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Regenecare Ha

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Active ingredient
Lidocaine Hydrochloride 20 mg/1 mL
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
Dosage form
Gel
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2009
Label revision date
January 5, 2026
Active ingredient
Lidocaine Hydrochloride 20 mg/1 mL
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
Dosage form
Gel
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2009
Label revision date
January 5, 2026
Manufacturer
MPM Medical LLC
Registration number
M017
NDC root
66977-117

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Drug Overview

This medication is designed to provide temporary relief from pain and itching caused by various skin issues, including minor burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritations. It helps soothe discomfort and promote healing, making it a useful option for everyday skin injuries and irritations.

If you experience any of these skin conditions, this product may help alleviate your symptoms and improve your comfort. Always follow the instructions on the label for the best results.

Uses

You can use this medication for the temporary relief of pain and itching caused by various skin issues. It is effective for minor burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritations. This means that if you have any of these conditions, this product can help soothe your discomfort and promote healing.

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

Dosage and Administration

If you are an adult or a child aged 2 years and older, you can apply the medication to the affected area up to 3 to 4 times a day. Make sure to follow this guideline to ensure the best results.

For children under 2 years of age, it’s important to consult a physician (a medical doctor) before using this medication. This step helps ensure safety and proper care for younger children. Always follow the advice of your healthcare provider regarding the use of any medication.

What to Avoid

It's important to keep this medication out of reach of children to ensure their safety. There are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence mentioned. Always follow these guidelines to use the medication safely and effectively.

Side Effects

It's important to be aware of some key warnings when using this product. It is meant for external use only, so avoid swallowing it. If you accidentally swallow it, seek medical help or contact a Poison Control Center immediately. Be careful to keep it away from your eyes, and if your condition worsens or symptoms last more than seven days, or if they improve and then return shortly after, stop using the product and consult your doctor. Additionally, avoid using large amounts, especially on raw or blistered skin.

Warnings and Precautions

This product is intended for external use only. If you accidentally swallow it, seek medical help or contact a Poison Control Center immediately. Be careful to avoid getting it in your eyes, as this can cause irritation.

If your condition worsens, or if symptoms last longer than 7 days, or if they improve and then return within a few days, stop using the product and consult your doctor. Additionally, avoid using large amounts, especially on raw or blistered skin, to prevent further irritation or complications.

Overdose

If you or someone else has swallowed too much of this medication, it’s important to seek medical help immediately. You can do this by contacting a Poison Control Center or going to the nearest emergency room.

Signs of an overdose can vary, but they may include unusual symptoms that are not typical for you. If you notice anything concerning, don’t hesitate to get help. Remember, acting quickly can make a significant difference in ensuring safety and health.

Pregnancy Use

Currently, there is no information available about the use of REGENECARE HA (lidocaine hcl gel) 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 essential to consult your healthcare provider before using this product to ensure your safety and the safety of your baby.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to talk to your doctor before using this product. There is a possibility that the ingredients could be passed into your breast milk, and the effects on your nursing infant are not fully understood. Taking this precaution can help ensure the safety and well-being of both you and your baby.

Pediatric Use

When using this medication for children, it's important to follow specific guidelines. For children aged 2 years and older, you can apply it to the affected area up to 3 to 4 times a day. However, if your child is under 2 years old, you should consult a physician (doctor) before using it. Always remember to keep the medication out of reach of children to ensure their safety.

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 best approach for you or your loved one, considering any existing health conditions or medications that may interact.

Remember, your safety and well-being are the top priority, so don’t hesitate to ask questions and discuss any concerns with your doctor.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines, dosage adjustments, or monitoring requirements mentioned for your condition in the provided information. This means that the standard recommendations for medication use may apply to you, but it's always best to consult with your healthcare provider for personalized advice. They can help ensure that any treatment you receive is safe and effective based on your kidney health.

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, and there are no special monitoring requirements or precautions outlined for patients with liver impairment.

However, it's always best to discuss your individual health situation with your healthcare provider, as they can offer personalized advice and ensure that any medications you take are safe for your liver health.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you. Always share your complete list of medications and any recent lab tests to avoid any potential issues. Your health and safety should always come first.

Storage and Handling

To ensure the best performance of your product, store it at room temperature. It's important to keep it away from freezing temperatures and excessive heat, as these conditions can damage the product.

When handling the product, always do so with care to maintain its integrity. Following these simple storage and handling guidelines will help ensure that your product remains safe and effective for use.

Additional Information

You can apply this medication to the affected area 3 to 4 times daily if you are an adult or a child aged 2 years and older. If your child is under 2 years old, it's important to consult a physician before use to ensure safety and proper guidance.

