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Burn

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This product has been discontinued

Active ingredient
Lidocaine Hydrochloride 20 mg/1 g
Other brand names
Dosage form
Gel
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2023
Label revision date
August 27, 2023
Active ingredient
Lidocaine Hydrochloride 20 mg/1 g
Other brand names
Dosage form
Gel
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2023
Label revision date
August 27, 2023
Manufacturer
Yiwu Ori-Power Medtech Co. , Ltd.
Registration number
part348
NDC root
72459-101

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If you are a consumer or patient please visit this version.

Drug Overview

If you are experiencing minor burns, there is a medication designed to provide temporary pain relief. This drug works specifically to alleviate the discomfort associated with these types of injuries, helping you feel more comfortable as you heal. While the exact mechanism of action isn't detailed, its primary purpose is to ease the pain you may be feeling from minor burns.

Uses

If you're dealing with minor burns, this medication can provide temporary relief from the pain associated with them. It's important to note that this medication has not been shown to cause any teratogenic effects (which means it doesn't cause birth defects) or any other harmful effects during pregnancy. Always consult with a healthcare professional if you have concerns about using this medication.

Dosage and Administration

To use the burn gel effectively, start by cleaning the affected area thoroughly. Once it’s clean, apply an even layer of the gel directly onto the burn. You can do this up to three to four times a day, depending on your needs.

Please note that this product is not suitable for children under 12 years of age, so make sure to keep it out of reach of younger kids. Always follow these guidelines to ensure safe and effective use of the burn gel.

What to Avoid

It's important to use this product safely to avoid any potential issues. You should not apply it in large amounts, especially on raw or blistered skin, as this could lead to irritation or other complications. Additionally, be careful not to use it near your eyes; if it accidentally gets into your eyes, rinse them thoroughly with water to prevent discomfort.

While there are no specific contraindications or concerns about abuse, misuse, or dependence associated with this product, following these guidelines will help ensure your safety and well-being.

Side Effects

This product is intended for external use only. Avoid using it in large amounts, especially on raw or blistered skin, and keep it away from your eyes. If the product accidentally gets into your eyes, rinse them thoroughly with water.

You should stop using the product and consult a doctor if your condition worsens, lasts longer than 7 days, or improves and then returns. Additionally, keep this product out of reach of children. If swallowed, seek medical assistance or contact a Poison Control Center immediately.

Warnings and Precautions

This product is for external use only, so please avoid applying it to large areas of your skin, especially if the skin is raw or blistered. Be careful not to get it near your eyes; if it does come into contact with them, rinse thoroughly with water.

If your condition worsens, does not improve after 7 days, or clears up and then comes back, stop using the product and consult your doctor. Additionally, keep this product out of reach of children. If a child accidentally swallows it, seek medical help or contact a Poison Control Center immediately.

Overdose

If you or someone else has swallowed too much of a medication, it’s important to seek medical help immediately. You can do this by contacting a Poison Control Center or going to the nearest emergency room. Acting quickly can make a significant difference in the outcome.

Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, don’t hesitate to get help right away. Remember, it’s always better to be safe and get checked by a medical professional.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that there are no specific warnings or dosage changes related to the use of lidocaine hydrochloride gel during pregnancy mentioned in the information provided. Additionally, the insert does not indicate whether this product is contraindicated (not recommended) for use during pregnancy or if there are any potential risks to your baby.

As always, it's best to consult with your healthcare provider before using any medication while pregnant to ensure it is safe for you and your developing 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 is no information available about whether this product is excreted in breast milk or any potential risks to your infant. Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

Pediatric Use

It's important to know that this medication should not be used in children under 12 years of age. If you have a child in this age group, please consult your healthcare provider for alternative options that are safe and appropriate for their age. Always prioritize your child's health and follow medical advice regarding medications.

Geriatric Use

It's important to note that this medication is not intended for children under 12 years of age. While there is no specific information available regarding its use in older adults, including any necessary dosage adjustments or safety concerns, you should always consult with a healthcare professional before starting any new medication. This is especially crucial for older adults, as they may have unique health considerations that need to be taken into account. Always prioritize open communication with your doctor to ensure safe and effective treatment.

Renal Impairment

It appears that there is no specific information regarding renal impairment (kidney problems) in the provided text. This means there are no dosage adjustments, special monitoring, or safety considerations outlined for patients with kidney issues. If you have concerns about how your kidney health may affect your treatment, it's important to discuss this with your healthcare provider, who can offer personalized guidance based on your individual situation.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines, dosage adjustments, or special monitoring instructions provided for your condition in the available information. This means that the medication may not have been studied in depth for its effects on individuals with liver impairment.

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 your treatment is safe and effective based on your individual health needs.

Drug Interactions

It's great to know that there are no known interactions between this medication and other drugs or laboratory tests. However, it's still very important to discuss all medications you are taking, including over-the-counter drugs and supplements, with your healthcare provider. This ensures that your treatment is safe and effective.

Always keep your healthcare provider informed about any changes in your health or new medications you may start. Open communication helps prevent any potential issues and supports your overall well-being.

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 not to freeze the product, as this can affect its effectiveness. Once you open the product, be sure to discard it after use to maintain safety and quality. Following these simple guidelines will help you use the product safely and effectively.

Additional Information

You should apply an even layer of burn gel over the cleaned affected area, but do not use it more than 3-4 times a day. This helps ensure effective treatment while minimizing the risk of irritation or other issues. If you have any questions about how to use the gel or its effects, be sure to consult with your healthcare provider.

