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Lidocaine hydrochloride

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Active ingredient
Lidocaine Hydrochloride 4 g/100 g
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 2026
Label revision date
March 12, 2026
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Lidocaine Hydrochloride 4 g/100 g
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 2026
Label revision date
March 12, 2026
Manufacturer
Matthias Therapeutics, LLC
Registration number
M017
NDC root
87137-101
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

Lidocaine HCL 4% Cream is a topical medication that temporarily relieves minor pain. It is commonly used to help soothe discomfort in various situations, such as minor skin irritations or injuries. By applying this cream to the affected area, you can experience relief from pain, making daily activities more comfortable.

Uses

You can use this medication to temporarily relieve minor pain. It’s designed to help you feel more comfortable when dealing with everyday aches and discomforts. Rest assured, there are no known teratogenic effects (which means it doesn’t cause birth defects) associated with this medication.

Dosage and Administration

When using this medication, if you are an adult or a child aged 12 years and older, you should apply a thin layer to the affected area every 6 to 8 hours. However, make sure not to apply it more than three times within a 24-hour period.

If the patient is a child under 12 years old, it’s important to consult a doctor before use to ensure safety and proper guidance. Always follow these instructions carefully to achieve the best results.

What to Avoid

It's important to use this medication safely to avoid potential risks. You should never apply it to puncture wounds or on large areas of your body, especially if your skin is cut, irritated, or swollen. If you need to use it for more than one week, consult your doctor first.

Additionally, avoid using this medication in large amounts, particularly on raw or blistered skin, and do not combine it with other topical pain relievers. Always keep it away from your eyes, and refrain from bandaging or applying heat to the treated area. Following these guidelines will help ensure your safety and the effectiveness of the treatment.

Side Effects

When using this product, it's important to apply it only as directed and avoid using it on puncture wounds, large areas of the body, or on cut, irritated, or swollen skin for more than a week without consulting a doctor. You should not use it in large quantities, especially on raw or blistered areas, and be careful to keep it away from your eyes. Additionally, do not bandage the area or apply heat, and avoid using it alongside other topical pain relievers.

If you notice that your condition worsens, if redness or irritation develops, or if symptoms last longer than seven days or return shortly after improvement, stop using the product and consult a doctor. If you are pregnant or breastfeeding, it's best to check with a healthcare professional before use. Always keep this product out of reach of children, and if swallowed, seek medical help immediately.

Warnings and Precautions

This product is for external use only, so please avoid applying it to puncture wounds or large areas of your body. If you have cut, irritated, or swollen skin, do not use it for more than one week without consulting your doctor. Always follow the directions on the carton carefully, and avoid using large amounts, especially on raw or blistered skin. Keep it away from your eyes, and do not cover the area with bandages or apply heat, such as a heating pad. It's also important not to use this product alongside other topical pain relievers.

If you notice that your condition worsens, if you see redness or irritation, or if your symptoms last longer than seven days or return after clearing up, stop using the product and contact your doctor. In case of accidental swallowing, seek medical help or call a Poison Control Center immediately.

Overdose

If you or someone else has swallowed a medication and you suspect an overdose, it’s important to act quickly. You should seek medical help immediately or contact a Poison Control Center for guidance.

Signs of an overdose can vary, but they may include unusual symptoms that are not typical for the medication. Always err on the side of caution and reach out for professional help if you have any concerns about an overdose. Your safety is the top priority.

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

If your child is under 12 years old, it's important to consult with a doctor before using this medication. For children aged 12 and older, you can apply a thin layer of the product to the affected area every 6 to 8 hours, but be sure not to exceed three applications in a 24-hour period. Always follow these guidelines to ensure safe and effective use for your child.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult, it’s important to consult with a healthcare provider for personalized advice. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

Renal Impairment

If you have kidney problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or safety considerations for your condition. This means that there are no tailored guidelines for how this medication should be used if you have renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your health situation. They can help you understand how to manage your treatment effectively while considering your kidney health.

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication should be used if you have hepatic impairment (liver issues).

Before starting any new medication, including this one, you should discuss your liver health with your healthcare provider. They can help determine the best approach for your treatment and ensure your safety.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. Currently, there are no specific drug interactions or laboratory test interactions noted for this medication. However, your healthcare provider can help ensure that your treatment plan is safe and effective, taking into account all the medications and tests you may be using. Always feel free to ask questions and share your complete health history to avoid any potential issues.

Storage and Handling

To ensure the best performance and safety of your product, store it at a controlled room temperature between 20° to 25° C (68° to 77° F). This temperature range helps maintain the integrity of the device.

When handling the product, always do so with clean hands and in a clean environment to avoid contamination. If you have any specific disposal instructions, be sure to follow them carefully to ensure safety.

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 Lidocaine HCL 4% Cream used for?

Lidocaine HCL 4% Cream is used to temporarily relieve minor pain.

How should I apply Lidocaine HCL 4% Cream?

