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Sunburnt Plus

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Active ingredient
Lidocaine Hydrochloride 4 g/100 mL
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 2020
Label revision date
February 18, 2026
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Lidocaine Hydrochloride 4 g/100 mL
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 2020
Label revision date
February 18, 2026
Manufacturer
Quest Products, LLC.
Registration number
M017
NDC root
68229-600
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

This medication is designed to temporarily relieve pain and itching associated with various skin conditions. You can use it for sunburn, minor burns, insect bites, minor skin irritations, minor cuts, and scrapes. It provides soothing relief to help you feel more comfortable while your skin heals.

Uses

You can use this medication to temporarily relieve pain and itching caused by various skin issues. It is effective for soothing discomfort from sunburn, minor burns, insect bites, minor skin irritations, minor cuts, and scrapes.

This product is designed to help you feel more comfortable when dealing with these common skin problems, allowing you to get back to your daily activities with less irritation.

Dosage and Administration

To use this medication, start by cleaning the skin in the area where you will apply it. Once the skin is clean, you can apply the medication directly to the affected area.

For adults and children who are 2 years old and older, you should apply the medication no more than 3 to 4 times a day. If your child is under 2 years of age, it’s important to consult a doctor before using the medication. This ensures that you are using it safely and effectively.

What to Avoid

It's important to be cautious when using this medication. You should not use it if you have an allergy or hypersensitivity to any of its ingredients, as this could lead to serious reactions. Additionally, avoid applying the medication in large quantities, especially on raw surfaces or blistered areas, as this can increase the risk of adverse effects.

Always prioritize your safety by following these guidelines closely. If you have any concerns or questions about using this medication, consult your healthcare provider for personalized advice.

Side Effects

When using this product, it's important to apply it only to the skin and avoid using large amounts, especially on raw or blistered areas. If you have an allergy to any of the ingredients, or if you have severe sunburn, a rash, or broken skin, you should not use it. Be careful to keep it away from your eyes.

If your condition worsens, or if your symptoms last more than 7 days or return after clearing up, stop using the product and consult a doctor. Additionally, keep this product out of reach of children. If swallowed, seek medical help or contact a Poison Control Center immediately.

Warnings and Precautions

This product is for external use only, so please avoid applying it to large areas of your skin, especially over raw or blistered surfaces. If you have an allergy to any of the ingredients, do not use this product. It's important to consult your doctor before using it if you have severe sunburn, a rash, or any broken skin.

While using this product, be careful to keep it away from your eyes. If your condition worsens, or if your symptoms last more than 7 days or improve and then return within a few days, stop using the product and contact your doctor. Always keep this product out of reach of children, and if it is swallowed, seek medical help or contact a Poison Control Center immediately.

Overdose

If you or someone else has swallowed too much of a medication, it’s important to seek medical help immediately. You can do this by contacting a Poison Control Center or going to the nearest emergency room.

Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, don’t hesitate to get help right away. Remember, acting quickly can make a significant difference in the outcome.

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. You should consult your doctor before using this medication, as potential risks to your fetus are not clearly defined. It's advised to exercise caution and only use the gel if it is clearly needed and after discussing it with your healthcare provider.

There are no specific dosage modifications for pregnant individuals, but always prioritize open communication with your doctor regarding any medications you consider using during this time. Your health and the health of your baby are paramount, so ensure you have all the necessary information before making decisions.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of this product while nursing. Currently, there is no information available about whether this product is excreted in breast milk or any potential risks 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 this product while breastfeeding. Your health and the health of your baby are important, and your provider can help you make informed decisions.

Pediatric Use

If you have a child 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 in a day. Always follow these guidelines to ensure the safety and effectiveness of the treatment for your child.

Geriatric Use

When considering the use of Sunburnt Plus (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, safety concerns, or 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. They can provide personalized advice based on individual health needs and any other medications you may be taking.

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 determine the best approach for managing your health, especially if you have concerns about your kidneys.

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 or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you.

Always feel free to ask questions and share your complete list of medications and any lab tests you may be undergoing. This way, you can receive the best possible care tailored to your needs.

Storage and Handling

To ensure the safety and effectiveness of your product, store it in a cool, dry place at a temperature between 15-30°C (59-86°F). This temperature range helps maintain the product's quality. Before using it, always check that the seal under the cap is intact; do not use the product if the seal is open or missing, as this could compromise its safety.

By following these simple storage and handling guidelines, you can help ensure that the product remains safe and effective for your use.

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. There are no additional details available regarding laboratory tests, abuse potential, or patient counseling.

FAQ

What conditions can this drug help relieve?

This drug temporarily relieves pain and itching due to sunburn, minor burns, insect bites, minor skin irritations, minor cuts, and scrapes.

How should I apply this drug?

Clean the skin and apply to the affected area not more than 3-4 times daily for adults and children 2 years of age and older. For children under 2 years, consult a doctor.

Are there any contraindications for using this drug?

