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Extra Strength Skin Repair

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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
April 12, 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
April 12, 2017
Manufacturer
ridge properties
Registration number
part348
NDC root
69804-051
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (4 NDCs)
Packaging & NDC Codes (4)

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Drug Overview

It seems that the information provided does not include a specific drug name or detailed descriptions of its uses or mechanisms. Therefore, I cannot create a summary about what the drug is or what it is used for. If you have more specific details or a particular drug in mind, please share that information, and I would be happy to help you craft a 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 can be used is not available. If you have any questions or need further information, it's best to consult with a healthcare professional who can provide guidance based on your individual health needs.

Dosage and Administration

To ensure you use this medication correctly, it's important to follow the detailed instructions provided in the accompanying image titled "Dosage and Administration.jpg." This image contains essential information about how to prepare and administer the medication safely.

While the specific route (how the medication is given), method, and frequency (how often you should take or apply it) are not included in the text, you can find all the necessary details in the image. Make sure to review it carefully to understand the best way to use this medication for your needs.

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 this medication is appropriate for you.

Side Effects

You can feel reassured that there are no specific side effects or adverse reactions associated with this medication as noted in the information provided. This means that, based on the available data, you are not likely to experience any common or severe side effects while using it. Always consult with your healthcare provider if you have any concerns or experience unusual symptoms.

Warnings and Precautions

It's important to be aware of potential warnings associated with your medication. While specific details are not provided here, you should always refer to the official warnings document for comprehensive information.

If you experience any unusual symptoms or have concerns about your health while taking this medication, it's crucial to stop using it and contact your doctor immediately. They can provide guidance tailored to your situation. Always prioritize your health and safety by staying informed and proactive.

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 potential risks to your developing baby. If you are considering using this medication, you should consult your healthcare provider to discuss any possible risks and to determine if it is necessary for your situation.

Additionally, if you do use this medication while pregnant, your healthcare provider may need to adjust the dosage to ensure safety. Always prioritize open communication with your healthcare provider about your pregnancy and any medications you are considering.

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 it may pose to your infant.

As always, if you have any concerns or questions about using this product while breastfeeding, it's a good idea to consult with your healthcare provider for personalized advice.

Pediatric Use

When considering this product for your child, it's important to know 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 issues, 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 include special monitoring or safety considerations tailored for patients with renal impairment (kidney problems).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your kidney health. They can provide guidance based on your individual situation.

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 tests to ensure your safety while using any medication. Your well-being is a priority, so don't hesitate to ask questions or express any concerns you may have.

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 medications, as they can help monitor your progress and adjust your treatment if necessary. Open communication is key to your overall health and well-being.

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 refer to for dosage and administration instructions?

Please refer to the image 'Dosage and Administration.jpg' for detailed instructions.

Are there any contraindications for this product?

No contraindications are listed in the provided text.

Is this product safe to use during pregnancy?

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

What precautions should pregnant women take when using this product?

Pregnant women should use this product only if clearly needed and after discussing with their healthcare provider.

Are there any specific instructions for nursing mothers?

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

How should I store this product?

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

What should I do if I need more information about warnings?

Refer to the image 'Warnings.jpg' for detailed warnings.

Is there any information on pediatric use?

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

What about use in elderly patients?

No specific information regarding geriatric use or precautions for elderly patients is provided.

Packaging Info

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

Packaging configurations for Extra Strength Skin Repair.
Details

Drug Information (PDF)

This file contains official product information for Extra Strength Skin Repair, 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 specific patient populations as determined by clinical guidelines. Currently, there are no specific indications or usage information provided. Additionally, there are no known teratogenic or nonteratogenic effects associated with this drug. Healthcare professionals should refer to the latest clinical data and guidelines for further information regarding appropriate use and patient selection.

Dosage and Administration

Healthcare professionals are advised to refer to the image "Dosage and Administration.jpg" for detailed instructions regarding the dosage and administration of the medication.

Specific information concerning the route, method, and frequency of administration is not included in the provided text. It is essential to consult the referenced image for comprehensive guidance on these aspects to ensure proper administration and patient safety.

Contraindications

There are no contraindications listed for the use of this product. It is important to evaluate each patient's individual circumstances and medical history when considering treatment options.

Warnings and Precautions

Healthcare professionals should be aware of the critical warnings associated with the use of this medication. For detailed warnings, please refer to the image "Warnings.jpg," which outlines specific risks and considerations that must be taken into account when prescribing or administering this treatment.

In addition to the warnings, it is essential to remain vigilant regarding the patient's overall health status and any potential adverse effects that may arise during treatment. While no specific general precautions or laboratory tests have been provided, healthcare providers are encouraged to monitor patients closely for any signs of complications or unexpected reactions.

In the event of severe side effects or an emergency situation, immediate medical assistance should be sought. Furthermore, if a patient experiences any concerning symptoms, it is imperative to discontinue the medication and consult with a healthcare professional promptly.

Side Effects

There are no specific adverse reactions or side effects associated with the use of this product as indicated in the available data. Clinical trials and postmarketing experiences have not reported any notable adverse reactions. Therefore, healthcare professionals should be aware that the absence of documented adverse reactions does not preclude the possibility of individual patient experiences. Continuous monitoring and reporting of any unexpected reactions in patients are encouraged to ensure comprehensive safety evaluation.

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 Extra Strength Skin Repair (lidocaine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Extra Strength Skin Repair.
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, and adolescents.

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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

Safety during pregnancy has not been established for this product. Use is contraindicated in pregnancy 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. Pregnant women should use this product only if clearly needed and after a thorough discussion with their healthcare provider regarding the potential risks and benefits.

Lactation

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

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

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, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

If available, consultation with a poison control center or a medical toxicologist is recommended to guide the management of the overdose effectively.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for appropriate treatment 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 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 and handling 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 prevent contamination and degradation. Additionally, the product should be protected from light exposure to ensure optimal stability. Once opened, the product must 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 Extra Strength Skin Repair, 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 Skin Repair, 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.