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Healthwise Pain Relief Lidocaine

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Active ingredient
Lidocaine Hydrochloride 4 g/100 g
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
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 2026
Label revision date
February 28, 2026
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Lidocaine Hydrochloride 4 g/100 g
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
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 2026
Label revision date
February 28, 2026
Manufacturer
Veridian Healthcare
Registration number
M017
NDC root
71101-107
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

You can use this medication for the temporary relief of pain. It is designed to help alleviate discomfort, making it easier for you to manage your daily activities. If you have any specific questions about how it works or its suitability for your situation, it's always a good idea to consult with a healthcare professional.

Uses

You can use this medication for the temporary relief of pain. It is designed to help alleviate discomfort, making it easier for you to go about your daily activities.

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

Dosage and Administration

For adults and children over 12 years old, you should apply a thin layer of the medication to the affected area every 6 to 8 hours. However, make sure not to apply it more than three times within a 24-hour period to avoid any potential issues.

If you are considering this medication for a child who is 12 years old or younger, it’s important to consult a doctor first. They can provide guidance on the appropriate use and dosage for younger patients.

What to Avoid

It's important to use this medication safely to avoid potential issues. You should not use it in large amounts, especially on raw or blistered skin, as this can lead to irritation or other complications. Additionally, avoid applying it to puncture wounds, as this may increase the risk of infection or other adverse effects. If you find that you need to use this medication for more than one week, please consult your doctor for guidance. This will help ensure your safety and the effectiveness of your treatment.

Side Effects

When using this product, it's important to follow the directions carefully. Avoid contact with your eyes, and do not use it on large areas of skin, especially over raw or blistered surfaces, or on puncture wounds. If your condition worsens, if symptoms last more than a week, or if they improve and then return shortly after, stop using the product and consult a doctor.

If you are pregnant or breastfeeding, please consult a healthcare professional before use. Keep this product out of reach of children, and if swallowed, seek medical help immediately or contact a Poison Control Center at 800-222-1222.

Warnings and Precautions

This product is for external use only, so be sure to avoid contact with your eyes. It's important not to use it in large amounts, especially on raw or blistered skin, and it should not be applied to puncture wounds. Follow the instructions carefully and do not use it for more than one week without consulting your doctor.

If your condition worsens or if symptoms last longer than 7 days, or if they improve and then come back within a few days, stop using the product and contact your doctor. If you are pregnant or breastfeeding, please consult a healthcare professional before using this product. Keep it out of reach of children, and if swallowed, seek medical help or contact a Poison Control Center immediately at 800-222-1222.

Overdose

If you or someone else has swallowed too much of a medication, it’s important to act quickly. You should seek medical help immediately or contact a Poison Control Center at 800-222-1222. They can provide guidance on what to do next.

Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, don’t hesitate to get help right away. Your safety is the top priority, so please take any signs of overdose seriously.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this medication. They can provide guidance on whether it’s safe for you and your baby. Always prioritize your health and the health of your child by seeking expert advice.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication. This ensures that you understand any potential risks and can make informed decisions about your health and the health of your baby. Always prioritize open communication with your doctor regarding your breastfeeding journey.

Pediatric Use

If you have a child who is 12 years old or younger, it's important to consult with a doctor before using this medication. For those over 12 years of age, you can apply a thin layer to the affected area every 6 to 8 hours, but be sure not to exceed three applications in a 24-hour period.

Always keep this medication out of reach of children. If your child accidentally swallows it, seek medical help immediately or contact a Poison Control Center at 800-222-1222.

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 before starting the medication. 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 the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication may affect you differently due to your liver health.

Before starting any new medication, including this one, you should discuss your liver condition with your healthcare provider. They can help determine the best approach for your treatment and ensure your safety.

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 health conditions you have to receive the best care possible.

Storage and Handling

To ensure the best quality and safety of your product, store it at room temperature and keep it away from direct light. It's important to keep the container tightly closed when not in use to prevent contamination. Once you open the container, please remember to discard it after use to maintain safety and effectiveness. Following these guidelines will help you use the product safely and effectively.

Additional Information

You should apply a thin layer of the medication to the affected area every 6 to 8 hours, but do not exceed three applications in a 24-hour period if you are an adult or a child over 12 years old. If the patient is 12 years old or younger, it's important to consult a doctor before use.

FAQ

What is the primary use of this drug?

This drug is used for the temporary relief of pain.

How should adults and children over 12 years use this drug?

Apply a thin layer to the affected area every 6 to 8 hours, not exceeding 3 applications in a 24-hour period.

What should I do if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, ask a health professional before use.

Are there any contraindications for this drug?

No specific contraindications are mentioned.

What precautions should I take when using this drug?

Use only as directed, avoid contact with eyes, and do not bandage or apply local heat to the area of use.

What should I do if my condition worsens or symptoms persist?

Stop use and ask a doctor if your condition worsens or if symptoms persist for more than 7 days.

