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Burn Relief Gel

Last content change checked dailysee data sync status

This product has been discontinued

Active ingredient
Lidocaine Hydrochloride 2.4123 g/482.46 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 2021
Label revision date
February 19, 2021
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Lidocaine Hydrochloride 2.4123 g/482.46 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 2021
Label revision date
February 19, 2021
Manufacturer
Cross Brands Contract Filling
Registration number
part348
NDC root
73440-2161
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 may find this medication helpful for the temporary relief of pain and itching. It is designed to soothe discomfort caused by various skin issues, including sunburn, minor burns, skin irritations, scrapes, and insect bites.

By targeting the affected areas, this medication works to alleviate pain and provide a calming effect, making it easier for you to manage discomfort from these common skin conditions.

Uses

If you're dealing with discomfort from minor skin issues, this medication can provide temporary relief from pain and itching. It’s particularly helpful for soothing the pain associated with sunburn, minor burns, skin irritations, scrapes, and insect bites.

Using this product can help you feel more comfortable and allow your skin to heal without the added burden of pain. Remember, it’s designed for short-term use to ease your symptoms effectively.

Dosage and Administration

When using this medication for burns, you should apply it generously to the affected area. This is suitable for both adults and children who are 2 years or older. If you find that the pain persists, you can reapply the medication as needed, but make sure not to exceed four applications in a single day.

If you have a child under 2 years of age, it's important to consult a doctor before using this product, as it is not recommended for that age group. Always follow these guidelines to ensure safe and effective relief from pain caused by burns.

What to Avoid

It's important to use this medication responsibly. You should avoid using it in large quantities, especially on raw surfaces or areas with blisters, as this can lead to complications.

Currently, there are no specific contraindications, controlled substance classifications, or noted risks of abuse, misuse, or dependence associated with this medication. Always follow the guidance provided by your healthcare professional to ensure safe and effective use.

Side Effects

You should be aware that this product is for external use only and should not come into contact with your eyes. If your condition worsens, or if symptoms last more than 7 days or return after clearing up, it's important to stop using the product and consult a doctor.

If you are pregnant or breastfeeding, please consult a healthcare professional before using this product. Additionally, avoid using it in large amounts, especially on raw surfaces or areas with blisters.

Warnings and Precautions

This product is for external use only, so please avoid applying it to any areas that may come into contact with your eyes. If you notice that your condition worsens, or if your symptoms last longer than 7 days, or if they improve and then return within a few days, stop using the product and consult your doctor.

In case of accidental swallowing, it’s important to seek emergency medical help immediately or contact a Poison Control Center. Your safety is a priority, so please take these precautions seriously.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there is no specific information available about the signs of overdose for this medication, general 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 always better to be safe and get checked by a healthcare professional if you have any concerns about your health. Remember, timely action can make a significant difference.

Pregnancy Use

If you are pregnant or breastfeeding, it is important to consult with a healthcare professional before using this medication. They can provide guidance on any potential risks and help you make informed decisions about your health and the health of your baby. Always prioritize open communication with your healthcare provider regarding any medications you may consider during this time.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication. This ensures that you understand any potential risks and can make informed decisions about your health and the health of your baby. Always prioritize open communication with your healthcare provider regarding your breastfeeding journey.

Pediatric Use

When using this medication for burns, you can apply it generously to the affected area for children aged 2 years and older. You may repeat the application as needed, but no more than four times a day, to help relieve pain.

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

Geriatric Use

When considering the use of Burn Relief Gel (lidocaine hydrochloride gel) for older adults, it's important to note that the drug insert does not provide specific information about how this medication should be adjusted or used differently for elderly patients. This means there are no special dosage changes or safety precautions outlined specifically for older adults.

As always, if you or a caregiver are considering this treatment, it's wise to consult with a healthcare professional to ensure it is appropriate for your individual health needs and circumstances.

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 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 you understand how to manage your treatment effectively.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. In this case, there are no known drug interactions or interactions with laboratory tests for the medication in question. However, every individual is different, and your healthcare provider can help ensure that your treatment is safe and effective for you. Always feel free to ask questions and share your complete list of medications and any tests you may be undergoing.

Storage and Handling

To ensure the best quality and safety of your product, store it at room temperature and keep it away from direct light. It's important to keep the container tightly closed when not in use to prevent contamination. Once you open the container, remember to discard it after use to maintain safety and effectiveness. Following these guidelines will help you use the product safely and effectively.

Additional Information

You should apply this medication topically to the burned area, using a generous amount. For adults and children aged 2 years and older, you can repeat the application as needed, but no more than four times a day to help relieve pain. If your child is under 2 years old, consult a doctor before use.

If you are pregnant or breastfeeding, check with a healthcare professional before using this product. It's important to stop using the medication and consult a doctor if your condition worsens, if symptoms last more than 7 days, or if they improve and then return within a few days. Always keep this medication out of reach of children, and if swallowed, seek medical help or contact a Poison Control Center immediately.

FAQ

What is the primary use of this drug?

This drug provides temporary relief of pain and itching, helping to soothe pain from sunburn, minor burns, skin irritations, scrapes, and insect bites.

Who can use this drug?

