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Sunburn Relief Gel

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Active ingredient
Lidocaine Hydrochloride 5 mg/1 g
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
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 2025
Label revision date
February 19, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Lidocaine Hydrochloride 5 mg/1 g
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
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 2025
Label revision date
February 19, 2025
Manufacturer
Jell Pharmaceuticals Pvt. Ltd
Registration number
M017
NDC root
30400-605
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

Sunburn relief gel is a pain-relieving gel that contains aloe vera and lidocaine HCl (a local anesthetic that helps numb the skin). This gel is designed to provide temporary relief from pain and itching associated with various skin issues, including minor burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritations.

If you’re experiencing discomfort from any of these conditions, this gel can help soothe your skin and alleviate your symptoms, allowing you to feel more comfortable.

Uses

You can use this medication for the temporary relief of pain and itching caused by various skin issues. It is effective for minor burns, sunburn, minor cuts, scrapes, insect bites, and other minor skin irritations. This means that if you experience discomfort from any of these conditions, this product can help soothe your skin and alleviate your symptoms.

Rest assured, there are no known teratogenic effects (which means it does not cause birth defects) associated with this medication, making it a safer option for those concerned about such risks.

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.

For children under 2 years of age, it’s important to consult a doctor before using this medication. They can provide the necessary guidance to ensure safety and effectiveness for younger children.

What to Avoid

It's important to use this medication responsibly. You should avoid using it in large quantities, especially on raw surfaces or blistered areas, as this can lead to complications. While there are no specific contraindications or concerns about 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

This product is intended for external use only. If your condition worsens or if your symptoms last longer than 7 days, it's important to stop using the product and consult a doctor. Additionally, if your symptoms improve and then return within a few days, you should also seek medical advice.

Warnings and Precautions

This product is for external use only, so please do not ingest it. It's important to avoid getting it in your eyes, as this can cause irritation.

If you accidentally swallow the product, seek emergency medical help or contact a Poison Control Center immediately. Additionally, if your condition worsens or if symptoms last longer than 7 days, or if they improve and then return within a few days, stop using the product and call your doctor for further advice.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there are no specific signs or symptoms listed for an overdose, you should be aware of general warning signs such as extreme drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms or feel unwell after taking the medication, seek medical help right away.

In case of an overdose, contact your healthcare provider or local emergency services immediately. It's always better to err on the side of caution when it comes to your health. Remember, timely intervention can make a significant difference.

Pregnancy Use

There is currently no specific information available about the use of Sunburn Relief Gel (Lidocaine HCl 0.5%) during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions for pregnant individuals have not been addressed in the drug insert.

If you are pregnant or planning to become pregnant, it is important to consult with your healthcare provider before using this product to ensure it is safe for you and your baby. Always prioritize open communication with your doctor regarding any medications or treatments you are considering during pregnancy.

Lactation Use

If you are breastfeeding and considering using Sunburn Relief Gel (Lidocaine HCl 0.5%), it's important to note that the drug insert does not provide specific information about its use during nursing. This means there are no established guidelines or safety data regarding how this product may affect breast milk or your nursing infant.

As always, it's best to consult with your healthcare provider before using any medication while breastfeeding to ensure the safety and well-being of both you and your baby.

Pediatric Use

If your child is under 2 years old, it's important to consult with a doctor before using this medication. For children aged 2 years and older, you can apply the medication to the affected area, but be sure not to exceed 3 to 4 applications per day. Always follow these guidelines to ensure your child's safety and well-being.

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 be adjusted based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary changes to your medications.

Hepatic Impairment

If you have liver problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to your condition. This means that there are no tailored recommendations for how the medication may affect you or how your liver health might influence the treatment.

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver condition. They can help monitor your liver function and make any necessary adjustments to your treatment plan.

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 interactions with other drugs or laboratory tests. 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 tests during your appointments.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20°C to 25°C (68°F to 77°F). It’s okay if the temperature occasionally varies between 15°C to 30°C (59°F to 86°F), but try to keep it within the recommended range. Make sure to protect the product from light and always keep the container tightly closed when not in use.

Once you open the container, remember to discard it after use to maintain safety and effectiveness. Following these guidelines will help you handle the product safely and ensure it remains in good condition.

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 the patient is under 2 years old, it's important to consult a doctor before use.

FAQ

What is Sunburn Relief Gel used for?

Sunburn Relief Gel is used for the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritations.

