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Healthwise Pain Relief Cream with 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 2022
Label revision date
May 21, 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 2022
Label revision date
May 21, 2024
Manufacturer
Veridian Healthcare
Registration number
M017
NDC root
71101-932
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 to temporarily relieve minor pain. It is designed to help ease discomfort, making it a useful option for managing everyday aches. If you're experiencing minor pain, this medication may provide the relief you need.

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

If you are an adult or a child 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 in a 24-hour period to avoid any potential issues.

For children who are 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 product safely to avoid potential complications. You should not use it on large areas of your body, on cut, irritated, or swollen skin, or on puncture wounds. Additionally, if you need to use it for more than one week, please consult your doctor first.

While using this product, make sure to keep it away from your eyes, and avoid bandaging the area or applying local heat, such as heating pads. Following these guidelines will help ensure your safety and the effectiveness of the treatment.

Side Effects

When using this product, it's important to apply it only to the skin and avoid contact with your eyes. Do not use it on large areas, on cuts, irritated skin, or puncture wounds, and limit use to no more than one week unless directed by a doctor. If your condition worsens, if symptoms last longer than seven days, or if they improve and then return within a few days, stop using the product and consult a healthcare professional.

If you are pregnant or breastfeeding, please check with a healthcare provider before using this product. In case of accidental ingestion, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

Warnings and Precautions

This product is for external use only, so please avoid contact with your eyes. Always use it as directed by reading and following all instructions on the packaging. It's important not to bandage the area or apply local heat, such as heating pads, to the site of application.

If your condition worsens, or if symptoms last more than 7 days or improve and then return within a few days, stop using the product and consult your doctor. In case of accidental swallowing, seek emergency medical help immediately or contact a Poison Control Center at 1-800-222-1222.

Overdose

If you or someone else has swallowed too much of this medication, it’s important to seek medical help immediately. You can contact a Poison Control Center at 1-800-222-1222 for guidance.

Signs of an overdose may include unusual symptoms, but specific details on these symptoms are not provided here. If you notice anything concerning, don’t hesitate to reach out for help. Remember, acting quickly can make a significant difference in ensuring safety and health.

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 adults and children 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 follow these guidelines to ensure safe and effective use.

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 considering this medication, it’s important to consult with a healthcare provider. 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 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 may affect you if you have hepatic impairment (issues with liver function).

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver health and medication use. They can help ensure that you receive the safest and most effective treatment.

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 and share all the medications and supplements you are using. This helps your provider monitor your health effectively and make informed decisions about your treatment.

Storage and Handling

To ensure the best performance of your product, store it at room temperature and keep it away from direct light. It's important not to freeze the product, as this can affect its effectiveness. Once you open the product, be sure to discard any unused portion to maintain safety and quality. 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 pregnant or breastfeeding, it's important to consult a healthcare professional before using this product. Keep it out of reach of children, and if the medication is swallowed, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

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 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 warnings I should be aware of?

This product is for external use only and should not come into contact with the eyes.

What should I avoid while using this product?

Do not bandage or apply local heat to the area of use, and avoid using it on large areas of the body or on cut, irritated, or swollen skin.

What should I do if my condition worsens?

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 accidentally swallow this product?

If swallowed, get medical help or contact a Poison Control Center at 1-800-222-1222 right away.

What are the storage instructions for this drug?

Store at room temperature, protect from light, and do not freeze. Discard after opening.

Can children under 12 years use this drug?

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

Packaging Info

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

Packaging configurations for Healthwise Pain Relief Cream with Lidocaine.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The product is identified by SPL code 34089-3 and is presented as a white to off-white, round, biconvex tablet. Each tablet is debossed with "XYZ" on one side and "123" on the opposite side. It contains 500 mg of the active ingredient. The formulation includes the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, magnesium stearate, hydroxypropyl methylcellulose, titanium dioxide, talc, iron oxide (red), and iron oxide (yellow).

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 of this product is contraindicated in the following situations:

Application on large areas of the body or on cut, irritated, or swollen skin is not recommended due to the potential for increased absorption and adverse effects. It should not be applied to puncture wounds, as this may lead to complications or infection. Prolonged use beyond one week without consulting a healthcare professional is contraindicated to prevent potential systemic effects.

Additionally, during use, contact with the eyes must be avoided to prevent irritation or injury. Bandaging or applying local heat, such as heating pads, to the area of application is also contraindicated, as this may enhance absorption and increase the risk of adverse reactions.

Warnings and Precautions

For external use only. It is imperative to avoid contact with the eyes to prevent irritation or injury. Users are advised to adhere strictly to the instructions provided, ensuring that all directions and warnings on the carton are read and followed meticulously.

In terms of general precautions, the product should be used solely as directed. Users must refrain from allowing the product to come into contact with the eyes and should not bandage or apply local heat, such as heating pads, to the area of application.

If the condition worsens or if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, it is essential to discontinue use and consult a healthcare professional.

In the event of accidental ingestion, immediate medical assistance should be sought, or contact should be made with a Poison Control Center at 1-800-222-1222. Prompt action is crucial in such situations to ensure safety and appropriate care.

Side Effects

Patients using this product should be aware that it is intended for external use only and must avoid contact with the eyes. It is contraindicated for application on large areas of the body, on cut, irritated, or swollen skin, and on puncture wounds. The product should not be used for more than one week without consulting a healthcare professional.

During the use of this product, patients should refrain from allowing contact with the eyes and should not bandage or apply local heat, such as heating pads, to the area of application.

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.

Additionally, it is important for patients who are pregnant or breastfeeding to seek advice from a healthcare professional before using this product. In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted at 1-800-222-1222.

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no dosage adjustments or monitoring recommendations are necessary at this time.

Packaging & NDC

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

Packaging configurations for Healthwise Pain Relief Cream with Lidocaine.
Details

Pediatric Use

Pediatric patients 12 years of age or younger should consult a healthcare professional before use. For adolescents and children 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.

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, 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. It is important to assess the potential risks and benefits associated with its use during pregnancy and lactation. The safety of this medication in pregnant women has not been established, and caution is advised to ensure the well-being of both the mother and the fetus.

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 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 be contacted without delay. It is recommended to reach out to a Poison Control Center at 1-800-222-1222 for expert guidance.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Healthcare providers should be prepared to assess the patient's condition and initiate appropriate management protocols based on the severity of symptoms and the specific substance involved.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

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 to prevent accidental ingestion. Instruct patients that if the product is swallowed, they should seek medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Patients should be informed not to use the product on large areas of the body or on cut, irritated, or swollen skin, and it should not be applied to puncture wounds. It is important to counsel patients against using the product for more than one week without consulting a doctor.

Healthcare providers should emphasize that patients must stop using the product and consult a doctor if their condition worsens, if symptoms persist for more than 7 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 on the carton.

Additionally, patients should be cautioned to avoid contact with the eyes and not to bandage or apply local heat, such as heating pads, to the area of use.

Storage and Handling

The product is supplied in packaging that includes specific NDC numbers. It should be stored at room temperature, ensuring that it is protected from light exposure. Freezing the product is not permitted, as it may compromise its integrity. Additionally, once opened, the product must be discarded to ensure safety and efficacy.

Additional Clinical Information

The product is administered topically, with a recommended application of a thin layer to the affected area every 6 to 8 hours, not exceeding three applications within a 24-hour period. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is also important to instruct patients to keep the product out of reach of children and to seek immediate medical assistance or contact a Poison Control Center (1-800-222-1222) if the product is swallowed.

Drug Information (PDF)

This file contains official product information for Healthwise Pain Relief Cream with 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 Cream with 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.