020.
- Professional Compounding Centers of America (PCCA). Formulation science and compounding resources. https://www.pccarx.com/Blog/