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Sunburn Pain Relief

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This product has been discontinued

Active ingredient
Lidocaine Hydrochloride 0.5 g/100 mL
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 2016
Label revision date
June 26, 2018
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Lidocaine Hydrochloride 0.5 g/100 mL
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 2016
Label revision date
June 26, 2018
Manufacturer
Top Care
Registration number
part348
NDC root
36800-883
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 providing temporary relief from pain and itching caused by various skin irritations. It is commonly used for conditions such as sunburn, minor burns, insect bites, cuts, and scrapes. This means that if you experience discomfort from any of these issues, this medication can help soothe your skin and alleviate your symptoms.

Uses

You can use this medication for the temporary relief of pain and itching caused by various skin irritations. It is effective for soothing discomfort from sunburn, minor burns, insect bites, cuts, and scrapes.

This product is designed to help you feel more comfortable while your skin heals, providing quick relief from those annoying sensations. Remember, it’s always important to follow the instructions for use to ensure safety and effectiveness.

Dosage and Administration

If you or your child is 2 years old or older and need to use this medication, you should apply it directly to the affected area. You can do this up to 3 to 4 times a day, but make sure not to exceed this amount.

For children under 2 years of age, it's important to consult a physician (doctor) before using the medication to ensure it's safe and appropriate for them. Always follow these guidelines to help ensure effective and safe use of the medication.

What to Avoid

It's important to be aware of certain guidelines when using this medication. If your symptoms persist for more than 7 days, you should stop using the product and consult your doctor for further advice. Additionally, be careful to avoid contact with your eyes; if this happens, rinse your eyes with water immediately.

While there are no specific contraindications, controlled substance classifications, or noted risks of abuse or dependence associated with this medication, following these precautions will help ensure your safety and well-being.

Side Effects

This product is intended for external use only, so it's important to avoid contact with your eyes. If you accidentally get it in your eyes, rinse them with water immediately.

If your symptoms persist for more than 7 days while using this product, you should stop using it and consult a doctor for further advice.

Warnings and Precautions

This product is intended for external use only, so please avoid applying it to any internal areas. Be careful to keep it away from your eyes; if it does come into contact with them, rinse thoroughly with water.

If you notice that your symptoms persist for more than 7 days while using this product, it’s important to stop using it and consult your doctor for further advice. Your health and safety are paramount, so don’t hesitate to seek help if you have any concerns.

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 effects of an overdose for this medication, you should be aware of general signs that may indicate a problem. These can include unusual drowsiness, confusion, or difficulty breathing.

If you notice any of these symptoms or if you believe you have taken too much of the medication, seek medical help right away. Contact your healthcare provider or go to the nearest emergency room. It's always better to be safe and get checked out if you're unsure.

Pregnancy Use

Currently, there is no available information about the use of SUNBURN PAIN RELIEF - lidocaine hydrochloride 0.5% gel during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions for pregnant individuals have not been established. 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.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or considerations regarding the use of this product while nursing. This means that it is not expected to affect your milk production or pose any risk to your infant through breast milk. Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

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 consult a physician (doctor) before using the medication. This ensures that you are taking the right steps for your child's health and safety.

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 considering this medication, it’s important to consult with a healthcare provider. 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 plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

Hepatic Impairment

If you have liver problems, it's important to know that the provided drug insert does not include specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no established guidelines for how this medication may affect you if you have hepatic impairment (liver issues).

Before starting any new medication, including this one, you should discuss your liver health with your healthcare provider. They can help determine the best approach for your treatment and ensure your safety.

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 of your product, store it at room temperature, ideally between 20°C to 25°C (68°F to 77°F). It's important to keep the container tightly closed and protect it from light to maintain its effectiveness. Once you open the container, please remember to discard it after use to ensure safety and prevent contamination. Following these guidelines will help you handle the product safely and effectively.

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 physician before use. There are no additional details available regarding laboratory tests, abuse potential, or postmarketing experiences related to this medication.

FAQ

What is this product used for?

This product is used for the temporary relief of pain and itching due to sunburn, minor burns, insect bites, cuts, and scrapes.

How should I apply this product?

Adults and children 2 years of age and older should apply it to the affected area no more than 3 to 4 times a day. For children under 2 years of age, consult a physician.

