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Topcare Pain Relieving

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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 2020
Label revision date
November 5, 2024
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 2020
Label revision date
November 5, 2024
Manufacturer
Topco Associates LLC
Registration number
M017
NDC root
36800-470
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® is a pain-relieving cream that contains 4% lidocaine (a local anesthetic that helps numb pain). It is designed to provide temporary relief from pain and is known for its maximum strength and fast-acting formula. The cream is non-greasy, odor-free, and includes aloe, which can help soothe the skin.

This product is often recommended by pharmacists and can be compared to other pain relief creams like Aspercreme®. With a convenient size of 2.7 ounces, it is easy to apply and can be a helpful option for managing discomfort.

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 manage your daily activities.

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

Dosage and Administration

If you are 12 years old or 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 safe and effective use. However, if you are under 12 years old, it’s important not to use this medication without first consulting a doctor. Always check with a healthcare professional if you have any questions or concerns about using this treatment.

What to Avoid

It's important to use this product safely to avoid any potential issues. You should not apply it to wounds or damaged skin, and be careful not to bandage tightly over the area where it's applied. Additionally, avoid using heating pads or other heating devices in conjunction with this product, as this can lead to complications. Lastly, refrain from using large quantities, especially on raw surfaces or blistered areas, to ensure your safety and well-being.

Side Effects

When using this product, it's important to be aware of some potential side effects and precautions. You should avoid contact with your eyes and refrain from applying it to wounds or damaged skin. It's also advised not to use it with heating pads or other heating devices, and to avoid tight bandaging. If you are pregnant or nursing, consult a healthcare professional before use.

If your condition worsens, or if symptoms persist for more than 7 days or return shortly after improvement, stop using the product and seek medical advice. Additionally, keep this product out of reach of children, and if swallowed, contact a Poison Control Center or seek medical help immediately.

Warnings and Precautions

This product is for external use only, so please avoid applying it to your eyes, wounds, or damaged skin. It's important not to bandage the area tightly or use it with heating pads or other heating devices. If you are pregnant or nursing, consult a healthcare professional before using this product.

Be cautious with the amount you apply, especially on raw surfaces or blistered areas. If your condition worsens, or if symptoms last more than 7 days or return shortly after improvement, stop using the product and contact your doctor. Always keep this product out of reach of children. If swallowed, seek medical help or call a Poison Control Center at 1-800-222-1222 immediately.

Overdose

It's important to keep this medication out of reach of children. If a child accidentally swallows it, you should seek medical help right away or contact a Poison Control Center at 1-800-222-1222.

In case of an overdose, you may notice signs such as unusual drowsiness, confusion, or difficulty breathing. If you or someone else experiences these symptoms, it's crucial to get medical assistance immediately. Always prioritize safety and act quickly in these situations.

Pregnancy Use

If you are pregnant or nursing, it’s important to consult with a healthcare professional before using this product. They can provide guidance tailored to your specific situation, ensuring both your health and the health of your baby are prioritized. Always prioritize open communication with your doctor regarding any medications or treatments you are considering during this time.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to consult with a healthcare professional before using any medication. This is to ensure the safety of both you and your baby. Always prioritize getting personalized advice to understand any potential effects on your milk production or your infant's health.

Pediatric Use

If your child is under 12 years old, it's important not to use this medication without first consulting a doctor. For those aged 12 and older, you can apply the medication to the affected area, but be sure to do so no more than 3 to 4 times a day. Always follow these guidelines to ensure safe and effective use.

Geriatric Use

While there is no specific information about the use of TopCare Pain Relieving Analgesic (lidocaine hydrochloride cream) in older adults, it’s important to approach its use with caution. Since the drug insert does not mention any dosage adjustments or safety concerns for elderly patients, you should consult with a healthcare professional before using this product. They can provide guidance tailored to your individual health needs and any other medications you may be taking.

Always prioritize safety and ensure that any treatment aligns with your overall health plan, especially if you or your loved ones are managing multiple health conditions.

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 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 condition and the use of this medication. 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 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 lab tests you may be undergoing. This way, you can receive the best possible care tailored to your needs.

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 it in a clean environment to ensure it remains safe for use. If you have any questions about disposal or other safety measures, refer to the guidelines provided with your product.

Additional Information

You should apply this medication topically to the affected area, using it no more than 3 to 4 times a day if you are an adult or a child aged 12 years and older. If the patient is under 12 years old, it's important to consult a doctor before use. There are no additional details available regarding laboratory tests, abuse potential, or postmarketing experiences related to this medication.

FAQ

What is TopCare health®?

TopCare health® is a pain-relieving cream that contains 4% Lidocaine HCl, designed for temporary relief of pain.

How should I use TopCare health®?

For adults and children 12 years and older, apply to the affected area not more than 3 to 4 times daily. Do not use on children under 12 years without consulting a doctor.

Are there any contraindications for using TopCare health®?

No specific contraindications are mentioned, but do not apply to wounds or damaged skin.

What should I avoid while using this product?

Avoid contact with eyes, do not bandage tightly, and do not use with heating pads or other heating devices.

