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Lidocaine hydrochloride

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Active ingredient
Lidocaine Hydrochloride 2 g/100 g
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
Dosage form
Gel
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 15, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Lidocaine Hydrochloride 2 g/100 g
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
Dosage form
Gel
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 15, 2025
Manufacturer
ProStat First Aid LLC
Registration number
M017
NDC root
58228-3866
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

PS-3866 Burn Ease is a topical product designed to provide temporary relief from pain associated with minor burns and sunburn. It can help soothe discomfort and promote a sense of comfort during the healing process. If you experience minor burns or sunburn, this product may be a helpful option for alleviating your pain.

Uses

If you're dealing with minor burns or sunburn, this product can help provide temporary relief from the pain associated with these skin irritations. It's designed to soothe discomfort, allowing you to feel more comfortable as your skin heals.

Rest assured, there are no concerns regarding teratogenic effects (which means it doesn't cause birth defects) or nonteratogenic effects (which refers to other potential harmful effects unrelated to birth defects) with this product. You can use it with confidence for the indicated purposes.

Dosage and Administration

If you are an adult or a child aged 2 years and 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.

For children under 2 years of age, it’s important to consult a doctor before using this medication. This will help ensure safety and proper care for younger children. Always follow your healthcare provider's advice regarding the use of any medication.

What to Avoid

It's important to use this medication safely. You should avoid applying it on wounds or damaged skin, as well as using it in large quantities, especially over raw surfaces or blistered areas. Following these guidelines will help ensure your safety and the effectiveness of the treatment. If you have any questions or concerns, please consult your healthcare provider for more information.

Side Effects

When using this product, it's important to apply it only to intact skin and avoid using it on wounds or damaged areas. You should also steer clear of your eyes and refrain from tightly bandaging the area after application. If your condition worsens, if symptoms last longer than seven days, or if symptoms improve and then return within a few days, stop using the product and consult a doctor.

Keep this product out of reach of children. If it is swallowed, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

Warnings and Precautions

This product is for external use only, so please avoid applying it to wounds or damaged skin, and do not use it in large amounts, especially on raw surfaces or blistered areas. While using this product, be careful to keep it away from your eyes and avoid wrapping the area tightly with a bandage.

If your condition worsens, if symptoms last longer than 7 days, or if symptoms improve and then return within a few days, stop using the product and contact your doctor. Additionally, if you accidentally swallow the product, seek emergency medical help immediately or call a Poison Control Center at 1-800-222-1222.

Overdose

If you or someone else has swallowed too much of this medication, it’s important to seek medical help immediately. You can contact a Poison Control Center at 1-800-222-1222 for guidance.

Signs of an overdose may include unusual symptoms, but specific details on these symptoms are not provided here. If you notice anything concerning, don’t hesitate to reach out for help. Remember, acting quickly can make a significant difference in ensuring safety and health.

Pregnancy Use

When it comes to using PS-3866 Burn Ease during pregnancy, there is currently no specific information available about its safety, dosage adjustments, or any special precautions you should take. This means that if you are pregnant or planning to become pregnant, it is essential to consult with your healthcare provider before using this product. They can help you understand any potential risks and guide you on the best course of action for your health and the health of your baby. Always prioritize open communication with your doctor regarding any medications or treatments during pregnancy.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or considerations regarding the use of this product while nursing. Additionally, there is no information available about whether this product is excreted in breast milk or any potential risks it may pose to your infant. Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

Pediatric Use

When using this medication for children, it's important to follow specific guidelines. For children aged 2 years and older, you can apply the medication to the affected area up to 3 to 4 times a day. However, if your child is under 2 years old, you should consult a doctor before using it. This ensures that the treatment is safe and appropriate for their age. Always prioritize your child's health by seeking professional advice when needed.

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 wise to discuss any potential risks or concerns with your healthcare provider. They can help determine the best approach, considering any unique health needs or conditions that may be present.

Always ensure that your doctor is aware of all medications being taken, as older adults may be more sensitive to certain drugs. Regular check-ins with your healthcare team can help monitor for any side effects or changes in health, ensuring that the treatment remains safe and effective.

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 may affect you 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 monitor your kidney function and make any necessary adjustments to your treatment plan.

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 (issues with liver function).

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. 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. This means keeping it in a place that is neither too hot nor too cold, typically between 68°F and 77°F (20°C to 25°C).

