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Cvs Health Sunburn Relief Cooling Lidocaine 0.5 Pain-Relieving

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Active ingredient
Lidocaine Hydrochloride 5 mg/1 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
October 17, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Lidocaine Hydrochloride 5 mg/1 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
October 17, 2024
Manufacturer
CVS Pharmacy
Registration number
M017
NDC root
51316-022
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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 issues, including sunburn, minor burns, cuts, scrapes, insect bites, and other minor skin irritations. It helps soothe discomfort and promotes a sense of relief, allowing you to feel more comfortable while your skin heals.

Uses

You can use this medication for the temporary relief of pain and itching caused by various skin issues. This includes discomfort from sunburn, minor burns, cuts, scrapes, insect bites, and other minor skin irritations.

It's important to note that there are no reported teratogenic effects (which means it doesn't cause birth defects) associated with this medication, making it a safer option for those concerned about such risks.

Dosage and Administration

If you or your child is 2 years old or older, you can apply the medication to the affected area up to 3 to 4 times a day. Make sure to follow this guideline to ensure the best results. However, if your child is under 2 years old, it’s important to consult a doctor before using the medication. They can provide the best advice tailored to your child's needs.

What to Avoid

It's important to use this medication responsibly. You should avoid using it in large quantities, especially on raw surfaces or blistered areas, as this can lead to complications. While there are no specific contraindications or concerns about abuse, misuse, or dependence associated with this medication, always follow the recommended guidelines to ensure your safety and well-being. If you have any questions or concerns, don't hesitate to reach out to your healthcare provider for more information.

Side Effects

It's important to use this product only on the skin and not for any other purpose. If your condition worsens, if symptoms last longer than 7 days, or if symptoms improve and then return within a few days, you should stop using the product and consult a doctor. These steps will help ensure your safety and well-being while using the medication.

Warnings and Precautions

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

If you accidentally swallow this product, seek medical help or contact a Poison Control Center right away. You should also stop using the product and call your doctor if your condition worsens, if your symptoms last longer than 7 days, or if your symptoms improve and then return within a few days.

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 signs of overdose for this medication, general symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's always better to be safe and get checked by a healthcare professional if you have any concerns about your health. Remember, timely intervention can make a significant difference.

Pregnancy Use

When it comes to using this medication during pregnancy, there is no specific information available about its safety, recommended dosage adjustments, or any special precautions you should take. This means that the effects of the medication on you and your developing baby are not well understood.

If you are pregnant or planning to become pregnant, it’s important to discuss any medications you are taking with your healthcare provider. They can help you weigh the potential risks and benefits to ensure the best care 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 are no known concerns about the product being passed into breast milk or any associated risks for your infant. This means you can use the product without worrying about its effects on your milk production or your baby's health.

Pediatric Use

When using this medication for children, you can apply it to the affected area no more than 3 to 4 times a day for kids aged 2 years and older. However, if your child is under 2 years old, it's important to consult a doctor before use. This ensures their safety and proper care. Always follow these guidelines to help manage your child's condition effectively.

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 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 feel free to ask questions or express any concerns you may have regarding your medications or tests.

Storage and Handling

To ensure the best use of your product, it's important to handle it with care. Be aware that it may stain some fabrics, so take precautions to avoid contact with clothing or other materials that could be damaged.

When storing the product, keep it in a safe place where it won't be exposed to extreme temperatures or conditions that could affect its quality. Always follow any specific instructions provided for storage to maintain its effectiveness and safety.

Additional Information

You can use this medication topically, applying it to the affected area no more than 3 to 4 times a day if you are an adult or a child aged 2 years and older. If your child 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 drug used for?

The drug is used for the temporary relief of pain and itching associated with sunburn, minor burns, minor cuts, scrapes, insect bites, and minor skin irritations.

How should I apply the drug?

Adults and children 2 years and older should apply it to the affected area not more than 3 to 4 times daily. For children under 2 years of age, you should ask a doctor.

Are there any contraindications for this drug?

No specific contraindications are mentioned for this drug.

What should I do if my condition worsens?

