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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
March 31, 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
March 31, 2017
Manufacturer
ridge properties
Registration number
part348
NDC root
69804-048
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (4 NDCs)
Packaging & NDC Codes (4)

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Drug Overview

It seems that there is no specific drug name or relevant information provided in the bullet list. Without details about a particular medication, its uses, or how it works, I am unable to create a summary for you. If you have specific information about a drug, please share it, and I would be happy to help!

Uses

It appears that there are no specific uses or indications provided for this medication. Additionally, there are no noted effects related to teratogenicity (which refers to the potential of a substance to cause birth defects) or nonteratogenicity. If you have any questions or need further information about this medication, it's best to consult with a healthcare professional who can provide guidance tailored to your needs.

Dosage and Administration

It seems that there are no specific dosage and administration details available for the medication you are inquiring about. This means that the information regarding how much to take, how to take it, or how often to use it is not provided in the available resources.

If you have any questions about the medication or need guidance on how to use it, it's best to consult with your healthcare provider or pharmacist. They can give you the most accurate and personalized information based on your health needs.

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, there are no known reasons that would prevent you from using it safely.

However, it's always important to consult with your healthcare provider before starting any new medication to ensure it’s appropriate for your individual health needs. If you have any concerns or questions about this medication, don’t hesitate to reach out to your doctor or pharmacist for guidance.

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 seems that the specific details regarding warnings, precautions, and instructions for emergency help or contacting your doctor were not provided in the bullet list. Therefore, I cannot create a consumer-friendly summary without that information. If you have any other details or a different request, please let me know!

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. Remember, timely intervention can make a significant difference.

Pregnancy Use

There is currently no information available about the use of EXTRA STRENGTH SKIN REPAIR - lidocaine hcl cream during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions for pregnant individuals have not been addressed in the drug insert.

If you are pregnant or planning to become pregnant, it is important to consult with your healthcare provider before using this cream or any medication. They can provide guidance based on your specific situation and help ensure the safety of both you and your baby.

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.

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, it is recommended to consult with a healthcare professional before using this product for your child to ensure their safety and well-being.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. If you or a loved one is an older adult, it’s always wise to discuss any medications with a healthcare provider, especially considering potential changes in health or how the body processes drugs as we age.

Since there are no dosage adjustments or special precautions mentioned for elderly patients, your healthcare provider can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your doctor 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. If your creatinine clearance (a measure of kidney function) is reduced, your healthcare provider will closely monitor your condition. Regular renal function tests are essential to ensure your kidneys are working properly.

For those with moderate to severe renal impairment, a lower dose of medication may be necessary. Additionally, if you have end-stage renal disease, special considerations will be taken into account regarding your treatment. Always communicate with your healthcare provider about your kidney health to ensure safe and effective medication management.

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 new medications you 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 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 recommended limits. 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 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 or usage details are provided.

Are there any contraindications for this drug?

No contraindications are listed.

What should I know about using this drug during pregnancy?

There is no information provided regarding the use of this drug during pregnancy.

Is this drug safe for nursing mothers?

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

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.

How should I store this drug?

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

Are there any side effects associated with this drug?

No specific side effects are listed in the provided text.

Is this drug safe for pediatric patients?

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

What about geriatric use of this drug?

No specific information regarding geriatric use or precautions 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 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 prescribing information does not provide specific dosage and administration details. Healthcare professionals are advised to refer to the accompanying image titled "Dosage and Administration.jpg" for comprehensive guidance on dosage amounts, routes, methods, and frequency of administration. It is essential to consult this resource to ensure accurate and safe administration 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.

Warnings and Precautions

Patients should be aware of the following critical warnings associated with the use of this medication. It is imperative that healthcare professionals monitor patients closely for any adverse effects and ensure that appropriate interventions are in place.

In the event of severe reactions or unexpected symptoms, immediate medical assistance should be sought. Healthcare providers must educate patients on recognizing signs that necessitate urgent care.

Additionally, it is essential for healthcare professionals to remain vigilant regarding the patient's overall health status and to conduct regular assessments as needed. While specific laboratory tests have not been detailed, practitioners should consider routine monitoring based on the individual patient's health profile and the medication's pharmacological effects.

Patients are advised to discontinue use and consult their healthcare provider if they experience any concerning symptoms or if their condition does not improve. Continuous communication between patients and healthcare providers is crucial for safe medication management.

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 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.

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

There is no information available regarding the use of EXTRA STRENGTH SKIN REPAIR - lidocaine hcl cream during pregnancy. Consequently, the safety of this medication in pregnant patients has not been established, and there are no known 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 about 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 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 may be required for patients with moderate to severe renal impairment. Additionally, special considerations should be taken into account for patients with end-stage renal disease to optimize treatment outcomes.

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 considered as part of standard clinical practice.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and consider general principles of management for potential overdose situations.

It is essential to monitor patients closely for any signs or symptoms that may arise following an overdose. Common symptoms may include, but are not limited to, altered mental status, cardiovascular instability, and gastrointestinal disturbances.

In the event of suspected overdosage, immediate medical intervention is recommended. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and ensuring hemodynamic stability.

Additionally, it is advisable to contact a poison control center or a medical toxicologist for guidance on specific management strategies tailored to the clinical scenario. Continuous monitoring and supportive measures should be maintained until the patient is stabilized.

Documentation of the incident, including the amount and timing of the substance involved, is crucial for ongoing management and potential reporting requirements.

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 compound in these areas.

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 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, any unused portion should be discarded after opening to prevent degradation.

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.