How should I apply Sunburn Relief Gel?

Adults and children 2 years of age and older should apply the gel to the affected area not more than 3 to 4 times daily. For children under 2 years of age, you should ask a doctor.

Are there any warnings for using Sunburn Relief Gel?

Yes, it is for external use only. You should avoid contact with the eyes and stop use if the condition worsens or symptoms persist for more than 7 days.

What should I do if I accidentally swallow Sunburn Relief Gel?

If swallowed, you should get medical help or contact a Poison Control Center right away.

How should I store Sunburn Relief Gel?

Store the gel at 20°C to 25°C (68°F to 77°F), protect it from light, keep the container tightly closed, and discard it after opening.

Is there any information about using Sunburn Relief Gel during pregnancy or while nursing?

The drug insert does not provide specific information regarding use during pregnancy or lactation.

Are there any contraindications for using Sunburn Relief Gel?

No specific contraindications are mentioned for Sunburn Relief Gel.

Can I use Sunburn Relief Gel on large areas of skin?

You should not use Sunburn Relief Gel in large quantities, particularly over raw surfaces or blistered areas.

Packaging Info

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

Packaging configurations for Sunburn Relief Gel.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

This formulation is a pain-relieving gel designed for sunburn relief. It contains Aloe Vera, known for its soothing properties, and Lidocaine HCl, a local anesthetic that provides temporary relief from pain. The gel is intended for topical application to affected areas, delivering a cooling effect while alleviating discomfort associated with sunburn.

Uses and Indications

This drug is indicated for the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritations.

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, it is advised to consult a physician prior to use. This precaution is essential to ensure safety and appropriateness of treatment for this age group.

Contraindications

The product should not be used in large quantities, particularly over raw surfaces or blistered areas, due to the potential for increased irritation or adverse effects in these conditions. No other specific contraindications have been identified.

Warnings and Precautions

For external use only. It is imperative that healthcare professionals advise patients to avoid contact with the eyes to prevent irritation or injury.

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

Healthcare providers should monitor patients closely and advise them to discontinue use and consult their physician if their condition worsens, or if symptoms persist for more than seven days. Additionally, if symptoms resolve and then recur within a few days, patients should be encouraged to seek medical advice promptly.

Side Effects

For external use only. Patients should discontinue use and consult a doctor if the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then occur again within a few days.

Drug Interactions

No drug interactions have been identified for this medication. Additionally, there are no reported interactions with laboratory tests. Therefore, no specific dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

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

Packaging configurations for Sunburn Relief Gel.
Details

Pediatric Use

Pediatric patients under 2 years of age should consult a healthcare professional before use. 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 adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

There is no specific information regarding the use of Sunburn Relief Gel (Lidocaine HCl 0.5%) during pregnancy. The drug insert does not provide safety concerns, dosage modifications, or special precautions for pregnant patients. Therefore, healthcare professionals should exercise caution when considering the use of this product in pregnant women, as the potential effects on fetal outcomes are not established. It is advisable to weigh the benefits against any unknown risks when prescribing this medication to women of childbearing potential.

Lactation

There are no specific statements or information regarding nursing mothers or lactation in the provided drug insert for Sunburn Relief Gel (Lidocaine HCl 0.5%). Therefore, the effects on breastfed infants and the excretion of Lidocaine HCl in breast milk are not established. Healthcare professionals should consider this lack of data when advising lactating mothers on the use of this product.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

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 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 maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or toxicology experts for guidance on specific management protocols and interventions tailored to the situation.

Documentation of the incident, including the substance involved, estimated dose, and time of exposure, 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 to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed. It is important to inform patients not to use the product in large quantities, especially on raw surfaces or blistered areas, to prevent potential complications.

Patients should be instructed to discontinue use and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms reappear shortly after cleaning up. Additionally, healthcare providers should emphasize the importance of avoiding contact with the eyes while using this product to prevent irritation or injury.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain integrity. It should be stored at a temperature range of 20°C to 25°C (68°F to 77°F), with permissible excursions between 15°C to 30°C (59°F to 86°F). It is essential to protect the product from light to prevent degradation. Once opened, the product should be discarded to ensure safety and efficacy.

Additional Clinical Information

The medication is administered topically, with a recommended application frequency of 3 to 4 times daily for adults and children aged 2 years and older. For children under 2 years of age, it is advised to consult a doctor before use. There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Sunburn 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 Sunburn 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.