Mediclarum
Medicine guide

Lidothol

5 g/100g + 4.5 g/100g · Gel

  • Prescription only
  • Amide Local Anesthetic
Active substance
Lidocaine Hcl, Menthol
Made by
ASCLEMED USA INC.

Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.

At a glance

Quoted from the official label · 2026-05-28

What it is

Amide Local Anesthetic

Used for
  • Lidothol Gel is indicated for relief of pain associated with arthritis, backache, cramps, discomfort, neckache, soreness, sprains, strains. It should be applied only to intact skin.
Warning

Medicines intended to be applied to the skin should not be swallowed.

All warnings ↓
Good to know
  • Prescription only
  • FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02
18other products contain Lidocaine Hcl, Menthol — compare makers, forms and strengths

Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed

What it is for

  • Lidothol Gel is indicated for relief of pain associated with arthritis, backache, cramps, discomfort, neckache, soreness, sprains, strains. It should be applied only to intact skin.

From the official label · 2026-05-28 · DailyMed

How it works

From this product’s own US prescribing label.

Lidocaine is an amide-type local anesthetic agent.

The penetration of lidocaine into intact skin after application of Lidothol Gel is sufficient to produce annalgesic effect, but less than the amount necessary to produce a complete sensory block.

Half-life81–149 min
Mostly cleared after≈ 9.6 hfive half-lives — our arithmetic
How the body breaks it down

It is not known if Lidothol Gel is metabolized in the skin.

How it leaves the body

Lidocaine and its metabolites are excreted by the kidneys.

Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2026-05-28

How to take it

These directions are for this exact strength and form. Another one is different.

  • Lidothol Gel is contraindicated in patients with a known history of sensitivity to local anesthetics of the amide type, or to any other component of the product.
  • Apply Lidothol Gel to intact skin to cover the most painful area.
  • Clean and dry the affected area.
  • Apply product directly to your skin, up to 4 times daily.
  • Clothing may be worn over the area of application.
  • If irritation or a burning sensation occurs during application, wash the product off your skin and do not reapply until the irritation subsides.
  • When Lidothol Gel is used concomitantly with other products containing local anesthetic agents, the amount absorbed from all formulations must be considered.

Quoted from the official label, section “Dosage & Administration”.

