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Regenecare Ha

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Active ingredient
Lidocaine Hydrochloride 20 mg/1 g
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 2007
Label revision date
December 11, 2025
Active ingredient
Lidocaine Hydrochloride 20 mg/1 g
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 2007
Label revision date
December 11, 2025
Manufacturer
MPM Medical LLC
Registration number
M017
NDC root
66977-107

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Drug Overview

RegeneCare HA Gel is a topical gel designed to provide temporary relief from pain and itching caused by various skin issues. You can use it for minor burns, sunburn, minor cuts, scrapes, insect bites, and other minor skin irritations. This gel helps soothe discomfort and supports the healing process, making it a helpful option for everyday skin injuries.

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 experience discomfort from any of these conditions, this product can help soothe your skin and alleviate your symptoms.

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.

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 associated with this medication. Always follow the guidance provided by your healthcare professional and use the medication responsibly.

Side Effects

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

By keeping these precautions in mind, you can use the product safely and effectively.

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 return after clearing up, stop using the product and consult your doctor. Additionally, avoid using large amounts, especially on raw or blistered skin, to prevent potential complications.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's important to be aware of the general signs of an overdose, which can include symptoms like extreme drowsiness, confusion, or difficulty breathing. If you suspect an overdose, it’s crucial to seek immediate medical help.

In case of an emergency, call your local emergency services or go to the nearest hospital. Always keep medications out of reach of children and follow the prescribed dosage to prevent any potential risks. If you have any concerns or questions about your medication, don’t hesitate to reach out to your healthcare provider for guidance.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that there is no specific information available about the use of REGENECARE HA (lidocaine hcl gel) during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions have not been clearly outlined.

Before using this product, you should consult with your healthcare provider to discuss any potential risks and to ensure that it is safe for you and your baby. Always prioritize open communication with your doctor regarding any medications or treatments during pregnancy.

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

When using this medication for children aged 2 years and older, you can apply it to the affected area no more than 3 to 4 times a day. However, if your child is under 2 years old, it's important to 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 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 there are no specific guidelines, dosage adjustments, or monitoring recommendations provided for your condition in the available information. This means that the standard instructions for the medication do not include special considerations for those with renal impairment (kidney issues).

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 tailored to your specific 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, and there are no special monitoring or precautions outlined for patients with 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 provide personalized advice and ensure that your treatment is safe and effective for you.

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 and safety 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 device.

When handling the product, always do so with clean hands and in a clean environment to maintain its integrity. Following these guidelines will help you use the product safely and effectively.

Additional Information

For adults and children aged 2 years and older, you should apply the medication to the affected area no more than 3 to 4 times a day. If the patient is under 2 years old, it's important to consult a physician before use to ensure safety and proper guidance.

FAQ

What is RegeneCare HA Gel used for?

RegeneCare HA Gel 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 RegeneCare HA Gel?

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

Are there any contraindications for using RegeneCare HA Gel?

No contraindications are listed for RegeneCare HA Gel in the provided information.

What should I do if I accidentally swallow RegeneCare HA Gel?

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

Can I use RegeneCare HA Gel if I am pregnant?

The insert does not provide specific information regarding the use of RegeneCare HA Gel during pregnancy.

Is RegeneCare HA Gel 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 when using RegeneCare HA Gel?

For external use only, avoid contact with the eyes, and do not use in large quantities, particularly over raw surfaces or blistered areas.

How should I store RegeneCare HA Gel?

Store RegeneCare HA Gel at room temperature, avoiding freezing and excessive heat.

What should I do if my condition worsens or does not improve?

If your condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use and consult with a doctor.

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 essential 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 other adverse effects. 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 should be exercised regarding the quantity of the product applied. It is advised not to use this product in large amounts, especially on raw surfaces or blistered areas, to prevent potential complications or exacerbation of the condition.

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 should refrain from 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 this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are necessary 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 recommended to consult a physician prior to use. Additionally, it is important to keep the product 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

The safety of REGENECARE HA (lidocaine hcl gel) during pregnancy has not been established, as the prescribing information does not provide specific data regarding its use in pregnant patients. There are no documented safety concerns, dosage modifications, or special precautions outlined for this population. Healthcare professionals should weigh the potential benefits against any unknown risks when considering the use of this product in women of childbearing potential. Given the lack of information, it is advisable to exercise caution and consider alternative treatments when managing conditions in pregnant patients.

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

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

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 overdosage information, it is essential for healthcare professionals to remain vigilant regarding the potential for overdose with this medication. In cases where an overdose is suspected, immediate medical attention should be sought.

Healthcare providers are advised to monitor patients closely for any signs or symptoms that may indicate an overdose. These may include, but are not limited to, increased severity of known side effects, altered mental status, or any unusual physiological responses.

Management of an overdose should be guided by the clinical presentation of the patient. Supportive care is paramount, and symptomatic treatment should be initiated as necessary. It is recommended that healthcare professionals consult local poison control centers or relevant toxicology resources for specific guidance on managing overdose cases.

In summary, while no specific overdosage information is available, healthcare professionals should exercise caution, monitor for symptoms, and provide appropriate management in the event of an overdose.

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 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 exposure to extreme temperatures.

Additional Clinical Information

Patients aged 2 years and older are advised to apply the medication to the affected area no more than 3 to 4 times daily. For children under 2 years of age, it is recommended that a physician be consulted prior to use. No further information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

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.