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Prostat First Aid Burn Ease, 0.9g

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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 2025
Label revision date
October 1, 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 2025
Label revision date
October 1, 2025
Manufacturer
ProStat First Aid LLC
Registration number
M017
NDC root
58228-3867
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

If you’re looking for relief from minor burns, this medication can help provide temporary pain relief. It is specifically designed to ease the discomfort associated with these types of injuries, allowing you to feel more comfortable as you heal.

Uses

If you’re dealing with minor burns, this medication can provide temporary relief from the pain. It’s designed to help ease the discomfort you may experience while your skin heals. Remember, this is specifically for minor burns, so if your injury is more severe, it’s important to seek medical attention.

Dosage and Administration

To use the burn gel effectively, start by cleaning the affected area thoroughly. Once it's clean, apply an even layer of the gel directly onto the burn. You can do this up to 3 to 4 times a day, ensuring that you don’t exceed this frequency for the best results.

It's important to note that this burn gel is not recommended for children under 12 years of age, so please avoid using it on younger individuals. Always follow these guidelines to help promote healing and comfort for your skin.

What to Avoid

It's important to follow specific guidelines when using this product to ensure your safety. You should never use any opened or torn packets, and avoid applying it in large amounts, especially on raw or blistered skin. Additionally, keep it away from your eyes; if contact occurs, rinse your eyes thoroughly with water.

To further protect yourself, avoid tight bandaging over the area where the product is applied, and always be cautious to prevent any contact with your eyes. Following these instructions will help you use the product safely and effectively.

Side Effects

When using this product, it's important to remember that it is for external use only. Avoid applying it to large areas of skin, especially if the skin is raw or blistered, and keep it away from your eyes. If the product accidentally gets into your eyes, rinse them thoroughly with water.

You should stop using the product and consult a doctor if your condition worsens, persists for more than 7 days, or if it clears up and then returns. Additionally, keep this product out of reach of children. If 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 using it on any opened or torn packets. Do not apply it in large amounts, especially on raw or blistered skin, and keep it away from your eyes. If it accidentally gets into your eyes, rinse them thoroughly with water.

Be cautious not to bandage the area tightly and avoid contact with your eyes. If your condition worsens, lasts more than 7 days, or clears up and then returns, stop using the product and consult your doctor.

If you accidentally swallow the product, seek emergency medical help immediately or contact 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

If you are pregnant or planning to become pregnant, it's important to know that the safety of this medication during pregnancy has not been established. While there are no specific contraindications listed, caution is advised since lidocaine may pose potential risks. The insert does not detail specific risks to the fetus, so it's essential to consult your healthcare provider before using this medication. They can provide guidance tailored to your situation, especially since there are no dosage modifications recommended for pregnant individuals.

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 to your infant. Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

Pediatric Use

It's important to know that this medication should not be used in children under 12 years of age. If you have a child in this age group, please consult your healthcare provider for alternative options that are safe and appropriate for their age. Always prioritize your child's health and follow medical advice regarding medication use.

Geriatric Use

When considering medication for older adults, it's important to note that this particular drug is not recommended for children under 12 years of age. While there is no specific information provided regarding its use in older adults, it's always wise to consult with a healthcare professional about any medications you or your loved ones may be taking. They can help ensure that the treatment is safe and appropriate for your individual health needs.

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 determine the best course of action based on your kidney function and overall health.

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 (issues with liver function).

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver health and medication use. They can help ensure that you receive the safest and most effective treatment based on your individual needs.

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 discuss your full list of medications, including over-the-counter drugs and supplements, as well as any upcoming lab tests. This way, you can avoid any potential issues and receive the best care possible.

Storage and Handling

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

When handling the product, be sure to use it from the tamper-evident sealed packets, which provide an added layer of safety by indicating whether the packaging has been opened or compromised. Always check the packaging before use to ensure it is intact.

Additional Information

No further information is available.

FAQ

What is the primary use of this drug?

This drug provides temporary pain relief associated with minor burns.

How should I apply the burn gel?

Apply an even layer of burn gel over the cleaned affected area no more than 3-4 times daily.

Is this drug safe for children?

This drug should not be used on children under 12 years of age.

What should I do if I accidentally get the gel in my eyes?

If the gel gets in your eyes, rinse thoroughly with water.

What precautions should I take when using this product?

Avoid contact with the eyes and do not bandage tightly.

When should I stop using this product?

Stop use and ask a doctor if your condition worsens, persists for more than 7 days, or clears up and returns.

What should I do if the product is swallowed?

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

Is it safe to use this drug during pregnancy?

