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Proheal Burn

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Active ingredients
  • Lidocaine Hydrochloride 0.5 g/100 g
  • Benzalkonium Chloride 0.13 g/100 g
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
Dosage form
Cream
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
January 19, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Lidocaine Hydrochloride 0.5 g/100 g
  • Benzalkonium Chloride 0.13 g/100 g
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
Dosage form
Cream
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
January 19, 2025
Manufacturer
Nantong Health & Beyond Hygienic Products Inc.
Registration number
M017
NDC root
43473-066
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

You can use this medication for the temporary relief of pain associated with minor cuts, scrapes, and burns. It works by helping to protect the affected area from harmful bacteria, which can aid in the healing process. This makes it a useful option for managing discomfort and preventing infection in minor skin injuries.

Uses

You can use this product for the temporary relief of pain caused by minor cuts, scrapes, and burns. It also helps protect your skin from harmful bacteria, which can prevent infections and promote healing.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) associated with this product, making it a safe option for many users.

Dosage and Administration

To use this medication effectively, start by cleaning the area that needs treatment. Once the area is clean, apply a small amount of the medication. You should do this no more than three times a day. If you prefer, you can cover the treated area with a sterile bandage to help protect it.

Remember to follow these steps consistently for the best results. If you have any questions or concerns about how to use the medication, don’t hesitate to reach out to your healthcare provider for guidance.

What to Avoid

It's important to keep this medication out of reach of children. If a child accidentally swallows it, seek medical help immediately or contact a Poison Control Center. There are no specific contraindications, risks of abuse or misuse, or concerns about dependence associated with this medication, but always use it responsibly and as directed.

Side Effects

It's important to use this product carefully to avoid potential side effects. This medication is for external use only, so you should not apply it to your eyes or use it in large amounts. Additionally, avoid using it on raw or blistered skin, deep puncture wounds, animal bites, or serious burns. If you need to use it for more than one week, please consult your doctor first. Following these guidelines can help ensure your safety while using the product.

Warnings and Precautions

This product is for external use only, so please avoid using it in your eyes or applying it in large amounts. Do not use it on raw or blistered skin, deep puncture wounds, animal bites, or serious burns. It's important to limit use to no more than one week unless your doctor advises otherwise.

If you accidentally swallow this product, seek emergency medical help or contact a Poison Control Center immediately. Always prioritize your safety and consult your doctor if you have any concerns about using this product.

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 intervention can make a significant difference.

Pregnancy Use

When considering the use of PROHEAL BURN cream during pregnancy, it's important to note that the drug insert does not provide specific information about its safety, dosage adjustments, or any special precautions for pregnant individuals. This means that there is no clear guidance on how the cream may affect you or your developing baby.

If you are pregnant or planning to become pregnant, it is always best to consult with your healthcare provider before using any medication, including topical treatments like PROHEAL BURN cream. They can help you weigh the potential risks and benefits based on your individual circumstances.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to talk to your healthcare professional before using this product. There is a possibility that it may be excreted in breast milk, which means it could pass to your baby. Since the effects on nursing infants have not been thoroughly studied, it's best to exercise caution. Your healthcare provider can help you weigh the benefits and risks to ensure the safety of both you and your baby.

Pediatric Use

It's important to keep this medication out of reach of children. If a child accidentally swallows it, you should seek medical help immediately or contact a Poison Control Center for guidance. Taking these precautions can help ensure your child's safety.

Geriatric Use

While there is no specific information about how this medication should be used by older adults, it's important to approach any new treatment with caution. Since older adults may have different health needs and may be taking multiple medications, you should always consult with a healthcare provider before starting any new medication. They can help ensure that the treatment is safe and appropriate for your individual health situation.

If you or a loved one is an older adult, be sure to discuss any concerns about potential side effects or interactions with other medications you may be taking. Your healthcare provider can provide guidance tailored to your specific needs.

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 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 you are taking, even if there are no specific drug interactions or laboratory test interactions noted for your treatment. This ensures that your healthcare team can provide the best care tailored to your needs.

Always feel free to ask questions and share all the medications and supplements you are using. This helps your provider monitor your health effectively and make informed decisions about your treatment.

Storage and Handling

To ensure the safety and effectiveness of your product, store it in a cool, dry place at a temperature between 68-77°F (20-25°C). It's important to keep the product in its tamper-evident sealed packets, which help ensure that the contents have not been compromised. If you notice any opened or torn packets, do not use them, as this could affect the safety and quality of the product.

By following these simple storage and handling guidelines, you can help maintain the integrity of the product and ensure its proper use.

Additional Information

You should apply this medication topically, using a small amount no more than three times a day. It's important to follow this guideline to ensure safe and effective use. If you have any questions about how to use the medication or its effects, be sure to consult with your healthcare provider.

