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Westlake Outdoor Pain and Itch Relieving

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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 2025
Label revision date
July 1, 2025
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 2025
Label revision date
July 1, 2025
Manufacturer
WESTLAKE HB PHARMA
Registration number
M017
NDC root
82895-718
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

This medication is designed to temporarily relieve pain and itching caused by various minor skin issues, including minor burns, sunburns, cuts, scrapes, insect bites, and other minor skin irritations. It works by soothing the affected area, helping you feel more comfortable while your skin heals.

Uses

You can use this medication to temporarily relieve pain and itching caused by various skin issues. It is effective for minor burns, sunburns, 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

You should apply the medication to the affected area no more than 3 to 4 times each day. Make sure to follow this guideline to ensure the best results and avoid any potential side effects. If you have any questions about how to use the medication or if you notice any unusual reactions, be sure to consult with your healthcare provider for further advice.

What to Avoid

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

While there are no specific contraindications or concerns about abuse, misuse, or dependence associated with this medication, following these guidelines will help ensure your safety and the effectiveness of the treatment. Always prioritize using the medication as directed.

Side Effects

It's important to note that this product is for external use only. If you notice that your condition worsens, if your symptoms last longer than 7 days, or if your symptoms improve and then return within a few days, you should consult your doctor. These signs may indicate that you need further evaluation or a different treatment approach.

Warnings and Precautions

This product is intended for external use only. If you accidentally swallow it, seek medical help or contact a Poison Control Center immediately. It's important to avoid using large amounts, especially on raw or blistered skin, and be careful not to get it in your eyes.

You should consult your doctor if your condition worsens, if your symptoms persist for more than seven days, or if your symptoms improve and then return within a few days. Taking these precautions can help ensure your safety while using this product.

Overdose

Using this medication in large amounts, especially on raw or blistered skin, can lead to serious issues. If you suspect an overdose, look for signs such as unusual redness, swelling, or irritation in the treated area.

If you experience any of these symptoms, it’s important to stop using the product immediately and seek medical advice. Always consult a healthcare professional if you have concerns about how much of the medication you have used or if you notice any adverse effects. Your safety is the top priority, so don’t hesitate to reach out for help.

Pregnancy Use

When considering medication during pregnancy, it's important to be aware that specific information about its use, safety concerns, dosage modifications, and special precautions is not provided. This means that if you are pregnant or planning to become pregnant, you should consult your healthcare provider for personalized advice. They can help you understand any potential risks and ensure that you make informed decisions about your health and the health of your baby. Always prioritize open communication with your doctor regarding any medications you may be taking.

Lactation Use

When it comes to breastfeeding, it's important to note that the drug insert does not provide specific information about nursing mothers or considerations for lactation (the process of producing milk). This means that there are no established guidelines or warnings regarding the use of this medication while breastfeeding.

If you are breastfeeding or planning to breastfeed, it's always a good idea to consult with your healthcare provider about any medications you may be taking. They can help you understand any potential risks and make informed decisions for you and your baby.

Pediatric Use

When using this medication for children aged 2 years and older, you can apply it to the affected area up to 3 to 4 times a day. However, if your child is under 2 years old, it's important to consult a doctor before use.

In case of accidental swallowing, seek medical help immediately or contact a Poison Control Center. Always prioritize safety and follow these guidelines to ensure the well-being of 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 healthcare providers may not have tailored guidelines for elderly patients, which can be important given the unique health considerations that often come with aging.

If you or a caregiver are considering this medication for an older adult, it’s essential to consult with a healthcare professional. They can provide personalized advice and ensure that the treatment is safe and appropriate based on individual health needs.

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, so don't hesitate to ask questions or express any concerns you may have.

Drug Interactions

It's great to know that there are no known interactions between this medication and other drugs, as well as no interactions with laboratory tests. This means you can feel more confident about taking this medication without worrying about it affecting other treatments or test results.

However, it's always important to discuss any medications or tests with your healthcare provider. They can provide personalized advice and ensure that your overall treatment plan is safe and effective for you.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20ºC and 25ºC (68ºF and 77ºF). This temperature range helps maintain the integrity and effectiveness of the device.

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 safety and compliance with regulations.

Additional Information

You should apply the medication to the affected area no more than 3 to 4 times a day. It's important to be cautious; if you accidentally swallow the medication, seek medical help or contact a Poison Control Center immediately for assistance.

FAQ

What conditions does this drug temporarily relieve?

This drug temporarily relieves pain and itching due to minor burns, sun burns, minor cuts, scrapes, insect bites, and minor skin irritations.

How often can I apply this drug?

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

Is this drug safe for children?

