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Theraworx Pain Relief Roll- on- Lidocaine

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Active ingredient
Lidocaine Hydrochloride 40 mg/1 mL
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 2024
Label revision date
October 23, 2023
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Lidocaine Hydrochloride 40 mg/1 mL
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 2024
Label revision date
October 23, 2023
Manufacturer
AVADIM HOLDINGS, INC.
Registration number
M017
NDC root
61594-028
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 for the temporary relief of pain. It is designed to help alleviate discomfort, making it easier for you to manage your daily activities. If you're experiencing pain, this drug may provide the support you need to feel more comfortable.

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 go about 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. Additionally, there are no reported nonteratogenic effects, ensuring that it is generally well-tolerated.

Dosage and Administration

Before using this medication, make sure to shake the bottle well. For adults and children aged 2 years and older, apply a thin layer of the product to each affected area of your skin and let it air dry. You can repeat this process, but remember to wash your hands thoroughly after applying the product to avoid any unwanted contact with your eyes or mouth.

It's important not to use this medication more than 3 to 4 times a day. If you have a child under 2 years of age, do not use this product without consulting a doctor first. Always follow these guidelines to ensure safe and effective use.

What to Avoid

It's important to use this medication responsibly. You should avoid using it in large quantities, especially on raw surfaces or blistered areas, as this can lead to complications. While there are no specific contraindications or concerns about abuse, misuse, or dependence associated with this medication, always follow the recommended guidelines to ensure your safety and well-being. If you have any questions or concerns, don't hesitate to reach out to your healthcare provider for more information.

Side Effects

This product is intended for external use only, so it's important to avoid applying it in large amounts, especially on raw or blistered skin. While using it, be careful not to let it come into contact with your eyes.

If your condition worsens, or if symptoms last longer than 7 days or return shortly after improvement, you should stop using the product and consult a doctor. Additionally, keep this product out of reach of children. If it is swallowed, seek medical assistance or contact a Poison Control Center immediately.

Warnings and Precautions

This product is intended for external use only, so please avoid applying it to large areas of your skin, especially over raw or blistered surfaces. Be careful to keep it away from your eyes, as contact can cause irritation.

If your condition worsens, or if your symptoms last longer than 7 days or return after clearing up, stop using the product and consult your doctor. Additionally, if you accidentally swallow any of the product, seek medical help immediately or contact a Poison Control Center for assistance.

Overdose

If you or someone else has swallowed a medication and you suspect an overdose, it’s important to act quickly. Get medical help immediately or contact a Poison Control Center. They can provide guidance on what to do next.

Signs of an overdose can vary, but they may include unusual symptoms that are not typical for the medication. If you notice any concerning changes in behavior or health, don’t hesitate to seek help. Remember, it’s always better to be safe and get professional advice in these situations.

Pregnancy Use

Currently, there is no information available about the use of Theraworx Pain Relief Roll-On Lidocaine during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions for pregnant individuals have not been addressed in the drug insert.

If you are pregnant or planning to become pregnant, it is important to consult with your healthcare provider before using this product to ensure it is safe for you and your baby. Always prioritize open communication with your doctor regarding any medications or treatments you are considering during pregnancy.

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

When using this product for children aged 2 years and older, you should shake the bottle well before applying a thin layer to the affected area. Allow it to air dry and repeat the process as needed, but do not apply it more than 3 to 4 times a day. After applying, make sure to wash your hands to avoid any unintended contact with other areas.

For children under 2 years of age, it is important not to use this product without first consulting a doctor. Always prioritize your child's safety and follow these guidelines closely.

Geriatric Use

While there is no specific information about how this medication should be used by older adults, it’s important to approach any new treatment with caution. If you or a loved one is an older adult, it’s wise to discuss any potential risks or concerns with your healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken.

Always keep in mind that older adults may have different responses to medications, so regular check-ins with your doctor can ensure safety and effectiveness.

