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PO First Aid Series Burn

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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)
Marketed in the U.S.
Since 2024
Label revision date
December 5, 2024
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
Marketed in the U.S.
Since 2024
Label revision date
December 5, 2024
Manufacturer
Nantong Health & Beyond Hygienic Products Inc.
Registration number
M017
NDC root
43473-062

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Drug Overview

If you're dealing with minor burns, there are medications available that can provide temporary relief from the associated pain. These products are specifically designed to help soothe discomfort and promote healing. While the exact mechanisms of action may not be detailed, their primary purpose is to alleviate the pain you experience from these minor injuries. Always consult with a healthcare professional for guidance on the best options for your needs.

Uses

If you’re dealing with minor burns, this medication can provide you with temporary relief from the pain associated with those injuries. It’s designed to help ease your discomfort, allowing you to go about your day with less irritation.

Rest assured, this medication does not have any known teratogenic effects, meaning it does not cause harm to a developing fetus. This makes it a safer option for those who are pregnant or may become pregnant.

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. Always follow these guidelines to help promote healing and avoid any complications.

What to Avoid

It's important to use this product safely to avoid any 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 not to use it near your eyes; if it accidentally gets into your eyes, rinse them thoroughly with water to prevent discomfort.

While there are no specific contraindications or concerns about abuse, misuse, or dependence associated with this product, following these guidelines will help ensure your safety and well-being.

Side Effects

This product is intended for external use only. If you notice that your condition worsens or does not improve after 7 days, or if it seems to clear up and then comes back, it’s important to stop using the product and consult a doctor. Your health and safety are paramount, so don’t hesitate to seek professional advice if you have concerns.

Warnings and Precautions

This product is for external use only, so please avoid applying it to any areas that may be sensitive or internal. It's important to keep this product out of reach of children. If a child accidentally swallows it, seek medical help or contact a Poison Control Center immediately.

If your condition worsens, persists for more than 7 days, or clears up and then returns, stop using the product and consult your doctor. Your health and safety are important, so don’t hesitate to reach out for professional advice if you have any concerns.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there is no specific information available about the signs of overdose for this medication, general symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, or if you are unsure, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's always better to be safe and get checked by a healthcare professional if you have any concerns about your health. Remember, timely action can make a significant difference.

Pregnancy Use

When it comes to using PO First Aid Series Burn Gel (lidocaine hydrochloride gel) during pregnancy, there is currently no information available about its safety, recommended dosage, or any special precautions you should take. This means that if you are pregnant or planning to become pregnant, it’s important to consult with your healthcare provider before using this product. They can help you understand any potential risks and guide you on the best options for your situation. Always prioritize your health and the health of your baby when considering any medication.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or considerations mentioned regarding nursing mothers or lactation in the information provided. This means that, based on the available data, there are no known risks associated with breastfeeding while using this medication. However, it's always a good idea to consult with your healthcare provider if you have any concerns or questions about your specific situation.

Pediatric Use

This medication is not recommended for children under 12 years of age. It's important to keep it out of reach of children to prevent accidental ingestion. If a child swallows this medication, seek medical help or contact a Poison Control Center immediately. Your vigilance can help ensure their safety.

Geriatric Use

It's important to note that this medication should not be used in children under 12 years of age. If you are caring for an older adult, be aware that their specific health needs may differ from younger individuals. Always consult with a healthcare professional to ensure the medication is appropriate for their age and health status.

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 information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to your condition. This means that there are no tailored recommendations for how the medication may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific situation. They can help determine the best approach based on your liver function and overall health.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking. In this case, there are no specific drug interactions or laboratory test interactions noted, which means that the medication is generally considered safe to use with other drugs and tests. However, every individual is different, and your healthcare provider can help ensure that your treatment plan is safe and effective for you.

Always discuss any changes in your medication or health status with your healthcare provider to avoid any potential issues and to get the best care possible.

Storage and Handling

To ensure the safety and effectiveness of your product, store it at room temperature. It's important to keep it out of reach of children to prevent any accidental ingestion or misuse. Once you open the product, be sure to discard it after use to maintain safety and hygiene. Following these simple guidelines will help you use the product safely and effectively.

