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Astonea Burn Cream

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This product has been discontinued

Active ingredients
  • Lidocaine Hydrochloride 0.5 g/100 g
  • Benzalkonium Chloride 0.13 g/100 g
Other brand names
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 2023
Label revision date
May 16, 2023
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
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 2023
Label revision date
May 16, 2023
Manufacturer
ASTONEA LABS PRIVATE LIMITED
Registration number
part348
NDC root
77338-100
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 may find this medication helpful for the temporary relief of pain and itching caused by various skin issues. It is commonly used for conditions such as sunburn, minor burns, insect bites, minor skin irritation, cuts, and scrapes. This means that if you experience discomfort from any of these conditions, this medication can provide soothing relief to help you feel more comfortable.

Uses

You can use this medication for temporary relief from pain and itching caused by various skin issues. It is effective for conditions such as sunburn, minor burns, insect bites, and minor skin irritations. Additionally, it can help soothe discomfort from cuts and scrapes.

This product is designed to provide quick relief, making it a handy option for everyday skin irritations. Whether you've spent too long in the sun or have a pesky insect bite, this medication can help you feel more comfortable.

Dosage and Administration

To use this product effectively, start by cleaning the affected area thoroughly. Once it's clean, apply a small amount of the product directly to the area you want to treat. You should do this 3 to 4 times each day for the best results. If you prefer, you can cover the area with a sterile bandage to protect it.

If you are using this product for a child under 2 years old, it's important to consult a doctor before applying it. This ensures that the treatment is safe and appropriate for their age.

What to Avoid

It's important to use this medication safely to avoid potential issues. You should not apply it in or around your eyes, as this can cause irritation. Additionally, avoid using it over large areas of your body, on deep puncture wounds, animal bites, or serious burns. Using large quantities, especially on raw surfaces or blistered areas, is also not recommended.

By following these guidelines, you can help ensure that you use the medication effectively and safely. If you have any questions or concerns about how to use it, please consult your healthcare provider for more information.

Side Effects

It's important to use this product only on the outside of your body. If you notice that your condition worsens, clears up and then comes back within a few days, or if it lasts longer than seven days, you should stop using the product. These signs may indicate that you need to seek further medical advice.

Warnings and Precautions

This product is for external use only, so please avoid applying it to your eyes or on large areas of your body, especially over deep puncture wounds, animal bites, or serious burns. If you accidentally swallow the product, seek medical help or contact a Poison Control Center immediately.

You should stop using this product if your condition worsens, if it clears up and then comes back within a few days, or if it does not improve after 7 days. Always use it as directed and in appropriate amounts, particularly avoiding large quantities on raw or blistered skin.

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 concerned about a possible overdose, seek medical help right away.

In case of an emergency, contact your local poison control center or go to the nearest hospital. It's always better to be safe and get professional assistance if you think an overdose may have occurred. Remember, your health and safety are the top priority.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this medication. They can provide guidance on whether it’s safe for you and your baby. Always prioritize your health and the health of your child by seeking professional advice.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication. This ensures that you understand any potential risks and can make informed decisions about your health and the health of your baby. Always prioritize open communication with your healthcare provider regarding your breastfeeding journey.

Pediatric Use

If your child is under 2 years old, it's important to consult a doctor before using this product. For children aged 2 years and older, you can apply a small amount to the affected area 3 to 4 times a day after cleaning the area. If needed, you may cover it with a sterile bandage to protect the area. Always follow these guidelines to ensure safe and effective use for your child.

Geriatric Use

While there is no specific information available about the use of this medication in 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, it’s always a good idea to 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 your medication dosage may need to be adjusted. This is because your kidneys may not process the medication as effectively, which can affect how well it works for you. Your healthcare provider will likely monitor your renal function tests, which are tests that check how well your kidneys are working.

If you have decreased creatinine clearance (a measure of kidney function), your doctor may recommend a reduced dose of your medication. This helps ensure that you receive the right amount of the drug without putting extra strain on your kidneys. Always follow your healthcare provider's guidance regarding your treatment plan.

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 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 all the medications and supplements you are using. This helps to avoid any potential issues and ensures that you receive the best possible treatment tailored to your needs.

Storage and Handling

To ensure the safety and effectiveness of your product, store it in a cool, dry area with a temperature range of 59°F to 86°F (15°C to 30°C). This helps maintain its quality and performance.

When handling the product, always use tamper-evident sealed packets. Avoid using any packets that are opened or torn, as this could compromise the product's integrity. Following these guidelines will help you use the product safely and effectively.

Additional Information

You should apply a small amount of this product to the affected area on your skin 3 to 4 times daily if you are an adult or a child aged 2 years and older. There are no additional details available regarding laboratory tests, abuse potential, or patient counseling information.

FAQ

What is this product used for?

This product is used for temporary relief of pain and itching associated with sunburn, minor burns, insect bites, minor skin irritation, cuts, and scrapes.

How should I use this product?

For adults and children 2 years and over, clean the affected area and apply a small amount of the product 3 or 4 times daily. It may be covered with a sterile bandage.

