Symptom checker
Select audience type

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

ADD CONDITION

items per page

Westlake Lidocaine

Last content change checked dailysee data sync status

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 2023
Label revision date
December 3, 2025
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 2023
Label revision date
December 3, 2025
Manufacturer
Westlake Pharma LLC
Registration number
M017
NDC root
82895-717
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% Topical Analgesic is a maximum strength cream designed to provide temporary relief from pain and itching. It is effective for various minor skin issues, including minor burns, sunburn, cuts, scrapes, insect bites, and other minor skin irritations. This non-greasy formula allows for easy application, making it a convenient option for soothing discomfort on the skin.

If you're looking for a product to help alleviate these types of pain, Lidocaine HCl 4% may be a suitable choice, and it comes with a 100% money-back guarantee, ensuring your satisfaction.

Uses

You can use this medication to temporarily relieve pain and itching caused by various skin issues. It is effective for minor burns, sunburn, minor cuts, scrapes, insect bites, and other minor skin irritations. This means that if you experience discomfort from any of these conditions, this product can help soothe your skin and provide some relief.

Rest assured, there are no known teratogenic effects (which means it does not cause birth defects) associated with this medication, making it a safer option for use.

Dosage and Administration

If you or your child is 2 years old or older, you can apply the medication to the affected area up to 3 to 4 times a day. Make sure to follow this guideline to ensure the best results. However, if your child is under 2 years old, it’s important to consult a doctor before using the medication. This will help ensure safety and effectiveness for younger children.

What to Avoid

It's important to use this product safely to avoid any potential issues. You should not apply it in large amounts, especially on raw or blistered skin, as this could lead to irritation or other complications. Additionally, be careful to keep the product away from your eyes, as contact can cause discomfort or harm.

While there are no specific contraindications or concerns about abuse, misuse, or dependence associated with this product, following these guidelines will help ensure your experience is safe and effective. Always prioritize your well-being when using any medical product.

Side Effects

This product is intended for external use only, so be sure to avoid applying it to large areas, especially over raw or blistered skin. While using it, take care not to get the product in your eyes.

If your condition worsens, symptoms persist for more than seven days, or if symptoms improve and then return within a few days, stop using the product and consult a doctor. Additionally, keep this product out of reach of children. If it is swallowed, seek medical assistance or contact a Poison Control Center immediately.

Warnings and Precautions

This product is intended for external use only, so please avoid applying it to large areas of your skin, especially over raw or blistered surfaces. Be careful not to get the product in your eyes, as this can cause irritation.

If your condition worsens, if symptoms persist for more than 7 days, or if symptoms improve and then return within a few days, stop using the product and consult your doctor. Additionally, 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 or someone else has swallowed too much of a medication, it’s important to seek medical help immediately. You can do this by contacting a Poison Control Center or going to the nearest emergency room. Acting quickly can make a significant difference in the outcome.

Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, don’t hesitate to get help right away. Remember, it’s always better to be safe and seek assistance if you suspect an overdose.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of using this product during pregnancy has not been established. It is generally not recommended for pregnant women due to potential risks to the fetus. If you feel that you need to use this product, please consult your healthcare provider first to discuss your specific situation and any necessary dosage adjustments.

Always prioritize your health and the health of your baby by only using this product if it is clearly needed and after a thorough discussion with your healthcare provider.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of this product while nursing. Currently, there is no information available about whether this product is excreted in breast milk or if it poses any risk to your infant.

As always, it's a good idea to consult with your healthcare provider if you have any concerns or questions about using this product while breastfeeding. Your health and the well-being of your baby are important, and your provider can offer personalized advice.

Pediatric Use

If you have a child under 2 years old, it's important to consult with a doctor before using this medication. For children aged 2 years and older, you can apply the medication to the affected area, but be sure not to exceed 3 to 4 applications in a day. Always follow these guidelines to ensure the safety and effectiveness of the treatment for your child.

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, especially since older adults may have different health needs and may be taking other medications.

Since there are no dosage adjustments or special precautions mentioned for elderly patients, your healthcare provider can help determine the best approach for you, considering your overall health and any other medications you may be taking. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

Renal Impairment

It appears that there is no specific information regarding renal impairment (kidney problems) in the provided text. This means there are no dosage adjustments, special monitoring, or safety considerations outlined for patients with kidney issues. If you have concerns about how your kidney health may affect your treatment, it's important to discuss this with your healthcare provider, who can offer personalized guidance based on your individual situation.

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 liver function tests (which check how well your liver is working) to ensure your safety while using any medication.

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 of your product, store it in a cool, dry place at a temperature between 20 °C and 25 °C (68 °F and 77 °F). This temperature range helps maintain the product's effectiveness and safety.