Additional Information

You should apply the burn gel topically, which means putting it directly on the skin. Make sure to clean the affected area first, then spread an even layer of the gel over it. You can do this up to 3-4 times a day as needed.

FAQ

What is the primary use of this drug?

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

How should I apply the burn gel?

Apply an even layer of burn gel over the cleaned affected area not 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 the condition worsens?

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

Are there any contraindications for this drug?

No specific contraindications are mentioned for this drug.

What precautions should I take when using this drug?

For external use only; keep out of reach of children, and do not use in large quantities, particularly over raw or blistered areas.

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

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

Is there any information regarding use during pregnancy?

There is no information provided regarding the use of this drug during pregnancy.

How should I store this drug?

Store at room temperature and keep out of reach of children. Discard after opening.

Packaging Info

Below are the non-prescription pack sizes of PO First Aid Series Burn (lidocaine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for PO First Aid Series Burn.
Details

Drug Information (PDF)

This file contains official product information for PO First Aid Series Burn, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

The product is identified by the SPL code 34089-3. No additional specific description details are provided in the available data.

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 is contraindicated in the following situations:

Application in large quantities, particularly over raw or blistered areas, is not recommended due to the potential for increased irritation or adverse effects. Additionally, application near the eyes is contraindicated; in the event of contact, the area should be rinsed thoroughly with water to mitigate any potential harm.

Warnings and Precautions

For external use only. It is imperative that this product is not ingested. In the event of accidental ingestion, immediate medical assistance should be sought, or contact a Poison Control Center without delay.

General precautions must be observed to ensure safety. This product should be kept out of reach of children to prevent accidental ingestion.

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 and then return. Monitoring for these signs is essential to ensure appropriate management of the patient's condition.

Side Effects

For external use only. Patients should discontinue use and consult a doctor if the condition worsens or persists for more than 7 days, or if the condition clears up and then returns.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions between the drug and laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

Packaging & NDC

Below are the non-prescription pack sizes of PO First Aid Series Burn (lidocaine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for PO First Aid Series Burn.
Details

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. It is important to keep the product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is advised.

Geriatric Use

Elderly patients should be considered when prescribing this medication, particularly those aged 65 years and older. 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, as age-related physiological changes may affect drug metabolism and response. Monitoring for efficacy and safety is recommended, and dose adjustments may be necessary based on individual patient factors.

Clinical findings specific to the geriatric population should be taken into account to ensure optimal therapeutic outcomes while minimizing potential risks.

Pregnancy

There is no information available regarding the use of PO First Aid Series Burn Gel (lidocaine hydrochloride gel) during pregnancy. Consequently, the safety of this medication in pregnant patients has not been established, and there are no known dosage modifications or special precautions recommended for use in this population. Healthcare professionals should consider the lack of data when prescribing this medication to women of childbearing potential and weigh the potential risks versus benefits.

Lactation

There are no specific warnings or considerations regarding nursing mothers or lactation mentioned in the provided text. Therefore, healthcare professionals may consider the use of this medication in lactating mothers without specific concerns related to breastfeeding. However, as with any medication, it is advisable to monitor breastfed infants for any potential adverse effects.

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 considered as part of standard clinical practice.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise, as the clinical presentation can vary depending on the substance involved. Common symptoms of overdose may include, but are not limited to, altered mental status, cardiovascular instability, and respiratory distress.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable. Continuous assessment and supportive measures are critical in ensuring patient safety and optimizing outcomes in cases of overdose.

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 text.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children. It is important to emphasize that if the medication is swallowed, patients should seek medical help or contact a Poison Control Center immediately. This precaution is crucial to ensure the safety and well-being of children who may inadvertently access the medication.

Storage and Handling

The product is supplied in a configuration that ensures optimal handling and storage. It should be stored at room temperature to maintain its efficacy. To ensure safety, it is imperative to keep the product out of reach of children. Additionally, once opened, the product must be discarded to prevent any potential degradation or contamination.

Additional Clinical Information

The burn gel is administered topically, with an even layer applied over the cleaned affected area. It is recommended that this application occurs no more than 3 to 4 times daily. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for PO First Aid Series Burn, 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 PO First Aid Series Burn, 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.