Symptom checker
Select audience type

Switch between content for healthcare professionals (PRO) and general audience (GEN).

ADD CONDITION

items per page

Mentholatum Lidocaine Heat

Last content change checked dailysee data sync status

Active ingredient
Lidocaine Hydrochloride 40 mg/1 mL
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2018
Label revision date
December 17, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Lidocaine Hydrochloride 40 mg/1 mL
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2018
Label revision date
December 17, 2024
Manufacturer
The Mentholatum Company
Registration number
M017
NDC root
10742-8386
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

If you are a consumer or patient please visit this version.

Drug Overview

Mentholatum Lidocaine Heat is a topical medication designed to temporarily relieve pain. It works by providing a soothing effect on the skin, helping to alleviate discomfort in the affected area. This product is often used for minor aches and pains, making it a helpful option for those seeking quick relief from discomfort.

Uses

You can use this medication to temporarily relieve pain. It’s important to note that there are no reported teratogenic effects, which means it does not cause birth defects. Additionally, there are no nonteratogenic effects mentioned, indicating that it does not have harmful effects unrelated to pregnancy. Always consult with your healthcare provider for personalized advice and information.

Dosage and Administration

If you are 12 years old or older, you should apply a thin layer of the medication to the affected area every 6 to 8 hours. However, make sure not to apply it more than three times in a 24-hour period. This helps ensure that you get the best results while minimizing the risk of side effects.

If you are caring for a child under 12 years old, it’s important to consult a doctor before using this medication. They can provide guidance on the appropriate treatment for younger children.

What to Avoid

You should avoid using this medication on large areas of your body or on skin that is cut, irritated, or blistered. It’s also important not to apply it to puncture wounds. If you need to use it for more than one week, please consult your doctor first.

Additionally, be careful not to get the medication in your eyes, and avoid tightly bandaging the area where you apply it or using external heat. Following these guidelines will help ensure your safety while using this product.

Side Effects

When using this product, it's important to apply it only as directed and to avoid using it on large areas of your body, on cut or irritated skin, or on puncture wounds. You should not use it for more than one week without consulting your doctor. Be careful not to get the product in your eyes, and avoid tightly bandaging or applying heat to the treated area.

If your condition worsens, if symptoms last longer than seven days, or if you notice any redness, rash, or irritation, stop using the product and consult your doctor.

Warnings and Precautions

This product is for external use only, so please avoid applying it to large areas of your body or on any cut, irritated, or blistered skin. It should not be used on puncture wounds, and you should not use it for more than one week without consulting your doctor.

If your condition worsens, if symptoms last longer than 7 days, or if they clear up and then return within a few days, stop using the product and contact your doctor. Additionally, if you notice any redness, rash, or irritation, it's important to seek medical advice.

Keep this product out of reach of children. If it is swallowed, seek medical help or contact a Poison Control Center immediately.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there is no specific information available about the signs of overdose for this medication, general symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, or if you are unsure, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's always better to be safe and get checked by a healthcare professional if you have any concerns about your health. Remember, timely intervention can make a significant difference.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this medication. They can provide guidance on whether it’s safe for you and your baby. Always prioritize your health and the health of your child by seeking expert advice.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication. This ensures that you understand any potential risks and can make informed decisions about your health and the health of your baby. Always prioritize open communication with your doctor regarding your breastfeeding journey.

Pediatric Use

When considering this medication for your child, it's important to note that you should consult a doctor if your child is under 12 years old. For those aged 12 and older, you can apply a thin layer of the medication to the affected area every 6 to 8 hours, but be sure not to exceed three applications in a 24-hour period.

Always keep the medication out of reach of children. If your child accidentally swallows it, seek medical help or contact a Poison Control Center immediately. Your child's safety is a priority, so following these guidelines is essential.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. Since older adults may have different health needs and may be taking multiple medications, it’s always a good idea to consult with a healthcare provider before starting any new medication. They can help ensure that the treatment is safe and appropriate for your individual health situation.

If you or a loved one is an older adult, be sure to discuss any concerns about dosage or potential side effects with your doctor, as they can provide personalized guidance based on your health history and current medications.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment plan.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may want to conduct regular tests to ensure your safety while using any medication. Your well-being is a priority, and your healthcare team is there to support you.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking, even if there are no specific drug interactions or laboratory test interactions noted for your treatment. This ensures that your healthcare team can provide the best care tailored to your needs.

Always feel free to ask questions about how different medications might work together or affect any tests you may need. Your health and safety are the top priority, and discussing these details can help prevent any potential issues.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20°C to 25°C (68°F to 77°F). It’s acceptable for the temperature to occasionally range from 15°C to 30°C (59°F to 86°F), but try to keep it within the recommended limits. Make sure to protect the product from light and always keep the container tightly closed when not in use.

Once you open the container, remember to discard it after use to maintain safety and effectiveness. Following these guidelines will help you handle the product safely and ensure it remains in good condition.

Additional Information

You should apply a thin layer of the medication to the affected area every 6 to 8 hours if you are an adult or a child aged 12 years and older. However, do not exceed three applications in a 24-hour period. If the patient is under 12 years old, it’s important to consult a doctor before use.

FAQ

What is Mentholatum Lidocaine Heat used for?

Mentholatum Lidocaine Heat is used to temporarily relieve pain.

How should I apply Mentholatum Lidocaine Heat?

For adults and children 12 years and over, apply a thin layer to the affected area every 6 to 8 hours, not exceeding 3 applications in a 24-hour period.

Can children under 12 use Mentholatum Lidocaine Heat?

Children under 12 years should ask a doctor before use.