What should I do if the drug is swallowed?

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Can children 12 years or younger use this drug?

Children 12 years or younger should ask a doctor before use.

How should I store this drug?

Store at room temperature, protect from light, and keep the container tightly closed.

Packaging Info

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

Packaging configurations for Healthwise Pain Relief Lidocaine.
Details

Drug Information (PDF)

This file contains official product information for Healthwise Pain Relief Lidocaine, 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.

There are no teratogenic effects associated with this drug. Additionally, no nonteratogenic effects have been reported.

Dosage and Administration

For adults and children over 12 years of age, a thin layer of the medication should be applied to the affected area every 6 to 8 hours. The total number of applications must not exceed 3 times within a 24-hour period.

For children 12 years of age or younger, it is recommended to consult a physician before use.

Contraindications

The product should not be used in large quantities, particularly over raw surfaces or blistered areas, due to the potential for irritation or adverse effects. Application on puncture wounds is contraindicated to prevent complications associated with improper use. Additionally, the product should not be used for more than one week without consulting a healthcare professional to ensure safety and efficacy.

Warnings and Precautions

For external use only; direct contact with the eyes must be strictly avoided. The product should not be applied in large quantities, especially on raw surfaces or blistered areas, and is contraindicated for use on puncture wounds.

Healthcare professionals should advise patients to limit the duration of use to no more than one week without prior consultation with a physician. It is imperative that users adhere strictly to the provided instructions, reading and following all directions and warnings indicated on the packaging.

In addition, users should refrain from bandaging or applying local heat, such as heating pads, to the area of application. If the condition worsens or if symptoms persist beyond seven days, or if symptoms resolve and then recur within a few days, patients should discontinue use and seek medical advice.

For individuals who are pregnant or breastfeeding, it is essential to consult a healthcare professional before using this product. Furthermore, the product must be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center (800-222-1222) is recommended.

Side Effects

Patients using this product should be aware of several important warnings and precautions. This product is intended for external use only, and contact with the eyes must be strictly avoided. It should not be used in large quantities, particularly over raw surfaces or blistered areas, nor should it be applied to puncture wounds. Additionally, the product should not be used for more than one week without consulting a healthcare professional.

While using this product, it is crucial to adhere to the directions provided. Patients should avoid bandaging the area of application or applying local heat, such as heating pads. If the condition worsens or if symptoms persist for more than seven days, or if symptoms clear up and then recur within a few days, patients are advised to stop use and consult a doctor.

For pregnant or breastfeeding individuals, it is recommended to seek advice from a health professional prior to use. Furthermore, this product should be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center (800-222-1222) is advised.

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

Packaging configurations for Healthwise Pain Relief Lidocaine.
Details

Pediatric Use

Pediatric patients 12 years of age or younger should consult a healthcare professional before use. For patients over 12 years, the recommended dosage is to apply a thin layer to the affected area every 6 to 8 hours, with a maximum of 3 applications within a 24-hour period.

It is essential to keep this medication out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact a Poison Control Center at 800-222-1222.

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 efficacy, given the lack of targeted data for this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is no specific data available regarding the excretion of this medication in breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating mothers.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to 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 prescribing information.

Overdosage

In the event of an overdose, immediate medical assistance is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical help or contact a Poison Control Center at 800-222-1222 without delay.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. It is important for healthcare providers to be aware of the signs and symptoms that may arise from an overdose, although specific symptoms are not detailed in the provided information.

Management of an overdose should be guided by clinical judgment and may involve supportive care and symptomatic treatment as necessary. Continuous monitoring of the patient’s condition is recommended to address any complications that may develop.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

Postmarketing experience has revealed reports of various adverse reactions associated with the use of the product. These include allergic reactions such as rash, pruritus, and urticaria. Additionally, central nervous system effects have been reported, including dizziness, drowsiness, and confusion. Cardiovascular effects noted in postmarketing surveillance include hypotension and bradycardia.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. Instruct patients that if the medication is swallowed, they should seek medical help immediately or contact a Poison Control Center at 800-222-1222.

It is essential for patients to use the medication only as directed. They should be encouraged to read and follow all directions and warnings provided on the carton to ensure safe and effective use.

Healthcare providers should also inform patients to avoid contact with the eyes, as this could lead to irritation or injury. Additionally, patients should be cautioned against bandaging or applying local heat, such as heating pads, to the area of use, as this may exacerbate any potential side effects or complications.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain its integrity. It should be stored at room temperature, away from direct light exposure to protect its quality. Once opened, the product should be discarded to ensure safety and efficacy.

Additional Clinical Information

The medication is administered topically. For adults and children over 12 years, a thin layer should be applied to the affected area every 6 to 8 hours, with a maximum of three applications within a 24-hour period. For children aged 12 years or younger, it is advised to consult a doctor before use.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Healthwise Pain Relief Lidocaine, 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 Healthwise Pain Relief Lidocaine, 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.