When handling the product, be sure to do so with clean hands and in a sterile field (a clean area free from germs) to prevent contamination. Always follow any specific disposal instructions provided to ensure safe and responsible disposal of any components.

Additional Information

You should apply this medication topically to the affected area, using it no more than 3 to 4 times a day if you are an adult or a child aged 2 years and older. If the patient is under 2 years old, it's important to consult a doctor before use. There are no additional details available regarding laboratory tests, abuse potential, or patient counseling.

FAQ

What is Lidocaine HCl 4% Topical Analgesic used for?

Lidocaine HCl 4% Topical Analgesic is used to temporarily relieve pain and itching due to minor burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritations.

How should I use Lidocaine HCl 4% Topical Analgesic?

For adults and children 2 years and over, apply to the affected area not more than 3 to 4 times daily. For children under 2 years, consult a doctor.

Are there any contraindications for using this product?

There are no specific contraindications mentioned, but it is not recommended for use in pregnant women due to potential risks.

What should I do if I experience worsening symptoms?

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

Is it safe to use Lidocaine HCl 4% during pregnancy?

Safety during pregnancy has not been established, and there may be risks to the fetus. Consult your healthcare provider before use.

What precautions should I take when using this product?

Do not use in large quantities, especially over raw surfaces or blistered areas, and avoid contact with eyes.

How should I store Lidocaine HCl 4% Topical Analgesic?

Store the product between 20 °C and 25 °C (68 °F and 77 °F).

What should I do if the product is swallowed?

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Packaging Info

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

Packaging configurations for Westlake Lidocaine.
Details

Drug Information (PDF)

This file contains official product information for Westlake Lidocaine, 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 pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritations.

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 application is to the affected area not 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, it is advised to consult a physician before use. This precaution is necessary to ensure safety and appropriateness of treatment for this age group.

Contraindications

The product should not be used in large quantities, particularly over raw surfaces or blistered areas, due to the potential for irritation or adverse effects. Additionally, it is contraindicated to allow the product to come into contact with the eyes, as this may lead to serious ocular complications.

Warnings and Precautions

For external use only. This product should not be applied in large quantities, especially on raw surfaces or blistered areas, to avoid potential adverse effects.

Care should be taken to prevent contact with the eyes during application. In the event of accidental exposure, immediate rinsing with water is recommended.

Healthcare professionals should advise patients to discontinue use and seek medical attention if any of the following occur: the condition worsens, symptoms persist for more than 7 days, or symptoms resolve and then recur within a few days.

It is imperative to keep this product out of reach of children. In the case of 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 for external use only. It is important to avoid using this product in large quantities, especially over raw surfaces or blistered areas, as this may lead to adverse effects.

While using this product, patients should take care to prevent contact with the eyes. If contact occurs, it is advised to rinse thoroughly with water.

Patients are instructed to stop using the product and consult a doctor if any of the following occur: the condition worsens, symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days.

Additionally, this product should be kept out of reach of children. In the event of accidental ingestion, it is crucial to seek medical assistance or contact a Poison Control Center immediately.

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 warranted at this time.

Packaging & NDC

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

Packaging configurations for Westlake Lidocaine.
Details

Pediatric Use

Pediatric patients under 2 years of age should consult a healthcare professional before use. For children aged 2 years and older, the recommended application is 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

Safety during pregnancy has not been established for this product. Use is not recommended in pregnant women due to potential risks to the fetus associated with the use of lidocaine during pregnancy. There may be risks to fetal outcomes, and therefore, pregnant patients should use this product only if clearly needed and after discussing the potential benefits and risks with their healthcare provider.

If dosage adjustments are necessary during pregnancy, it is advised that healthcare providers be consulted for appropriate modifications.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants.

Renal Impairment

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

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

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

Prompt action 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

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the product out of reach of children. Instruct patients that if the product is swallowed, they should seek medical help or contact a Poison Control Center immediately.

Patients should be cautioned against using the product in large quantities, especially on raw surfaces or blistered areas, as this may lead to adverse effects.

Healthcare providers should inform patients to discontinue use and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days.

Additionally, it is important to remind patients to avoid contact with the eyes while using this product, as this may cause irritation or other complications.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product within the temperature range of 20 °C to 25 °C (68 °F to 77 °F) to ensure its stability and efficacy. Proper storage conditions must be maintained, and the product should be kept in a suitable container to protect it from environmental factors. Special handling requirements should be observed to preserve the integrity of the product throughout its shelf life.

Additional Clinical Information

The medication is administered topically, with the recommended application frequency for adults and children aged 2 years and older being 3 to 4 times daily to the affected area. For children under 2 years of age, it is advised to consult a doctor before use. No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

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