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Lidocaine hydrochloride

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This product has been discontinued

Active ingredient
Lidocaine Hydrochloride 18 mg/1 g
Other brand names
Dosage form
Gel
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2022
Label revision date
March 8, 2022
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Lidocaine Hydrochloride 18 mg/1 g
Other brand names
Dosage form
Gel
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 2022
Label revision date
March 8, 2022
Manufacturer
Dealmed Medical Supplies LLC
Registration number
part348
NDC root
70082-500
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

dealmed Burn Gel is designed to provide temporary relief for minor burns. It works by alleviating pain associated with these injuries, helping you feel more comfortable as you heal. This gel is intended for professional use only, ensuring that it is applied correctly and safely for effective results.

Uses

You can use this medication for temporary relief from the pain associated with minor burns. It's important to note that this product is intended for professional use only, so it should be administered by a qualified healthcare provider.

Additionally, there are no reported teratogenic effects (which means it does not cause birth defects) or nonteratogenic effects associated with this medication. Always consult with your healthcare professional for more information and guidance on its use.

Dosage and Administration

If you are an adult or a child aged 2 years or older, you can apply this medication to the affected area up to 3 to 4 times a day. Make sure to follow this guideline to ensure the best results.

However, if your child is under 2 years old, it’s important not to use this medication without first consulting a doctor. Always prioritize safety and seek professional advice when it comes to younger children.

What to Avoid

It's important to use this product safely. Avoid applying it in large amounts, especially on raw or blistered skin, as this can lead to irritation. Additionally, keep the product away from your eyes; if it accidentally gets into your eyes, rinse them thoroughly with water to prevent discomfort.

By following these guidelines, you can help ensure a safer experience with the product. If you have any concerns or questions, don't hesitate to reach out for more information.

Side Effects

This product is intended for external use only. It's important to avoid using it in large amounts, especially on raw or blistered skin, and to 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, if symptoms last longer than 7 days, or if they improve and then return within a few days.

Warnings and Precautions

This product is for external use only, so please keep it out of reach of children. If you accidentally ingest it, seek medical help or contact a Poison Control Center immediately.

Be cautious when applying the product; avoid using large amounts, especially on raw or blistered skin, and keep it away from your eyes. If the product does come into contact with your eyes, rinse them thoroughly with water. If your condition worsens, or if symptoms last more than 7 days or return after clearing up, stop using the product and consult your doctor.

Overdose

If you suspect an overdose, it’s crucial to seek medical help immediately or contact a Poison Control Center. Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing.

Don’t wait for symptoms to worsen; acting quickly can make a significant difference in your safety. Always keep emergency contact numbers handy and be aware of the signs of overdose to ensure you can respond effectively if needed.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that there is no specific information available about the use of Lidocaine Hydrochloride gel during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions related to its use in pregnant individuals have not been clearly established.

Before using this gel, you should consult with your healthcare provider to discuss any potential risks and to ensure that it is safe for you and your baby. Always prioritize open communication with your doctor regarding any medications you may consider during pregnancy.

Lactation Use

If you are breastfeeding and considering the use of lidocaine hydrochloride gel, you can feel reassured that there are no specific warnings or recommendations against its use for nursing mothers. Additionally, there is no information available about whether this medication passes into breast milk or poses any risk to your infant.

As always, it's a good idea to consult with your healthcare provider if you have any concerns or questions about using medications while breastfeeding. They can provide personalized advice based on your situation.

Pediatric Use

When using this medication for children, it's important to follow specific guidelines. For children aged 2 years and older, you can apply it to the affected area up to 3 to 4 times a day. However, if your child is under 2 years old, you should not use this medication without first consulting a doctor. Always prioritize your child's safety and seek professional advice if you're unsure.

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, it’s important to consult with a healthcare provider before starting the medication. 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 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 should be used if you have hepatic impairment (issues with liver function).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver health. They can help you understand how to manage your treatment effectively.

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 avoid freezing. It's important to keep the product in its original packaging and never use any opened or torn packets, as this can compromise safety and effectiveness. By following these simple storage and handling guidelines, you can help maintain the quality of the product for your use.

Additional Information

No further information is available.

FAQ

What is dealmed Burn Gel used for?

Dealmed Burn Gel is used for the temporary relief of minor burns.

Who can use dealmed Burn Gel?

