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Aosi Healthcare 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)
Marketed in the U.S.
Since 2024
Label revision date
September 25, 2024
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
Marketed in the U.S.
Since 2024
Label revision date
September 25, 2024
Manufacturer
Nantong Health & Beyond Hygienic Products Inc.
Registration number
M017
NDC root
43473-055

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 minor skin injuries and discomfort.

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 affected area thoroughly. Once it's 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 area with a sterile bandage (a clean, protective covering) after applying the medication to help keep it clean and promote healing.

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 be aware of some key warnings when using this product. It is meant for external use only, so you should avoid applying it to your eyes or using it in large amounts. Additionally, do not use it over raw or blistered skin, on deep puncture wounds, animal bites, or serious burns. If you find that you need to use it for more than one week, please consult your doctor for guidance.

Warnings and Precautions

This product is for external use only, so please avoid using it in your eyes or on large areas of your skin. Do not apply it over 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 healthcare provider 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 feel unwell after taking the medication, seek medical help right away.

In case of an overdose, contact your healthcare provider or local poison control center for guidance. If you experience severe symptoms, such as trouble breathing or loss of consciousness, call emergency services immediately. Always prioritize your safety and well-being.

Pregnancy Use

When it comes to using this medication during pregnancy, there is no specific information available regarding its safety, dosage adjustments, or any special precautions you should take. This means that the potential risks and benefits have not been clearly established for pregnant individuals.

If you are pregnant or planning to become pregnant, it’s important to discuss any medications you are taking with your healthcare provider. They can help you understand the best options for your health and the health of your baby. Always prioritize open communication with your doctor about any concerns you may have.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to know that there is no specific information available regarding the use of this medication during nursing. This means that the effects on breast milk and your nursing infant are not clearly defined.

As always, it's best to consult with your healthcare provider about any medications you are considering while breastfeeding. They can help you weigh the potential risks and benefits 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, seek medical help immediately or contact a Poison Control Center. Taking quick action can help ensure their safety. Always be vigilant and store medications securely to prevent any accidents.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult considering this medication, it’s important to consult with a healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

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 is safe and effective, especially if you have any concerns about your kidney health. They can provide guidance based on your individual situation.

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 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 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 monitor your health effectively and make informed decisions about your care.

Always feel free to ask questions and share any other medications or supplements you may be using. This helps to create a comprehensive picture of your health and ensures your safety while receiving treatment.

Storage and Handling

To ensure the safety and effectiveness of your product, store it at room temperature. It's important to keep the packets sealed until you are ready to use them. Always check that the packets are tamper-evident, meaning they should show no signs of being opened or damaged. If you find any packets that are opened or torn, do not use them, as this could compromise the product's safety. Following these guidelines will help you handle the product properly and maintain its integrity.

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 your healthcare provider for more information.

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 while relieving pain.

How should I apply this drug?

Clean the affected area and apply a small amount no 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 avoid when using this drug?

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

What should I do if I accidentally swallow this drug?

If swallowed, get medical help or contact a Poison Control Center directly.

Is this drug safe for children?

Keep this drug out of reach of children.

What are the storage instructions for this drug?

Store at room temperature and do not use any opened or torn packets.

Is there any information regarding use during pregnancy or nursing?

No specific information is provided regarding use during pregnancy or nursing.

Are there any known drug interactions?

No specific drug interactions are mentioned.

Packaging Info

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

Packaging configurations for Aosi Healthcare Burn.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The drug identified by the SPL code 34089-3 is characterized by its chemical name, physical properties, and inactive ingredients. It is formulated in a specific dosage form and strength, with detailed packaging information provided. The drug's appearance is defined by its color, shape, and size, ensuring clear identification. Specific storage conditions and handling instructions are outlined to maintain the drug's integrity. Additionally, the insert may detail the drug's mechanism of action or pharmacological class, along with its intended use or therapeutic indications.

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 overall management of minor skin 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 treated area may be covered with a sterile bandage to protect it and enhance the effectiveness of the treatment.

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.

These warnings are critical to ensure the safe and effective use of the product, and adherence to these guidelines is essential to minimize the risk of adverse reactions.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions with 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 Aosi Healthcare Burn (lidocaine hydrochloride, benzalkonium chloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Aosi Healthcare 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 is no specific information regarding the use of this drug during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled on the absence of established safety data and the importance of discussing any plans for pregnancy with their healthcare provider.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or any considerations related to lactation. Healthcare professionals should exercise caution and consider the potential risks and benefits when prescribing this medication to lactating mothers. Further research may be necessary to fully understand the implications for 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 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 implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

If available, specific antidotes or treatments should be administered as per established protocols. Continuous assessment and supportive care are critical in managing the patient's condition effectively.

Healthcare professionals are encouraged to report any cases of overdose to the appropriate regulatory authorities to enhance the understanding of the substance's safety profile and to contribute to ongoing pharmacovigilance efforts.

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 understanding of potential risks associated with the compound in nonclinical settings.

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 to prevent accidental ingestion. In the event that the medication is swallowed, patients should be instructed to seek medical help immediately or contact a Poison Control Center for assistance. It is important for patients to understand the potential risks associated with improper use and to take necessary precautions to ensure safety.

Storage and Handling

The product is supplied in tamper-evident sealed packets to ensure safety and integrity. It is essential to store the packets at room temperature. Healthcare professionals are advised not to use any opened or torn packets to maintain product efficacy and safety.

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 Aosi Healthcare 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 Aosi Healthcare 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.