Active Ingredient
Lidocaine 4% w/w ...... Purpose: Topical anesthetic
Menthol 1% w/w ...... Purpose: Topical analgesic
The following Structured Product Label (SPL) was submitted to the FDA by Fabrication Enterprises Inc� for the product Lidospot Patch (NDC 51452-172). 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, purposes, uses, warnings, when using this product:, do not use:, stop use and ask a doctor if:, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Lidocaine 4% w/w ...... Purpose: Topical anesthetic
Menthol 1% w/w ...... Purpose: Topical analgesic
Topical anesthetic (Lidocaine)
Topical analgesic (Menthol)
Temporarily relieves minor pain.
For external use only
Condition worsens
Redness is present
lrritation develops
Symptoms persist for more than 7 days or clear up and occur again within a few days
You experiencesigns of skin injury such as pain, swelling or blistering where the product was applied.
Ask a health professional before use
If swallowed, get medical help or contact a Poison Control Center right away
Adult and Children 12 years of age and over:
Children under 12 years of age:consult a physician.
Dihydroxyaluminium Aminoacetate, Edetate Disodium, Glycerin, Hydroxyacetophenone, Kaolin,L(+)-Tartaric Acid,Mineral oil,Polysorbate 80, Polyacrylic Acid, Polyvinylpyrrolidone K90, Propylene Glycol, Sodium Polyacrylate, Titanium Dioxide,Water,
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