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Topcare Pain Relieving Cream

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Active ingredient
Lidocaine Hydrochloride 40 mg/1 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
January 16, 2026
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Lidocaine Hydrochloride 40 mg/1 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
January 16, 2026
Manufacturer
Topco Associates, LLC
Registration number
M017
NDC root
76162-291
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

TopCare Health Pain Relieving Cream is a maximum strength, fragrance-free topical analgesic designed to provide fast relief from minor pain. It contains 4% Lidocaine HCl, which works by numbing the area where it is applied, helping to alleviate discomfort. This non-greasy cream also includes aloe, making it gentle on the skin while effectively targeting pain relief.

You can use this cream to temporarily relieve minor aches and pains, allowing you to feel more comfortable in your daily activities.

Uses

You can use this medication to temporarily relieve minor pain. It contains Lidocaine HCl, a topical analgesic that helps numb the area where it's applied, providing quick relief from discomfort.

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 concerned about such risks.

Dosage and Administration

If you are an adult or a child aged 2 years and older, you can apply this medication to the affected area up to 3 to 4 times a day. Make sure to follow this guideline to ensure the best results. However, if you have a child under 2 years old, it’s important not to use this medication without first consulting a doctor. Always prioritize safety and seek professional advice when it comes to younger children.

What to Avoid

It's important to use this medication safely to avoid potential issues. You should not apply it in large quantities, especially on raw or blistered areas of your skin, as this could lead to irritation or other complications. Additionally, be careful to avoid getting the medication in your eyes, as this can cause discomfort or damage.

While there are no specific contraindications or concerns about abuse, misuse, or dependence associated with this medication, following these guidelines will help ensure your safety and the effectiveness of your treatment. Always consult with your healthcare provider if you have any questions or concerns.

Side Effects

When using this product, it's important to remember that it is for external use only. Avoid applying it in large amounts, especially on raw or blistered skin. If you notice that your condition worsens, if symptoms persist for more than seven days, or if symptoms improve and then return within a few days, you should stop using the product and consult a doctor.

Be careful not to get the product in your eyes. Additionally, keep it out of reach of children, as swallowing it can be harmful. If ingestion occurs, seek medical help or contact a Poison Control Center immediately.

Warnings and Precautions

This product is intended for external use only. Avoid applying it in large amounts, especially on raw or blistered skin. If you notice that your condition worsens, if symptoms persist for more than 7 days, or if symptoms improve and then return within a few days, stop using the product and consult your doctor.

Be careful not to get the product in your eyes. If you accidentally swallow it, seek medical assistance immediately or contact a Poison Control Center for help. Your safety is important, so please take these precautions seriously.

Overdose

If you or someone else has swallowed too much of a 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. Acting quickly can make a significant difference in the outcome.

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. Remember, it’s always better to be safe and seek assistance if you suspect an overdose.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of using this medication during pregnancy has not been established. It is generally not recommended for pregnant women due to potential risks to the developing fetus. If you are considering using this medication, you should consult your healthcare provider to discuss any possible risks and to determine if it is necessary for your situation.

Additionally, if you do use this medication while pregnant, your healthcare provider may need to adjust the dosage. Always prioritize open communication with your healthcare provider to ensure the best care for you and your baby.

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 it may pose to your infant.

As always, if you have any concerns or questions about using this product while breastfeeding, it's a good idea to consult with your healthcare provider for personalized advice.

Pediatric Use

If your child is under 2 years old, it's important not to use this medication without consulting a doctor first. For children aged 2 years and older, you can apply the medication to the affected area, but be sure to do this no more than 3 to 4 times a day. Always follow these guidelines to ensure your child's safety and well-being.

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 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 the medication may apply to you without any special considerations. However, always consult your healthcare provider for personalized advice and to ensure your treatment is safe and effective based on your kidney health.

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.

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver function and how it relates to your treatment. They can help ensure that your medication 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 feel free to ask questions and share your complete list of medications and any tests you might be undergoing. This way, you can avoid any potential issues and ensure the best possible care.

Storage and Handling

To ensure the best performance of your product, store it at a controlled room temperature between 20° and 25°C (68° and 77°F). This temperature range helps maintain the integrity and effectiveness of the device.

When handling the product, make sure to do so with clean hands and in a clean environment to avoid contamination. Always follow any specific instructions provided for use to ensure safety and effectiveness. If you have any questions about disposal or further handling, please refer to the guidelines provided with your product.

Additional Information

No further information is available.

FAQ

What is TopCare Health Pain Relieving Cream used for?

TopCare Health Pain Relieving Cream is used to temporarily relieve minor pain.

How often can I apply this cream?

Adults and children 2 years and over can apply it to the affected area not more than 3 to 4 times daily.

