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Topcare Pain Relief

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Active ingredient
Lidocaine Hydrochloride 4 g/100 g
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
Dosage form
Liquid
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2019
Label revision date
November 11, 2025
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
Liquid
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 2019
Label revision date
November 11, 2025
Manufacturer
TOPCO ASSOCIATES
Registration number
M017
NDC root
36800-529
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 Maximum Strength Pain Relief Roll-On Liquid is a topical product designed to temporarily relieve minor pain. It contains 4% lidocaine HCl, which works by numbing the pain-affected areas on your skin. This roll-on liquid is odor-free, oil-free, and formulated with aloe to provide a soothing experience without the use of parabens or alcohol.

The convenient no-touch applicator makes it easy to apply directly to the skin, allowing you to target specific areas of discomfort. Whether you're dealing with muscle aches, joint pain, or other minor pains, this product aims to help you find relief quickly and effectively.

Uses

You can use this medication to temporarily relieve minor pain, making it helpful for areas that are affected by discomfort. Whether you're dealing with a headache, muscle ache, or other minor pains, this medication can provide you with some relief. It's designed to target the specific areas where you're feeling pain, helping you feel more comfortable.

Rest assured, there are no teratogenic effects (which means it doesn't cause birth defects) associated with this medication, so it is considered safe in that regard.

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 exceed more than 3 applications within a 24-hour period. This helps ensure that you are using the medication safely and effectively.

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 your healthcare provider's instructions to ensure the best results.

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 any cut, irritated, or swollen skin. Additionally, avoid using it on puncture wounds. If you find that you need to use it for more than one week, please consult your doctor first.

Make sure to keep it away from your eyes, and do not cover the treated area with a bandage or apply local heat, like heating pads. Following these guidelines will help ensure your safety while using this medication.

Side Effects

When using this product, it's important to follow the directions carefully. You should only apply it to the affected area and avoid using it on large areas of your body, on cuts, irritated skin, or puncture wounds. If your condition worsens, if symptoms last more than seven days, or if they clear up and then return shortly after, stop using the product and consult a doctor.

Please remember that this product is flammable, so keep it away from fire or flames. If you accidentally swallow it, 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 applying it to large areas of your body, on cut, irritated, or swollen skin, or on puncture wounds. It’s important to use the product exactly as directed and to read all instructions carefully. Make sure to keep it away from your eyes, and do not cover the treated area with bandages or apply heat, like heating pads.

If your condition worsens, or if your symptoms last longer than seven days or return after clearing up, stop using the product and consult your doctor. Remember, this product is flammable, so keep it away from fire or flames. Always store it out of reach of children and pets. If swallowed, seek 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 about 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 your child is 12 years old or younger, it's important to consult with a doctor before using this medication. For children and adults over 12, you can apply a thin layer to the affected area every 6 to 8 hours, but be careful 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, 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 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 should be used if you have 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 health situation. They can help you understand how to manage your treatment effectively while considering 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 if you have hepatic impairment (issues with liver function).

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

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 of your product, store it at room temperature. This helps maintain its effectiveness and safety. When handling the product, be sure to follow any specific instructions provided to avoid contamination or damage. Always keep the product in a clean environment to ensure it remains safe for use. If you have any questions about disposal or specific handling procedures, refer to the guidelines provided with your product.

Additional Information

No further information is available.

FAQ

What is TopCare Health Maximum Strength Pain Relief Roll-On Liquid?

It is a topical pain relief product containing 4% Lidocaine HCl, designed to temporarily relieve minor pain.

How should I use this product?

Apply a thin layer to the affected area every 6 to 8 hours, not exceeding 3 applications in a 24-hour period for adults and children over 12 years.

Are there any warnings associated with this product?

Yes, it is for external use only, should not be used on large areas of the body, and should not come into contact with the eyes.

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.

Is this product safe for children?

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

What should I do if I accidentally swallow this product?

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

Can I use this product if I am pregnant or breastfeeding?

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

What are the storage instructions for this product?

Store at room temperature and keep away from fire or flame.

Does this product have any contraindications?

No specific contraindications are mentioned in the provided information.

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 puncture wounds or irritated skin.

Packaging Info

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

Packaging configurations for Topcare Pain Relief.
Details

Drug Information (PDF)

This file contains official product information for Topcare Pain Relief, 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 drug.

Uses and Indications

This drug is indicated for the temporary relief of minor pain. It is designed to assist in alleviating discomfort in pain-affected areas.

There are no teratogenic or nonteratogenic effects associated with this drug.

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 and younger, it is recommended to consult a physician before use.

Contraindications

Use is contraindicated in the following situations:

  • Application on large areas of the body or on cut, irritated, or swollen skin due to the potential for adverse effects.

  • Application on puncture wounds, as this may lead to complications.

  • Use for more than one week without consulting a healthcare professional, to avoid potential risks associated with prolonged 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 use is contraindicated, as this may exacerbate adverse reactions.

Warnings and Precautions

For external use only. This product is contraindicated for application on large areas of the body, as well as on cut, irritated, or swollen skin. It should not be used on puncture wounds. Prolonged use beyond one week is not recommended without prior consultation with a healthcare professional.

When utilizing this product, it is imperative to adhere strictly to the provided directions. Users must read and follow all instructions and warnings indicated on the packaging. Care should be taken to avoid contact with the eyes. Additionally, the area of application should not be bandaged or subjected to local heat, such as heating pads.

Users are advised to discontinue use and seek medical advice if the condition worsens, if symptoms persist for more than seven days, or if symptoms resolve and then recur within a few days.

This product is flammable; therefore, it must be kept away from fire or flame. It is essential to store this product out of reach of children and pets. In the event of accidental ingestion, immediate medical assistance should be sought, or contact a Poison Control Center at 1-800-222-1222.

Side Effects

Patients using this product should be aware that it is intended for external use only. 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.

While using this product, patients must adhere strictly to the directions provided. It is important to avoid contact with the eyes and to refrain from bandaging or applying local heat, such as heating pads, to the area of use.

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, the product is flammable; therefore, it should be kept away from fire or flame. In the event of accidental ingestion, patients should seek medical assistance immediately or contact a Poison Control Center at 1-800-222-1222.

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

Packaging configurations for Topcare Pain Relief.
Details

Pediatric Use

Pediatric patients 12 years and younger should consult a healthcare professional before use. For adolescents and adults over 12 years, the recommended application is 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

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

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 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 absence of guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

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 overdosage, immediate medical assistance is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical help without delay. It is recommended to contact a Poison Control Center at 1-800-222-1222 for expert guidance on managing the situation.

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

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. No non-teratogenic effects have been provided in the insert. Additionally, there is no information available regarding nonclinical toxicology or animal pharmacology and toxicology in the insert.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children and pets to prevent accidental ingestion or misuse. 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 to avoid application on puncture wounds. It is important to counsel patients that they should not use 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 instructed to use the product only as directed and to read and follow all directions and warnings on the carton.

Additionally, healthcare providers should remind patients to avoid contact with the eyes while using this product. They should also be cautioned against bandaging or applying local heat, such as heating pads, to the area of use. Finally, patients should be advised to keep the product away from fire or flame to ensure safety during use.

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 to maintain its integrity and efficacy. No special handling requirements are noted; however, standard precautions should be observed to ensure optimal storage conditions.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Topcare Pain Relief, 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 Relief, 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.