Other warnings

  • Medicines intended to be applied to the skin should not be swallowed.
  • Lidothol Gel is flammable.
  • Keep away from open flame.
  • You should never heat, microwave, or add the medicine to hot water.
  • Risk of Methemoglobinemia Cases of methemoglobinemia have been reported in association with lidocaine use.
  • Although all patients are at risk for methemoglobinemia, patients with glucose-6-phosphate dehydrogenase deficiency, congenital or idiopathic methemoglobinemia, cardiac or pulmonary compromise, infants under 6 months of age, and concurrent exposure to oxidizing agents or their metabolites are more susceptible to developing the condition.
  • If lidocaine must be used in these patients, close monitoring for symptoms and signs of methemoglobinemia is recommended.
  • Signs of methemoglobinemia may occur immediately or may be delayed some hours after exposure, and are characterized by a cyanotic skin discoloration and/or abnormal coloration of the blood.
  • Methemoglobin levels may continue to rise; therefore, immediate treatment is required to avert more serious central nervous system and cardiovascular adverse effects, including seizures, coma, arrhythmias, and death.
  • Excessive Dosing Excessive dosing by applying Lidothol Gel to larger areas could result in increased absorption of lidocaine and high blood concentrations, leading to serious adverse effects (see ADVERSE REACTIONS, Systemic Reactions).
  • Lidocaine toxicity could be expected at lidocaine blood concentrations above 5 mcg/mL.
  • The blood concentration of lidocaine is determined by the rate of systemic absorption and elimination.
  • Longer duration of application of more than the recommended number of doses, smaller patients, or impaired elimination may all contribute to increased blood concentration of lidocaine.
  • General Hepatic Disease Patients with severe hepatic disease are at greater risk of developing toxic blood concentrations of Lidocaine and menthol, because of their inability to metabolize lidocaine and menthol normally.
  • Allergic Reactions Patients allergic to para-aminobenzoic acid derivatives (procaine, tetracaine, benzocaine, etc.) have not shown cross sensitivity to lidocaine.
  • However, Lidothol Gel should be used with caution in patients with a history of drug sensitivities, especially if the etiologic agent is uncertain.
  • Although rare, get emergency medical help
  • if you have signs of an allergic reaction from oral or topical application of menthol:
  • hives, difficulty breathing, or swelling of your face, lips, tongue, or throat.
  • Non-intact Skin Application to broken or inflamed skin, although not tested, may result in higher blood concentrations of lidocaine and menthol from increased absorption.
  • Lidothol Gel is only recommended for use on intact skin.
  • External Heat Sources Placement of external heat sources, such as heating pads or electric blankets, over Lidothol Gel is not recommended as this has not been evaluated and may increase plasma lidocaine levels.
  • Eye Exposure The contact of Lidothol Gel with eyes, although not studied, should be avoided based on the findings of severe eye irritation with the use of similar products in animals.
  • If eye contact occurs, immediately wash out the eye with water or saline and protect the eye until sensation returns.
  • Information for Patients Methemoglobinemia Inform patients that use of local anesthetics may cause methemoglobinemia, a serious condition that must be treated promptly.
  • Advise patients or caregivers to
  • stop use and seek immediate medical attention if they or someone in their care experience the following signs or symptoms:
  • pale, gray, or blue colored skin (cyanosis); headache; rapid heart rate; shortness of breath; lightheadedness; or fatigue.
  • Drug Interactions Antiarrhythmic Drugs Lidothol Gel should be used with caution in patients receiving Class I antiarrhythmic drugs (such as tocainide and mexiletine) since the toxic effects are additive and potentially synergistic.
  • Local Anesthetics When Lidothol Gel is used concomitantly with other products containing local anesthetic agents, the amount absorbed from all formulations must be considered.
  • Drugs That May Cause Methemoglobinemia When Used with Lidothol Gel Patients who are administered local anesthetics are at increased risk of developing methemoglobinemia when concurrently exposed to the following drugs, which could include other local anesthetics:
  • Examples of Drugs Associated with Methemoglobinemia:
  • Class Examples Nitrates/Nitrites nitric oxide, nitroglycerin, nitroprusside, nitrous oxide Local anesthetics articaine, benzocaine, bupivacaine, lidocaine, mepivacaine, prilocaine, procaine, ropivacaine, tetracaine Antineoplastic agents cyclophosphamide, flutamide, hydroxyurea, ifosfamide, rasburicase, Antibiotics dapsone, nitrofurantoin, para-aminosalicylic acid, sulfonamides, Antimalarials chloroquine, primaquine Anticonvulsants Phenobarbital, phenytoin, sodium valproate, Other drugs acetaminophen, metoclopramide, quinine, sulfasalazine Carcinogenesis, Mutagenesis Impairment of Fertility The effect of Lidothol Gel on fertility has not been studied.
  • Pregnancy Teratogenic Effects Pregnancy Category B.
  • Lidothol Gel has not been studied in pregnancy.
  • Labor and Delivery Lidothol Gel has not been studied in labor and delivery.
  • Nursing Mothers Lidothol Gel has not been studied in nursing mothers.
  • Pediatric Use Safety and effectiveness in pediatric patients have not been established.

Quoted from the official label, section “Warnings”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

  • Lidocaine overdose from cutaneous absorption is rare but could occur.
  • If there is any suspicion of lidocaine overdose (see ADVERSE REACTIONS, Systemic Reactions), drug blood concentration should be checked.
  • The management of overdose includes close monitoring, supportive care, and symptomatic treatment.
  • Dialysis is of negligible value in the treatment of acute overdose with lidocaine.
  • In the absence of massive topical overdose or oral ingestion, evaluation of symptoms of toxicity should include consideration of other etiologies for the clinical effects, or overdosage from other sources of lidocaine or other local anesthetics.

Quoted from the official label, section “Overdosage”.