Is this cream safe for children under 2 years?

No, do not use this cream on children under 2 years without consulting a doctor.

What should I do if I accidentally get the cream in my eyes?

You should avoid getting the cream in your eyes. If it happens, rinse thoroughly with water and seek medical attention if necessary.

Can I use this cream if I am pregnant?

Safety during pregnancy has not been established, and it is not recommended for use in pregnant women due to potential risks to the fetus.

What should I do if my condition worsens or symptoms last more than 7 days?

You should stop using the cream and consult a healthcare provider if your condition gets worse or if symptoms last for more than 7 days.

How should I store TopCare Health Pain Relieving Cream?

Store the cream at a controlled room temperature of 20°-25°C (68°-77°F).

What are the key ingredients in this cream?

The cream contains Lidocaine HCl 4%, which is a topical analgesic used for pain relief.

Are there any contraindications for using this cream?

There are no specific contraindications mentioned, but it should not be used in large quantities, particularly over raw surfaces or blistered areas.

What should I do if I swallow the cream?

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

Packaging Info

Below are the non-prescription pack sizes of Topcare Pain Relieving Cream (lidocaine hcl 4%). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Topcare Pain Relieving Cream.
Details

Drug Information (PDF)

This file contains official product information for Topcare Pain Relieving Cream, 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 minor pain. It contains Lidocaine HCl 4% as a topical analgesic, providing localized pain relief.

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, the product should not be used without consulting a healthcare professional. It is essential to seek medical advice before administering this treatment to this age group.

Contraindications

Use is contraindicated in the following situations:

Application in large quantities, especially over raw surfaces or blistered areas, is not recommended due to the potential for adverse effects. Additionally, contact with the eyes should be strictly avoided to prevent irritation or injury.

Warnings and Precautions

For external use only. The product should not be applied in large quantities, especially over raw surfaces or blistered areas, as this may lead to adverse effects.

Healthcare professionals should advise patients to discontinue use if any of the following occur: the condition worsens, symptoms persist for more than 7 days, or symptoms resolve and then recur within a few days.

It is imperative to avoid contact with the eyes. In the event of accidental ingestion, immediate medical assistance should be sought, or the patient should contact a Poison Control Center without delay.

Side Effects

Patients should be aware that the product is for external use only. It is important to avoid applying the product in large quantities, particularly over raw surfaces or blistered areas, as this may lead to adverse reactions.

During the use of this product, patients are advised to take precautions to prevent contact with the eyes. If the product inadvertently gets into the eyes, it may cause irritation.

Patients should discontinue use and consult a healthcare professional if any of the following occur: the condition worsens, symptoms persist for more than 7 days, or symptoms resolve and then recur within a few days. These situations may indicate a need for further medical evaluation.

Additionally, it is crucial to keep the product out of reach of children. In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately.

Drug Interactions

There are currently no documented drug interactions associated with 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 Topcare Pain Relieving Cream (lidocaine hcl 4%). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Topcare Pain Relieving Cream.
Details

Pediatric Use

Pediatric patients under 2 years of age should not use this product and must consult a healthcare professional for guidance. For adults and children aged 2 years and older, the recommended application is to the affected area no more than 3 to 4 times daily.

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

Safety during pregnancy has not been established for this product. Use is not recommended in pregnant women due to potential risks to the fetus. There may be risks associated with the use of lidocaine during pregnancy; therefore, it is essential for healthcare providers to be consulted for advice regarding its use.

Dosage adjustments may be necessary for pregnant patients, and specific recommendations should be obtained from a healthcare provider. Pregnant women should use this product only if clearly needed and after thorough discussion with their healthcare provider to weigh the potential benefits against the risks.

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 renal impairment, including dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of specific guidance when treating patients with renal impairment.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this medication. 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 overdosage, 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 without delay.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are recommended to ensure patient safety and effective resolution of any complications arising from the overdosage.

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

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: allergic reactions, including anaphylaxis, as well as skin reactions such as rash, pruritus, and erythema.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed. It is important to emphasize that the product should not be applied in large quantities, especially over raw surfaces or blistered areas, to avoid potential complications.

Patients should be cautioned against getting the product into their eyes, as this may lead to irritation or injury. Healthcare providers should instruct patients to discontinue use if any of the following occur: the condition worsens, symptoms persist for more than 7 days, or symptoms resolve and then recur within a few days. This guidance is essential to ensure patient safety and effective management of their condition.

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 a controlled room temperature, maintaining a range of 20° to 25°C (68° to 77°F). Proper storage conditions are crucial to ensure the integrity and efficacy of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Topcare Pain Relieving 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 Topcare Pain Relieving 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.