What should I do if I am under 2 years old?

If you are under 2 years old, consult a doctor before use.

Are there any contraindications for this product?

No specific contraindications are mentioned for this product.

What should I avoid when using this product?

Do not use this product in the eyes, over large areas of the body, on deep puncture wounds, animal bites, or serious burns, and avoid using large quantities over raw surfaces or blistered areas.

What should I do if my condition worsens?

Stop use if the condition gets worse, if it clears up and recurs within a few days, or if it persists for more than 7 days.

Is this product safe to use during pregnancy or breastfeeding?

If you are pregnant or breastfeeding, ask a health care professional before use.

How should I store this product?

Store the product in a cool, dry area between 59°F to 86°F (15°C to 30°C) and use tamper-evident sealed packets.

Packaging Info

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

Packaging configurations for Astonea Burn Cream.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The product is a topical cream indicated for the treatment of burns. It contains active ingredients that offer pain relief and promote the healing process. This formulation is intended for external use only. Inactive ingredients comprise water, glycerin, and a selection of emulsifiers and preservatives. The cream is conveniently packaged in a tube to facilitate easy application.

Uses and Indications

This drug is indicated for the temporary relief of pain and itching associated with various dermatological conditions, including sunburn, minor burns, insect bites, minor skin irritation, cuts, and scrapes.

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

Dosage and Administration

For adults and children aged 2 years and older, the affected area should be cleaned prior to application. A small amount of the product is to be applied to the area 3 to 4 times daily. If desired, the treated area may be covered with a sterile bandage to protect it.

For children under 2 years of age, it is recommended to consult a doctor before use.

Contraindications

Use is contraindicated in the following situations:

  • Application in the eyes is prohibited due to potential irritation and damage to ocular tissues.

  • The product should not be applied over large areas of the body, on deep puncture wounds, animal bites, or serious burns, as this may lead to adverse effects and complications.

  • Avoid using large quantities, especially on raw surfaces or blistered areas, to prevent exacerbation of skin irritation or other adverse reactions.

Warnings and Precautions

FOR EXTERNAL USE ONLY. This product is intended solely for external application.

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

Contraindications for Use This product should not be applied in or around the eyes. It is also contraindicated for use over extensive areas of the body, on deep puncture wounds, animal bites, or serious burns. Caution should be exercised to avoid application in large quantities, particularly on raw surfaces or blistered areas.

Discontinuation of Use Healthcare professionals should advise patients to discontinue use if any of the following occur: the condition worsens, the condition resolves and then recurs within a few days, or if the condition persists for more than 7 days. Monitoring for these signs is essential to ensure patient safety and effective treatment outcomes.

Side Effects

Patients should be advised that the product is for external use only. In the event that the condition worsens, or if the condition clears up and recurs within a few days, or persists for more than 7 days, patients should discontinue use and consult a healthcare professional. These warnings are essential to ensure the safety and well-being of individuals using the product.

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 Astonea Burn Cream (lidocaine). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Astonea Burn Cream.
Details

Pediatric Use

Pediatric patients under 2 years of age should consult a healthcare professional before use. For children aged 2 years and older, the affected area should be cleaned, and a small amount of the product should be applied 3 to 4 times daily. The area may be covered with a sterile bandage if desired.

Geriatric Use

There is no specific information available 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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The safety of this drug during pregnancy has not been established, and potential risks to fetal outcomes are not fully understood. Therefore, it is essential for women of childbearing potential to seek medical advice to weigh the benefits and risks associated with the use of this medication during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a healthcare professional prior to using this medication. There is currently no available data on the excretion of this drug in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment may require dosage adjustments to ensure safety and efficacy. It is essential to monitor renal function tests in these individuals to assess their kidney status. Additionally, a reduced dose should be considered for patients with decreased creatinine clearance to mitigate the risk of adverse effects associated with impaired renal function.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions 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 warranted based on clinical judgment.

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, even in the absence of documented overdosage effects. Symptoms may vary 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 standard supportive measures, which may include maintaining airway patency, providing supplemental oxygen, and ensuring adequate circulation.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols. Continuous assessment and supportive care are critical in managing any potential complications that may arise from an overdose scenario.

Documentation of the incident and any interventions performed is crucial for ongoing patient care and for informing future treatment decisions.

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 that in the event of accidental ingestion, it is crucial to seek medical assistance immediately or contact a Poison Control Center. This prompt action is essential to ensure the safety and well-being of the patient.

Storage and Handling

The product is supplied in tamper-evident sealed packets to ensure integrity and safety. It is essential to avoid using any packets that are opened or torn.

For optimal storage, the product should be kept in a cool, dry area, with a temperature range of 59°F to 86°F (15°C to 30°C). Proper adherence to these storage conditions will help maintain the product's quality and efficacy.

Additional Clinical Information

The product is administered topically, with a recommended application of a small amount to the affected area three to four times daily for adults and children aged 2 years and older. There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Astonea Burn Cream, 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 Astonea Burn Cream, 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.