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Lidocaine hydrochloride

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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)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2013
Label revision date
March 7, 2016
Drug Information (PDF)
Prescribing information, PDF file
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
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2013
Label revision date
March 7, 2016
Manufacturer
Acme United Corporation
Registration number
part348
NDC root
0924-5000
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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

Burn Gel is a product designed to provide temporary pain relief for minor burns. It works by soothing the affected area, helping to alleviate discomfort associated with burns. This gel is intended for professional use, ensuring that it is applied correctly for effective relief. If you experience a minor burn, Burn Gel can be a helpful option to ease your pain.

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 guidance tailored to your specific situation.

Dosage and Administration

If you are an adult or a child aged 2 years and older, you can apply the 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 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 comes into contact with 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

You should be aware that this product is for external use only and must be kept out of reach of children. If ingested, seek medical help or contact a Poison Control Center immediately. Avoid using it in large amounts, especially on raw or blistered skin, and keep it away from your eyes. If the condition you are treating worsens, or if symptoms last more than 7 days or return shortly after improvement, stop using the product and consult your doctor.

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.

Avoid using this product in large amounts, especially on raw or blistered skin, and do not apply it near your eyes. If the product does come into contact with your eyes, rinse them thoroughly with water.

You should stop using the product and consult your doctor if your condition worsens, if symptoms last longer than 7 days, or if symptoms improve and then return within a few days.

Overdose

If you suspect an overdose, it’s important to seek medical help immediately. You can do this by contacting a healthcare professional or calling a Poison Control Center directly. Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing.

Remember, acting quickly can make a significant difference in your safety and health. If you or someone else is experiencing these symptoms after taking a medication, don’t hesitate to reach out for help right away.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of lidocaine hydrochloride gel during pregnancy has not been established. In fact, lidocaine is generally not recommended for use during pregnancy due to potential risks to your developing baby. There may be specific risks associated with its use, so it's crucial to consult your healthcare provider for personalized advice.

If you do need to use lidocaine while pregnant, your doctor may suggest dosage adjustments to ensure safety. Always approach the use of any medication during pregnancy with caution and have an open discussion with your healthcare professional to understand the best options for you and your baby.

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 regarding its use for nursing mothers. Additionally, the information available does not indicate any concerns about the gel being passed into breast milk or posing any risk to your infant.

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

Pediatric Use

If your child is under 2 years old, it's important not to use this medication without first consulting a doctor. For children aged 2 years and older, you can apply the medication to the affected area, but be sure to do this no more than 3 to 4 times a day. Always follow these guidelines to ensure your child's safety and well-being.

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 responses to medications, you should always consult with a healthcare provider before starting any new medication. They can help determine the right dosage and monitor for any potential side effects, ensuring that the treatment is safe and effective for you or your loved one.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

It's always best to discuss your individual situation with your healthcare provider, who can offer personalized advice and ensure that any medications you take are safe and effective for you.

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 (liver issues).

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 determine the best course of action based on your individual situation.

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 best performance and safety of your product, store it at room temperature and avoid freezing it. It's important to keep the product in its original packaging until you're ready to use it. If you notice any opened or torn packs, do not use them, as this could compromise the product's integrity and safety. Following these guidelines will help you use the product effectively and safely.

Additional Information

You should apply this medication topically to the affected area, using it no more than 3 to 4 times a day if you are an adult or a child aged 2 years and older. If your child is under 2 years old, it's important to consult a doctor before use. There are no additional details available regarding laboratory tests, abuse potential, or patient counseling.

FAQ

What is Burn Gel used for?

Burn Gel is used for temporary pain relief of minor burns.

Who can use Burn Gel?

Adults and children 2 years and over can use Burn Gel, applying it to the affected area no more than 3 to 4 times daily. Children under 2 years should not use it and should consult a doctor.

Are there any contraindications for using Burn Gel?

There are no specific contraindications listed for Burn Gel.

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

If Burn Gel gets in your eyes, rinse thoroughly with water.

What precautions should I take when using Burn Gel?

Use Burn Gel for external use only, keep it out of reach of children, and do not use it in large quantities, especially over raw or blistered areas.