You should stop using the drug and ask a doctor if your condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then occur again within a few days.

Is this drug safe to use during pregnancy?

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

Can nursing mothers use this drug?

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

What should I do if I accidentally swallow the drug?

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

Are there any warnings I should be aware of?

This drug is for external use only, and you should avoid contact with eyes. If contact occurs, rinse with water to remove.

Can this drug stain fabrics?

Yes, the drug may stain some fabrics.

Packaging Info

Below are the non-prescription pack sizes of Cvs Health Sunburn Relief Cooling Lidocaine 0.5 Pain-Relieving (lidocaine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Cvs Health Sunburn Relief Cooling Lidocaine 0.5 Pain-Relieving.
Details

Drug Information (PDF)

This file contains official product information for Cvs Health Sunburn Relief Cooling Lidocaine 0.5 Pain-Relieving, 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 data.

Uses and Indications

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

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 more than 3 to 4 times daily. It is important to ensure that the application is limited to the specified frequency to avoid potential adverse effects.

For children under 2 years of age, it is advised to consult a physician prior to use. This precaution is essential to ensure safety and appropriateness of treatment for this age group.

Contraindications

The product should not be used in large quantities, particularly over raw surfaces or blistered areas, due to the potential for adverse effects in these conditions. No other specific contraindications have been identified.

Warnings and Precautions

For external use only. It is imperative to avoid contact with the eyes; should contact occur, the affected area must be rinsed thoroughly with water to remove the substance.

In the event of ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Healthcare professionals should advise patients to discontinue use and consult a physician if any of the following occur: the condition worsens, symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. These precautions are essential to ensure patient safety and effective management of their condition.

Side Effects

For external use only. Patients are advised to discontinue use and consult a healthcare professional if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days.

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 Cvs Health Sunburn Relief Cooling Lidocaine 0.5 Pain-Relieving (lidocaine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Cvs Health Sunburn Relief Cooling Lidocaine 0.5 Pain-Relieving.
Details

Pediatric Use

Pediatric patients aged 2 years and older may apply the medication to the affected area no more than 3 to 4 times daily. For children under 2 years of age, it is advised to consult a doctor before 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 no specific information available regarding the use of this medication during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled on the importance of effective contraception during treatment and the need to inform their healthcare provider if they become pregnant or plan to become pregnant while using this medication.

Lactation

There are no specific warnings or recommendations regarding the use of this product by lactating mothers. Additionally, there are no statements concerning the potential for excretion in breast milk or any associated risks to breastfed infants during the use of this product.

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 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 absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and consider 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 and symptomatic treatment as necessary. This may include monitoring vital signs, providing respiratory support, and administering intravenous fluids if indicated.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols tailored to the substance involved.

Overall, due diligence in assessing the patient's condition and implementing appropriate interventions is crucial in managing any suspected overdose effectively.

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

Patients should be advised to seek medical help or contact a Poison Control Center immediately if the product is swallowed. It is important to inform patients not to use the product in large quantities, especially over raw surfaces or blistered areas, as this may lead to adverse effects.

Patients should be instructed to stop using the product and consult a doctor if their condition worsens or if symptoms persist for more than 7 days. Additionally, they should be made aware that if symptoms clear up and then reoccur within a few days, they should also stop use and seek medical advice.

While using this product, patients must be cautioned to avoid contact with their eyes. In the event of accidental contact, they should rinse their eyes with water immediately to remove the product.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is important to note that the product may stain some fabrics, and therefore, care should be taken during handling to avoid contact with clothing and other materials that may be susceptible to staining.

For optimal storage, the product should be kept at controlled room temperature, ensuring that it is protected from excessive heat and moisture. Containers should be sealed properly to maintain product integrity and prevent contamination. Special handling precautions should be observed to minimize the risk of spills or exposure to sensitive surfaces.

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 Cvs Health Sunburn Relief Cooling Lidocaine 0.5 Pain-Relieving, 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 Cvs Health Sunburn Relief Cooling Lidocaine 0.5 Pain-Relieving, 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.