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Healthwise 4% Lidocaine Cream

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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 2024
Label revision date
December 19, 2024
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 2024
Label revision date
December 19, 2024
Manufacturer
Veridian Healthcare
Registration number
M017
NDC root
71101-919
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 may find that this medication is designed to temporarily relieve minor pain. It works by targeting the discomfort you may experience, helping to make daily activities more manageable. If you're looking for a solution to ease minor aches, this drug could be a helpful option for you.

Uses

You can use this medication to temporarily relieve minor pain. It’s designed to help you feel more comfortable when dealing with everyday aches and discomforts. 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 who may be concerned about such risks.

Dosage and Administration

When using this medication, if you are an adult or a child over 12 years old, you should apply a thin layer to the affected area every 6 to 8 hours. However, make sure not to apply it more than three times in a 24-hour period to avoid any potential issues.

If you are caring for a child who is 12 years old or younger, it’s important to consult a doctor before using this medication. They can provide guidance on the appropriate use and dosage for younger patients. Always follow these instructions carefully to ensure safe and effective treatment.

What to Avoid

It's important to use this medication safely to avoid potential issues. You should not apply it to large areas of your body or on skin that is cut, irritated, or swollen. Additionally, avoid using it on puncture wounds. If you find that you need to use this medication for more than one week, please consult your doctor for guidance. Following these instructions will help ensure your safety and the effectiveness of the treatment.

Side Effects

When using this product, it's important to apply it only as directed and avoid contact with your eyes. You should not use it on large areas of your body, on cut or irritated skin, or on puncture wounds. If your condition worsens, if symptoms last more than seven days, or if they clear up and then return within a few days, stop using the product and consult a doctor.

Additionally, if you are pregnant or breastfeeding, it's advisable to speak with a healthcare professional before use. Always keep the product out of reach of children, and if it is 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. Do not apply it to large areas of your body or on any cut, irritated, or swollen skin, and avoid using it on puncture wounds. It's important to follow the directions carefully and not to use the product for more than one week without consulting your doctor.

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

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.

Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, do not hesitate to get help right away. Remember, it's always better to be safe and seek assistance if you suspect an overdose.

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, 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

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. As you age, your body may process medications differently, and factors like kidney function (renal impairment) and changes in cognition can affect how well a drug works or how it may impact you.

If you are an older adult or a caregiver, it’s wise to discuss any concerns with your healthcare provider. They can help determine the best approach for your individual health needs, ensuring that any medication you take is safe and effective for you. Always keep your doctor informed about all medications you are taking, as this can help prevent potential interactions or side effects.

Renal Impairment

If you have kidney problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or safety considerations for your condition. This means that there are no tailored guidelines for how this medication may affect you if your kidneys are not functioning properly.

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 help monitor your condition and make any necessary adjustments to your treatment plan.

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 should be used if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver health. They can help you understand how to manage your treatment effectively.

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 new medications or tests with your healthcare provider to avoid potential issues and to get personalized advice tailored to your health needs.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20°C to 25°C (68°F to 77°F). It's important to protect it from light, so keep it in its original packaging or a dark container. Always make sure the container is tightly closed when not in use to maintain its integrity.

Once you open the container, please remember to discard it after use to avoid any safety risks. Following these guidelines will help you handle 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 temporarily relieves minor 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 to exceed 3 applications in a 24-hour period.

What should I do if I am under 12 years old?

If you are 12 years or younger, ask a doctor before use.

Are there any teratogenic effects associated with this drug?

No teratogenic effects 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 I am pregnant or breastfeeding?

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

What should I do if the drug is swallowed?

If swallowed, get medical help or contact a Poison Control Center at 800-222-1222 right away.

Are there any contraindications for this drug?

No specific contraindications are mentioned.

How should I store this drug?

Store at 20°C to 25°C (68°F to 77°F), protect from light, and keep the container tightly closed.

