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Restoriden Lidocaine Cream

Last content change checked dailysee data sync status

This product has been discontinued

Active ingredient
Lidocaine Hydrochloride 2.24 g/56 g
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 2020
Label revision date
October 20, 2020
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Lidocaine Hydrochloride 2.24 g/56 g
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 2020
Label revision date
October 20, 2020
Manufacturer
RENU LABORATORIES, INC.
Registration number
part348
NDC root
76348-583
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

If you are a consumer or patient please visit this version.

Drug Overview

Restoriden Nutrition LIDOCAINE PAIN RELIEF CREAM is a topical cream designed to help reduce pain or discomfort associated with various skin irritations. This includes conditions like sunburn, insect bites, poison ivy, poison oak, poison sumac, and minor cuts, scratches, or burns.

By applying this cream to the affected area, you can find relief from the discomfort caused by these skin issues, allowing for a more comfortable experience as you heal.

Uses

You can use this medication to help relieve pain or discomfort from various skin irritations. This includes issues like sunburn, insect bites, and reactions to plants such as poison ivy, poison oak, and poison sumac. It is also effective for soothing minor cuts, scratches, and burns.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) associated with this medication, making it a safer option for those concerned about such risks.

Dosage and Administration

If you or your child is 2 years old or older, you can apply the medication directly to the affected area of the skin. You should do this up to 3 to 4 times a day, depending on your needs. Make sure to follow the instructions carefully to ensure the best results.

If your child is under 2 years old, it's important to consult with a doctor before using this medication. They can provide guidance on the appropriate treatment for younger children. Always prioritize safety and follow professional advice when it comes to medication for little ones.

What to Avoid

It's important to use this product safely to avoid any potential issues. You should never apply it in or near your eyes, as this can cause irritation or harm. Additionally, avoid using large amounts, especially on raw surfaces or blistered areas, to prevent adverse effects.

By following these guidelines, you can help ensure a safe and effective experience with the product. Always prioritize your health and well-being when using any medication.

Side Effects

You should use this product only on the skin and be aware of potential side effects. If you experience an allergic reaction, which may include symptoms like rash or itching, it's important to stop using the product and consult a doctor. Additionally, if your condition worsens or does not improve within 7 days, or if symptoms clear up and then return after a few days, you should seek medical advice. Be alert for any signs of redness, irritation, swelling, pain, or other unusual symptoms, and contact your healthcare provider if these occur.

Warnings and Precautions

This product is intended for external use only, so please avoid swallowing it. Keep it out of reach of children to prevent accidental ingestion. If you or someone else swallows the product, seek medical help or contact a Poison Control Center immediately.

You should stop using this product and consult your doctor if you experience an allergic reaction, if your condition worsens or does not improve within 7 days, if symptoms improve and then return within a few days, or if you notice any redness, irritation, swelling, pain, or other concerning symptoms. Your health and safety are important, so don’t hesitate to reach out for help if needed.

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 feel something is wrong, 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 product during pregnancy has not been established. Due to potential risks to the fetus, it is generally not recommended for use while pregnant. If you have any questions or concerns about using this product during your pregnancy, please consult your healthcare provider for personalized advice and guidance. They can help you understand any necessary dosage modifications or alternative options that may be safer for you and your baby.

Lactation Use

If you are breastfeeding, you can use Restoriden Lidocaine Cream without specific warnings or recommendations against it. The information available does not indicate any concerns about the cream being passed into breast milk or any risks to your infant. However, as always, it's a good idea to consult with your healthcare provider if you have any questions or concerns about using this product while nursing.

Pediatric Use

If you have a child aged 2 years or older, you can apply this medication externally to the affected area up to 3 to 4 times a day. However, if your child is under 2 years old, it’s important to consult a doctor before using this product. Always ensure you follow these guidelines to keep your child safe and healthy.

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 for personalized advice. 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 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 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 changes in your medication or health status with your healthcare provider to avoid any potential issues and to get the best care possible.

Storage and Handling

To ensure the best performance of your product, store it at a temperature between 20 and 25° C (68 to 77° F). This temperature range helps maintain the integrity and effectiveness of the device.

When handling the product, be sure to do so with clean hands and in a clean environment to avoid contamination. Always follow any specific disposal instructions provided to ensure safety and compliance with regulations.

Additional Information

No further information is available.

FAQ

What is Restoriden Nutrition Lidocaine Pain Relief Cream used for?

Restoriden Nutrition Lidocaine Pain Relief Cream is used to reduce pain or discomfort caused by skin irritations such as sunburn, insect bites, poison ivy, poison oak, poison sumac, and minor cuts, scratches, or burns.

How should I use this cream?

For adults and children 2 years and older, apply the cream externally to the affected area up to 3 to 4 times a day. For children under 2 years, consult a doctor.

Are there any precautions I should take when using this cream?

