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Sunburnt Plus Pain Relief

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Active ingredient
Lidocaine Hydrochloride 1 g/100 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 2018
Label revision date
March 13, 2018
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Lidocaine Hydrochloride 1 g/100 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 2018
Label revision date
March 13, 2018
Manufacturer
Welmedix LLC dba Welmedix Consumer Healthcare
Registration number
part348
NDC root
24330-240
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

SUNBURNT® PLUS PAIN RELIEF GEL is a topical gel that contains lidocaine HCl (a local anesthetic) at a concentration of 1%. It is designed to provide fast relief from pain and itching associated with various skin issues, including sunburn, minor burns, insect bites, minor skin irritations, minor cuts, and scrapes. The gel is ultra-hydrating and features nourishing botanicals, all while maintaining a non-sticky formula for your comfort.

When applied, this gel temporarily alleviates discomfort, helping you feel more at ease during recovery from these common skin conditions.

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. Whether you've had a day in the sun or a run-in with an insect, this medication can help you feel more comfortable.

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 safe and effective use tailored to younger children.

What to Avoid

You should avoid using this product in large quantities, especially on raw surfaces or blistered areas, as this can lead to irritation or other complications. Additionally, if you have an allergy or hypersensitivity to any of the ingredients, it is important not to use this product to prevent adverse reactions. 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 remember that it is for external use only. Avoid applying it in large amounts, especially on raw or blistered skin, and do not use it if you are allergic to any of its ingredients. If you have severe sunburn or a rash, or if your skin is broken or compromised, consult your doctor before using it.

While using the product, be careful to keep it away from your eyes. If your condition worsens, if symptoms persist for more than 7 days, or if they improve and then return within a few days, stop using the product and seek medical advice. Additionally, if the product is swallowed, seek medical help or contact a Poison Control Center immediately.

Warnings and Precautions

This product is for external use only, so please avoid using it on 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 return after clearing up, stop using the product and contact your doctor. Always keep this product out of reach of children. If a child accidentally swallows it, 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. Acting quickly can make a significant difference in the outcome.

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, it’s always better to be safe and seek assistance if you suspect an overdose has occurred.

Pregnancy Use

Currently, there is no information available about the use of SunBurnt Plus Pain Relief Gel 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 during pregnancy.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to consult your doctor before using this product. There is a possibility that it may be excreted in breast milk, which means it could potentially affect your nursing infant. However, the specific effects on infants who are breastfed are not known. Always prioritize your health and your baby's well-being by discussing any medications or products with your healthcare provider.

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 in a day. Always follow these guidelines to ensure your child's safety and well-being.

Geriatric Use

While there is no specific information about the use of SunBurnt Plus Pain Relief Gel in older adults, it's always important to approach any new medication with caution. Since the drug insert does not mention dosage adjustments or safety concerns for elderly patients, you should consult with a healthcare professional before using this product. They can provide personalized advice based on your health needs and any other medications you may be taking.

As a caregiver or older adult, being aware of how your body may respond to new treatments is crucial. Always prioritize open communication with your healthcare provider to ensure safe and effective use of any medication.

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 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 differently due to your liver health.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific situation. They can help determine the best approach based on your liver function and overall health.

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 lab 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 15-30ºC (59-86ºF). This range helps maintain its quality. Always check the seal under the cap before use; 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 needs.

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 SUNBURNT® PLUS PAIN RELIEF GEL used for?

SUNBURNT® PLUS PAIN RELIEF GEL is used to temporarily relieve pain and itching due to sunburn, minor burns, insect bites, minor skin irritations, minor cuts, and scrapes.

How should I apply SUNBURNT® PLUS PAIN RELIEF GEL?

Clean the skin and apply the gel 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 warnings associated with this product?

Yes, it is for external use only. Avoid contact with eyes and do not use in large quantities, especially over raw surfaces or blistered areas.

What should I do if I experience worsening symptoms?

Stop using the product and consult a doctor if your condition worsens or if symptoms last more than 7 days or recur within a few days.

Can I use this product if I am pregnant or nursing?

There is no specific information regarding use during pregnancy. Nursing mothers should consult a doctor before use, as there is a potential for excretion in breast milk.

What should I do if I accidentally swallow SUNBURNT® PLUS PAIN RELIEF GEL?

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

What ingredients are in SUNBURNT® PLUS PAIN RELIEF GEL?

The gel contains LIDOCAINE HCL 1%, which helps to provide fast relief for pain and itch.

Is there any information on drug interactions?

No specific drug interactions are mentioned for SUNBURNT® PLUS PAIN RELIEF GEL.

Packaging Info

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

Packaging configurations for Sunburnt Plus Pain Relief.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

SUN BURNT® PLUS PAIN RELIEF GEL contains Lidocaine HCl at a concentration of 1%. This formulation is designed to provide fast relief from pain and itching associated with sunburn. The gel is ultra-hydrating and incorporates nourishing botanicals to enhance skin care. It features a non-sticky formula, ensuring ease of application. The product is available in a net weight of 5 oz (142 g).

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 the following situations:

Patients should not use this product in large quantities, especially over raw surfaces or blistered areas, due to the potential for exacerbating irritation or injury. Additionally, individuals with a known allergy or hypersensitivity to any of the ingredients should avoid use to prevent adverse reactions.

Warnings and Precautions

For external use only. This product should not be applied in large quantities, especially over raw surfaces or blistered areas. It is contraindicated in individuals with known allergies 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 are instructed to discontinue use and seek medical advice if their condition worsens, or if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days.

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 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 a known 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 or if they are experiencing a rash or have 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 resolve and then recur within a few days.

In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately.

Drug Interactions

No specific drug interactions have been identified in the available data. 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 Sunburnt Plus Pain Relief (lidocaine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Sunburnt Plus Pain Relief.
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 Pain Relief Gel in geriatric patients. The prescribing information does not provide details on dosage adjustments, safety concerns, or special precautions for elderly patients. Therefore, healthcare providers should exercise caution and consider individual patient factors when prescribing this medication to geriatric patients, as the absence of specific data necessitates careful monitoring and assessment of treatment efficacy and safety in this population.

Pregnancy

There is currently no information available regarding the use of SunBurnt Plus Pain Relief Gel during pregnancy. This includes any safety concerns, dosage modifications, or special precautions that may be necessary for pregnant patients. Healthcare professionals should exercise caution when considering the use of this product in women of childbearing potential, as the lack of data precludes a comprehensive assessment of potential risks to fetal outcomes. It is advisable to weigh the benefits against any unknown risks when prescribing this medication to pregnant patients.

Lactation

Lactating mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and the effects on a nursing infant are not known.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the prescribing information regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients 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 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 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; therefore, a thorough assessment by a medical professional is recommended to determine the appropriate course of action.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are advised 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 for SUNBURNT PLUS PAIN RELIEF (lidocaine hydrochloride gel).

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. It is important to emphasize that if the medication is swallowed, patients should seek medical help or contact a Poison Control Center immediately. This guidance is crucial to ensure the safety and well-being of patients, particularly in households with children.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers. It should be stored at a temperature range of 15-30ºC (59-86ºF) to maintain its integrity and efficacy. It is essential to ensure that the container is intact; do not use the product if the seal under the cap is open or missing. Proper handling and storage conditions are critical to ensure the product remains safe and effective for use.

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 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 Sunburnt Plus 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.