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Lidocaine hydrochloride

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Active ingredient
Lidocaine Hydrochloride 40 mg/1 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
January 9, 2026
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Lidocaine Hydrochloride 40 mg/1 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
January 9, 2026
Manufacturer
Trifluent Pharma, LLC
Registration number
M017
NDC root
73352-204
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

You can use this medication for the temporary relief of pain and itching caused by minor burns, sunburn, minor cuts, scrapes, insect bites, and skin irritations, including rashes from poison ivy, poison oak, or poison sumac. It is designed to help soothe discomfort and promote healing in these common skin issues.

Uses

You can use this medication for the temporary relief of pain and itching caused by various skin issues. This includes minor burns, sunburn, cuts, scrapes, insect bites, and irritations or rashes from plants like poison ivy, poison oak, or poison sumac. It’s designed to help soothe discomfort and promote healing in these situations.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) associated with this medication, making it a safer option for those concerned about such risks.

Dosage and Administration

You can use this medication by applying it directly to the affected area of your skin. For adults and children who are 2 years old and older, you should apply it no more than 3 to 4 times a day. It's important to follow this guideline to ensure safe and effective use.

If your child is under 2 years of age, do not use this medication without first consulting a doctor. Always make sure to follow the recommended application frequency to help manage the condition effectively.

What to Avoid

It's important to keep this product out of reach of children to ensure their safety. If a child accidentally swallows it, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

There are no specific contraindications, controlled substance classifications, or noted risks of abuse, misuse, or dependence associated with this product. However, always use it responsibly and follow the instructions provided.

Side Effects

When using this product, it's important to be aware of some potential side effects and warnings. You should only use it externally and avoid contact with your eyes. It's advised not to apply it in large amounts, especially on raw or blistered skin. If your condition worsens, symptoms last more than seven days, or if they improve and then return shortly after, stop using the product and consult a doctor. Additionally, if you are pregnant or breastfeeding, please consult a healthcare professional before using it.

Warnings and Precautions

This product is for external use only, so please avoid using it on your eyes or in large amounts, especially on raw or blistered skin. If your condition worsens, or if symptoms last longer than 7 days, or if they improve and then come back within a few days, stop using the product and consult your doctor.

If you accidentally swallow this product, seek emergency medical help immediately or contact a Poison Control Center at 1-800-222-1222. Your safety is important, so please take these precautions seriously.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's important to be aware of the general signs of an overdose, which can include symptoms like extreme drowsiness, confusion, or difficulty breathing. If you suspect an overdose, it is crucial to seek immediate medical attention.

In case of an emergency, call your local emergency services or go to the nearest hospital. Always keep medications out of reach of children and follow the prescribed dosage to prevent any potential risks. If you have any concerns or questions about your medication, don’t hesitate to reach out to your healthcare provider for guidance.

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 2 years old, it's important not to use this medication without consulting a doctor first. For children aged 2 years and older, you can apply the medication to the affected area, but make sure to do so no more than 3 to 4 times a day. Always follow these guidelines to ensure your child's safety and well-being.

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. If you or a loved one is an older adult, it’s always a good idea to discuss any medications with a healthcare provider. They can help ensure that the treatment is safe and appropriate, considering any unique health needs or conditions that may be present.

Since there are no dosage adjustments or special precautions mentioned for elderly patients, your healthcare provider will be the best resource for personalized advice. Always keep them informed about any other medications or health issues to ensure safe and effective care.

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 standard recommendations for the medication do not include special monitoring or safety considerations tailored for patients with renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific health needs. They can provide guidance based on your kidney function and overall health.

Hepatic Impairment

If you have liver problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to your condition. This means that there are no tailored recommendations for how the medication may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific situation. They can help determine the best approach based on your liver function and overall health.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you.

Always feel free to ask questions and share your complete list of medications and any lab tests you may be undergoing. This way, you can receive the best possible care tailored to your needs.

Storage and Handling

To ensure the best performance of your product, store it at room temperature, ideally between 68°F and 77°F (20°C to 25°C). It’s acceptable for the temperature to occasionally range from 58°F to 86°F (15°C to 30°C), but try to keep it within the recommended limits for optimal safety and effectiveness.

When handling the product, make sure to do so in a clean environment to maintain its integrity. Always follow any specific instructions provided with the product for safe use and disposal. This will help you avoid any potential issues and ensure that the product remains effective throughout its intended use.

Additional Information

No further information is available.

FAQ

What is the drug used for?

The drug is used for the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, minor skin irritations, and rashes due to poison ivy, poison oak, or poison sumac.

What is the recommended dosage for adults and children 2 years and older?

