Topical Analgesic Solution
(Lidocaine 2% / Epinephrine 0.05% / Tetracaine 0.5%)
For External Use Only
JanuLET is the topical anesthetic used for Micro pigmentation, medical tattoos and Micro needling.
Indications and Usage:
JanuLET is a combination of lidocaine,epinephrine and tetracaine available as an aqueous solution. The local anesthetics cause sensory and motor blockade primarily by reversible inhibition of axonal sodium channels, blocking conduction of action potentials. This lead to numbness and weakness.
Epinephrine causes local vasoconstriction that slows systemic absorption and metabolism of the anesthetics. Lidocaine, in the amide class of anesthetics, is metabolized by the liver; Tetracaine, in the ester class, is metabolized in plasma by pseudo cholinesterase.
JanuLET should not be used for children under the age of 2 years.
JanuLET contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening asthmatic episodes in susceptible people. If anaphylaxis, asthma or other clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue this solution.
Warnings and Interactions:
Before using this product consult your physician or pharmacist if you:
- suffer heart disease, arrhythmia and you are taking antiarrhythmic – or take medicine to treat abnormal heart rhythms.
- have a history of allergic reactions.
Pregnancy and breastfeeding:
You must tell your doctor if you are pregnant or think you may be pregnant.
There are currently no data available relevant to the clinical questions formulated on the use of topical anesthesia in pregnant or nursing woman. Animal studies have revealed no evidence of harm to the fetus with infiltrated lidocaine. Based on these reports, lidocaine-tetracaine topical has been assigned to pregnancy category B and epinephrine topical is pregnancy category C by the FDA.
This product is excreted in breast milk and should be used with caution.
Adverse effects are due to excessive absorption of lidocaine-tetracaine, resulting in systemic toxicity. Toxic effects of JanuLET solution are primarily on the cardiovascular and central nervous systems. Central nervous system (CNS) symptoms include headache, irritability, restlessness, metallic taste, tingling around the lips, somnolence, blurred vision, and Seizure.
Other possible side effects:
Rash, feeling short of breath, low blood pressure, mild burning or itching sensation, mild allergic reactions.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, stop use and contact your doctor or pharmacist immediately.
Proposed storage conditions:
- Keep solution in the container and out of light. Protect from freezing.
- Do not use if solution is discolored.
- Keep out of reach of children.
Pharmaceutical form: 5 mL dropper bottle with HDPE Cap.