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Roosin Burn

Last content change checked dailysee data sync status

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)
Marketed in the U.S.
Since 2021
Label revision date
December 15, 2021
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
Marketed in the U.S.
Since 2021
Label revision date
December 15, 2021
Manufacturer
ROOSIN MEDICAL CO. , LTD
Registration number
part348
NDC root
81552-002

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 as a first aid treatment to help prevent infection and provide temporary relief from pain and itching caused by minor cuts, scrapes, and burns. It is designed to support your healing process and make you more comfortable during recovery.

Uses

If you have minor cuts, scrapes, or burns, this product can be a helpful first aid option. It works to prevent infection in these wounds, which is important for your healing process. Additionally, it provides temporary relief from pain and itching, making it easier for you to manage discomfort while your skin heals.

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 can do this 1 to 3 times each day, depending on your needs.

If you are considering using this medication for a child under the age of 2, it’s important to consult with a doctor first to ensure it’s safe and appropriate for them.

What to Avoid

You should avoid using this product if you are allergic to any of its ingredients. Additionally, there are important guidelines to follow for safe use: do not apply it in or around your eyes, and avoid using it over large areas of your body. It's also crucial not to use this product for more than one week unless your doctor specifically instructs you to do so. Lastly, refrain from using it on deep puncture wounds, animal bites, or serious burns to ensure your safety and well-being.

Side Effects

This product is intended for external use only. You should avoid using it in your eyes, on large areas of your body, or for more than one week unless your doctor advises otherwise. If you have an allergy to any of the ingredients, do not use this product. It is also not suitable for deep puncture wounds, animal bites, or serious burns.

It's important to keep this product out of reach of children. If a child swallows it, seek medical help or contact a poison control center immediately.

Warnings and Precautions

This product is intended for external use only. You should avoid using it in your eyes, on large areas of your body, or for more than one week unless your doctor has specifically instructed you to do so. If you have any allergies to the ingredients, do not use this product. Additionally, it should not be applied to deep puncture wounds, animal bites, or serious burns.

Make sure 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. Always prioritize your safety and consult your doctor if you have any concerns or questions about using this product.

Overdose

It's important to keep this medication out of reach of children. If a child accidentally swallows it, you should seek medical help or contact a poison control center immediately.

In case of an overdose, you may notice signs such as unusual drowsiness, confusion, or difficulty breathing. If you or someone else experiences these symptoms, it's crucial to get medical assistance right away. Always prioritize safety and act quickly in these situations.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to be aware that there is no specific information available regarding the use of this medication during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions have not been established.

Before taking this medication, you should consult with your healthcare provider to discuss any potential risks and to ensure that you are making informed decisions for your health and the health of your baby. Always prioritize open communication with your doctor about any medications you are considering during pregnancy.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of this product while nursing. Additionally, there are no concerns about the product being passed into breast milk or any associated risks for your infant. This means you can use the product without worrying about its effects on your milk production or your baby's health.

Pediatric Use

If you have a child under the age of 2, it's important to consult your doctor before using this medication. This ensures that the treatment is safe and appropriate for your little one. Always prioritize your child's health by seeking professional advice when it comes to their medical care.

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. If you or a loved one is an older adult, it’s wise to discuss any potential risks or benefits with a healthcare provider. They can help determine the best approach, considering any unique health needs or conditions.

Always keep in mind that older adults may have different responses to medications, so monitoring for any side effects or changes in health is essential. If you notice anything unusual after starting a new medication, be sure to reach out to a healthcare professional for guidance.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines, dosage adjustments, or monitoring requirements mentioned for your condition in the provided information. This means that the medication may not have special considerations for those with renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that any treatment you receive is safe and appropriate for your kidney health. They can provide guidance tailored to your specific 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 (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 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 best performance of your product, store it at room temperature and keep it away from direct light. It's important to keep the tube tightly closed when not in use to maintain its integrity. If you have any unused portion after opening, please discard it to ensure safety and effectiveness. Following these simple guidelines will help you use the product safely and effectively.

Additional Information

You should apply this medication topically, using a small amount 1 to 3 times a day. This means you will put it directly on the skin where needed. There are no additional details available regarding laboratory tests, abuse potential, or patient counseling.