When handling the product, make sure to do so with clean hands and in a clean environment to maintain its safety and effectiveness. Always follow any specific instructions provided with the product for optimal use.

Additional Information

No further information is available.

FAQ

What is PS-3866 Burn Ease used for?

PS-3866 Burn Ease is used for the temporary relief of pain associated with minor burns and sunburn.

How should I apply PS-3866 Burn Ease?

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

Are there any warnings for using PS-3866 Burn Ease?

Yes, it is for external use only. Do not use it on wounds or damaged skin, and avoid contact with the eyes.

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

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

What should I do if PS-3866 Burn Ease is swallowed?

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

Can I use PS-3866 Burn Ease during pregnancy or while nursing?

The insert does not provide specific information regarding the use of PS-3866 Burn Ease during pregnancy or nursing.

How should I store PS-3866 Burn Ease?

Store PS-3866 Burn Ease at room temperature.

Packaging Info

Below are the non-prescription pack sizes of Ps-3866 Burn Ease, 0.9g. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Ps-3866 Burn Ease, 0.9g.
Details

Drug Information (PDF)

This file contains official product information for Ps-3866 Burn Ease, 0.9g, 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 associated with minor burns and sunburn.

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 frequency is to 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 healthcare professional prior to use.

Contraindications

Use is contraindicated on wounds or damaged skin due to the potential for irritation and adverse effects. Additionally, application in large quantities, particularly over raw surfaces or blistered areas, is not recommended to avoid exacerbating skin conditions or causing further harm.

Warnings and Precautions

For external use only, this product should not be applied to wounds or damaged skin. Caution is advised against using large quantities, especially over raw surfaces or blistered areas, as this may exacerbate irritation or lead to adverse effects.

When utilizing this product, it is imperative to avoid contact with the eyes to prevent irritation or injury. Additionally, bandaging should not be applied tightly over the treated area to allow for proper ventilation and to minimize the risk of skin irritation.

Patients are advised to discontinue use and consult a healthcare professional if their condition worsens, if symptoms persist beyond 7 days, or if symptoms resolve only to recur within a few days. These actions are crucial to ensure appropriate management of the condition being treated.

In the event of accidental ingestion, immediate medical assistance should be sought. Contact a Poison Control Center at 1-800-222-1222 without delay to receive guidance on the necessary steps to take.

Side Effects

Patients using this product should be aware of several important warnings and precautions. This product is intended for external use only and should not be applied to wounds or damaged skin. It is advised to avoid using large quantities, particularly over raw surfaces or blistered areas.

During use, patients should take care to avoid contact with the eyes and should not bandage the area tightly. If the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, patients are advised to stop use and consult a doctor.

Additionally, this product should be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted without delay.

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 Ps-3866 Burn Ease, 0.9g. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Ps-3866 Burn Ease, 0.9g.
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 prior to use.

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

The safety of PS-3866 Burn Ease during pregnancy has not been established, as the prescribing information does not provide specific data regarding its use in pregnant patients. There are no known safety concerns, dosage modifications, or special precautions outlined for this population. Healthcare professionals should exercise caution when considering the use of this product in women of childbearing potential and weigh the potential benefits against any unknown risks to fetal outcomes. It is advisable to consult relevant clinical guidelines and consider alternative treatments with established safety profiles during pregnancy.

Lactation

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

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 swallowed, healthcare professionals should be contacted without delay. It is recommended to reach out to a Poison Control Center at 1-800-222-1222 for expert guidance.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Healthcare providers should be prepared to assess the patient's condition and implement appropriate management strategies based on the severity of symptoms presented.

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 seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 if the product is swallowed. It is important to inform patients that the product should only be applied to wounds or damaged skin as directed. They should be cautioned against using the product in large quantities, especially over raw surfaces or blistered areas, as this may lead to adverse effects.

Patients should be instructed to monitor their condition closely. If symptoms worsen or persist for more than 7 days, they should contact their healthcare provider. Additionally, if symptoms initially clear up but then recur within a few days, patients should be advised to seek further medical evaluation.

Healthcare providers should emphasize the importance of avoiding contact with the eyes to prevent irritation or injury. Furthermore, patients should be informed not to bandage the treated area tightly, as this may impede healing and exacerbate any potential side effects.

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 at room temperature to maintain its integrity and efficacy. No special handling requirements are necessary beyond standard storage practices.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Ps-3866 Burn Ease, 0.9g, 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 Ps-3866 Burn Ease, 0.9g, 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.