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Safly 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 2024
Label revision date
May 17, 2024
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 2024
Label revision date
May 17, 2024
Manufacturer
Nantong Health & Beyond Hygienic Products Inc.
Registration number
M017
NDC root
43473-039
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 minor injuries and ensuring they stay clean and protected.

Uses

You can use this medication 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 medication, making it a safer option for use.

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 your treatment, don’t hesitate to reach out to your healthcare provider.

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, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this medication. Always prioritize safety and follow these guidelines to ensure proper use.

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 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 medical help immediately or contact a Poison Control Center for assistance. Always prioritize your safety and well-being when using any medication.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While the specific signs of an overdose are not detailed, common 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 crucial to provide them with as much information as possible about the substance taken and the amount, if known. Remember, acting quickly can make a significant difference in your health and safety.

Pregnancy Use

You can use SAFLY BURN (lidocaine hydrochloride cream) during pregnancy, as there are no specific warnings or precautions mentioned regarding its use. The information available does not indicate that the product is contraindicated (not recommended) for pregnant individuals, nor does it suggest any risks to the fetus associated with its use.

Additionally, there are no dosage modifications or special precautions required for those who are pregnant. However, it's always a good idea to consult with your healthcare provider before using any medication during pregnancy to ensure it’s safe for you and your baby.

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 known concerns about the product being passed into breast milk or any associated risks for your infant. Always consult with your healthcare provider if you have any questions or concerns about medications while breastfeeding.

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. Taking quick action can help ensure their safety. Always be vigilant about where you store medications to prevent any accidental ingestion.

Geriatric Use

While there is no specific information about the use of SAFLY BURN (lidocaine hydrochloride cream) in older adults, it’s important to approach its use with caution. Since the drug insert does not mention any dosage adjustments or safety concerns for elderly patients, you should consult with a healthcare professional before using this cream. They can provide guidance tailored to your individual health needs and any other medications you may be taking.

Always prioritize safety and ensure that any treatment aligns with your overall health plan, especially if you or a loved one is managing multiple health conditions.

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 for your specific condition. They can help you understand any necessary precautions or adjustments based on your kidney health.

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 how it may relate to your treatment. They can help ensure that you receive the safest and most effective care.

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 this medication is generally considered safe to use alongside other treatments and tests. However, every individual is different, and your healthcare provider can help ensure that your overall treatment plan is safe and effective for you. Always feel free to ask questions or express any concerns you may have regarding your medications or tests.

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're ready to use them. Each packet is tamper evident, meaning it shows if it has been 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. Always handle the packets with care to maintain their 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 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 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 the eyes, in large quantities, over raw or blistered areas, on deep puncture wounds, animal bites, or serious burns, and 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 to use during pregnancy?

There are no specific warnings or contraindications regarding its use during pregnancy mentioned in the provided text.

Can nursing mothers use this drug?

There are no specific warnings or recommendations regarding its use by nursing mothers.

How should I store this drug?

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

Packaging Info

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

Packaging configurations for Safly Burn.
Details

Drug Information (PDF)

This file contains official product information for Safly 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 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 area may be covered with a sterile bandage following application to protect it and enhance the treatment effect.

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

This product is intended for external use only. It is imperative that the product is not applied in or around the eyes, nor should it be used in large quantities. Application over raw or blistered areas, deep puncture wounds, animal bites, or serious burns is contraindicated. Additionally, the product should not be used for more than one week unless specifically directed by a healthcare professional.

In the event of accidental ingestion, immediate medical assistance should be sought, or the individual should contact a Poison Control Center without delay.

Healthcare professionals are advised to monitor patients for any adverse reactions and to ensure that the product is used in accordance with the outlined precautions to promote safe and effective use.

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

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

Packaging configurations for Safly 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 SAFLY BURN (lidocaine hydrochloride cream) in geriatric patients. The prescribing information does not provide guidance on dosage adjustments, safety concerns, or special precautions for elderly patients. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients, considering the lack of data on its use in this population. Monitoring for efficacy and potential adverse effects is advisable when administering SAFLY BURN to elderly patients.

Pregnancy

There are no specific warnings or precautions regarding the use of SAFLY BURN (lidocaine hydrochloride cream) during pregnancy. The available data does not indicate whether the product is contraindicated in pregnancy or if there are any risks to the fetus associated with its use. Additionally, no dosage modifications or special precautions for pregnant individuals are provided. Healthcare professionals should consider the lack of specific information and weigh the potential benefits against any unknown risks when prescribing this medication to pregnant patients.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating 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 while nursing.

Renal Impairment

Patients with renal impairment may not have specific dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing to this population, as the absence of detailed guidance necessitates careful clinical judgment regarding the use of the medication in individuals with reduced kidney function. Regular monitoring of renal function is advisable to ensure patient safety and therapeutic efficacy.

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 when administering the medication. It is essential to monitor patients closely for any signs of adverse effects or symptoms that may arise from excessive dosing.

In the event of suspected overdosage, immediate medical attention should be sought. Healthcare providers should implement supportive measures as necessary, which may include symptomatic treatment and monitoring of vital signs.

Due to the lack of detailed overdosage information, it is recommended that healthcare professionals refer to established clinical guidelines and protocols for managing overdose situations relevant to the specific medication in question. Additionally, contacting a poison control center may provide further guidance on appropriate management strategies.

Continued vigilance and patient assessment are crucial in mitigating potential risks associated with overdosage.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or 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 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 room temperature to maintain their efficacy. Healthcare professionals are advised not to use any packets that are opened or torn, as this may compromise the product's quality 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 Safly 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 Safly 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.