You should apply the drug to the affected area not more than 3 to 4 times daily.

Can children under 2 years of age use this drug?

No, do not use this drug in children under 2 years of age; consult a doctor instead.

What should I do if I accidentally swallow the drug?

If swallowed, get medical help or contact a Poison Control Center at 1-800-222-1222 right away.

Are there any warnings I should be aware of?

Yes, this drug is for external use only, avoid contact with eyes, and do not use in large quantities, especially over raw surfaces or blistered areas.

What should I do if my condition worsens or symptoms persist?

Stop use and ask a doctor if your condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

Is it safe to use this drug if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, you should ask a health professional before using this drug.

How should I store this drug?

Store the drug at room temperature between 68° to 77°F (20 to 25°C), with excursions permitted between 58°F to 86°F (15° to 30°C).

Packaging Info

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

Packaging configurations for Lidocaine Hci.
Details

Drug Information (PDF)

This file contains official product information for Lidocaine Hci, 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 drug.

Uses and Indications

This drug is indicated for the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, minor skin irritations, and rashes due to poison ivy, poison oak, or poison sumac.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

For adults and children aged 2 years and older, the recommended dosage is to apply the product to the affected area no more than 3 to 4 times daily. It is important to ensure that the application is limited to the specified frequency to avoid potential adverse effects.

For children under 2 years of age, the product should not be used without consulting a healthcare professional. It is essential to seek medical advice before administering this product to this age group.

Contraindications

There are no specific contraindications listed for this product. However, it is essential to keep the product out of reach of children to prevent accidental ingestion. In the event of swallowing, immediate medical assistance should be sought, or contact a Poison Control Center at 1-800-222-1222.

Warnings and Precautions

The product is intended for external use only. Healthcare professionals should advise patients to avoid contact with the eyes to prevent irritation or injury. It is crucial to instruct patients not to apply the product in large quantities, especially on raw surfaces or blistered areas, as this may exacerbate adverse effects.

Patients should be informed to discontinue use and consult a healthcare provider if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. In such cases, further evaluation by a healthcare professional is warranted to determine the appropriate course of action.

In the event of accidental ingestion, immediate medical assistance should be sought. Patients should be directed to contact a Poison Control Center at 1-800-222-1222 for urgent guidance.

Side Effects

Patients using this product should be aware of several important warnings and precautions. The product is intended for external use only, and contact with the eyes should be avoided. It is crucial not to use the product in large quantities, especially over raw surfaces or blistered areas.

In the event that the condition worsens, or if symptoms persist for more than 7 days, patients are advised to stop use and consult a doctor. Additionally, if symptoms clear up and then recur within a few days, discontinuation of the product and consultation with a healthcare professional is recommended.

For pregnant or breastfeeding individuals, it is essential to seek advice from a health professional before using this product. These precautions are important to ensure the safety and well-being of patients during treatment.

Drug Interactions

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

Packaging & NDC

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

Packaging configurations for Lidocaine Hci.
Details

Pediatric Use

Pediatric patients under 2 years of age should not use this medication; consultation with a healthcare professional is advised. For adults and children aged 2 years and older, the medication may be applied to the affected area no more than 3 to 4 times daily.

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 potential adverse effects or changes in efficacy, 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 safe use during pregnancy and lactation.

Lactation

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

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

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 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 available information.

Overdosage

There is currently no specific information available regarding overdosage for this medication. In the absence of documented overdosage data, healthcare professionals are advised to exercise caution and monitor patients closely for any unusual symptoms or adverse effects that may arise following administration.

In the event of suspected overdosage, it is recommended that healthcare providers initiate supportive care and symptomatic treatment as necessary. Monitoring of vital signs and laboratory parameters may be warranted to assess the patient's condition and guide further management.

Healthcare professionals should remain vigilant for potential symptoms that could indicate an overdosage scenario, although specific symptoms have not been detailed. If any concerning signs or symptoms develop, appropriate medical intervention should be sought immediately.

For further guidance, healthcare providers are encouraged to consult local poison control centers or relevant medical authorities to obtain the most current recommendations for managing suspected overdosage cases.

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 compound in these areas.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. It is crucial to emphasize the importance of seeking immediate medical assistance or contacting a Poison Control Center at 1-800-222-1222 if the medication is swallowed. This information is vital for ensuring patient safety and prompt action in case of an emergency.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at room temperature, ideally between 68°F to 77°F (20°C to 25°C). Temporary excursions in temperature are permissible, allowing storage between 58°F to 86°F (15°C to 30°C). Proper container requirements and special handling needs should be adhered to in order to maintain product integrity.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Lidocaine Hci, 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 Hci, 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.