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Sore 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
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
June 19, 2020
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Lidocaine Hydrochloride 40 mg/1000 mg
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
June 19, 2020
Manufacturer
ridge properties llc
Registration number
part348
NDC root
69804-077
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (3 NDCs)
Packaging & NDC Codes (3)

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Drug Overview

It seems that there is no specific drug name or detailed information provided in the bullet list. Therefore, I am unable to create a summary about what the drug is or its uses. If you have a specific drug name or additional details, please share them, and I would be happy to help you with a consumer-friendly summary.

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.

Additionally, there are no mentions of teratogenic effects (which are harmful effects on a developing fetus) or nonteratogenic effects (which do not affect fetal development). If you have any questions or need further information about this medication, it's best to consult with a healthcare professional.

Dosage and Administration

It seems that the specific dosage and administration details for the medication you are inquiring about are not available in the information provided. Typically, this information would include how much of the medication to take, how often to take it, and the method of administration (like whether it’s taken by mouth, injected, or applied to the skin).

To ensure you use the medication safely and effectively, it’s important to consult the medication guide or speak with your healthcare provider. They can provide you with the necessary instructions tailored to your needs. Always follow their guidance for the best results.

What to Avoid

There are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this medication. Additionally, there are no explicit instructions indicating that you should not take or use this medication. Always consult with your healthcare provider for personalized advice and to ensure safe use.

Side Effects

You may not experience any specific side effects from this medication, as there are no adverse reactions or warnings listed in the provided information. It's always important to monitor how you feel while taking any medication and to discuss any concerns with your healthcare provider. If you notice anything unusual, be sure to reach out for guidance.

Warnings and Precautions

It's important to be aware of certain warnings and precautions when using this medication. While specific details are not provided here, you should consult the accompanying images for comprehensive information on potential risks and necessary precautions.

You may need to undergo specific laboratory tests while using this medication, so be sure to follow your healthcare provider's recommendations. If you experience any severe side effects or unusual symptoms, seek emergency medical help immediately. Additionally, if you notice any concerning changes in your health, stop taking the medication and contact your doctor right away. Always prioritize your safety and well-being.

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, 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 always better to be safe and get checked by a healthcare professional if you have any concerns about your health.

Pregnancy Use

It’s important to know that the safety of this medication during pregnancy has not been established. Because of potential risks to the developing fetus, it is advised that you do not use this medication if you are pregnant. Always consult with your healthcare provider for guidance and to discuss any concerns regarding medications while you are pregnant or planning to become pregnant. Your health and the health of your baby are the top priority.

Lactation Use

When it comes to breastfeeding, it's important to be aware that there are no specific guidelines or statements regarding nursing mothers or lactation (the process of producing milk). This means that if you are breastfeeding, you may not find detailed information about how certain medications or treatments could affect you or your baby.

If you have concerns about breastfeeding while taking any medication, it's always best to consult with your healthcare provider. They can provide personalized advice based on your situation and help ensure the safety and well-being of both you and your infant.

Pediatric Use

It's important to know that the safety and effectiveness of this product have not been established for children. This means that there hasn't been enough research to confirm whether it is safe or works well for pediatric patients (children and adolescents).

As a parent or caregiver, you should be cautious and consult with a healthcare professional before considering this product for your child. Always prioritize their safety and well-being by seeking guidance from a qualified expert.

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 particularly true if you have reduced creatinine clearance (a measure of how well your kidneys are filtering waste). Regular monitoring of your kidney function through tests is essential to ensure your safety and the effectiveness of your treatment.

For those with significant renal impairment, a lower dose of medication is recommended. Staying in close contact with your healthcare provider and following their guidance on monitoring and dosage adjustments will help manage your condition effectively.

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 determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may want 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 the medication is generally considered safe to use with other drugs and tests. However, every individual is different, and your healthcare provider can help ensure that your treatment plan is safe and effective for you.

Always discuss any new medications or tests with your healthcare provider to avoid potential issues and to get the best care tailored to your needs.

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 ideal range. 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 any remaining product, as it should not be reused. Following these guidelines will help maintain the safety and effectiveness of the product.

Additional Information

No further information is available.

FAQ

What are the indications and usage for this drug?

No specific indications and usage details are provided in the text.

Are there any teratogenic effects associated with this drug?

No teratogenic effects are mentioned in the text.

What are the contraindications for this drug?

There are no contraindications listed in the provided text.

Is this drug classified as a controlled substance?

No controlled substance classification details are provided in the text.

What should I do if I experience adverse reactions?

The text does not specify any adverse reactions; however, you should seek medical help if you experience any concerning symptoms.