Adults and children 2 years and over can use it, but for children under 2 years, you should ask a doctor.

Are there any contraindications for this drug?

No contraindications are specified for this drug.

What should I do if I accidentally swallow this drug?

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

Can I use this drug on large areas of skin?

Do not use this drug in large quantities, particularly over raw surfaces or blistered areas.

What should I do if my condition worsens?

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

What are the storage conditions for this drug?

Store the drug between 20ºC and 25ºC (68ºF and 77ºF).

Is this drug safe to use during pregnancy or while nursing?

The provided text does not specify information regarding use during pregnancy or nursing.

Are there any known drug interactions?

No drug interactions were found for this drug.

Packaging Info

Below are the non-prescription pack sizes of Westlake Outdoor Pain and Itch Relieving (lidocaine 4% pain and itch relieving). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Westlake Outdoor Pain and Itch Relieving.
Details

Drug Information (PDF)

This file contains official product information for Westlake Outdoor Pain and Itch Relieving, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Uses and Indications

This drug is indicated for the temporary relief of pain and itching associated with minor burns, sunburns, minor cuts, scrapes, insect bites, and minor skin irritations.

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

Dosage and Administration

The medication should be applied to the affected area no more than 3 to 4 times daily. Healthcare professionals are advised to instruct patients on the importance of adhering to this frequency to optimize therapeutic outcomes while minimizing the risk of potential side effects. Care should be taken to ensure that the application is performed gently and uniformly across the affected area.

Contraindications

Use is contraindicated in patients who may apply the product in large quantities, particularly over raw surfaces or blistered areas, due to the potential for adverse effects. Additionally, contact with the eyes should be strictly avoided to prevent irritation or injury.

Warnings and Precautions

For external use only. In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Caution is advised against the application of large quantities, especially on raw surfaces or blistered areas, as this may exacerbate irritation or lead to adverse effects. Care should also be taken to avoid contact with the eyes, as this may result in significant discomfort or injury.

Healthcare professionals should advise patients to seek medical consultation if any of the following conditions arise: if the condition worsens, if symptoms persist beyond 7 days, or if symptoms resolve only to recur within a few days. Monitoring these parameters is essential to ensure patient safety and effective management of the condition.

Side Effects

For external use only. Patients should be advised to seek medical attention if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. These considerations are important to ensure appropriate management and to prevent potential complications associated with prolonged or recurrent symptoms.

Drug Interactions

No drug interactions have been identified for this medication. Additionally, there are no interactions noted between this drug and laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Westlake Outdoor Pain and Itch Relieving (lidocaine 4% pain and itch relieving). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Westlake Outdoor Pain and Itch Relieving.
Details

Pediatric Use

Pediatric patients aged 2 years and older may apply the medication to the affected area no more than 3 to 4 times daily. For children under 2 years of age, it is advised to consult a doctor before use. 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 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 should be aware that the safety of this medication during pregnancy has not been specifically established. There are no available data regarding the potential risks or fetal impacts associated with the use of this medication in pregnant individuals. Healthcare professionals are advised to consider the lack of information when prescribing this medication to women of childbearing potential and to weigh the potential benefits against any unknown risks. It is recommended that healthcare providers discuss the implications of medication use during pregnancy with their patients, ensuring informed decision-making.

Lactation

There is no specific information regarding the use of this drug in lactating mothers or any lactation considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to nursing mothers, as the effects on breastfed infants are not established.

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 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 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

Overdosage of the product is primarily a concern when it is applied externally. It is crucial to note that the product is intended for external use only.

In cases where the product is applied in large quantities, particularly over raw surfaces or blistered areas, there is an increased risk of adverse effects. Healthcare professionals should be vigilant for potential symptoms that may arise from such overdosage.

Management of overdosage should involve immediate cessation of the product's use and thorough cleansing of the affected area. If symptoms persist or if there is significant concern regarding the extent of the overdosage, it is advisable to seek further medical evaluation and intervention.

Nonclinical Toxicology

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

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 to avoid contact with the eyes, as this may lead to irritation or injury.

Additionally, healthcare providers should encourage patients to 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. This guidance is essential to ensure appropriate management and to prevent potential complications.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It is essential to store the product at a controlled room temperature, specifically between 20ºC and 25ºC (68ºF and 77ºF). Proper storage conditions must be maintained to ensure the integrity and efficacy of the product.

Additional Clinical Information

Patients should apply the medication to the affected area no more than 3 to 4 times daily. Clinicians should advise patients that if the medication is swallowed, they should seek medical help or contact a Poison Control Center immediately. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Westlake Outdoor Pain and Itch Relieving, 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 Outdoor Pain and Itch Relieving, 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.