FAQ

What is the drug used for?

This drug is used for the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritations.

How should I apply the drug?

Adults and children 2 years of age and older should apply it to the affected area not more than 3 to 4 times daily. Children under 2 years of age should consult a physician prior to use.

Are there any warnings I should be aware of?

Yes, this product is for external use only. Avoid contact with the eyes, and if swallowed, seek medical help immediately. Discontinue use if the condition worsens or persists for more than 7 days.

Is there any information about use during pregnancy?

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

What should nursing mothers do?

Nursing mothers should consult a physician prior to using this product, as there is a potential for excretion in breast milk.

How should I store the drug?

Store the drug at room temperature, avoiding freezing and excessive heat.

Are there any contraindications for this drug?

No contraindications are listed for this drug in the provided information.

What should I do if I accidentally swallow the drug?

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

Can I use this drug on large areas of skin?

Do not use in large quantities, particularly over raw surfaces or blistered areas.

Is there any information about drug interactions?

No drug interactions information is provided for this product.

Packaging Info

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

Packaging configurations for Regenecare Ha.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritations.

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

Dosage and Administration

For adults and children aged 2 years and older, the recommended application is to the affected area not more than 3 to 4 times daily. It is important to ensure that the application is limited to the specified frequency to avoid potential adverse effects.

For children under 2 years of age, it is advised to consult a physician prior to use to ensure safety and appropriateness of treatment.

Contraindications

There are no specific contraindications listed for this product. However, it is advised to keep the product out of reach of children to prevent accidental ingestion or misuse.

Warnings and Precautions

This product is intended for external use only. In the event of accidental ingestion, immediate medical assistance should be sought, or the local Poison Control Center should be contacted without delay.

Healthcare professionals should advise patients to avoid contact with the eyes, as this may lead to irritation or injury. Should the patient's condition worsen, or if symptoms persist beyond 7 days, or if symptoms resolve and then recur within a few days, it is imperative to discontinue use of the product and consult a physician for further evaluation.

Additionally, caution is advised against the application of this product in large quantities, especially on raw surfaces or blistered areas, as this may exacerbate adverse effects or lead to complications.

Side Effects

Patients should be aware that the product is intended for external use only. In the event of accidental ingestion, it is imperative to seek medical assistance or contact a Poison Control Center immediately. Care should be taken to avoid contact with the eyes, as this may lead to adverse effects.

In clinical practice, if a patient's condition worsens, or if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days, it is recommended to discontinue use of the product and consult with a healthcare professional. Additionally, patients are advised against using the product in large quantities, especially over raw surfaces or blistered areas, to minimize the risk of adverse reactions.

Drug Interactions

There are currently no documented drug interactions associated with the use of this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

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

Packaging configurations for Regenecare Ha.
Details

Pediatric Use

Pediatric patients aged 2 years and older may apply the medication to the affected area no more than 3 to 4 times daily. For children under 2 years of age, it is advised to consult a physician prior to use. Additionally, the product should be kept out of reach of children to ensure safety.

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

There is no information available regarding the use of REGENECARE HA - lidocaine hcl gel during pregnancy. Consequently, the safety of this product in pregnant patients has not been established, and there are no specific 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

Lactating mothers should consult a physician prior to using this product. There is a potential for excretion in breast milk, and the effects on a nursing infant are not known.

Renal Impairment

There is no information available 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 specific guidelines or recommendations are not provided in the current data.

Hepatic Impairment

There is no information available regarding the use of this medication in patients with hepatic impairment. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions specified for individuals with compromised liver function. Healthcare professionals should exercise clinical judgment when considering the use of this medication in patients with liver problems, as the absence of specific guidance necessitates careful evaluation of the potential risks and benefits.

Overdosage

In the event of an overdosage, immediate medical intervention is crucial. If the substance is ingested, it is imperative to seek medical assistance or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt action can significantly influence the outcome of an overdosage situation. Symptoms may vary depending on the specific substance involved, and monitoring for any adverse effects is essential.

Management of overdosage should include supportive care and symptomatic treatment as necessary. Continuous assessment of the patient's condition is recommended to address any complications that may arise.

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 for patients to understand the potential risks associated with improper access to the medication by young individuals.

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 room temperature, ensuring that it is kept away from freezing conditions and excessive heat to maintain its integrity and efficacy. Proper handling should be observed to prevent any compromise in quality.

Additional Clinical Information

For patients aged 2 years and older, the medication should be applied to the affected area no more than 3 to 4 times daily. For children under 2 years of age, it is advised to consult a physician prior to use. There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Regenecare Ha, 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 Regenecare Ha, 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.

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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.