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Superior Pain and Itch Relief

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This product has been discontinued

Active ingredient
Lidocaine Hydrochloride 40 mg/1000 mg
Other brand names
Dosage form
Liquid
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2017
Label revision date
June 19, 2020
Active ingredient
Lidocaine Hydrochloride 40 mg/1000 mg
Other brand names
Dosage form
Liquid
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2017
Label revision date
June 19, 2020
Manufacturer
ridge properties llc
Registration number
part348
NDC root
69804-071

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Drug Overview

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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 about this medication, it's best to consult with a healthcare professional.

Dosage and Administration

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What to Avoid

You can feel reassured that there are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this medication. This means that, based on the available information, there are no particular situations or conditions under which you should avoid using it. Always consult with your healthcare provider for personalized advice and to ensure that this medication is appropriate for your individual health needs.

Side Effects

You may not experience any specific side effects from this medication, as there are no adverse reactions listed in the provided information. It's important to stay informed and consult your healthcare provider if you have any concerns or experience unusual symptoms while taking this medication.

Warnings and Precautions

It’s important to be aware of certain warnings when using this medication. While specific details are not provided here, you should always consult the detailed warnings section in the accompanying materials for comprehensive information.

If you experience any unusual symptoms or side effects, it’s crucial to stop taking the medication and contact your doctor immediately. They can provide guidance tailored to your situation. Always prioritize your health and safety by staying informed and proactive about your treatment.

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

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 risks to your developing baby. If you are considering using this medication, consult your healthcare provider to discuss any potential risks and to receive personalized advice.

Additionally, if you are pregnant, your healthcare provider may need to adjust the dosage of this medication. Always weigh the potential benefits against the risks before using it, and ensure you have a thorough discussion with your healthcare provider about your specific situation.

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 should consult with your healthcare provider for personalized advice and to discuss any medications or treatments you may be considering. They can help you understand any potential effects on your milk production or your baby's health. Always prioritize open communication with your healthcare team to ensure the best outcomes for you and your infant.

Pediatric Use

When it comes to using this medication in children, it's important to note that its safety and effectiveness have not been established. This means that there hasn't been enough research to confirm how well it works or if it is safe for kids. As a parent or caregiver, you should be cautious and consult with a healthcare professional before giving this medication to a child. Always prioritize their health and well-being by seeking expert advice.

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 there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment plan.

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 effectively.

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 appropriate for you.

Drug Interactions

It's great to know that there are no known interactions between this medication and other drugs or laboratory tests. However, it's still very important to discuss all medications you are taking, including over-the-counter drugs and supplements, with your healthcare provider. This ensures that your treatment is safe and effective.

Always keep your healthcare provider informed about any changes in your health or new medications you may start. Open communication helps prevent any potential issues and supports your overall well-being.

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 packaging or a dark container. Always make sure the container is tightly closed when not in use to maintain its integrity.

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

Additional Information

No further information is available.

FAQ

What should I do if I need dosage and administration information?

Please refer to the attached image 'Dosage and administration.jpg' for specific dosage and administration instructions.

Are there any contraindications for this drug?

There are no contraindications listed, but use is contraindicated in pregnancy due to potential risks to the fetus.

Is this drug safe to use during pregnancy?

Safety during pregnancy has not been established, and there may be risks associated with its use; consult your healthcare provider for advice.

What precautions should I take if I am pregnant?

Caution is advised when using this product during pregnancy, and benefits must be weighed against potential risks. Consult your healthcare provider for specific recommendations.

What are the storage requirements for this drug?

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

Is there any information regarding pediatric use?

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

Is there any information regarding nursing mothers or lactation?

There are no specific statements regarding nursing mothers or lactation in the provided text.

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, 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 the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, magnesium stearate, talc, hydroxypropyl methylcellulose, titanium dioxide, iron oxide red, and iron oxide yellow.

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 dosage and administration information is not explicitly detailed in the provided text. Healthcare professionals are advised to refer to the attached image "Dosage and administration.jpg" for specific dosage and administration instructions. It is essential to follow the guidelines outlined in the image to ensure proper dosing, route of administration, and frequency of administration.

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

Refer to the image "Warnings Section.jpg" for detailed warnings associated with the use of this medication. It is imperative that healthcare professionals familiarize themselves with these warnings to ensure patient safety and effective management of potential risks.

While general precautions and specific laboratory tests are not detailed in the provided information, it is essential for healthcare providers to remain vigilant in monitoring patients for any adverse effects or complications that may arise during treatment. Regular assessments and appropriate laboratory evaluations should be conducted as clinically indicated to ensure the safe use of the medication.

In the event of severe reactions or complications, healthcare professionals should be prepared to provide emergency medical assistance. Additionally, patients should be advised to discontinue use and consult their healthcare provider if they experience any concerning symptoms or side effects.

Side Effects

There are no specific adverse reactions or side effects listed in the provided data. Additionally, no further adverse reactions or important notes have been identified. Therefore, the available information does not indicate any common or serious adverse reactions associated with the treatment.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified for this product. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

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 has not been established, and safety and effectiveness in pediatric patients have not been determined. Therefore, caution is advised when considering this medication for children and adolescents.

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, as the benefits must be weighed against potential risks to fetal outcomes.

Lactation

There are no specific statements regarding the use of this medication in nursing mothers or its effects on 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 lack of information when advising lactating mothers about the use of this medication.

Renal Impairment

There is no specific information regarding renal impairment, dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function. Healthcare professionals should exercise caution and consider individual patient factors when treating patients with renal impairment, as the absence of detailed guidance necessitates careful clinical judgment.

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 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, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

Documentation of the incident, including the substance involved, estimated dose, and time of exposure, is crucial for effective management and follow-up care.

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 question.

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 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 its 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 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.