Safety during pregnancy has not been established, so consult a healthcare provider before use.

Are there any specific warnings for nursing mothers?

There are no specific warnings or considerations mentioned for nursing mothers regarding this product.

What is the recommended storage temperature for this drug?

Store the drug at 68-77°F (20-25°C).

Packaging Info

Below are the non-prescription pack sizes of Prostat First Aid Burn Ease, 0.9g (lidocaine). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Prostat First Aid Burn Ease, 0.9g.
Details

Drug Information (PDF)

This file contains official product information for Prostat First Aid 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.

Uses and Indications

This drug is indicated for the temporary relief of pain associated with minor burns. It is intended for use in patients experiencing discomfort due to such injuries.

Dosage and Administration

Healthcare professionals are advised to apply an even layer of burn gel over the cleaned affected area. This application should not exceed 3 to 4 times daily.

It is important to note that this product is contraindicated for use in children under 12 years of age.

Contraindications

The use of this product is contraindicated in the following situations:

Opened or torn packets should not be used to ensure product integrity and efficacy. Application in large quantities, especially over raw or blistered areas, is contraindicated due to the potential for increased irritation or adverse effects. The product should not be applied near the eyes; in the event of contact, it is essential to rinse thoroughly with water to prevent irritation. Additionally, tight bandaging is contraindicated as it may lead to restricted circulation or increased local irritation.

Warnings and Precautions

For external use only. It is imperative that the product is not applied to any opened or torn packets. Additionally, the application of this product in large quantities, particularly over raw or blistered areas, is contraindicated. Care should be taken to avoid contact with the eyes; in the event of accidental exposure, the affected area should be rinsed thoroughly with water.

General precautions include avoiding tight bandaging of the treated area. Healthcare professionals should advise patients to discontinue use and consult a physician if the condition worsens, persists for more than 7 days, or if symptoms resolve only to return.

In cases of ingestion, immediate medical assistance should be sought. Patients should be instructed to contact a Poison Control Center at 1-800-222-1222 without delay.

Side Effects

Patients should be aware of the following adverse reactions associated with the use of this product. It is intended for external use only, and caution is advised to prevent serious complications.

Warnings include the necessity to avoid using any opened or torn packets, as well as the application of large quantities, particularly over raw or blistered areas. Patients should also take care to avoid contact with the eyes; in the event of contact, it is crucial to rinse thoroughly with water. Additionally, it is recommended not to bandage the area tightly while using the product.

Patients are advised to discontinue use and consult a healthcare professional if their condition worsens or persists for more than 7 days, or if the condition clears up and then returns.

It is important to keep this product 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 is no information available regarding 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 Prostat First Aid Burn Ease, 0.9g (lidocaine). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Prostat First Aid Burn Ease, 0.9g.
Details

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. Safety and efficacy have not been established in this population, and therefore, it is contraindicated for children in this age group. Healthcare professionals should consider alternative treatments for pediatric patients who fall within this age range.

Geriatric Use

Elderly patients may require special consideration when prescribing this medication, as no specific geriatric use information is provided in the insert. It is important to note that this medication is not indicated for use in children under 12 years of age.

Healthcare providers should exercise caution when prescribing to geriatric patients, taking into account the potential for altered pharmacokinetics and increased sensitivity to medications in this population. Monitoring for efficacy and adverse effects is recommended, and dose adjustments may be necessary based on the individual patient's health status and response to treatment.

Pregnancy

Safety during pregnancy has not been established for this medication. While specific contraindications are not mentioned, caution is advised as lidocaine may pose risks to the fetus. The prescribing information does not detail potential risks to the fetus, and no specific dosage modifications for pregnant individuals are provided. It is recommended that pregnant patients or those planning to become pregnant consult a healthcare provider before use to discuss potential risks and benefits.

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 not been specifically addressed in the drug insert text regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to 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 prescribing 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 for patients to be aware of the signs that may indicate a worsening condition or if symptoms persist for more than 7 days, or if the condition appears to improve and then returns.

Patients should be instructed to avoid contact with the eyes, as this may lead to irritation or other complications. Additionally, healthcare providers should emphasize the importance of not bandaging the affected area tightly, as this could impede circulation and lead to further issues.

Storage and Handling

The product is supplied in tamper-evident sealed packets, ensuring the integrity and safety of the contents. It is recommended to store the product at a temperature range of 68-77°F (20-25°C) to maintain optimal quality and efficacy. Proper storage conditions are essential to preserve the product's effectiveness and ensure patient safety.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Prostat First Aid 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 Prostat First Aid 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.