What should I do if my condition worsens or does not improve?

Stop using Burn Gel and consult a doctor if your condition worsens or if symptoms persist for more than 7 days.

Is Burn Gel safe to use during pregnancy?

The safety of Burn Gel during pregnancy has not been established, and it is advised to consult a healthcare provider before use.

How should I store Burn Gel?

Store Burn Gel at room temperature and do not freeze. Do not use any opened or torn packs.

What should I do if I ingest Burn Gel?

If ingested, seek medical help or contact a Poison Control Center immediately.

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

Burn Gel is indicated for the temporary relief of pain associated with minor burns. The product has a net weight of 3.5 grams and is distributed by Acme United Corporation, located in Fairfield, CT 06824. For inquiries, the contact number is 1.800.835.2263, and additional information can be found on the website www.FirstAidOnly.com. Burn Gel is marketed under the trademark FIRST AID ONLY® and has been effective since March 7, 2016.

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

Use is contraindicated in the following situations:

Application in large quantities, especially over raw or blistered areas, is not recommended due to the potential for increased irritation or adverse effects. Additionally, the product should not be applied near the eyes; in the event of contact, it is essential to rinse thoroughly with water to prevent irritation.

Warnings and Precautions

For external use only; this product must be kept out of reach of children. In the event of ingestion, it is imperative to seek medical assistance or contact a Poison Control Center immediately.

This product should not be applied in large quantities, especially on raw or blistered areas. Care should be taken to avoid contact with the eyes; should contact occur, the affected area must be rinsed thoroughly with water.

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.

Side Effects

Patients should be aware that the product is for external use only and must be kept out of reach of children. Ingestion of the product requires immediate medical attention or contact with a Poison Control Center.

The product should not be used in large quantities, especially over raw or blistered areas, and care should be taken to avoid contact with the eyes. In the event of eye contact, it is essential to rinse thoroughly with water.

Patients are advised to discontinue use and consult a healthcare professional if the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days.

Drug Interactions

There are no specific drug interactions identified for this medication. Additionally, no laboratory test interactions have been reported. 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 Lidocaine Hydrochloride. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Lidocaine Hydrochloride.
Details

Pediatric Use

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

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

The safety of lidocaine hydrochloride gel during pregnancy has not been established. Lidocaine is contraindicated in pregnancy due to potential risks to the fetus. There may be risks associated with the use of lidocaine during pregnancy; therefore, it is essential for pregnant patients to consult a healthcare provider for advice.

Dosage adjustments may be necessary for pregnant individuals, and specific recommendations should be obtained from a healthcare professional. Use during pregnancy should be approached with caution, and it is advised that women of childbearing potential discuss the use of lidocaine with their healthcare provider prior to administration.

Lactation

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

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and 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 available prescribing information.

Overdosage

In the event of an overdosage, it is imperative to seek immediate medical assistance. Healthcare professionals are advised to contact a Poison Control Center directly for guidance on managing the situation effectively.

Symptoms of overdosage may vary depending on the substance involved; therefore, a thorough assessment of the patient's condition is essential. Prompt recognition of symptoms can facilitate timely intervention and improve patient outcomes.

Management of overdosage should be tailored to the specific circumstances and may include supportive care, symptomatic treatment, and, if appropriate, decontamination procedures. Continuous monitoring of the patient's vital signs and clinical status is crucial during the management process.

In all cases of suspected overdosage, the involvement of medical professionals is critical to ensure appropriate care and intervention.

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 that the product is intended for external use only and must be kept out of reach of children to prevent accidental ingestion. In the event of ingestion, patients should be instructed to seek medical help immediately or contact a Poison Control Center for further 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 packaging that ensures integrity and safety. It is essential to store the product at room temperature, avoiding exposure to freezing conditions. Healthcare professionals are advised to refrain from using any opened or torn packs to maintain product efficacy and safety.

Additional Clinical Information

The medication is administered topically, with the recommended application frequency for adults and children aged 2 years and older being 3 to 4 times daily to the affected area. For children under 2 years of age, it is advised not to use the medication without consulting a doctor. No further information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

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.