What should I do if my condition worsens?

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

Is TopCare health® safe to use during pregnancy?

As with any drug, if you are pregnant or nursing, seek the advice of a health professional before using this product.

What are the side effects of TopCare health®?

For external use only, and avoid contact with eyes. If you experience any adverse effects, discontinue use and consult a doctor.

How should I store TopCare health®?

Store TopCare health® at room temperature.

What should I do if TopCare health® is swallowed?

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

Packaging Info

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

Packaging configurations for Topcare Pain Relieving.
Details

Drug Information (PDF)

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

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

Dosage and Administration

For adults and children aged 12 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 12 years of age, the product should not be used without consulting a healthcare professional. It is essential to seek medical advice to determine the appropriate course of action for this age group.

Contraindications

The product is contraindicated in the following situations:

Application to wounds or damaged skin is prohibited due to the potential for adverse effects. Tight bandaging is not recommended, as it may lead to complications. The use of heating pads or other heating devices in conjunction with this product is contraindicated, as it may increase the risk of irritation or injury. Additionally, the application of large quantities, especially over raw surfaces or blistered areas, is not advised to prevent exacerbation of the condition.

Warnings and Precautions

For external use only, this product should not come into contact with the eyes. It is imperative to avoid application on wounds or damaged skin to prevent adverse reactions. Additionally, the product should not be bandaged tightly, nor should it be used in conjunction with heating pads or other heating devices, as this may lead to increased absorption and potential side effects.

Healthcare professionals are advised to counsel patients who are pregnant or nursing to seek medical advice prior to using this product. Caution is warranted regarding the application of large quantities, particularly over raw surfaces or blistered areas, as this may exacerbate irritation or lead to systemic effects.

Patients should be instructed to discontinue use and consult a healthcare provider if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days.

It is essential to keep this product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted.

Side Effects

Patients using this product should be aware that it is intended for external use only. It is crucial to avoid contact with the eyes and to refrain from applying the product to wounds or damaged skin. Additionally, patients should not bandage the area tightly or use the product in conjunction with heating pads or other heating devices.

In clinical practice, it is advised that pregnant or nursing individuals seek the guidance of a healthcare professional prior to using this product. Caution should be exercised to avoid the application of large quantities, especially over raw surfaces or blistered areas.

Patients are instructed to discontinue use and consult a healthcare provider if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days.

Furthermore, it is imperative to keep this product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center (1-800-222-1222) is recommended.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

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

Packaging configurations for Topcare Pain Relieving.
Details

Pediatric Use

Pediatric patients under 12 years of age should not use this medication without consulting a doctor. For adolescents and adults aged 12 years and older, the recommended application is to the affected area no more than 3 to 4 times daily.

Geriatric Use

There is no specific information regarding the use of TopCare Pain Relieving Analgesic (lidocaine hydrochloride cream) in geriatric patients. The prescribing information does not provide guidance on dosage adjustments, safety concerns, or special precautions for elderly patients. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients, considering the lack of data on its use in this population. Monitoring for efficacy and potential adverse effects is advisable, given the absence of specific recommendations.

Pregnancy

Pregnant patients and nursing mothers should seek the advice of a healthcare professional before using this product. The safety of this medication during pregnancy has not been established, and potential risks to fetal outcomes are not fully understood. Therefore, it is essential for women of childbearing potential to discuss their individual circumstances with a healthcare provider to weigh the benefits and risks associated with the use of this product during pregnancy and lactation.

Lactation

Lactating mothers are advised to seek the advice of a health professional before using this product. There is no specific data available regarding the excretion of this drug in breast milk or its effects on breastfed infants. Therefore, caution is recommended when considering the use of this product during lactation.

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 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, it is imperative to keep the product out of reach of children. Should ingestion occur, immediate medical assistance is required. Healthcare professionals are advised to contact a Poison Control Center at 1-800-222-1222 for guidance on appropriate management.

Prompt action is crucial in mitigating 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 any clinical manifestations that arise.

Nonclinical Toxicology

Pregnant or nursing individuals are advised to consult a healthcare professional prior to using this product, as teratogenic effects may be a concern. There are no specific non-teratogenic effects or detailed nonclinical toxicology data available. Additionally, no specific information regarding animal pharmacology and toxicology has been provided.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs. Allergic reactions have been noted, including manifestations such as rash, itching, and hives. Additionally, systemic reactions have been observed, which include symptoms like dizziness, drowsiness, and confusion.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children. 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 to discontinue use and consult a doctor if their condition worsens, or if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days.

When using this product, patients must be cautioned to avoid contact with the eyes and not to apply it to wounds or damaged skin. They should also be advised against bandaging the area tightly and using heating pads or other heating devices in conjunction with the product.

Additionally, patients who are pregnant or nursing should be encouraged to seek the advice of a healthcare professional before using this product. It is important to inform patients not to use the product in large quantities, especially over raw surfaces or blistered areas.

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

The medication is administered topically, with a recommended application frequency of 3 to 4 times daily for adults and children aged 12 years and older. For children under 12 years of age, it is advised to consult a doctor before use. There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

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

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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.