Are there any contraindications for using this product?

Do not use on large areas of the body, on cut, irritated, or blistered skin, or on puncture wounds. Avoid using for more than one week without consulting a doctor.

What should I do if I experience irritation or worsening symptoms?

Stop use and ask a doctor if your condition worsens, symptoms persist for more than 7 days, or if redness, rash, or irritation occurs.

Is Mentholatum Lidocaine Heat safe to use during pregnancy or breastfeeding?

If you are pregnant or breastfeeding, ask a health professional before use.

What precautions should I take when using this product?

Use only as directed, do not get it into your eyes, and do not bandage tightly or apply external heat to the area of use.

How should I store Mentholatum Lidocaine Heat?

Store at 20°C to 25°C (68°F to 77°F), protect from light, and keep the container tightly closed.

What should I do if Mentholatum Lidocaine Heat is swallowed?

If swallowed, get medical help or contact a Poison Control Center right away.

Packaging Info

Below are the non-prescription pack sizes of Mentholatum Lidocaine Heat (lidocaine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Mentholatum Lidocaine Heat.
Details

Drug Information (PDF)

This file contains official product information for Mentholatum Lidocaine Heat, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

Mentholatum Lidocaine Heat is a topical formulation designed for pain relief. It contains menthol and lidocaine as active ingredients, which work synergistically to provide a soothing effect. The product is presented in a cream dosage form, characterized by its smooth texture and easy application. The formulation is designed to deliver localized analgesic effects, making it suitable for the management of minor aches and pains associated with muscle strains and joint discomfort.

Uses and Indications

This drug is indicated for the temporary relief of pain.

There are no teratogenic effects associated with this drug. Additionally, no nonteratogenic effects have been reported.

Dosage and Administration

For adults and children aged 12 years and older, a thin layer of the medication should be applied to the affected area every 6 to 8 hours. The total number of applications must not exceed 3 times within a 24-hour period.

For children under 12 years of age, it is recommended to consult a physician before use.

Contraindications

Use is contraindicated in the following situations:

Application on large areas of the body, or on cut, irritated, or blistered skin is not recommended due to the potential for increased absorption and adverse effects. The product should not be applied to puncture wounds, as this may lead to complications or infection. Prolonged use beyond one week without consulting a healthcare professional is contraindicated to prevent potential adverse reactions. Additionally, contact with the eyes must be avoided to prevent irritation or injury. Tight bandaging or the application of external heat to the area of use is also contraindicated, as it may exacerbate local reactions or increase systemic absorption.

Warnings and Precautions

For external use only. This product is contraindicated for application on large areas of the body, as well as on cut, irritated, or blistered skin. It should not be used on puncture wounds. Prolonged use beyond one week is not recommended without prior consultation with a healthcare professional.

Healthcare providers should advise patients to discontinue use and seek medical attention if the condition worsens, if symptoms persist for more than seven days, or if symptoms resolve and then recur within a few days. Additionally, patients should be instructed to stop use and consult a physician if any redness, rash, or irritation develops during treatment.

It is imperative to keep this product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center should be established without delay.

Side Effects

Patients using this product should be aware that it is intended for external use only. It is contraindicated for application on large areas of the body, on cut, irritated, or blistered skin, and on puncture wounds. Additionally, patients should not use this product for more than one week without consulting a healthcare professional.

During the use of this product, it is essential to follow the directions provided. Patients should avoid contact with the eyes and should not apply tight bandages or external heat to the area of use.

Patients are advised to discontinue use and consult a doctor if any of the following occur: the condition worsens, symptoms persist for more than seven days, or if symptoms clear up and then recur within a few days. Furthermore, if redness, rash, or irritation develops, patients should seek medical advice.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions between the drug and laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

Packaging & NDC

Below are the non-prescription pack sizes of Mentholatum Lidocaine Heat (lidocaine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Mentholatum Lidocaine Heat.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For adolescents and adults aged 12 years and older, the recommended dosage is to apply a thin layer to the affected area every 6 to 8 hours, with a maximum of 3 applications within a 24-hour period.

It is essential to keep this product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact a Poison Control Center without delay.

Geriatric Use

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data on the excretion of this drug in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

Documentation of the incident, including the substance involved, estimated dose, and time of exposure, is crucial for effective management and follow-up care.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the use of the compound in question.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. In the event of swallowing the product, patients should seek medical help or contact a Poison Control Center immediately.

Patients should be instructed not to use the product on large areas of the body or on cut, irritated, or blistered skin, and it should not be applied to puncture wounds. It is important to inform patients that they should not use the product for more than one week without consulting a doctor.

Healthcare providers should counsel patients to stop using the product and seek medical advice if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Additionally, patients should be advised to discontinue use and consult a doctor if they experience redness, rash, or irritation.

When using this product, patients must be reminded to follow the directions carefully. They should avoid contact with the eyes and should not bandage the area tightly or apply external heat to the site of application.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain integrity. It should be stored at a temperature range of 20°C to 25°C (68°F to 77°F), with permissible excursions between 15°C to 30°C (59°F to 86°F). It is essential to protect the product from light to prevent degradation. Once opened, the product should be discarded to ensure safety and efficacy.

Additional Clinical Information

The medication is administered topically. For adults and children aged 12 years and older, a thin layer should be applied to the affected area every 6 to 8 hours, with a maximum of three applications within a 24-hour period. For children under 12 years of age, it is advised to consult a doctor regarding the appropriate use.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Mentholatum Lidocaine Heat, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Mentholatum Lidocaine Heat, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

Learn more in our Editorial Policy

Last AI update:

Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.