FAQ

What is the primary use of this drug?

This drug is used as first aid to help prevent infection and provide temporary relief of pain and itching associated with minor cuts, scrapes, and burns.

How should I apply this drug?

You should clean the affected area and apply a small amount 1-3 times daily.

Are there any age restrictions for using this drug?

If you are considering using this drug for a child under 2 years old, you should consult a doctor.

What should I avoid when using this drug?

Do not use this drug in the eyes, over large areas of the body, or for more than one week unless directed by a doctor. Avoid using it on deep puncture wounds, animal bites, or serious burns.

What are the warnings associated with this drug?

This drug is for external use only and should be kept out of reach of children. If swallowed, seek medical help or contact a poison control center immediately.

What should I do if I am allergic to any of the ingredients?

Do not use this drug if you are allergic to any of its ingredients.

How should I store this drug?

Store the drug at room temperature, protect it from light, and keep the tube tightly closed when not in use. Discard any unused portion after opening.

Packaging Info

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

Packaging configurations for Roosin Burn.
Details

Drug Information (PDF)

This file contains official product information for Roosin 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 first aid to help prevent infection in minor cuts, scrapes, and burns. Additionally, it provides temporary relief of pain and itching associated with these minor skin injuries.

Dosage and Administration

The affected area should be cleaned prior to application. A small amount of the medication should be applied to the affected area 1 to 3 times daily, depending on the severity of the condition. For children under the age of 2, it is recommended to consult a healthcare professional before use to ensure safety and appropriateness of treatment.

Contraindications

Use of this product is contraindicated in individuals with a known allergy to any of its ingredients.

Additionally, the product should not be applied to the eyes or used over large areas of the body. It is contraindicated for use beyond one week unless directed by a healthcare professional. The product should not be applied to deep puncture wounds, animal bites, or serious burns.

Warnings and Precautions

For external use only. This product is contraindicated for application in the eyes, over large areas of the body, or for durations exceeding one week unless specifically directed by a healthcare professional. It should not be used in individuals with known allergies to any of its ingredients. Additionally, the product is not suitable for application on deep puncture wounds, animal bites, or serious burns.

Healthcare professionals are advised to ensure that this product is kept 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.

Side Effects

Patients should be aware that the product is for external use only. It is contraindicated for use in the eyes, over large areas of the body, and for durations exceeding one week unless directed by a healthcare professional. Additionally, it should not be applied to deep puncture wounds, animal bites, or serious burns.

Patients with known allergies to any of the ingredients should avoid using this product.

It is crucial to keep the product out of reach of children. In the event of accidental ingestion, patients should seek medical assistance or contact a poison control center immediately.

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 Roosin Burn (lidocaine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Roosin Burn.
Details

Pediatric Use

Pediatric patients under the age of 2 should be evaluated by a healthcare professional before use. It is essential to consult a doctor to determine the appropriateness of treatment and any necessary precautions for this age group.

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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

Pregnancy

There is no specific information regarding the use of this medication 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 importance of effective contraception during treatment and should be informed of the need to discuss any plans for pregnancy with their healthcare provider.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there are no statements concerning the potential for excretion in breast milk or any associated risks to breastfed infants during the use of this product in lactation.

Renal Impairment

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

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, it is imperative to keep the product out of reach of children. Should ingestion occur, immediate medical assistance is required. Healthcare professionals are advised to contact a poison control center without delay to ensure appropriate management and intervention.

Prompt action is crucial in mitigating potential adverse effects associated with overdosage. The symptoms may vary depending on the specific substance involved; therefore, a thorough assessment and monitoring of the patient are essential.

Management procedures should include supportive care and symptomatic treatment as necessary. Continuous evaluation of the patient's condition will guide further therapeutic interventions.

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 question. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

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 tube that must be stored at room temperature. It is essential to protect the tube from light exposure to maintain product integrity. To ensure optimal conditions, the tube should be kept tightly closed when not in use. Any unused portion should be discarded after opening to prevent contamination and ensure safety.

Additional Clinical Information

The medication is administered topically, with a recommended application of a small amount 1 to 3 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 Roosin 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 Roosin 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.