Side effects

  • Application Site Reactions During or immediately after treatment with Lidothol Gel, the skin at the site of application may develop blisters, bruising, burning sensation, depigmentation, dermatitis, discoloration, edema, erythema, exfoliation, irritation, papules, petechia, pruritus, vesicles, or may be the locus of abnormal sensation.
  • These reactions are generally mild and transient, resolving spontaneously within a few minutes to hours.
  • Other Adverse Events Due to the nature and limitation of spontaneous reports in post marketing surveillance, causality has not been established for additional reported adverse events including:
  • Asthenia, confusion, disorientation, dizziness, headache, hyperesthesia, hypoesthesia, lightheadedness, metallic taste, nausea, nervousness, pain exacerbated, paresthesia, somnolence, taste alteration, vomiting, visual disturbances such as blurred vision, flushing, tinnitus, and tremor.
  • Systemic (Dose-Related) Reactions Systemic adverse reactions following appropriate use of Lidothol Gel are unlikely, due to the small dose absorbed (see CLINICAL PHARMACOLOGY, Pharmacokinetics).
  • Systemic adverse effects of lidocaine is similar in nature to those observed with other amide local anesthetic agents, including CNS excitation and/or depression (light headedness, nervousness, apprehension, euphoria, confusion, dizziness, drowsiness, tinnitus, blurred or double vision, vomiting, sensations of heat, cold or numbness, twitching, tremors, convulsions, unconsciousness, respiratory depression and arrest).
  • Excitatory CNS reactions may be brief or not occur at all, in which case the first manifestation may be drowsiness merging into unconsciousness.
  • Cardiovascular manifestations may include bradycardia, hypotension and cardiovascular collapse leading to arrest.
  • Sensitivity reactions associated with the use of mentholated products have been reported.
  • Use of mentholated nasal drops in infants has evidently caused isolated cases of spasm of the larynx, and a few cases of nervous or digestive system disturbance have been associated with excessive inhalation or oral exposure to menthol

Quoted from the official label, section “Adverse Reactions”.

What it looks like and how it is packed

  • Lidothol Gel is available as the following:
  • 1 tube, 3.5oz NDC 87063-218-99 (relabeled from NDC 83881-455-35)
  • Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature].
  • For more information, contact Clinic Pharma.
  • Info@Clinicpharma.com Relabeled by: Enovachem PHARMACEUTICALS Torrance, CA 90501

Quoted from the official label, section “How Supplied”.

How to store it

HANDLING AND DISPOSAL Hands should be washed after the handling of Lidothol Gel, and eye contact with Lidothol Gel should be avoided. Store in a cool, dry place with lid tightly closed. Lidothol Gel should be kept out of the reach of children.

Quoted from the official label, section “Storage and Handling”.

What is in it

  • Lidothol Gel (Lidocaine 4.5%, Menthol 5%) is comprised of a gel inside of a tube containing 4.5% Lidocaine and 5% Menthol.
  • Inactive ingredients:
  • Acrylates/Cl0-30 Alkyl Acrylate Crosspolymer, Aqua (Water), Amica Montana Flower Extract, Boswellia Serrata Gum Extract, Butylene Glycol, Dimethyl Sulfone (MSM), Ethylhexylglycerin, Glycerin, llex Paraguariensis Leaf Extract, Magnesium Sulfate, Phenoxyethanol, Polysorbate 20, SD Alcohol 40-B, Sodium Hydroxide, Xanthan Gum

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

  • Alcohol (ethanol)SD Alcohol 40-BMatters for children, in pregnancy, in recovery and with some medicines.

Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.

Every version of this medicine (4)

The same active substance, strength and kind of form, from every company that sells it — with what each label lists.

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Same active substance, strength and form in other countries

Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.

Medicine passport: one printable page to show a pharmacist abroad

CanadaNo exact match for this strength and form

Every strength and form (4)

Details

Made byASCLEMED USA INC.
Active substanceLidocaine Hcl, Menthol
Used inPain, sleep, mood, epilepsy and the brain
Strength5 g/100g + 4.5 g/100g
FormGel
RouteCutaneous
Packs1 TUBE in 1 BOX / 99.2 g in 1 TUBE
NDC87063-218

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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Other strengths and forms

5 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

Aloe Vera Gel7 mg/mL + 2 mg/mLWithout prescriptionGel Meijer, Inc. · Lidocaine Hcl, MentholAloe Vera Gel7 mg/mL + 2 mg/mLWithout prescriptionGel Publix Super Markets, Inc. · Lidocaine Hcl, MentholAloe Vera Gel7 mg/mL + 2 mg/mLWithout prescriptionGel Amazon.com Services LLC · Lidocaine Hcl, MentholAloe Vera Gel7 mg/mL + 2 mg/mLWithout prescriptionGel Retail Business Services, LLC · Lidocaine Hcl, MentholAloe Vera Gel7 mg/mL + 2 mg/mLWithout prescriptionGel Walmart Inc. · Lidocaine Hcl, MentholCvs Health Maximum Strength Lidocaine Pain Relief Cream Plus Menthol40 mg/g + 10 mg/gWithout prescriptionCream CVS Pharmacy · Lidocaine Hcl, Menthol

See every product with Lidocaine Hcl, Menthol