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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 2024
Label revision date
February 23, 2024
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 2024
Label revision date
February 23, 2024
Manufacturer
Quest Products, LLC.
Registration number
M017
NDC root
68229-601
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 issues like sunburn, minor burns, insect bites, minor skin irritations, minor cuts, and scrapes. It works by soothing the affected area, helping to alleviate discomfort and promote healing.

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, and minor skin irritations. Additionally, it can help with pain and itching associated with minor cuts and scrapes.

This product is designed to provide quick relief, making it a handy option for everyday skin irritations.

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 the person using the medication is under 2 years of age, it’s important to consult a doctor before applying it. This ensures safety and proper use for younger children.

What to Avoid

You should avoid using this medication if you have an allergy or hypersensitivity to any of its ingredients, as this could lead to serious reactions. Additionally, do not apply it in large quantities, especially on raw surfaces or blistered areas, as this can increase the risk of adverse effects. Always prioritize your safety and consult with a healthcare professional if you have any concerns.

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 improve and then return within a few days, stop using the product and consult a doctor. Additionally, keep it out of reach of children, and 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 seven days or return after clearing up, stop using the product and contact your doctor. Always keep this product out of reach of children. If swallowed, seek medical help or contact a Poison Control Center immediately.

Overdose

If you or someone else has swallowed a medication and you suspect an overdose, it’s important to act quickly. You should seek medical help immediately or contact a Poison Control Center for guidance.

Signs of an overdose can vary, but they may include unusual symptoms that are not typical for the medication. Always err on the side of caution and get help if you are unsure. Remember, timely action can make a significant difference in ensuring safety and health.

Pregnancy Use

You can use SUNBURNT PLUS (lidocaine hydrochloride gel) during pregnancy, as there are no specific warnings, precautions, or dosage changes mentioned for its use in this context. The information provided does not indicate that the product is contraindicated (not recommended) during pregnancy, nor does it suggest any risks to the fetus.

However, it's always a good idea to consult with your healthcare provider before using any medication while pregnant to ensure it’s safe for you and your baby.

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. Additionally, there is no information available about whether this product is excreted in breast milk or any potential risks to your infant. Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

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 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

When it comes to using SUNBURNT PLUS (lidocaine hydrochloride gel) for older adults, there is no specific information available regarding dosage adjustments or safety concerns. This means that the standard recommendations apply, but it’s always wise to consult with a healthcare provider before starting any new medication.

If you or a loved one are considering this gel, be sure to discuss any existing health conditions or medications with your doctor, as they can provide personalized advice and ensure safe use. Remember, your healthcare provider is the best resource for understanding how any medication may affect you, especially as you age.

Renal Impairment

If you have kidney problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or safety considerations for your condition. This means that there are no tailored guidelines for how this medication may affect you if you have renal impairment (kidney issues).

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

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 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 share your complete list of medications and any tests you may undergo to avoid any potential issues.

Storage and Handling

To ensure the safety and effectiveness of your product, store it at a temperature between 15-30°C (59-86°F). This range helps maintain its quality. Before using the product, always check that the seal under the cap is intact; do not use it 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 is the primary use of this drug?

The drug temporarily relieves pain and itching due to conditions like 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, ask 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 clear up and occur again within a few days.

Is this drug safe to use during pregnancy?

There are no specific warnings or contraindications regarding the use of this drug during pregnancy mentioned in the provided information.

Can nursing mothers use this drug?

There are no specific warnings or recommendations regarding the use of this product in nursing mothers.

What should I do if I accidentally swallow this drug?

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

What are the storage conditions for 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

The product is a topical formulation intended for external use only, packaged in a 118 mL tube. It contains the active ingredient: active ingredient name. The formulation includes inactive ingredients such as list of inactive ingredients. The product exhibits a color/appearance description and has a pH of pH value. Additionally, it is characterized by specific characteristics, e.g., fragrance, texture.

Uses and Indications

This drug is indicated for the temporary relief of pain and itching associated with 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. Additionally, the product should not be applied in large quantities, especially over raw surfaces or blistered areas, due to the potential for adverse effects.

Warnings and Precautions

For external use only. This product should not be applied in large quantities, especially on raw surfaces or blistered areas. It is contraindicated in individuals with a known allergy or hypersensitivity to any of its ingredients.

Healthcare professionals should advise patients to consult a doctor prior to use if they have severe sunburn or if they present with a rash or any broken or compromised skin. During application, it is crucial to avoid contact with the eyes to prevent irritation.

Patients should be instructed 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.

Additionally, this product must 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 of several important warnings and precautions. This product is intended for external use only. It should not be applied in large quantities, particularly over raw surfaces or blistered areas. Patients with known allergies or hypersensitivity to any of the ingredients should refrain from using this product.

Before using the product, patients are advised to consult a healthcare professional if they have severe sunburn, a rash, or broken or compromised skin. While using the product, it is crucial 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 help or contact a Poison Control Center immediately.

Drug Interactions

There are no specific drug interactions reported for this medication. Additionally, no laboratory test interactions have been identified in the available data. 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 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 medication may be applied to the affected area no more than 3 to 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 and the potential for altered pharmacokinetics and pharmacodynamics in this population. Monitoring for efficacy and adverse effects is recommended when administering SUNBURNT PLUS to elderly patients.

Pregnancy

There are no specific warnings, precautions, or dosage modifications regarding the use of SUNBURNT PLUS (lidocaine hydrochloride gel) during pregnancy. The available data does not indicate whether the product is contraindicated in pregnancy or if there are any associated risks to the fetus. Healthcare professionals should consider the potential benefits and risks when prescribing this product to pregnant patients, as well as the lack of established safety data in this population.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there is no information available concerning the potential for excretion in breast milk or any associated risks to breastfed infants.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the drug insert regarding dosage adjustments, special monitoring, or safety considerations. 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. 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 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 provided in the insert.

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 instruct patients not to use the product in large quantities, especially on raw surfaces or blistered areas, to prevent potential complications.

Patients should be informed that they must not use the product if they have a known allergy or hypersensitivity to any of its ingredients. They should be encouraged to stop using the product and consult a doctor if their condition worsens or if symptoms persist for more than 7 days, or if symptoms improve and then recur within a few days.

When discussing the use of this product, healthcare providers should emphasize the importance of avoiding contact with the eyes. Additionally, patients should be advised to consult a doctor before using the product if they have severe sunburn, a rash, or any broken or compromised skin.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at a temperature range of 15-30°C (59-86°F) to maintain its integrity and efficacy.

Care should be taken to ensure that the seal under the cap remains intact; the product should not be used if this seal is open or missing, as this may compromise the quality and safety of the product. Proper handling and storage conditions are crucial for optimal performance.

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, clinicians are 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

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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.