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Restore Lidocaine Pain Relief Cream

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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 2021
Label revision date
May 5, 2021
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 2021
Label revision date
May 5, 2021
Manufacturer
RENU LABORATORIES, INC.
Registration number
part348
NDC root
76348-605
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

Restore By Pure Research 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, as well as minor cuts, scratches, and burns.

By applying this cream to the affected area, you can find relief from the discomfort caused by these skin issues. It is formulated to target pain directly at the site of irritation, providing soothing effects to help you feel more comfortable.

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 use.

What to Avoid

It's important to use this product safely. You should avoid using it in or near your eyes, as this can cause irritation or harm. Additionally, refrain from applying it in large amounts, especially on raw surfaces or blistered areas, to prevent potential complications. Always follow these guidelines to ensure your safety and well-being.

Side Effects

If you experience an allergic reaction, such as rash or itching, while using this product, stop using it and consult your doctor. It's also important to seek medical advice if your condition worsens or does not improve within 7 days, if symptoms clear up and then return within a few days, or if you notice any redness, irritation, swelling, pain, or other concerning symptoms.

Remember, this product is for external use only, so please use it as directed.

Warnings and Precautions

This product is for external use only, so please avoid swallowing it. Keep it out of reach of children, and if it is accidentally ingested, seek medical help or contact a Poison Control Center immediately.

You should stop using this product and consult your doctor if you experience any allergic reactions, if your condition worsens or does not improve within 7 days, if symptoms clear up 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 you need it.

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 healthcare provider or local poison control center is crucial. They can provide guidance on what steps to take next. Always err on the side of caution—if you feel something is wrong, don’t hesitate to get help.

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. It is generally not recommended for use while pregnant due to potential risks to your developing baby. If you have any questions or concerns about using this product, you should consult your healthcare provider for personalized advice.

There are no specific dosage adjustments provided for pregnant individuals, so it's crucial to discuss your situation with a healthcare professional. Always seek medical guidance before using this medication to ensure the best care for 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. Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

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

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. Since older adults may have different health needs and responses to medications, you should always consult with a healthcare provider before starting any new medication. They can help determine the right dosage and monitor for any potential side effects, ensuring that the treatment is safe and effective for you or your loved one.

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), your healthcare provider will closely monitor your condition. Regular renal function tests (tests that check how well your kidneys are working) should be performed to ensure your safety.

For those with significant renal impairment, a reduced dose of medication is recommended. Always communicate with your healthcare team about your kidney health to ensure you receive the appropriate care and adjustments to 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 before starting any new medication. They can help ensure that your treatment is safe and effective for you.

Make sure to keep your doctor informed about any liver issues you may have, as they may want to monitor your liver function regularly to ensure your safety while using the medication.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking, even if there are no specific drug interactions or laboratory test interactions noted for your treatment. This ensures that your healthcare team can provide the best care tailored to your needs.

Always feel free to ask questions about how different medications might work together or affect any tests you may need. Your health and safety are the top priority, and discussing these details can help prevent any potential issues.

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 its effectiveness and safety. When using the product, you may apply it under an occlusive dressing, which is a type of covering that helps keep the area moist and can enhance the product's effectiveness.

Always handle the product with care to maintain its integrity. Make sure to follow any specific disposal instructions provided to ensure safe and responsible disposal.

Additional Information

No further information is available.

FAQ

What is Restore By Pure Research LIDOCAINE PAIN RELIEF CREAM used for?

It 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?

Adults and children 2 years and older should apply it 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 it in or near the eyes, and avoid using large quantities, especially over raw surfaces or blistered areas.

What should I do if I experience an allergic reaction?

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

Is this cream safe to use during pregnancy?

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

What should I do if I swallow the cream?

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

How should I store this cream?

Store it at 20 - 25° C.

Are there any side effects I should be aware of?

For external use only, and you should stop use and ask a doctor if redness, irritation, swelling, or other symptoms begin.

Can I use this cream if I have kidney problems?

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

Packaging Info

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

Packaging configurations for Restore Lidocaine Pain Relief Cream.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No relevant information is available for SPL code 34089-3.

Uses and Indications

This drug is indicated for the reduction of pain or discomfort associated with 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 the following situations:

Application near the eyes is prohibited due to the potential for irritation or damage. Additionally, the product should not be applied in large quantities, especially over raw surfaces or blistered areas, as this may exacerbate irritation or lead to 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 contact a Poison Control Center 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, or lack of improvement within 7 days of use. Additionally, if symptoms resolve and then recur within a few days, or if any signs of redness, irritation, swelling, pain, or other adverse symptoms develop, medical advice should be sought promptly.

Side Effects

Patients using this product should be aware that it is for external use only. In the event of an allergic reaction, patients are advised to stop use and consult a healthcare professional. Additionally, if the condition being treated worsens or does not improve within 7 days, or if symptoms clear up and then return within a few days, medical advice should be sought.

Patients should also discontinue use and seek medical attention if they experience any signs of redness, irritation, swelling, pain, or other concerning symptoms. These reactions may indicate a need for further evaluation and management by a healthcare provider.

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

Packaging configurations for Restore Lidocaine Pain Relief 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

There is no specific information 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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

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 lidocaine during pregnancy; therefore, it is essential for pregnant patients to consult a healthcare provider for advice.

No specific dosage modifications are provided for pregnant individuals; healthcare providers should be consulted for personalized recommendations. Pregnant women are advised to seek medical advice before using this product to ensure the safety and well-being of both the mother and the fetus.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there is no information available concerning 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. For patients with significant renal impairment, a reduced dose is recommended to mitigate potential risks associated with inadequate clearance.

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, as the clinical presentation can vary depending on the substance involved and the individual patient's response. Common symptoms of overdose may include, but are not limited to, altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of an overdose, immediate medical intervention is recommended. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and ensuring adequate circulation. The use of activated charcoal may be considered if the patient presents within a suitable timeframe and is deemed appropriate based on clinical judgment.

Furthermore, it is crucial to consult local poison control centers or toxicology experts for guidance on specific management protocols and antidotes, if applicable. Continuous monitoring and supportive care should be maintained until the patient is stabilized and any potential complications are addressed.

Documentation of the incident, including the substance involved, estimated dose, time of exposure, and any interventions performed, is vital for ongoing patient management and future reference.

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

Storage and Handling

The product is supplied in configurations that include specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at a controlled temperature range of 20 to 25° C.

For optimal application, the product may be used under an occlusive dressing, ensuring that the conditions of use are maintained to achieve the desired therapeutic effect. Proper handling and storage are crucial to maintain 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 Restore Lidocaine Pain Relief 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 Restore Lidocaine Pain Relief 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.