FAQ

What is the primary use of this drug?

This drug provides temporary relief of pain associated with minor cuts, scrapes, and burns.

How does this drug work?

It helps protect against harmful bacteria.

How should I apply this drug?

Clean the affected area and apply a small amount not more than 3 times daily. It may be covered with a sterile bandage.

Are there any contraindications for this drug?

No contraindications are listed for this drug.

What should I do if this drug is swallowed?

Get medical help or contact a Poison Control Center directly.

What precautions should I take when using this drug?

For external use only. Do not use in eyes, in large quantities, over raw or blistered areas, or on deep puncture wounds, animal bites, or serious burns. Do not use for more than one week unless directed by a doctor.

Is this drug safe to use during pregnancy?

There are no specific statements regarding safety concerns or precautions for use during pregnancy.

Can nursing mothers use this drug?

Nursing mothers should consult a healthcare professional before using this product, as there is a potential for excretion in breast milk.

What is the recommended storage condition for this drug?

Store at 68-77°F (20-25°C) and use tamper evident sealed packets. Do not use any opened or torn packets.

Packaging Info

Below are the non-prescription pack sizes of Proheal Burn (lidocaine hydrochloride, benzalkonium chloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Proheal Burn.
Details

Drug Information (PDF)

This file contains official product information for Proheal 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 text.

Uses and Indications

This drug is indicated for the temporary relief of pain associated with minor cuts, scrapes, and burns. Additionally, it helps protect against harmful bacteria, contributing to the prevention of infection in these minor injuries.

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

Dosage and Administration

The affected area should be cleaned thoroughly prior to application. A small amount of the medication should be applied to the affected area, not exceeding three times daily. If desired, the area may be covered with a sterile bandage following application to protect the site.

Contraindications

Use is contraindicated in children due to the risk of accidental ingestion. In the event of swallowing, immediate medical assistance should be sought or contact with a Poison Control Center is advised.

Warnings and Precautions

For external use only. This product should not be applied in or around the eyes, nor should it be used in large quantities. It is contraindicated for application over raw or blistered areas, deep puncture wounds, animal bites, or serious burns. The duration of use should not exceed one week unless directed by a healthcare professional.

In the event of accidental ingestion, it is imperative to seek emergency medical assistance or contact a Poison Control Center immediately.

Healthcare professionals are advised to monitor patients for any adverse reactions and to provide guidance on the appropriate use of this product to ensure safety and efficacy.

Side Effects

Patients should be aware that the product is intended for external use only. It is contraindicated for use in the eyes, in large quantities, over raw or blistered areas, on deep puncture wounds, animal bites, or serious burns. Additionally, the product should not be used for more than one week unless directed by a healthcare professional.

While specific adverse reactions have not been detailed, the warnings indicate potential risks associated with improper use. Patients are advised to adhere strictly to the guidelines provided to minimize the risk of adverse effects.

Drug Interactions

There are no specific drug interactions reported for this medication. Additionally, no laboratory test interactions have been identified in the available data. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Proheal Burn (lidocaine hydrochloride, benzalkonium chloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Proheal Burn.
Details

Pediatric Use

Pediatric patients should be advised to keep this medication 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 recommended.

Geriatric Use

There is no specific information 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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

There are no specific statements regarding the use of PROHEAL BURN cream during pregnancy, including safety concerns, dosage modifications, or special precautions. As such, the available data does not provide sufficient information to assess the potential risks or benefits of this medication in pregnant patients. Healthcare professionals should consider the lack of information and weigh the potential risks versus benefits when prescribing this medication to women of childbearing potential. It is advisable to monitor any pregnant patients closely and to discuss alternative treatment options if necessary.

Lactation

Lactating mothers should consult a healthcare professional before using this product. There is a potential for excretion in breast milk, and the effects on a nursing infant are not well studied; therefore, caution is advised.

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 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 from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

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

If available, the use of specific antidotes or treatments should be considered based on the clinical scenario and the substance involved. Consultation with a poison control center or a medical toxicologist may provide additional guidance on the management of overdose cases.

Documentation of the incident, including the substance involved, the amount ingested, and the time of ingestion, is crucial for effective management and treatment planning.

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

Storage and Handling

The product is supplied in tamper-evident sealed packets to ensure integrity and safety. It is essential to store the packets at a temperature range of 68-77°F (20-25°C). Care should be taken to avoid using any packets that are opened or torn, as this may compromise the product's quality and efficacy.

Additional Clinical Information

The medication is administered topically, with a recommended application of a small amount not exceeding three 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 Proheal 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 Proheal 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.