Checked
Lidospot patch
lidocaine and menthol · Lidospot patch is an amide local anesthetic (over-the-counter) containing lidocaine and menthol, made by Fabrication Enterprises Inc.
- Type
- Over the counter
- Drug class
- Amide Local Anesthetic
- Route
- Topical
- Manufacturers
- 1
Temporarily relieves minor pain.
Drug facts
- Generic name
- lidocaine and menthol
- Active ingredients
- Lidocaine, Menthol
- Drug class
- Amide Local AnestheticAntiarrhythmic
- Dosage forms
- Patch
- Label holder
- Fabrication Enterprises Inc
- FDA application
- M017
- Label updated
- 12/12/2025
Active ingredients
Lidocaine 4% w/w ...... Purpose: Topical anesthetic Menthol 1% w/w ...... Purpose: Topical analgesic
Purpose
Topical anesthetic (Lidocaine) Topical analgesic (Menthol)
Uses
Temporarily relieves minor pain.
Directions
Adult and Children 12 years of age and over: Clean and dry affected area Carefully remove backing from patch starting at a corner. Apply sticky side of patch to affected area. Use one patch for up to 12 hours. Children under 12 years of age: consult a physician.
Warnings
For external use only
Do not use
More than 1 patch on your body at a time On cut, irritated or swollen skin On puncture wounds For more than one week without consulting a doctor lf you are allergic to any active or inactive ingredients lf pouch is damaged or opened.
When using this product
Use only as directed Read and follow all directions and warnings on this carton Do not alow contact with the eyes Do not use at the same time as other topical analgesics Do not bandage tightly or apply local heat (such as heating pads) to the area of use Do not microwave Dispose of used patch in manner that always keeps product away from children and pets. Used patches stil containthe drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.
Stop use and ask a doctor
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.
Pregnancy or breastfeeding
Ask a health professional before use
Keep out of reach of children
If swallowed, get medical help or contact a Poison Control Center right away
Other information
Store in a clean, dry place outside of direct sunlight, Protect from excessive moisture.
Inactive ingredients
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,
Questions?
1-800-431-2830
Forms and strengths
From the FDA NDC Directory · 1 product codes
| Dosage form | Strength | Route | NDCs |
|---|---|---|---|
| Patch | .01 g/g / .04 g/g | topical | 1 |
Side effect reports to FDA
FDA Adverse Event Reporting System (FAERS), 58 reports that list lidocaine and menthol, data through 07/30/2026
Anyone can report a problem to FDA, and a report does not mean the drug caused the problem. Reports can be duplicated or incomplete, and counts depend on how widely a drug is used. Do not stop or change a medicine because of this list. Talk to your doctor or pharmacist.
Most often reported reactions
- Drug ineffective13
- No adverse event12
- Pain8
- Pneumonia4
- Application site pain3
- Dizziness3
- Atrial fibrillation2
- Back pain2
- Discomfort2
- Drug hypersensitivity2
To report a side effect, use FDA MedWatch.
Manufacturers and labels
1 FDA label
- Fabrication Enterprises IncShown hereM017 · Label 12/12/2025 · NDC 51452-172Full label
Related recalls
FDA drug recalls that name this drug or its active ingredient
- Class IIDrugOngoing10/14/2026Lidocaine Ointment USP, 5% (Generic for Xylocaine), packaged in a 50 g jar, Rx only, Mfg: Taro...Preferred Pharmaceuticals, Inc. · Failed Content Uniformity Specifications
- Class IIDrugOngoing09/23/2026Lidocaine Ointment USP, 5%, Speermint Flavor, 50 g Jar, Rx only, Mfd. by: Taro Pharmaceuticals Inc....SUN PHARMA /TARO · Failed Content Uniformity Specifications. Out of Specification for...
- Class IIDrugOngoing09/02/2026Zicam, Cold Remedy, Medicated Nasal Swabs, With Cooling Menthol & Eucalyptus, 20 Single-Use Swabs per...Church & Dwight Co., Inc. · CGMP Deviations; FDA inspection of the contract manufacturer noted...
- Class IIDrugOngoing07/29/2026Lidocaine HCl Injection, USP, 2%, 100 mg per 5 mL (20 mg per mL), 25 Single Dose Vials, 5 mL per vial, Rx...Fresenius Kabi USA, LLC · 3 products · Presence of Particulate Matter: Hair was found in products
- Class IIIDrugOngoing07/29/2026Lidolog Kit, Kit Contains: Lidocaine HCl Injection, USP, 2% (2mL) vial, 1 Dose, Single use Only, Rx Only...Asclemed USA Inc. · Labeling: Not Elsewhere Classified: The label wrap covers the...
Lidospot patch: common questions
- What is Lidospot patch used for?
- Temporarily relieves minor pain.
- Is Lidospot patch a prescription drug?
- No. Lidospot patch is sold over the counter (OTC) without a prescription.
- Are there other products with the same active ingredient as Lidospot patch?
- Yes. Other FDA-listed products with the same active ingredients include Pain Relief Gel-Patch, Numbing Cream, Jakwork Numbing Cream, Lidocaine Pain Relief Patch.
- Who makes Lidospot patch?
- Fabrication Enterprises Inc lists Lidospot patch with the FDA.
Source: U.S. Food and Drug Administration, openFDA drug label (SPL) and NDC Directory · Last updated 12/12/2025 · Label text is shown as published by the manufacturer. Not medical advice