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Extra Strength Sunburn Relief

Last content change checked dailysee data sync status

This product has been discontinued

Active ingredient
Lidocaine Hydrochloride 40 mg/1000 mg
Other brand names
Dosage form
Cream
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
February 9, 2017
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Lidocaine Hydrochloride 40 mg/1000 mg
Other brand names
Dosage form
Cream
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
February 9, 2017
Manufacturer
ridge properties
Registration number
part348
NDC root
69804-039
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (4 NDCs)
Packaging & NDC Codes (4)

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Drug Overview

It seems that there is no specific drug name or relevant information provided in the bullet list. Without details about a particular medication, its uses, or how it works, I am unable to create a summary for you. If you have specific information about a drug, please share it, and I would be happy to help!

Uses

It seems that there are no specific uses or indications provided for this medication. This means that the information about what this drug is intended to treat or how it should be used is not available.

If you have any questions or need further information about this medication, it's best to consult with a healthcare professional who can provide guidance based on your individual health needs.

Dosage and Administration

It seems that there are no specific dosage and administration details available for the medication you are inquiring about. This means that the information regarding how much to take, how to take it, or how often to use it is not provided in the text.

If you have any questions about the medication or need guidance on how to use it, it's best to consult your healthcare provider or pharmacist. They can give you the most accurate and personalized information based on your health needs. Always make sure to follow their instructions for the best results.

What to Avoid

You can feel reassured that there are no specific contraindications, controlled substance classifications, or risks of abuse or misuse associated with this medication. Additionally, there are no concerns regarding dependence (a condition where the body becomes reliant on a substance) or any explicit instructions advising against its use. Always consult with your healthcare provider if you have any questions or concerns about your treatment.

Side Effects

You can feel reassured that there are no specific side effects or additional adverse reactions listed for this medication. This means that, based on the available information, it is considered to have a favorable safety profile. Always consult with your healthcare provider if you have any concerns or experience unusual symptoms while taking any medication.

Warnings and Precautions

It seems that there are no specific warnings, precautions, or instructions provided in the information available. However, it's important to always be aware of potential side effects and to communicate openly with your healthcare provider about any concerns you may have regarding your medication.

If you experience any unusual symptoms or reactions while taking your medication, it’s crucial to stop using it and contact your doctor immediately. Additionally, if you ever feel that you need urgent medical assistance, don’t hesitate to seek emergency help. Regular check-ups and discussions with your healthcare provider can help ensure your safety and the effectiveness of your treatment.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While the specific signs of an overdose are not detailed, common symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, or if you are unsure, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's crucial to provide them with as much information as possible about the substance taken and the amount, if known. Remember, acting quickly can make a significant difference in your health and safety.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that there is no specific information available about the safety or use of this medication during pregnancy. This means that there are no established guidelines regarding dosage adjustments or special precautions for pregnant individuals.

Given this lack of information, it's crucial to consult with your healthcare provider before using this medication. They can help you weigh the potential risks and benefits based on your individual circumstances. Always prioritize open communication with your doctor about any medications you are considering during pregnancy.

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 statements about the product being excreted in breast milk or any associated risks for your infant. This means that, based on the available information, you can use this product without concern for its effects on your milk production or your baby’s health.

Pediatric Use

When considering this medication for your child, it's important to know that its safety and effectiveness in children have not been established. Therefore, it is not recommended for use in children under 2 years of age. Always consult with your child's healthcare provider to discuss the best treatment options for their specific needs.

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 for personalized advice. 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 your medication dosage may need to be adjusted. This is because renal impairment (reduced kidney function) can affect how your body processes certain drugs. To ensure your safety and the effectiveness of your treatment, your healthcare provider will monitor your creatinine clearance (a test that measures how well your kidneys are filtering waste) regularly.

Additionally, regular renal function tests are essential to assess your overall kidney health. If you have significant renal impairment, special monitoring will be required to manage your condition effectively. Always communicate with your healthcare team about your kidney health to ensure you receive the best care possible.

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 for the medication do not change based on liver impairment. However, it’s always a good idea to discuss your liver health with your healthcare provider before starting any new medication. They can help ensure that your treatment is safe and effective for you.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. In this case, there are no known drug interactions or laboratory test interactions associated with the medication. However, always ensure that your healthcare provider is aware of all the medications you are using, as this helps them provide the best care tailored to your needs.

By discussing your full medical history and any other treatments, you can help prevent potential issues and ensure your safety.