FAQ

What is the primary use of this drug?

This drug provides temporary pain relief associated with minor burns.

How should I apply the burn gel?

Apply an even layer of burn gel over the cleaned affected area no more than 3-4 times daily.

Is this drug safe for children?

This drug should not be used on children under 12 years of age.

Are there any warnings I should be aware of?

This product is for external use only. Do not use in large quantities, particularly over raw or blistered areas, and avoid contact with eyes.

What should I do if my condition worsens?

Stop use and ask a doctor if the condition worsens or persists for more than 7 days, or if it clears up and returns.

What should I do if the gel is swallowed?

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Can I use this drug during pregnancy?

There are no specific warnings or contraindications regarding the use of this product during pregnancy mentioned.

Is it safe to use while breastfeeding?

There are no specific warnings or recommendations regarding the use of this product in nursing mothers.

How should I store this drug?

Store at room temperature, protect from light, and do not freeze. Discard after opening.

Packaging Info

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

Packaging configurations for Burn.
Details

Drug Information (PDF)

This file contains official product information for 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 SPL code 34089-3 and is a sterile, non-pyrogenic, isotonic solution. It comprises sodium chloride, sodium bicarbonate, and dextrose, with the pH adjusted to a range of 7.0 to 7.5. The solution is packaged in a flexible plastic pouch, with each pouch containing 1000 mL of the clear and colorless solution. Inactive ingredients include water for injection.

Uses and Indications

This drug is indicated for the temporary relief of pain associated with minor burns. There are no teratogenic or nonteratogenic effects associated with its use.

Dosage and Administration

Healthcare professionals are advised to apply an even layer of burn gel over the cleaned affected area. This application should not exceed 3 to 4 times daily.

It is important to note that this product is contraindicated for use in children under 12 years of age.

Contraindications

Use is contraindicated in the following situations:

  • Application in large quantities, particularly over raw or blistered areas, is not recommended due to the potential for increased irritation or adverse effects.

  • Avoid application near the eyes; in the event of contact, rinse thoroughly with water to prevent irritation or injury.

Warnings and Precautions

For external use only. This product should not be applied in large quantities, especially over raw or blistered areas. Care should be taken to avoid contact with the eyes; in the event of accidental exposure, the eyes should be rinsed thoroughly with water.

Healthcare professionals should advise patients to discontinue use and seek medical attention if the condition worsens, persists for more than 7 days, or if symptoms resolve and then return.

It is imperative to keep this product out of reach of children. In the event of ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center should be made without delay.

Side Effects

Patients should be aware that the product is for external use only. It is advised not to apply the product in large quantities, particularly over raw or blistered areas, and to avoid contact with the eyes. In the event of accidental contact with the eyes, it is important to rinse thoroughly with water.

Patients are instructed to discontinue use and consult a healthcare professional if the condition worsens or persists for more than 7 days, or if the condition clears up and then returns.

Additionally, the product should be kept out of reach of children. In the case of ingestion, it is crucial to seek medical assistance or contact a Poison Control Center immediately.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified for this product. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary.

Packaging & NDC

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

Packaging configurations for Burn.
Details

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. Safety and efficacy have not been established in this population, and therefore, it is contraindicated for children in this age group. Healthcare professionals should consider alternative treatments for pediatric patients who fall within this age range.

Geriatric Use

Elderly patients, defined as those aged 65 years and older, have not been specifically studied in relation to the use of this medication. Consequently, there is no available information regarding dosage adjustments, safety concerns, or special precautions that may be necessary for this population.

Healthcare providers should exercise caution when prescribing this medication to geriatric patients, given the lack of data on its use in this age group. It is advisable to monitor these patients closely for any potential adverse effects or complications that may arise during treatment. Additionally, since the medication is contraindicated in children under 12 years of age, similar considerations regarding safety and efficacy should be applied to elderly patients.

Pregnancy

Lidocaine hydrochloride gel has not been associated with specific warnings, precautions, or dosage modifications for use during pregnancy. The available prescribing information does not indicate whether the product is contraindicated in pregnant patients or if there are any known risks to fetal outcomes. As such, healthcare professionals should consider the lack of data when prescribing this medication to women of childbearing potential and weigh the potential benefits against any unknown risks.

Lactation

There are no specific warnings or recommendations regarding the use of this product in lactating mothers. Additionally, there is no information available concerning the potential for excretion in breast milk or any associated risks to breastfed infants.

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

There is no available information regarding the use of this medication in patients with hepatic impairment. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions specified for individuals with compromised liver function. Healthcare professionals should exercise caution and consider the overall clinical context when prescribing this medication to patients with liver problems, as the absence of specific guidance necessitates careful evaluation of potential risks and benefits.

Overdosage

In the event of an overdosage, immediate medical assistance is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical help or contact a Poison Control Center without delay.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. It is recommended that healthcare providers monitor the patient closely for any symptoms that may arise as a result of the overdosage.

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 the 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 urgency of the situation and the necessary steps to take if an accidental ingestion occurs.

Storage and Handling

The product is supplied in packaging that includes specific NDC numbers. It should be stored at room temperature, ensuring that it is protected from light exposure. Freezing the product is not permitted, as it may compromise its integrity. Additionally, once opened, the product must be discarded to maintain safety and efficacy.

Additional Clinical Information

Patients should apply an even layer of burn gel over the cleaned affected area, ensuring that it is not applied more than 3-4 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 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 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

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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.