It is for professional use only and can be applied to adults and children 2 years of age and older.

How often can I apply dealmed Burn Gel?

You can apply it to the affected area not more than 3 to 4 times daily.

Are there any contraindications for dealmed Burn Gel?

No specific contraindications are mentioned in the provided text.

What should I do if I accidentally get dealmed Burn Gel in my eyes?

If it gets in your eyes, rinse thoroughly with water.

What should I do if my condition worsens or symptoms persist?

Stop use and ask a doctor if your condition worsens or if symptoms persist for more than 7 days.

Is dealmed Burn Gel safe to use during pregnancy?

There is no specific information regarding the use of dealmed Burn Gel during pregnancy.

Can nursing mothers use dealmed Burn Gel?

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

How should I store dealmed Burn Gel?

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

What should I do if I ingest dealmed Burn Gel?

If ingested, get medical help or contact a Poison Control Center right away.

Packaging Info

Below are the non-prescription pack sizes of Lidocaine Hydrochloride. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Lidocaine Hydrochloride.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

NDC 70082-500-01 identifies the product as Burn Gel, manufactured by dealmed. This formulation is designed for the temporary relief of minor burns. Each packet contains a net weight of 0.9 grams, and the product is available in a total of 144 packets.

Uses and Indications

This drug is indicated for the temporary relief of pain associated with minor burns. It is intended for professional use only.

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

Dosage and Administration

For adults and children aged 2 years and older, the recommended application is to the affected area not more than 3 to 4 times daily. It is important to ensure that the application is limited to the specified frequency to avoid potential adverse effects.

For children under 2 years of age, the product should not be used without consulting a healthcare professional. It is essential to seek medical advice before administering this treatment to this age group.

Contraindications

The product should not be applied in large quantities, especially over raw or blistered areas, due to the potential for irritation or adverse effects. Additionally, application near the eyes is contraindicated; in the event of contact, the area should be rinsed thoroughly with water to mitigate any risk of irritation.

Warnings and Precautions

For external use only. It is imperative to keep this product out of reach of children to prevent accidental ingestion. In the event of ingestion, immediate medical assistance should be sought, or contact a Poison Control Center without delay.

Caution is advised regarding the application of this product. It should not be used in large quantities, especially on raw or blistered areas, as this may exacerbate irritation or lead to adverse effects. Additionally, care must be taken to avoid contact with the eyes. Should contact occur, the affected area should be rinsed thoroughly with water to mitigate potential harm.

Healthcare professionals should advise patients to discontinue use and consult a physician if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. Monitoring for these signs is essential to ensure patient safety and effective management of the condition being treated.

Side Effects

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

Participants are instructed to discontinue use and consult a healthcare professional if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. These precautions are essential to ensure the safety and well-being of patients using the product.

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no dosage adjustments or monitoring recommendations are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Lidocaine Hydrochloride. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Lidocaine Hydrochloride.
Details

Pediatric Use

Pediatric patients aged 2 years and older may apply the medication to the affected area no more than 3 to 4 times daily. For children under 2 years of age, the use of this medication is not recommended without consulting a doctor.

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 available regarding the use of Lidocaine Hydrochloride gel 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. The potential risks and benefits should be carefully evaluated, and alternative treatments may be considered in the absence of established safety profiles for this population. Women of childbearing potential should be counseled on the unknowns associated with the use of this medication during pregnancy.

Lactation

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

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 patients with reduced kidney function, as the lack of detailed guidance necessitates careful clinical judgment and individualized patient assessment. 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 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 prescribing information.

Overdosage

In the event of an overdosage, immediate medical assistance is crucial. Healthcare professionals are advised to seek medical help or contact a Poison Control Center without delay if an overdose is suspected.

Symptoms of overdosage may vary depending on the substance involved and the amount ingested. It is essential for healthcare providers to monitor the patient closely for any signs of adverse reactions or complications.

Management of an overdosage should be guided by the specific circumstances of the case, including the substance involved and the patient's clinical status. Prompt intervention and supportive care are critical in mitigating potential risks associated with 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 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 ingested, 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 packets that must be stored at room temperature. It is essential to avoid freezing the product to maintain its integrity. Healthcare professionals should ensure that only unopened and undamaged packets are utilized, as opened or torn packets should not be used.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Lidocaine Hydrochloride, 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 Lidocaine Hydrochloride, 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.