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LexiLido Patch

Generic Name: levomenthol and lidocaine
Dosage Form: patch

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

LexiLido Patch

PRESCRIBER INFORMATION

LexiLido Patch® (Menthol 5% / Lidocaine 4%Topical Patch)

DESCRIPTION:

LexiLido Patch® is a prescription topical patch containing 15 articulated patches (5 per resealable pouch x 3 pouches). Lidocaine is present in a 4% concentration (w/w). It is chemically designated as 2-(diethylamino)-N-(2,6-dimethylphenyl) acetamide and has an empirical formula of C14H22N2O. The molecular weight of lidocaine is 234.34 g/mol. Menthol is present in a 5% concentration (w/w). The chemical name is (1R,2S,5R)-2-isopropyl-5-methylcyclohexanol. The empirical formula for menthol is C10H20O with a molecular weight of 156.27 g/mol. 

The structural formulas are:

** Menthol **

** Lidocaine**

CLINICAL PHARMACOLOGY:

Lidocaine is a topical anesthetic and stabilizes the neuronal membrane by inhibiting the ionic fluxes required for the initiation and conduction of impulses, thereby effecting local anesthetic action.

Menthol has local anesthetic and counterirritant qualities, and it also acts as a weak kappa (κ) opioid receptor agonist. Menthol acts to chemically trigger the cold-sensitive TRPM-8 receptors in the skin - responsible for the well-known cooling sensation it stimulates when applied directly to the skin. Menthol's analgesic properties are not fully understood, however they are mediated through a selective activation of κ-opioid receptors. Menthol also blocks voltage-sensitive sodium channels, reducing neural activity that may stimulate muscle tissue.

INDICATIONS AND USAGE:

LexiLido Patch® is a formulation used to assist patients in the treatment of mild to moderate acute or chronic aches or pain. Muscle or joint pain can be due to musculoligamentous strains, simple backache, tendonitis, osteoarthritis, rheumatoid arthritis, peripheral neuropathies such as diabetic neuropathy or post herpetic neuralgia, and other complex regional pains. It can also be used to help with certain types of headaches, but use with caution when applying in order to avoid eye contact. If consulted by your physician.

Other uses may be considered if deemed clinically relevant

CONTRAINDICATIONS:

Known hypersensitivity to menthol, lidocaine, or any of the topical amide-like anesthetic preparations. .

WARNINGS:

Excessive dosage, or short interval between doses, can result in high plasma levels and serious adverse effects. Patients should be instructed to strictly adhere to the recommended dosage and administration guidelines set forth in this literature and on your prescription label. The management of serious adverse reactions may require the use of resuscitative equipment, oxygen or other resuscitative drugs.

PRECAUTIONS:

Because of the possibility of sedation, patients should be cautioned regarding the operation of serious machinery or automobiles, and activities made hazardous by decreased alertness.

DRUG INTERACTIONS:

No Drug interactions have been assessed with LexiLido Patch ®

CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY:

Nonclinical toxicity studies to determine the potential of this topical preparation to cause carcinogenicity or mutagenicity have not been performed. The effect of the product on fertility has not been evaluated in animals.  

PREGNANCY:

The safety of LexiLido Patch® has not been established during pregnancy. There are no well-controlled studies in pregnant women.

PEDIATRIC / GERIATRIC USE:

Safety and effectiveness in pediatric and geriatric patients have not been established.

NURSING MOTHERS:

The effect of LexiLido Patch® on the nursing infant has not been evaluated.

ADVERSE REACTIONS:

The most common adverse reactions are application site reactions, including dermatitis, itching or scaling. These tend to be dose-limiting and diminish with time.

Serious adverse experiences following the administration of LexiLido Patch® are similar in nature to those observed in other amide anesthetic-containing agents. These adverse experiences are, in general, dose-related and may result from high plasma levels caused by excessive dosage, rapid absorption, or may result from hypersensitivity, idiosyncrasy, or a diminished tolerance on the part of the patient. Serious adverse experiences are generally systemic in nature.

OVERDOSAGE:

There have been no reports of over-dosage with LexiLido Patch®. Signs of overdosage would include vomiting, drowsiness, coma, respiratory depression, and seizures. In the case of an overdosage, discontinue the product immediately, treat the patient symptomatically, and institute supportive measures.

STORAGE:

Store at room temperature at 68°F to 77°F (20°C to 25° C). Keep away from heat or sunlight. Protect from excessive moisture. The product can be considered safe and effective to use when maintained under these recommended conditions within the posted expiration date.

HOW SUPPLIED:

LexiLido Patch® is supplied in the following dosage form:

  • 15 Articulated Patches [ (5 per Re-sealable Pouch) x 3 ]

Manufactured for: Alexso Inc
2317 Cotner Ave • Los Angeles, CA 90064
www.alexso.com • 888.495.6078

NDC: 50488-1301-1 Size: 15 Patches

__________________________________________________________________________________________________________

PATIENT INFORMATION

(updated 3/2015)

Read the patient information sheet provided before you start using this medication and each time you get a refill. If you have any questions, please consult your doctor or pharmacist. Inform your doctor if your condition does not improve or if it worsens.

This information may not include all of the information needed to use LexiLido Patch® safely and effectively.

