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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
58228-2012
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 are 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. Always consult with a healthcare professional for guidance on how to use it effectively.

Uses

If you’re dealing with minor burns, this medication can provide temporary relief from the pain associated with those injuries. It’s designed to help ease your discomfort, allowing you to manage your symptoms more effectively.

Rest assured, there are no known teratogenic effects (which means it doesn’t cause birth defects) or nonteratogenic effects associated with this medication. This makes it a safer option for those in need of pain relief from minor burns.

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 limit 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, as this could compromise the product's effectiveness. Additionally, avoid applying it in large quantities, especially on raw or blistered areas of your skin. Be cautious not to use it near your eyes; if contact occurs, rinse your eyes thoroughly with water.

By adhering to these instructions, you can help prevent any potential issues and ensure a safer experience with the product.

Side Effects

You should be aware that this product is for external use only. Avoid using it on any opened or torn packets, in large amounts, or on raw or blistered skin. Be careful not to apply it near your eyes; if it does come into contact with your eyes, rinse thoroughly with water.

If your condition worsens, persists for more than 7 days, or clears up and then returns, stop using the product and consult a doctor. Keep it out of reach of children, and 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. Avoid using it on any opened or torn packets, in large amounts, or on raw or blistered skin. Be careful not to apply it near your eyes; if it does come into contact with your eyes, rinse them thoroughly with water.

If your condition worsens, persists for more than 7 days, or clears up and then returns, stop using the product and consult your doctor. Additionally, 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, so it's crucial to be aware of any changes in behavior or health. If you notice anything concerning, don’t hesitate to get help right away. Your safety is the top priority, so act quickly if you suspect an overdose.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety and effectiveness of this medication have not been established for pregnant women. Due to potential risks to the developing fetus, using this medication during pregnancy is not recommended.

Before considering this medication, you should consult with your healthcare provider to discuss any concerns and explore safer alternatives. Your health and the health of your baby are the top priority, so make sure to seek professional guidance.

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 younger children, make sure to keep the medication out of their reach to prevent accidental ingestion. In the event that a child swallows the medication, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. Your child's safety is a top priority, so always follow these guidelines carefully.

Geriatric Use

It's important to note that this medication is not recommended for children under 12 years of age. For older adults, there are no specific guidelines regarding dosage adjustments or safety concerns mentioned. However, as with any medication, it's always wise to consult with a healthcare provider to ensure it is appropriate for your individual health needs, especially if you have any underlying conditions or are taking other medications. Your safety and well-being should always come first.

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 standard recommendations for the medication do not change based on renal impairment. However, it’s always a good idea to discuss your kidney health with your healthcare provider, as they can offer personalized advice and monitor your condition effectively.

Make sure to keep your doctor informed about any changes in your kidney function, as they may need to adjust your treatment plan accordingly. Regular check-ups and open communication are key to managing your health safely.

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 differently due to your liver health.

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver function and how it relates to your treatment. They can help ensure that your medication is safe and effective for you.

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 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 product's effectiveness and safety.

When handling the product, be sure to use it from tamper-evident sealed packets, which provide an extra layer of safety by indicating whether the packaging has been opened or altered. Always check the integrity of the packaging before use to ensure that the product is safe and effective.

Additional Information

No further information is available.

FAQ

What is the primary use of this drug?

This drug is used for 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 swallow the gel?

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

Are there any contraindications for using this drug?

There are no specific contraindications listed, but do not use opened or torn packets.

Can I use this drug if I am pregnant?

Use is contraindicated in pregnancy due to potential risks to the fetus; consult a healthcare provider if pregnant or planning to become pregnant.

What should I do if my condition worsens?

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

What precautions should I take when using this drug?

For external use only; do not use in large quantities, particularly over raw or blistered areas, and avoid contact with eyes.

How should I store this drug?

Store at 68-77°F (20-25°C) in tamper-evident sealed packets.

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 for the drug.

Uses and Indications

This drug is indicated for the temporary relief of pain associated with minor burns.

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

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

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 adverse effects.

  • The product should not be applied near the eyes; in the event of contact, thorough rinsing with water is required.

Warnings and Precautions

For external use only. The product should not be applied to any opened or torn packets, nor should it be used in large quantities, especially over raw or blistered areas. 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.

Healthcare professionals should advise patients to discontinue use and seek medical advice if the condition worsens or persists for more than 7 days, or if the condition appears to improve and then returns.

In cases of ingestion, it is imperative to obtain emergency medical assistance immediately or contact a Poison Control Center at 1-800-222-1222.

Side Effects

Patients should be aware that the product is intended for external use only. It is contraindicated to use any opened or torn packets and should not be applied in large quantities, particularly over raw or blistered areas. 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.

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.

Additionally, the product should be kept out of reach of children. In the case of accidental ingestion, it is imperative to seek medical assistance or contact a Poison Control Center immediately at 1-800-222-1222.

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. It is essential to keep the product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact a Poison Control Center at 1-800-222-1222.

Geriatric Use

Elderly patients, defined as those aged 65 years and older, have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments or safety concerns specifically pertaining to this population.

It is important to note that this medication is contraindicated for use in children under 12 years of age. Healthcare providers should exercise caution and consider individual patient factors when prescribing this medication to elderly patients, as the absence of specific geriatric use information necessitates careful monitoring and assessment of treatment outcomes.

Pregnancy

Safety and efficacy have not been established in pregnant women. Use of this medication is contraindicated during pregnancy due to potential risks to the fetus. Pregnant patients or those planning to become pregnant should 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 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 in these areas limits the understanding of the compound's safety profile in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients that in the event of accidental ingestion, it is crucial to seek medical assistance immediately. Patients should be instructed to contact a Poison Control Center at 1-800-222-1222 without delay. This information is vital for ensuring prompt and appropriate care in case of an emergency.

Storage and Handling

The product is supplied in tamper-evident sealed packets, ensuring the integrity and safety of the contents. It is essential to store the product at a temperature range of 68 to 77 degrees Fahrenheit (20 to 25 degrees Celsius) to maintain its efficacy and quality. Proper storage conditions should be observed to prevent any degradation of the product.

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.