Active Ingredient
Lidocaine 4%
Menthol 1%
Lidopro Patch
FDA Label NDC 80425-0438
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Advanced Rx Of Tennessee, Llc for the product Lidopro Patch (NDC 80425-0438). 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, purpose, uses, warnings, do not use, ask a doctor before use if you have, when using this product, stop use and consult a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical Anesthetic
Topical Analgesic
Uses
For the temporary relief of pain.
Warnings
For external use only
Do Not Use
• on the face or rashes, on wounds or damaged skin
• in the eyes, mouth, or other mucous membranes
• on genitals
• with a heating pad
• right before or after heart surgery
• any patch from a pouch that has been opened for 7 or more days
• in large quantities, particularly over raw surfaces or blistered areas
• if tamper-evident seal is torn, broken, or missing
• more than 2 patches per day unless directed by a doctor
• children under 18 years of age
Ask A Doctor Before Use If You Have
• allergies to topical products
• high blood pressure, heart disease, or kidney disease.
When Using This Product
• avoid contact with eyes. If eye contact occurs, rinse thoroughly with water
• the risk of heart attack or stroke may increase if you use more than directed or for longer than directed.
Stop Use And Consult A Doctor If
condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.
If Pregnant Orbreast Feeding, Ask A Health Professional Before Use.
Do not use during last 3 months of pregnancy because it may cause problems in the unborn child or complications during delivery.
Keep Out Of Reach Of Children.
If put in mouth, seek medical help or contact a Poison Control Center right away. Dispose of the used patches by folding sticky ends together.
Directions
Adults 18 years and older:
• clean and dry affected area
• open pouch and remove one patch
• remove protective film from patch
• apply one patch to the affected area of pain and leave in place for 8 to 12 hours
• if pain lasts after using the first patch, a second patch may be applied for up to another 8 to 12 hours
• only use one patch at a time
• wash hands with soap and water after applying or removing patch
• reseal pouch containing unused patches after each use
Other Information
• some individuals may not experience pain relief until several minutes or hours after applying the patch
• avoid storing product in direct sunlight
• protect product from excessive moisture
• store at 67-77°F (19-25°C)
Inactive Ingredients
dihydroxyaluminum aminoacetate, glycerol, methylparaben, polysorbate 80, propylene glycol, sodium polyacrylate, tartaric acid, water
Questions?
877-985-8377
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