Do not use this drug if you have an allergy or hypersensitivity to any ingredients, or in large quantities over raw surfaces or blistered areas.

What should I do if my condition worsens?

Stop use and ask a doctor if your condition worsens or if symptoms last more than 7 days or recur within a few days.

Is this drug safe to use during pregnancy?

The safety of this drug during pregnancy has not been established. Consult a doctor before use if pregnant or planning to become pregnant.

What precautions should I take when using this drug?

Avoid contact with eyes, keep out of reach of children, and if swallowed, seek medical help or contact a Poison Control Center immediately.

What should I do if I have severe sunburn or broken skin?

Ask a doctor before using this product if you have severe sunburn or a rash, broken, or compromised skin.

How should I store this drug?

Store the drug at 15-30°C (59-86°F) and do not use if the seal under the cap is open or missing.

Packaging Info

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

Packaging configurations for Sunburnt Plus.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No description information is available for the specified drug.

Uses and Indications

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

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

Dosage and Administration

The affected area should be cleaned prior to application. For adults and children aged 2 years and older, the product may be applied 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 before use.

Contraindications

Use is contraindicated in patients with a known allergy or hypersensitivity to any of the ingredients in the product. Additionally, application in large quantities, especially over raw surfaces or blistered areas, is not recommended due to the potential for adverse effects.

Warnings and Precautions

This product is intended for external use only. It is imperative that healthcare professionals advise patients against using this product in large quantities, particularly on raw surfaces or blistered areas, to prevent potential adverse effects.

Patients should be cautioned not to use this product if they have a known allergy or hypersensitivity to any of its ingredients. Prior to use, individuals with severe sunburn, rashes, or broken or compromised skin should consult a healthcare provider to assess the appropriateness of this treatment.

During application, it is essential to avoid contact with the eyes. If the condition being treated worsens, or if symptoms persist for more than 7 days or resolve only to recur within a few days, patients should discontinue use and seek medical advice.

Additionally, this product should be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center should be made without delay.

Side Effects

Patients using this product should be aware that it is intended for external use only. It is contraindicated for use in large quantities, particularly over raw surfaces or blistered areas, and should not be used by individuals with an allergy or hypersensitivity to any of its ingredients.

Before using this product, patients are advised to consult a healthcare professional if they have severe sunburn, a rash, or broken or compromised skin. During application, it is important to avoid contact with the eyes.

Patients should discontinue use and seek medical advice 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, this product should be kept out of reach of children. In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

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

Packaging configurations for Sunburnt Plus.
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 not more than 3-4 times daily.

Geriatric Use

There is no specific information regarding the use of Sunburnt Plus (lidocaine hydrochloride gel) in geriatric patients. The prescribing information does not provide guidance on dosage adjustments, safety concerns, or special precautions for elderly patients. Therefore, 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 advisable when administering this product to elderly individuals.

Pregnancy

The safety of lidocaine hydrochloride gel during pregnancy has not been established. Pregnant patients or those planning to become pregnant should consult a healthcare provider before use. Potential risks to the fetus are not clearly defined; therefore, caution is advised when considering the use of this medication in pregnant individuals. No specific dosage modifications for pregnant patients are provided. It is recommended that lidocaine hydrochloride gel be used only if clearly needed and after a thorough discussion with a healthcare provider regarding the potential risks and benefits.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there is no information available about the potential for excretion 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 this medication to individuals with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment and monitoring of these patients.

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. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical help or contact a Poison Control Center without delay.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are recommended to ensure patient safety and effective resolution of any complications arising from the 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 assessment of potential risks associated with the use of the compound in these contexts.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. Instruct patients that if the product is swallowed, they should seek medical help or contact a Poison Control Center immediately.

Patients should be cautioned against using the product in large quantities, especially on raw surfaces or blistered areas, as this may lead to adverse effects. It is important to inform patients that they should not use the product if they have an allergy or hypersensitivity to any of its ingredients.

Healthcare providers should encourage patients to stop using the product and consult a doctor if their condition worsens or if symptoms persist for more than 7 days. Additionally, patients should be advised to seek medical advice if symptoms improve and then recur within a few days.

While using the product, patients must be reminded to avoid contact with their eyes. Providers should also recommend that patients consult a doctor before using the product if they have severe sunburn, a rash, or broken or compromised skin.

Storage and Handling

The product is supplied in a configuration that includes an NDC number for identification. It should be stored at a temperature range of 15-30°C (59-86°F) to ensure its stability and efficacy.

Healthcare professionals are advised to inspect the product prior to use; it should not be utilized if the seal under the cap is open or missing, as this may compromise the integrity of the product. Proper handling and storage conditions are essential to maintain the quality of the product throughout its shelf life.

Additional Clinical Information

The medication is administered topically, with a recommended application frequency of 3-4 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 experiences.

Drug Information (PDF)

This file contains official product information for Sunburnt Plus, 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 Sunburnt Plus, 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.