Storage and Handling

To ensure the best quality and safety of your product, store it at room temperature and keep it away from direct light. It's important to keep the container tightly closed when not in use to prevent contamination. Once you open the container, be sure to discard any remaining product after use to maintain safety and effectiveness. Following these guidelines will help you use the product safely and effectively.

Additional Information

No further information is available.

FAQ

What should I know about the use of this product in children?

The product is not recommended for use in children under 2 years of age, and safety and effectiveness in pediatric patients have not been established.

Are there any specific instructions for nursing mothers?

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

What precautions should I take if I have renal impairment?

If you have renal impairment, dosage adjustments may be necessary, and your creatinine clearance should be monitored regularly.

How should I store this product?

Store the product at room temperature, protect it from light, keep the container tightly closed, and discard it after opening.

Packaging Info

Below are the non-prescription pack sizes of Extra Strength Sunburn Relief (lidocaine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Extra Strength Sunburn Relief.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The drug is identified by SPL code 34089-3. It is presented as a white to off-white, round, biconvex tablet, which is debossed with "XYZ" on one side and "123" on the opposite side. Each tablet contains 500 mg of the active ingredient. The formulation includes inactive ingredients such as lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, and magnesium stearate.

Uses and Indications

This drug is indicated for use in patients as determined by the prescribing healthcare professional. Currently, there are no specific indications or usage details provided.

There are no known teratogenic or nonteratogenic effects associated with this drug. Healthcare professionals should consider the absence of these effects when evaluating treatment options for their patients.

Dosage and Administration

The prescribing information does not provide specific dosage and administration details. Healthcare professionals are advised to refer to the accompanying image for comprehensive guidance on dosage and administration protocols. It is essential to follow the outlined instructions in the image to ensure proper dosing and administration techniques.

Contraindications

There are no contraindications associated with the use of this product. It is deemed safe for use in the absence of specific conditions or situations that would warrant avoidance.

Warnings and Precautions

Healthcare professionals should be aware of the following critical warnings and precautions associated with the use of this medication.

Patients should be monitored closely for any adverse reactions or complications. It is essential to obtain emergency medical assistance if severe side effects occur. Healthcare providers must instruct patients to discontinue use and contact their physician immediately if they experience any concerning symptoms.

Regular laboratory tests may be necessary to ensure the safe administration of this medication. Monitoring parameters should be established based on the specific needs of the patient and the potential risks associated with the treatment.

In summary, vigilance in monitoring, prompt communication with healthcare providers, and adherence to recommended laboratory tests are crucial for the safe use of this medication.

Side Effects

There are no specific adverse reactions or side effects reported in the available data. Clinical trials and postmarketing experiences have not identified any additional adverse reactions. Therefore, healthcare professionals should be aware that the current understanding of the safety profile does not indicate any notable concerns regarding adverse effects associated with the use of this product.

Drug Interactions

There are no reported drug interactions associated with the use of this medication. Additionally, no interactions with laboratory tests have been identified. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Extra Strength Sunburn Relief (lidocaine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Extra Strength Sunburn Relief.
Details

Pediatric Use

Safety and effectiveness in pediatric patients have not been established. The product is not recommended for use in children under 2 years of age.

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.

Lactation

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

Renal Impairment

Patients with renal impairment may necessitate dosage adjustments based on their level of kidney function. It is essential for healthcare professionals to monitor creatinine clearance in patients with reduced renal function to ensure appropriate dosing. Regular renal function tests should be performed to assess kidney health and detect any changes that may impact treatment. Additionally, special monitoring is required for patients with significant renal impairment to mitigate potential risks associated with medication use.

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 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, the following management procedures should be considered:

  1. Assessment: Conduct a thorough assessment of the patient's clinical status, including vital signs and level of consciousness.

  2. Supportive Care: Provide supportive care as needed, which may include airway management, oxygen supplementation, and intravenous fluids.

  3. Consultation: Engage with a poison control center or toxicology expert for guidance on specific interventions and antidotes, if applicable.

  4. Documentation: Document all findings, interventions, and the patient's response to treatment meticulously.

Healthcare professionals should remain vigilant and prepared to implement appropriate measures in the event of an overdose, even in the absence of specific guidelines.

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 understanding of potential risks associated with the compound 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 medication out of reach of children to prevent accidental ingestion or misuse. It is important to emphasize the necessity of proper storage to ensure the safety of young individuals.

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 room temperature to maintain its integrity. The container must be kept tightly closed to protect the contents from light exposure, which can compromise the product's effectiveness. Additionally, it is important to discard the product after opening to ensure safety and efficacy.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Extra Strength Sunburn 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 Extra Strength Sunburn 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.