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Sunburn Pain Reliever

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This product has been discontinued

Active ingredient
Lidocaine Hydrochloride 0.5 g/100 g
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 2017
Label revision date
November 30, 2017
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Lidocaine Hydrochloride 0.5 g/100 g
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 2017
Label revision date
November 30, 2017
Manufacturer
CVS
Registration number
part348
NDC root
69842-840
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 provide temporary relief from pain and itching caused by various skin irritations, including sunburn, minor burns, insect bites, cuts, and scrapes. It works by soothing the affected area, helping to alleviate discomfort and promote healing. If you're experiencing any of these issues, this drug may help you feel more comfortable as your skin recovers.

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 when dealing with these common skin issues, allowing you to get back to your daily activities with less irritation.

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 or concerns regarding abuse, misuse, or dependence associated with this medication, following these instructions will help ensure your safety and well-being.

Side Effects

This product is intended for external use only, so it's important to avoid getting it in your eyes. If contact does occur, rinse your eyes 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 have concerns about a possible overdose, 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 professional advice if you think something might be wrong.

Pregnancy Use

When it comes to using this product during pregnancy, there is no specific information available in the drug insert. This means that there are no clear guidelines on whether the product is safe or poses any risks to you or your developing baby. Additionally, there are no recommendations for changing the dosage or taking special precautions while pregnant.

If you are pregnant or planning to become pregnant, it’s always best to consult with your healthcare provider before using any medication. They can help you weigh the potential benefits and risks based on your individual situation.

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 it. This ensures that the treatment is safe and appropriate for their age. Always prioritize your child's health by following these recommendations.

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 there are no specific guidelines, dosage adjustments, or monitoring requirements mentioned for your condition in the provided information. This means that the standard recommendations for medication use may apply to you without any special considerations. However, it's always best to discuss your individual health needs with your healthcare provider, as they can offer personalized advice based on your kidney function and overall health.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help monitor your liver function and determine the best course of action for your treatment.

Make sure to keep your doctor informed about your liver health, as they may need to conduct regular liver function tests (which check how well your liver is working) to ensure your safety while using any medication.

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 in a cool, dry place at a temperature between 20°C to 25°C (68°F to 77°F). It’s acceptable for the temperature to occasionally range from 15°C to 30°C (59°F to 86°F), but try to keep it within the recommended limits. 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 physician before use. There are no additional details available regarding laboratory tests, abuse potential, or postmarketing experiences related to this medication.

FAQ

What is the drug indicated for?

The drug is indicated for temporary relief of pain and itching due to sunburn, minor burns, insect bites, cuts, and scrapes.

How should adults and children 2 years of age and older use this drug?

Adults and children 2 years of age and older should apply the drug to the affected area no more than 3 to 4 times a day.

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 drug safe to use during pregnancy?

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

Can nursing mothers use this drug?

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 drug?

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

Are there any contraindications for this drug?

No contraindications are specified for this drug.

What should I do if I accidentally get this drug in my eyes?

If contact with eyes occurs, rinse with water immediately.

Packaging Info

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

Packaging configurations for Sunburn Pain Reliever.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The product is identified by the SPL code 34089-3. No additional specific description details are provided in the available text.

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 specified contraindications for this product. However, it is advised to discontinue use and consult a healthcare professional if symptoms persist for more than 7 days. Additionally, avoid contact with the eyes; in the event of contact, rinse thoroughly with water.

Warnings and Precautions

This product is intended for external use only. Healthcare professionals should advise patients to avoid contact with the eyes during application. In the event of accidental eye contact, it is imperative to rinse the eyes thoroughly with water.

Patients should be 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

There are no specific drug interactions identified for this medication. Additionally, no laboratory test interactions have been reported. 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 Reliever (lidocaine hydrochloride 0.5%). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Sunburn Pain Reliever.
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

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

There is no specific information regarding the use of this product in pregnant patients. The prescribing information does not indicate whether the product is contraindicated during pregnancy or outline any associated risks to the fetus. Additionally, there are no dosage modifications or special precautions recommended for use in this population. Healthcare professionals should consider the lack of data when prescribing this product to women of childbearing potential and weigh the potential benefits against any unknown risks.

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

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

Hepatic Impairment

There is no information available regarding the use of this medication in patients with hepatic impairment. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions specified for individuals with compromised liver function. Healthcare professionals should exercise clinical judgment when considering the use of this medication in patients with liver problems, as the absence of data necessitates careful evaluation of potential risks and benefits.

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 initiate supportive care, which may include maintaining airway patency, ensuring adequate ventilation, and monitoring vital signs.

If available, the use of specific antidotes or treatments should be considered based on the substance involved and the clinical presentation. Consultation with a poison control center or a medical toxicologist may provide additional guidance on the management of overdose cases.

Documentation of the incident, including the substance, amount ingested, and time of ingestion, is crucial for effective management and treatment planning.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

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 or misuse.

Patients should be informed to discontinue use and consult a doctor if their symptoms persist for more than 7 days, as this may indicate a need for further evaluation or alternative treatment options.

Additionally, it is important to instruct patients to avoid contact with their eyes while using this product. In the event of accidental contact, patients should be advised to rinse their eyes thoroughly with water to mitigate any potential irritation.

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 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 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 physician prior to 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 Sunburn Pain Reliever, 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 Reliever, 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.