For Topical Use Only

What is LexiLido Patch® ?

This is a topical patch consisting of the topical analgesic, menthol, and the local anesthetic, lidocaine.  

What is LexiLido Patch® used for?

The patch is applied to the skin assisting patients in the management of mild to moderate acute or moderate aches or pain. The diagnosis of acute or chronic topical pain can be made relatively simply by the diagnostic practitioner, however discovering the underlying pathology manifesting as pain and discomfort is much more difficult.

The combination of lidocaine and menthol is a highly effective combination of pain relievers working synergistically to ameliorate the discomfort while the root cause is being managed and treated by your healthcare team.

DO NOT USE:

  • If you are allergic to any of the ingredients in this product
  • On wounds or damaged skin
  • With a heating pad
  • Concurrently with any other external pain-relieving products
  • If you are pregnant, planning to become pregnant, or breastfeeding

What are the possible side effects with LexiLido Patch®

  • Common (≥10%): itching, redness or flaking of the skin following application (note: the majority of patients experience no significant adverse events following patch application).
  • NOTE: serious side effects are, in general, related to accidental toxicity of medication by applying considerably more than directed by your doctor or pharmacist or by ingesting the contents of the patch.
  • Tell your healthcare provider about all the medicines you take.
    This includes prescription and nonprescription medicines, vitamins, and herbal supplements
  • Avoid excessive alcohol usage, since it may increase the potential for CNS effects such as dizziness, confusion, lightheadedness and orthostatic hypotension.

This is not a complete list of the possible side effects. For more information, talk with your doctor or pharmacist. You may report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

KEEP OUT OF REACH OF CHILDREN

WARNINGS

  1. Do not use:
       On wounds, cuts, damaged or infected skin
       On eyes, mouth, genitals, or other mucous membranes
  2. Consult physician for children under 12 years of age
  3. Stop and consult your prescriber if pain worsens

Call your healthcare provider right away if you get any of the following warning signs or any other unusual symptoms that concern you:

  • Shortness of breath
  • Swelling or numbness of the tongue or throat
  • Severe headache or vomiting
  • Dizziness or faintness
  • Changes in vision or speech

DIRECTIONS FOR USE

Adults and children 12 years and over:

Apply 1 to 2 patches to the affected area of intact skin. LexiLido Patch® should be removed after 12 hours of continuous use and remain off for at least 12 hours.  

  1. Determine area of patch application. If the pain area is smaller than the patch, patches may be cut into smaller sizes with scissors. Safely discard the remaining unused pieces of cut patches where children and pets cannot reach. 
  2. Remove the transparent release liner (clear plastic backing) before application of patches to the skin. Apply immediately after removal from the protective envelope.
  3. Apply 1 patch to the affected area so that the patch covers most of the painful area. Apply patch only once during each 24-hr period (12 hours on / 12 hours off).
  4. Remove patch if irritation occurs.

Children under 12 years of age:

Consult a doctor

General information about the safe and effective use LexiLido Patch®

Medicines are sometimes prescribed for purposes other than those listed in a patient information leaflet. Do not use this product for another indication. Do not give this drug to anyone else, even if they have the same condition.

How should I store LexiLido Patch®

Store product at room temperature at 68°F to 77°F (20°C to 25°C). Keep away from heat or sunlight. Protect from excessive moisture. Discard product after expiration date posted on the product label.

DO NOT use the product after the expiration date printed on the box.

This leaflet provides the most important information about LexiLido Patch®. If you would like more information, talk with your healthcare provider or pharmacist. There is additional information in the following sections intended for healthcare professionals

What are the active ingredients in LexiLido Patch® ?

The patch consists of 5% menthol and 4% lidocaine. .

INACTIVE INGREDIENTS:

Water
Aloe Barbadesis Leaf (Aloe Vera Gel)
Glycerin
EDTA Disodium salt
Sodium Polyacrylate
Diazolidinyl Urea
Polysorbate 80
Propylparaben
Iodopropynyl Butylcarbamate
Methylparaben
Citrus Medica Limonum
(Lemon) Peel Oil

PRINCIPAL DISPLAY PANEL

Rx Only
NDC: 50488-1501-1
LexiLido
Patch

Qty: 15 patches

3
Resealable Pouches (5 patches in each)

LEXILIDO 
levomenthol and lidocaine patch
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:50488-1501
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVOMENTHOL (LEVOMENTHOL) LEVOMENTHOL 470 mg
LIDOCAINE (LIDOCAINE) LIDOCAINE 375 mg
Inactive Ingredients
Ingredient Name Strength
WATER  
ALOE VERA LEAF  
GLYCERIN  
EDETATE DISODIUM  
SODIUM POLYACRYLATE (8000 MW)  
DIAZOLIDINYL UREA  
POLYSORBATE 80  
PROPYLPARABEN  
IODOPROPYNYL BUTYLCARBAMATE  
METHYLPARABEN  
LEMON OIL  
Packaging
# Item Code Package Description
1 NDC:50488-1501-1 3 POUCH in 1 BOX
1 5 PATCH in 1 POUCH
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 03/01/2015
Labeler - Alexso, Inc. (070822737)
Revised: 03/2015
 
Alexso, Inc.



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