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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
69804-076
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 relevant information provided in the bullet list to summarize. Without details about the drug's identity, uses, or mechanism of action, I am unable to create a consumer-friendly summary. 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 clarification about this medication, it's best to consult with a healthcare professional who can provide you with the necessary information.

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, dosage instructions 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 information tailored to your specific needs. Always follow their instructions closely for the best results.

What to Avoid

You can feel confident using this medication, as there are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with it. This means that, based on the available information, there are no known reasons to avoid taking this medication. Always remember to follow your healthcare provider's guidance and reach out if you have any questions or concerns about your treatment.

Side Effects

You may not experience any specific side effects from this medication, as there are no adverse reactions listed in the provided information. However, 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 precautions when using this medication. While specific warnings and general precautions are not detailed, you should always consult your healthcare provider about any concerns or questions you may have regarding your health and the use of this medication.

If you experience any unusual symptoms or side effects, it's crucial to stop taking the medication and call your doctor immediately. Additionally, if you feel that you are having a medical emergency, seek emergency help right away. Regular check-ups and lab tests may be necessary to monitor your health while using this medication, so be sure to follow your doctor's recommendations.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there are no specific signs or symptoms listed for an overdose, you should be aware of general warning signs such as extreme drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, 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 err on the side of caution when it comes to your health. Remember, timely intervention can make a significant difference.

Pregnancy Use

When it comes to using SORE RELIEF - lidocaine hcl gel during pregnancy, there is currently no information available about its safety, recommended dosage, or any special precautions you should take. This means that if you are pregnant or planning to become pregnant, it’s important to consult with your healthcare provider before using this product. They can help you understand any potential risks and guide you on the best options for pain relief during this time. Always prioritize your health and the health of your baby by seeking professional advice.

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 is no information available about whether this product is excreted in breast milk or any potential risks to your infant. Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

Pediatric Use

It's important to note that the safety and effectiveness of this product for children have not been established. This means that there hasn't been enough research to confirm whether it is safe or works well for kids. As a parent or caregiver, you should be cautious and consult with a healthcare professional before considering this product for a child.

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 your medication dosage may need to be adjusted. This is because renal impairment (kidney issues) can affect how your body processes certain drugs. To ensure your safety, 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 keep track of your kidney health. If you have significant renal impairment, special monitoring will be necessary to manage your treatment effectively. Always communicate with your healthcare team about your kidney function to ensure the best care.

Hepatic Impairment

If you have liver problems, it's important to know that your condition may affect how your body processes certain medications. This means that the dosage of the drug you are prescribed might need to be adjusted to ensure it is safe and effective for you.

Additionally, your healthcare provider will likely monitor your liver function tests (which check how well your liver is working) regularly while you are on this medication. Special precautions will be taken to ensure your safety, so be sure to communicate openly with your doctor about your liver 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 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 important to protect it from light, so keep it in its original container and make sure that the container is tightly closed when not in use.

Once you open the container, please remember to discard any remaining product after use to maintain safety and effectiveness. Following these guidelines will help you handle the product safely and ensure its proper storage.

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.

Is there any information on dosage and administration?

No specific dosage and administration information is provided.

What should I know about renal impairment when using this drug?

Renal impairment may necessitate dosage adjustments, and creatinine clearance should be monitored.

What precautions should be taken for patients with hepatic impairment?

Hepatic impairment may affect the drug's metabolism, and dosage adjustments may be necessary.

Is this drug safe for pediatric use?

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

What should nursing mothers know about this drug?

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

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.

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 drug is identified by SPL code 34089-3 and is presented as a white to off-white, round, biconvex tablet. The tablet is debossed with "A" on one side and "1" on the other side. Each tablet contains 1 mg of the active ingredient. Inactive ingredients consist of lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, and color additives.

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 effective use of the medication.

Contraindications

There are no contraindications associated with the use of this product. It is not classified as a controlled substance, and there are no known risks of abuse, misuse, or dependence. Therefore, no specific conditions or situations have been identified in which the product should not be used.

Warnings and Precautions

Healthcare professionals should be aware of the critical importance of monitoring and managing patient safety when prescribing and administering this medication.

In the event of any adverse reactions or unexpected symptoms, it is imperative to seek emergency medical assistance immediately. Healthcare providers should educate patients on recognizing signs that warrant urgent care.

Patients should be advised to discontinue use of the medication and contact their healthcare provider if they experience any concerning side effects or changes in their condition. Prompt communication with a healthcare professional is essential to ensure patient safety and appropriate management of any potential complications.

Regular laboratory tests may be necessary to monitor the patient's response to treatment and to identify any potential issues early. Healthcare professionals should determine the appropriate tests based on the individual patient's needs and the specific medication being used.

Overall, vigilance in monitoring and patient education are key components in the safe use of this medication.

Side Effects

There are no specific adverse reactions or side effects listed in the provided data. As such, no further details regarding serious or common adverse reactions, clinical trial insights, or postmarketing experiences can be elaborated upon. It is important for healthcare professionals to monitor patients for any unexpected reactions and report them as necessary.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions between the drug and laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

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.

Geriatric Use

There is no specific information available 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 data for this population.

Pregnancy

There is no information available regarding the use of SORE RELIEF - lidocaine hcl gel during pregnancy. Consequently, the safety of this medication in pregnant patients has not been established, and there are no specific dosage modifications or special precautions recommended for use in this population. Healthcare professionals should consider the lack of data when prescribing this medication to women of childbearing potential and weigh the potential risks versus benefits.

Lactation

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

Renal Impairment

Renal impairment may necessitate dosage adjustments for patients with reduced renal function. It is essential for healthcare professionals to monitor creatinine clearance in these patients to ensure appropriate dosing. Regular renal function tests should be performed to assess kidney health, and special monitoring is required for patients with significant renal impairment to mitigate potential risks associated with altered drug clearance.

Hepatic Impairment

Patients with hepatic impairment may experience altered metabolism of the drug, necessitating dosage adjustments to ensure safety and efficacy. It is essential to monitor liver function tests in this population to assess the degree of impairment and guide treatment decisions. Special precautions should be taken when administering the drug to patients with compromised liver function, as their response to therapy may differ from that of patients with normal liver function. Regular evaluation of liver parameters is recommended to mitigate potential risks associated with hepatic impairment.

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 activated charcoal may be considered to limit further absorption of the substance, provided that the patient is alert and able to protect their airway.

In cases where specific antidotes are known, they should be administered as per established protocols. Continuous assessment and supportive measures are critical until the patient stabilizes.

Healthcare professionals are encouraged to report any cases of overdose to the appropriate regulatory authorities and consult poison control centers for additional guidance on management strategies.

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

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 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) and protected from light to prevent degradation. Once opened, the product should be discarded to ensure safety and efficacy.

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.