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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 2024
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 2024
Label revision date
December 15, 2025
Manufacturer
ProStat First Aid LLC
Registration number
M017
NDC root
58228-2010
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-8610 is a medication designed to provide temporary relief from pain associated with minor burns and sunburn. It helps soothe discomfort, allowing you to feel more comfortable while your skin heals. If you’re dealing with the pain of a minor burn or sunburn, PS-8610 may be a helpful option for you.

Uses

If you're looking for temporary relief from pain caused by minor burns or sunburn, this product may be suitable for you. It is specifically designed to help ease the discomfort associated with these types of skin injuries.

You can use it to soothe the affected areas, allowing for a more comfortable recovery. Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) associated with this product, making it a safer option for many users.

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 of age, 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 medication safely to ensure your well-being. You should avoid applying it on wounds or damaged skin, as this can lead to complications. Additionally, refrain from using large quantities, especially on raw surfaces or blistered areas, to prevent adverse effects.

By following these guidelines, you can help ensure that you use the medication effectively and safely. If you have any questions or concerns about its use, 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. Be cautious not to use large amounts, especially on raw or blistered skin, and keep it away from your eyes. If your condition worsens, persists for more than seven days, or clears up only to return shortly after, you should stop using the product and consult a doctor.

Additionally, 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. It's important not to use large amounts, especially on raw surfaces or blistered areas. Be careful to keep it away from your eyes, and do not wrap 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. In case of accidental swallowing, 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 about 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

The safety of this product during pregnancy has not been established, which means that it may not be safe for you or your developing baby. In fact, using this product while pregnant is contraindicated, meaning it is not recommended due to potential risks to the fetus.

If you are pregnant or planning to become pregnant, it is essential to consult your healthcare provider before using this product. They can help you understand the risks and make informed decisions about your health and the health of your baby.

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. Additionally, there is no information available about whether this product is excreted in breast milk or any potential risks 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 always a good idea to discuss any medications with a healthcare provider. They can help determine the best approach, considering any unique health needs or conditions.

Since there are no dosage adjustments or special precautions mentioned for elderly patients, your healthcare provider will guide you on the appropriate use of this medication based on individual health status. Always keep them informed about any other medications being taken or health changes that occur.

Renal Impairment

If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

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 may affect you if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and how it may relate to your treatment. They can help ensure that you receive the safest and most effective care.

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 tests you might be undergoing. This way, you can avoid any potential issues and receive the best care possible.

Storage and Handling

To ensure the best performance and safety of your product, store it at a controlled room temperature between 20º-25ºC (68º-77ºF). This temperature range helps maintain the product's effectiveness. Additionally, please check the packaging for a tamper-evident seal. If the seal is damaged in any way, do not use the product, as this could compromise its safety and integrity.

By following these simple storage and handling guidelines, you can help ensure that the product remains safe and effective for your use.

Additional Information

No further information is available.

FAQ

What is PS-8610 used for?

PS-8610 is used for the temporary relief of pain associated with minor burns and sunburn.

How should I apply PS-8610?

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 of age, consult a doctor.

Are there any contraindications for using PS-8610?

Yes, do not use PS-8610 on wounds or damaged skin, and avoid using it in large quantities, particularly over raw surfaces or blistered areas.

What should I do if I experience worsening symptoms?

Stop using PS-8610 and call your doctor if your condition worsens, symptoms persist for more than 7 days, or if symptoms clear up and then occur again within a few days.

Is PS-8610 safe to use during pregnancy?

The safety of PS-8610 during pregnancy has not been established, and it is contraindicated due to potential risks to the fetus. Consult a healthcare provider if pregnant or planning to become pregnant.

What precautions should I take when using PS-8610?

Avoid contact with the eyes and do not bandage tightly when using PS-8610.

What should I do if PS-8610 is swallowed?

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

How should I store PS-8610?

Store PS-8610 at controlled room temperature between 20º-25ºC (68º-77ºF).

Packaging Info

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

Packaging configurations for Burn Ease.
Details

Drug Information (PDF)

This file contains official product information for Burn Ease, 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 contraindicated to prevent exacerbation of skin conditions and to minimize the risk of systemic absorption.

Warnings and Precautions

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

Healthcare professionals should instruct patients to avoid contact with the eyes to prevent irritation or injury. Additionally, it is important to advise against tightly bandaging the area of application, as this may hinder proper healing and increase the risk of complications.

Patients should be advised 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. These actions are crucial for ensuring patient safety and effective management of their condition.

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 without delay. Prompt action is essential to mitigate potential health risks associated with ingestion.

Side Effects

Patients using this product may experience adverse reactions that necessitate caution and awareness. The product is intended for external use only and should not be applied to wounds or damaged skin. It is advised to avoid using the product in large quantities, particularly over raw surfaces or blistered areas, as this may exacerbate adverse effects.

While using this product, patients should take care to avoid contact with the eyes and should not bandage the area tightly. If a patient's condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, it is recommended that they stop use and consult a healthcare professional.

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 patient should contact a Poison Control Center at 1-800-222-1222.

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 Burn Ease. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Burn Ease.
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

There is no specific information available 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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

Pregnancy

The safety of this product during pregnancy has not been established. Use of this product is contraindicated in pregnancy due to potential risks to the fetus. Pregnant patients or women of childbearing potential should consult a healthcare provider before use if they are pregnant or planning to become pregnant.

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

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

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 without delay. It is recommended to contact a Poison Control Center at 1-800-222-1222 for expert guidance on managing the situation.

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 and the specific substance involved.

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 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 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 for further evaluation. Additionally, patients should be made aware that if symptoms initially clear up but then recur within a few days, they should also seek medical advice.

Healthcare providers should emphasize the importance of avoiding contact with the eyes to prevent irritation or injury. Furthermore, patients should be advised 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 a tamper-evident container. It is essential to inspect the seal before use; do not use the product if the seal is damaged.

For optimal storage, the product should be maintained at a controlled room temperature between 20ºC and 25ºC (68ºF to 77ºF). Proper handling and storage conditions are crucial to ensure the integrity and efficacy of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Burn Ease, 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 Burn Ease, 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.