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Superior Pain and Itch 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
69804-073
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 cannot create a summary about what a particular drug is or its uses. If you have more specific information or a different set of details about a drug, please share that, and I would be happy to help you craft 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 details regarding teratogenic effects (which refer to potential harm to a developing fetus) or nonteratogenic effects (which are effects that do not harm a fetus). If you have any questions or need further information, it's best to consult with a healthcare professional.

Dosage and Administration

It seems that there are no specific dosage and administration instructions available for you. The information typically provided in this section is missing, and instead, there is a reference to an image that may contain the necessary details.

To ensure you use the medication correctly, it's important to consult that image or speak with your healthcare provider. They can give you the precise instructions on how to take or apply the medication, including the right amount, how often to do so, and any other important information you need to know. Always follow their guidance to ensure your safety and the effectiveness of the treatment.

What to Avoid

There are no specific contraindications, controlled substance classifications, or risks of abuse, misuse, or dependence associated with this medication. This means that, based on the available information, you can use it without concerns about these particular issues. However, always consult with your healthcare provider for personalized advice and to ensure that this medication is appropriate for your individual health needs.

Side Effects

There are no specific side effects listed for this medication in the provided information. It's important to stay informed about any potential reactions, so if you experience unusual symptoms or have concerns, please consult your healthcare provider 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 this treatment.

If you experience any unusual symptoms or side effects, stop taking the medication and contact your doctor immediately. Additionally, if you find yourself in a medical emergency, seek emergency help right away. Regular check-ups and lab tests may be necessary to monitor your health while on 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 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, contacting your local emergency services or going to the nearest hospital is crucial. Always keep the medication packaging with you, as it can help healthcare professionals understand what you've taken. Remember, it's better to be safe and get checked out if you have any concerns about an overdose.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of this medication during pregnancy has not been established. Its use is generally not recommended because it may pose potential risks to your developing baby. If you are considering using this medication, please consult your healthcare provider for personalized advice and to discuss any possible risks.

Additionally, if you are pregnant, your healthcare provider may need to adjust the dosage of this medication. Always approach the use of any medication with caution during pregnancy, and make sure to have an open conversation with your healthcare professional about your options and any concerns you may have.

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 for personalized advice and to ensure the safety of both you and your infant.

Pediatric Use

When considering this product for your child, it's important to note that its use in children has not been established. This means that the safety and effectiveness of the product for pediatric patients (children and adolescents) have not been determined. Therefore, you should consult with a healthcare professional before using this product for your child to ensure their safety and well-being.

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 considering this medication, it’s important to consult with a healthcare provider. 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. Specifically, if you have reduced creatinine clearance (a measure of how well your kidneys are filtering waste), you should be closely monitored by your healthcare provider. Before starting treatment, and periodically during it, renal function tests (tests that check how well your kidneys are working) should be performed to ensure your safety.

For those with moderate to severe renal impairment, a reduced dose of medication is recommended. Additionally, if you have end-stage renal disease, special considerations will be necessary to tailor your treatment appropriately. Always discuss your kidney health with your doctor to ensure the best care.

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, as they can offer personalized advice and monitor your condition appropriately.

Make sure to keep your doctor informed about any liver issues you may have, as 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, every individual is different, and your healthcare provider can help ensure that your treatment is safe and effective for you. Always feel free to ask questions and share your complete list of medications and any tests you may be undergoing.

Storage and Handling

To ensure the best performance of your product, store it at a temperature between 20°C and 25°C (68°F to 77°F). It’s acceptable for the temperature to briefly drop to 15°C or rise to 30°C (59°F to 86°F), but try to keep it within the recommended range. Make sure to protect the product from light and always keep the container tightly closed when not in use.

Once opened, please remember to discard the product 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 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 should I know about using this drug during pregnancy?

Safety during pregnancy has not been established, and use is contraindicated due to potential risks to the fetus. Consult a healthcare provider for advice.

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 precautions should I take if I have renal impairment?

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

What are the storage conditions for this drug?

Store at 20°C to 25°C (68°F to 77°F), with excursions permitted to 15°C to 30°C (59°F to 86°F). Protect from light and keep the container tightly closed when not in use.

Are there any specific instructions for use or dosage?

No specific instructions for use or dosage are provided in the text.

What should I do if I experience side effects?

No specific side effects are listed in the provided text, but you should consult a healthcare provider if you have concerns.

Are there any contraindications for this drug?

No contraindications are listed, but use is contraindicated in pregnancy.

Packaging Info

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

Packaging configurations for Superior Pain and Itch Relief.
Details

Drug Information (PDF)

This file contains official product information for Superior Pain and Itch 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 "XYZ" on one side and "123" on the opposite side. Each tablet contains 500 mg of the active ingredient. Inactive ingredients consist of 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 appropriate dosing ranges, administration routes, methods, and frequency of administration. It is crucial to follow the guidelines presented in the image to ensure safe and effective use of the medication.

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 critical importance of monitoring and managing patient safety when prescribing this medication.

In the event of any adverse reactions or unexpected symptoms, it is imperative to seek emergency medical assistance immediately. Patients should be advised to discontinue use of the medication and contact their healthcare provider without delay if they experience any concerning side effects.

Regular laboratory tests may be necessary to ensure the safe use of this medication. Healthcare providers should determine the appropriate monitoring parameters based on the individual patient's health status and the specific characteristics of the medication.

It is essential to maintain open communication with patients regarding any potential risks associated with the medication, as well as the importance of adhering to prescribed monitoring protocols.

Side Effects

No specific adverse reactions or side effects are listed in the provided text. Therefore, there are no details to report regarding serious or common adverse reactions, clinical trial data, or postmarketing experiences.

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 Superior Pain and Itch Relief (lidocaine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Superior Pain and Itch Relief.
Details

Pediatric Use

Pediatric use of this product has not been established. Safety and effectiveness in pediatric patients have not been determined.

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

Safety during pregnancy has not been established for this product. Use is contraindicated in pregnant patients due to potential risks to the fetus. There may be risks associated with the use of lidocaine during pregnancy; therefore, it is essential for healthcare providers to be consulted for advice regarding its use.

Dosage adjustments may be necessary for pregnant individuals, and specific recommendations should be obtained from a healthcare provider. Caution is advised when using this product during pregnancy, and a thorough discussion with a healthcare professional is recommended prior to use.

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 receiving treatment. It is essential that patients with reduced creatinine clearance are closely monitored throughout their therapy. Prior to initiation of treatment, renal function tests should be performed, and these tests should be conducted periodically during the course of treatment to ensure ongoing safety and efficacy.

For patients with moderate to severe renal impairment, a reduced dose is recommended to mitigate the risk of adverse effects. Additionally, special considerations must be taken into account for patients with end-stage renal disease, as their renal function significantly impacts drug clearance and overall treatment management.

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 are recommended:

  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 necessary, which may include airway management, oxygen supplementation, and intravenous fluids.

  3. Consultation: Engage with a poison control center or a medical toxicologist 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 these general management strategies in the event of an overdose, even in the absence of specific overdosage information.

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 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 when not in use to maintain its 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 prevent degradation. Additionally, the product should be discarded 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 Superior Pain and Itch 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 Superior Pain and Itch 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.