Do not use the cream in or near the eyes, and avoid using it in large quantities, especially over raw surfaces or blistered areas.

What should I do if I experience an allergic reaction?

If an allergic reaction occurs, or if the condition worsens or does not improve within 7 days, stop using the cream and consult a doctor.

Is it safe to use this cream during pregnancy?

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

What should I do if the cream is swallowed?

If swallowed, seek medical help or contact a Poison Control Center immediately.

How should I store this cream?

Store the cream at a temperature between 20 - 25° C.

Packaging Info

Below are the non-prescription pack sizes of Restoriden Lidocaine Cream (lidocaine). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Restoriden Lidocaine Cream.
Details

Drug Information (PDF)

This file contains official product information for Restoriden Lidocaine Cream, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

Restoriden is presented as a powder for oral solution. The specific chemical name and physical characteristics are not provided. Additionally, the formulation includes inactive ingredients that are not detailed in the available information.

Uses and Indications

This drug is indicated for the relief of pain or discomfort associated with various skin irritations, including but not limited to sunburn, insect bites, poison ivy, poison oak, poison sumac, as well as minor cuts, scratches, and burns.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Adults and children aged 2 years and older should apply the medication externally to the affected area up to 3 to 4 times daily. For children under 2 years of age, it is recommended to consult a physician prior to use.

Contraindications

Use is contraindicated in or near the eyes due to the potential for irritation or damage. Additionally, application in large quantities, particularly over raw surfaces or blistered areas, is contraindicated to prevent exacerbation of the condition or adverse effects.

Warnings and Precautions

For external use only. It is imperative to keep this product out of reach of children to prevent accidental ingestion. In the event of swallowing, immediate medical assistance should be sought, or the local Poison Control Center should be contacted without delay.

Healthcare professionals should advise patients to discontinue use and consult a physician if any of the following occur: an allergic reaction, worsening of the condition, lack of improvement within 7 days, recurrence of symptoms after they have resolved, or the emergence of redness, irritation, swelling, pain, or any other concerning symptoms. Monitoring for these signs is essential to ensure patient safety and effective management of the condition being treated.

Side Effects

Patients using this product should be aware that it is intended for external use only. In the event of an allergic reaction, it is imperative to stop use and consult a healthcare professional. Additionally, patients should seek medical advice if the condition worsens or does not improve within 7 days of use.

If symptoms initially clear up but then return within a few days, or if any signs of redness, irritation, swelling, pain, or other concerning symptoms develop, it is also recommended to discontinue use and contact a doctor. These precautions are essential to ensure patient safety and effective management of their condition.

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 Restoriden Lidocaine Cream (lidocaine). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Restoriden Lidocaine Cream.
Details

Pediatric Use

Pediatric patients aged 2 years and older may apply the medication externally to the affected area up to 3 to 4 times a day. For children under 2 years of age, it is advised to consult a doctor before use.

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 potential 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 not recommended during pregnancy due to potential risks to the fetus. There may be risks associated with the use of this product during pregnancy, and healthcare providers should be consulted for advice on dosage modifications and overall management for pregnant patients. Women of childbearing potential should be informed of these risks and the importance of discussing any potential use of this product during pregnancy with their healthcare provider.

Lactation

There are no specific warnings or recommendations regarding the use of Restoriden Lidocaine Cream in lactating mothers. Additionally, there is no information available about the potential for excretion of the drug 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 patients 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 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 when administering the medication. It is essential to monitor patients closely for any signs of adverse effects or symptoms that may arise from excessive dosing.

In the event of suspected overdosage, immediate medical attention should be sought. Healthcare providers should implement supportive measures as necessary, which may include symptomatic treatment and monitoring of vital signs.

Due to the lack of detailed overdosage data, it is recommended that healthcare professionals refer to established clinical guidelines and protocols for managing overdose situations relevant to the specific medication in question. Additionally, contacting a poison control center may provide further guidance on appropriate management strategies.

Continued vigilance and patient assessment are crucial in mitigating potential risks associated with overdosage.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: allergic reactions, redness, irritation, swelling, and pain. These events have been documented in the context of routine pharmacovigilance activities.

Patient Counseling

Healthcare providers should advise patients to keep the product out of reach of children. In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately.

Patients should be instructed to discontinue use and consult a doctor if they experience any allergic reactions, if their condition worsens or does not improve within 7 days, if symptoms resolve and then return within a few days, or if they notice any redness, irritation, swelling, pain, or other concerning symptoms.

It is important to inform patients that the product should not be applied in or near the eyes. Additionally, they should be cautioned against using the product in large quantities, especially on raw surfaces or blistered areas, to avoid potential complications.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a controlled temperature range of 20 to 25° C. Proper storage conditions must be maintained to ensure the integrity and efficacy of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Restoriden Lidocaine Cream, 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 Restoriden Lidocaine Cream, 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.