Adults and children 2 years or older can use this drug. Children under 2 years of age should not use it without consulting a doctor.

How should I apply this drug?

Apply generously to the affected area and repeat as necessary, but no more than four times daily.

What should I do if my condition worsens?

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

Are there any warnings I should be aware of?

This drug is for external use only, and you should avoid contact with your eyes.

What should I do if I swallow this drug?

If swallowed, get medical help or contact a Poison Control Center immediately.

Can I use this drug if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, consult a healthcare professional before use.

How should I store this drug?

Store at room temperature, protect from light, and keep the container tightly closed. Discard after opening.

Are there any contraindications for this drug?

There are no specific contraindications listed, but do not use in large quantities, especially over raw surfaces or blisters.

Packaging Info

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

Packaging configurations for Burn Relief Gel.
Details

Drug Information (PDF)

This file contains official product information for Burn Relief Gel, 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 classified as a topical analgesic. It contains lidocaine as the active ingredient and is formulated as a clear, colorless gel. The formulation includes several inactive ingredients: carbomer, glycerin, propylene glycol, purified water, sodium hydroxide, and triethanolamine.

Uses and Indications

This drug is indicated for the temporary relief of pain and itching associated with various dermatological conditions. It helps to relieve and soothe pain resulting from sunburn, minor burns, skin irritations, scrapes, and insect bites.

Limitations of Use: This drug is intended for external use only and should not be applied to large areas of the body or used on deep wounds or serious burns.

Dosage and Administration

For adults and children aged 2 years and older, the product should be applied generously to the affected burned area. Applications may be repeated as necessary, not exceeding four times daily, to alleviate pain effectively.

For children under 2 years of age, the use of this product is not recommended. Healthcare professionals should advise caregivers to consult a physician for appropriate alternatives.

Contraindications

Use is contraindicated in patients who may apply the product in large quantities, particularly over raw surfaces or areas with blisters, due to the potential for adverse effects in these conditions. No other specific contraindications have been identified.

Warnings and Precautions

For external use only. It is imperative to avoid contact with the eyes to prevent irritation or injury.

Healthcare professionals should advise patients to discontinue use and seek medical advice if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. These actions are crucial to ensure appropriate management of the patient's condition.

In the event of accidental ingestion, immediate medical assistance should be sought. Patients or caregivers are encouraged to contact a Poison Control Center or seek emergency medical help without delay.

Side Effects

Patients using this product should be aware of several important warnings and precautions. The product is intended for external use only, and contact with the eyes should be strictly avoided.

In clinical practice, patients are advised 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.

Additionally, special consideration should be given to pregnant or breastfeeding individuals, who are encouraged to seek advice from a healthcare professional prior to use. It is also important to note that the product should not be applied in large quantities, particularly over raw surfaces or areas with blisters, to prevent potential adverse effects.

Drug Interactions

There are no documented drug interactions associated with the use of this medication. Additionally, there are no reported interactions between this medication and laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

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

Packaging configurations for Burn Relief Gel.
Details

Pediatric Use

Pediatric patients aged 2 years and older may apply the medication generously to the affected burned area, with the option to repeat the application as necessary, not exceeding four times daily, to alleviate pain. For children under 2 years of age, the use of this medication is not recommended; consultation with a healthcare professional is advised.

Geriatric Use

There is no specific information regarding the use of Burn Relief Gel (lidocaine hydrochloride gel) in geriatric patients. The prescribing information does not provide guidance on dosage adjustments, safety concerns, or special precautions for elderly patients.

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 recommended, as elderly patients may have altered pharmacokinetics and increased sensitivity to medications.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is essential to evaluate the potential risks and benefits associated with the use of this drug during pregnancy and lactation. Healthcare providers should consider the available data and individual patient circumstances when advising on the use of this medication in these populations.

Lactation

Lactating mothers are advised to consult a healthcare professional prior to using this medication. There is currently no available data on the excretion of this drug in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

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 this medication. Consequently, there are no 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.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

If available, consultation with a poison control center or a medical toxicologist is recommended to guide further management and treatment options.

Documentation of the incident, including the substance involved, the amount taken, and the time of ingestion, is crucial for effective management and follow-up care.

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 compound in these areas.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients that in the event of accidental ingestion, it is crucial to seek medical assistance immediately or contact a Poison Control Center. This prompt action is essential to ensure the safety and well-being of the patient.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain its integrity. It should be stored at room temperature, away from direct light exposure to protect its quality. Once opened, the product should be discarded to ensure safety and efficacy.

Additional Clinical Information

The product is administered topically, with a recommended application for adults and children aged 2 years or older to apply generously to the affected burned area. Applications may be repeated as necessary, not exceeding four times daily. For children under 2 years of age, consultation with a doctor is advised prior to use.

Clinicians should counsel patients to consult a healthcare professional if they are pregnant or breastfeeding. Patients are also advised to discontinue use and seek medical advice if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. It is important to keep the product out of reach of children, and in the event of ingestion, medical assistance or contact with a Poison Control Center should be sought immediately.

Drug Information (PDF)

This file contains official product information for Burn Relief Gel, 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 Relief Gel, 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.