Is this drug safe to use during pregnancy?

Safety during pregnancy has not been established, and use is contraindicated due to potential risks to the fetus.

Can this drug be used in pediatric patients?

Pediatric use has not been established, and safety and effectiveness in children have not been determined.

What precautions should be taken for patients with renal impairment?

Renal impairment may necessitate dosage adjustments, and patients with reduced creatinine clearance should be closely monitored.

How should this drug be stored?

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

Packaging Info

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

Packaging configurations for Sore Relief.
Details

Drug Information (PDF)

This file contains official product information for Sore Relief, 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 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 this information when evaluating treatment options for their patients.

Dosage and Administration

Healthcare professionals are advised to refer to the accompanying image for comprehensive dosage and administration details. The image contains essential information regarding the specific dosing ranges, administration routes, methods, and frequency of administration. It is crucial to consult this visual reference to ensure accurate and safe dosing practices.

Contraindications

There are no contraindications listed for this product. It is important to evaluate individual patient circumstances and consult relevant clinical guidelines when considering its use.

Warnings and Precautions

Healthcare professionals should be aware of the critical warnings and precautions associated with the use of this medication. Specific warnings are detailed in the accompanying image, which should be reviewed thoroughly to ensure patient safety.

General precautions must also be considered, as outlined in the referenced image. It is essential for healthcare providers to remain vigilant regarding these precautions to mitigate potential risks associated with the medication.

Monitoring parameters and recommended laboratory tests are crucial for safe administration. Details regarding these tests can be found in the corresponding image, and healthcare professionals are encouraged to utilize this information to guide patient management effectively.

In the event of a medical emergency, immediate assistance should be sought as indicated in the emergency medical help instructions provided in the image. Additionally, patients should be advised to discontinue use of the medication and contact their healthcare provider if they experience any concerning symptoms, as specified in the stop instructions image.

It is imperative that healthcare professionals remain informed and proactive in monitoring their patients while utilizing this medication to ensure optimal therapeutic outcomes.

Side Effects

Patients may experience a range of adverse reactions associated with the use of the medication. However, no specific side effects have been identified in the available data. Clinical trials and postmarketing experiences have not reported any additional adverse reactions or important notes that warrant attention. It is essential for healthcare providers to monitor patients for any unexpected effects during treatment, as ongoing surveillance is crucial for ensuring patient safety.

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no dosage adjustments or monitoring recommendations are necessary at this time.

Packaging & NDC

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

Packaging configurations for Sore Relief.
Details

Pediatric Use

Pediatric use has not been established for this product. Safety and effectiveness in pediatric patients have not been determined. Therefore, caution should be exercised when considering this product for use in children, infants, or adolescents.

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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted clinical data in this population.

Pregnancy

Safety during pregnancy has not been established for this medication. Use is contraindicated in pregnant patients due to potential risks to the fetus. Healthcare professionals should carefully consider the benefits and risks when prescribing this medication to women of childbearing potential. It is essential to discuss alternative treatment options with patients who are pregnant or planning to become pregnant.

Lactation

There are no specific statements regarding the use of this medication in nursing mothers or its effects during lactation. Additionally, there is no available data on the excretion of this medication in breast milk or its potential effects on breastfed infants. Healthcare professionals should consider the absence of information when advising lactating mothers about the use of this medication.

Renal Impairment

Renal impairment may necessitate dosage adjustments for patients with reduced kidney function. It is essential that patients with reduced creatinine clearance are closely monitored to ensure safety and efficacy. Regular renal function tests should be performed in patients with kidney problems to assess their condition. A reduced dose is recommended for patients with significant renal impairment to mitigate the risk of adverse effects.

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, as the clinical presentation can vary depending on the substance involved and the individual patient's response. Common symptoms of overdose may include, but are not limited to, altered mental status, cardiovascular instability, and respiratory distress.

In the event of an overdose, immediate medical intervention is recommended. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs. The use of activated charcoal may be considered if the patient presents within a suitable timeframe and if the ingestion was recent.

Furthermore, it is crucial to consult local poison control centers or toxicology experts for guidance on specific management protocols and antidotes, if applicable. Continuous assessment and supportive measures should be prioritized until the patient stabilizes or further treatment is determined.

Documentation of the incident, including the substance involved, estimated dose, and time of ingestion, is vital for ongoing management and potential reporting to regulatory authorities.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: skin irritation, allergic reactions, and systemic effects related to lidocaine. These events have been documented in the context of routine pharmacovigilance activities.

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 and handling to ensure the safety of young individuals.

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. Additionally, the product should be discarded after opening to prevent any potential degradation or contamination.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Sore 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 Sore 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.