Packaging Info

Below are the non-prescription pack sizes of Healthwise 4% Lidocaine Cream (lidocaine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Healthwise 4% Lidocaine Cream.
Details

Drug Information (PDF)

This file contains official product information for Healthwise 4% Lidocaine Cream, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

The drug is identified by SPL Code 34089-3 and is presented as a white to off-white, round, biconvex tablet. The tablet is debossed with "XYZ" on one side and "123" on the opposite side. Each tablet contains 500 mg of the active ingredient. Inactive ingredients consist of lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, and magnesium stearate.

Uses and Indications

This drug is indicated for the temporary relief of minor 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 advised to consult a physician before use.

Contraindications

Use is contraindicated on large areas of the body or on cut, irritated, or swollen skin due to the potential for adverse effects. Application on puncture wounds is also contraindicated to prevent complications. Prolonged use beyond one week without consulting a healthcare professional is not recommended, as it may lead to unforeseen risks.

Warnings and Precautions

For external use only; direct contact with the eyes must be strictly avoided. This product should not be applied to large areas of the body or on cut, irritated, or swollen skin. Additionally, it is contraindicated for use on puncture wounds.

Users are advised to adhere strictly to the recommended usage guidelines. It is imperative to read and follow all directions and warnings provided on the carton. The product should not be used for more than one week without prior consultation with a healthcare professional.

In the event of worsening conditions, or if symptoms persist beyond seven days or resolve only to recur within a few days, users should discontinue use and seek medical advice. Furthermore, it is essential to avoid bandaging or applying local heat, such as heating pads, to the area of application.

Pregnant or breastfeeding individuals should consult a healthcare professional before using this product. It is crucial to keep this product out of reach of children. In case of accidental ingestion, immediate medical assistance should be sought, or contact a Poison Control Center at 800-222-1222.

Side Effects

Patients using this product should be aware of several important safety warnings and potential adverse reactions. This product is intended for external use only, and contact with the eyes should be strictly avoided. It is contraindicated for use on large areas of the body, on cut, irritated, or swollen skin, and on puncture wounds. Additionally, patients should not use the product for more than one week without consulting a healthcare professional.

While using this product, it is crucial to adhere to the directions provided on the carton. Patients should avoid bandaging the area of application or applying local heat, such as heating pads, to the treated area.

Patients are advised to discontinue use and consult a doctor if their condition worsens, if symptoms persist for more than seven days, or if symptoms clear up and then recur within a few days.

For pregnant or breastfeeding individuals, it is recommended to seek advice from a healthcare 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 the Poison Control Center should be contacted at 800-222-1222.

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 Healthwise 4% Lidocaine Cream (lidocaine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Healthwise 4% Lidocaine Cream.
Details

Pediatric Use

Pediatric patients 12 years of age or younger should consult a healthcare professional before use. For patients over 12 years, a thin layer of the medication should be applied 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 the product 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

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

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 considered in these populations to ensure the safety of both the mother and the fetus or infant.

Lactation

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

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this drug. Consequently, there are no 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 assess the situation thoroughly and initiate appropriate management procedures based on the specific circumstances of the 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 compound in these areas.

Postmarketing Experience

No postmarketing experience details are available for SPL code 90375-7.

Patient Counseling

Patients should be advised to seek immediate medical assistance or contact a Poison Control Center at 800-222-1222 if the product is swallowed. It is important to inform patients that the product should not be applied to large areas of the body or on cut, irritated, or swollen skin. Additionally, patients should be cautioned against using the product on puncture wounds.

Healthcare providers should emphasize that the product should not be used for more than one week without consulting a doctor. Patients must be instructed to discontinue use and consult a healthcare professional if their condition worsens or if symptoms persist for more than seven days, or if symptoms clear up and then recur within a few days.

Patients should be reminded to use the product only as directed and to read and follow all directions and warnings provided on the carton. It is crucial to advise patients to avoid contact with the eyes and to refrain from bandaging or applying local heat, such as heating pads, to the area of use.

Storage and Handling

The product is supplied in a container that must be stored at a temperature range of 20°C to 25°C (68°F to 77°F). It is essential to protect the product from light to maintain its integrity. The container should remain tightly closed when not in use to prevent contamination. Additionally, the product should be discarded after opening 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 3 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 4% 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 Healthwise 4% 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.