For adults and children 12 years and older, 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 Lidocaine HCL 4% Cream?

Children under 12 years should ask a doctor before use.

Are there any contraindications for using Lidocaine HCL 4% Cream?

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

What precautions should I take when using this cream?

Use only as directed, avoid contact with eyes, and do not bandage or apply local heat to the area of use.

What should I do if my condition worsens while using this cream?

Stop use and ask a doctor if your condition worsens, redness is present, or irritation develops.

Is it safe to use Lidocaine HCL 4% Cream if I am pregnant or breastfeeding?

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

What should I do if I accidentally swallow Lidocaine HCL 4% Cream?

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

What is the storage requirement for Lidocaine HCL 4% Cream?

Store at USP controlled room temperature between 20° to 25° C (68° to 77° F).

Packaging Info

Below are the non-prescription pack sizes of Lidocaine Hcl. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Lidocaine Hcl.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the temporary relief of minor 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 for appropriate dosing and administration guidance.

Contraindications

Use of this product is contraindicated in the following situations:

The product should not be applied to puncture wounds. Additionally, it is contraindicated for use on large areas of the body or on cut, irritated, or swollen skin for more than one week without prior consultation with a healthcare professional.

Application over raw surfaces or blistered areas, particularly in large quantities, is also contraindicated. Concurrent use with other topical analgesics is not recommended.

Contact with the eyes must be avoided. Furthermore, bandaging or applying local heat, such as heating pads, to the area of use is prohibited.

Warnings and Precautions

For external use only. This product is contraindicated for application on puncture wounds, large areas of the body, or on cut, irritated, or swollen skin for more than one week without prior consultation with a healthcare professional.

When utilizing this product, it is imperative to adhere strictly to the provided instructions. Users should read and follow all directions and warnings indicated on the carton. The product should not be applied in large quantities, particularly over raw surfaces or blistered areas. Care must be taken to avoid contact with the eyes. Additionally, users should refrain from bandaging or applying local heat, such as heating pads, to the area of application. Concurrent use with other topical analgesics is not recommended.

Healthcare professionals should advise patients to discontinue use and seek medical advice if any of the following occur: worsening of the condition, presence of redness, or development of irritation. Furthermore, if symptoms persist for more than seven days or if they resolve and then recur within a few days, medical consultation is warranted.

In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is advised.

Side Effects

Patients should be aware that this product is intended for external use only. It is contraindicated for application on puncture wounds, large areas of the body, or on cut, irritated, or swollen skin for more than one week without consulting a healthcare professional.

When using this product, it is essential to adhere strictly to the directions provided. Users should avoid applying the product in large quantities, particularly over raw surfaces or blistered areas. Contact with the eyes must be avoided, and the area of application should not be bandaged or subjected to local heat, such as heating pads. Additionally, concurrent use with other topical analgesics is not recommended.

Patients are advised to discontinue use and consult a doctor if the condition worsens, if redness or irritation develops, or if symptoms persist for more than seven days or resolve only to recur within a few days.

For pregnant or breastfeeding individuals, it is recommended to seek advice from a healthcare professional prior to use. This product should be kept out of reach of children, and in the event of ingestion, immediate medical assistance or contact with a Poison Control Center is necessary.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Lidocaine Hcl. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Lidocaine Hcl.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For adolescents and children 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.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure the safety of both the mother and the developing fetus or nursing infant.

Lactation

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

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this medication. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions outlined 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 prescribing information.

Overdosage

In the event of an overdosage, immediate medical assistance is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical help or contact a Poison Control Center without delay.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are recommended to ensure patient safety and effective resolution of any complications arising from the overdosage.

Nonclinical Toxicology

There is currently no available information regarding teratogenic effects, non-teratogenic effects, or any specific findings in the nonclinical toxicology section. Additionally, there are no details provided concerning animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed. It is important to instruct patients not to use the product on puncture wounds or on large areas of the body. Patients should be informed that the product should not be applied to cut, irritated, or swollen skin for more than one week without consulting a healthcare professional.

Patients should be counseled to discontinue use and consult a doctor if their condition worsens, if redness or irritation develops, or if symptoms persist for more than seven days or resolve and then recur within a few days. Emphasize the importance of using the product only as directed and encourage patients to read and follow all directions and warnings provided on the carton.

Additionally, patients should be cautioned against using the product in large quantities, especially over raw surfaces or blistered areas. It is crucial to inform patients to avoid contact with the eyes and to refrain from bandaging or applying local heat, such as a heating pad, to the area of use. Patients should also be advised not to use this product concurrently with other topical analgesics.

For California residents, it is important to note that the product does not conform to Proposition 65.

Storage and Handling

The product is supplied in accordance with the National Drug Code (NDC) specifications. It should be stored at a controlled room temperature, specifically within the range of 20° to 25° C (68° to 77° F). Proper storage conditions are essential to maintain the integrity and efficacy of the product.

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 Lidocaine Hcl, 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 Lidocaine Hcl, 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

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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.