Are there any contraindications for this product?

No contraindications are listed for this product.

What should I do if symptoms last more than 7 days?

You should stop using the product and ask a doctor if symptoms last more than 7 days.

Is this product safe to use during pregnancy?

There is no specific information regarding the safety of this product during pregnancy.

Can nursing mothers use this product?

There are no specific warnings or considerations mentioned regarding the use of this product by nursing mothers.

What precautions should I take when using this product?

This product is for external use only. Avoid contact with eyes, and rinse with water if contact occurs.

How should I store this product?

Store at room temperature, between 20°C to 25°C (68°F to 77°F), protect from light, and keep the container tightly closed.

Packaging Info

Below are the non-prescription pack sizes of Sunburn Pain Relief (lidocaine hydrochloride 0.5%). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Sunburn Pain Relief.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No specific description details are available for SPL code 34089-3.

Uses and Indications

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

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 exceeding 3 to 4 times per day. It is essential to ensure that the application is performed with clean hands and that the affected area is clean and dry prior to administration.

For children under 2 years of age, it is advised to consult a physician before use to determine the appropriate course of action.

Contraindications

There are no contraindications listed for this product.

Patients should discontinue use and consult a healthcare professional if symptoms persist for more than 7 days. Additionally, contact with the eyes should be avoided; in the event of contact, the eyes should be rinsed with water immediately.

Warnings and Precautions

For external use only. Healthcare professionals should advise patients to avoid contact with the eyes while using this product. In the event of accidental eye contact, it is imperative to rinse the eyes thoroughly with water.

Patients are also instructed to discontinue use and consult a healthcare provider if symptoms persist for more than 7 days. This precaution is essential to ensure appropriate evaluation and management of any underlying conditions that may require further medical attention.

Side Effects

Patients should be aware that this product is for external use only. It is important to avoid contact with the eyes; in the event of contact, the affected area should be rinsed with water immediately.

In clinical practice, patients are advised to discontinue use and consult a healthcare professional if symptoms persist for more than 7 days. This precaution is essential to ensure appropriate management and to rule out any underlying conditions that may require further evaluation.

Drug Interactions

No specific drug interactions have been identified for the product. Additionally, there are no reported interactions with laboratory tests. 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 Sunburn Pain Relief (lidocaine hydrochloride 0.5%). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Sunburn Pain Relief.
Details

Pediatric Use

Pediatric patients aged 2 years and older may apply the medication to the affected area up to 3 to 4 times daily. For children under 2 years of age, it is recommended to consult a physician prior to use.

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 currently no information available regarding the use of lidocaine hydrochloride 0.5% gel during pregnancy, including safety concerns, dosage modifications, or any special precautions that should be taken. Given the absence of data, healthcare professionals are advised to exercise caution when considering the use of this medication in pregnant patients. The potential risks to fetal outcomes remain undetermined, and the decision to use this product should involve a careful assessment of the benefits versus the risks in each individual case. Women of childbearing potential should be informed of the lack of data and encouraged to discuss any concerns with their healthcare provider.

Lactation

There are no specific warnings or considerations regarding the use of this product by lactating mothers. Additionally, there are no known concerns related to the potential for excretion in breast milk or risks to breastfed infants during lactation.

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 this medication. Consequently, there is no information available regarding dosage adjustments, special monitoring requirements, or precautions 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 absence of data to guide treatment decisions 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 the management of the overdose effectively.

Documentation of the incident, including the substance involved, the amount taken, and the time of ingestion, is crucial for appropriate treatment 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 medical attention if their symptoms persist for more than 7 days. It is important for patients to understand that prolonged symptoms may indicate a need for further evaluation and management.

Additionally, healthcare providers should instruct patients to avoid contact with their eyes while using the medication. In the event of accidental contact, patients should be informed to rinse their eyes thoroughly with water to mitigate any potential irritation or adverse effects.

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, specifically within the range of 20°C to 25°C (68°F to 77°F). It is essential to protect the product from light exposure to ensure its stability. Once opened, the product should be discarded to prevent any potential degradation or contamination.

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 per day to the affected area. For children under 2 years of age, it is advised to consult a physician prior to use. 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 Sunburn Pain Relief, 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 Pain Relief, 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.