Renal Impairment

There are no specific guidelines, dosage adjustments, or monitoring requirements mentioned for patients with kidney problems in the provided information. If you have renal impairment (kidney issues), it's important to consult your healthcare provider for personalized advice and to ensure your treatment is safe and effective. Always keep your doctor informed about your kidney health, as they can provide the best recommendations tailored to your needs.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines, dosage adjustments, or special monitoring instructions provided for your condition in the available information. This means that the medication may not have been studied in depth for its effects on individuals with liver impairment.

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 your treatment is safe and effective based on your individual health needs.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking, even if there are no known drug interactions or laboratory test interactions associated with them. This ensures that your treatment plan is safe and effective for your individual health needs.

Always feel free to ask questions and share any concerns you may have regarding your medications or tests. Your healthcare provider is there to help you understand how to manage your health safely.

Storage and Handling

To ensure the best performance and safety of your product, store it in a temperature range between 32°F and 120°F (0°C to 49°C). This helps maintain its effectiveness and integrity.

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 safety and reliability. If you have any questions about disposal or further handling, consult the guidelines provided with your product.

Additional Information

You should apply this medication topically, which means you will be applying it directly to your skin. For adults and children aged 2 years and older, roll a thin layer onto each affected area and let it air dry. Make sure not to use it more than 3 to 4 times a day to avoid any potential issues.

FAQ

What is the primary use of this drug?

This drug is used for temporary relief of pain.

Who can use this product?

Adults and children 2 years of age and older can use this product. Children under 2 years should not use it and should consult a doctor.

How should I apply this product?

Shake the bottle well, roll a thin layer to each affected area, allow it to air dry, and wash your hands after applying. Do not use more than 3 to 4 times daily.

Are there any contraindications for this drug?

No specific contraindications are mentioned for this drug.

What should I do if I experience worsening symptoms?

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

Is this product safe for use during pregnancy or breastfeeding?

There is no specific information regarding the use of this product during pregnancy or breastfeeding.

What precautions should I take when using this product?

Avoid contact with the eyes and do not use in large quantities, especially over raw surfaces or blistered areas.

What should I do if the product is swallowed?

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

How should I store this product?

Store the product between 32°F and 120°F.

Packaging Info

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

Packaging configurations for Theraworx Pain Relief Roll- on- Lidocaine.
Details

Drug Information (PDF)

This file contains official product information for Theraworx Pain Relief Roll- on- 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, which 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 microcrystalline cellulose, magnesium stearate, and sodium starch glycolate. The product is supplied in bottles containing 100 tablets.

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 2 years and older, the product should be administered as follows:

The bottle must be shaken well prior to use. A thin layer of the product should be rolled onto each affected area, allowing it to air dry. This application may be repeated as necessary, but it is important to wash hands thoroughly after applying the product. The maximum recommended frequency of application is 3 to 4 times daily.

For children under 2 years of age, the product is not recommended. Consultation with a healthcare professional is advised before use in this age group.

Contraindications

The product should not be used in large quantities, particularly over raw surfaces or blistered areas, due to the potential for increased irritation or adverse effects in these conditions. No other specific contraindications have been identified.

Warnings and Precautions

This product is intended for external use only. It is imperative that healthcare professionals advise patients against using this product in large quantities, especially on raw surfaces or blistered areas, to prevent potential adverse effects.

Care should be taken to avoid contact with the eyes during application. In the event of accidental eye contact, immediate rinsing with water is recommended, and if irritation persists, medical attention should be sought.

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. This precaution is essential to ensure appropriate management of the underlying condition.

In cases of ingestion, it is critical to seek medical assistance or contact a Poison Control Center immediately. Prompt action is necessary to mitigate any potential risks associated with swallowing the product.

Side Effects

Patients should be aware that this product is for external use only. It is important to avoid using it in large quantities, particularly over raw surfaces or blistered areas. During use, contact with the eyes should be avoided to prevent irritation.

In clinical practice, patients are advised to discontinue use and consult a healthcare professional if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days.

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

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions with 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 Theraworx Pain Relief Roll- on- Lidocaine (lidocaine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Theraworx Pain Relief Roll- on- Lidocaine.
Details

Pediatric Use

Pediatric patients aged 2 years and older may use the product by shaking the bottle well and applying a thin layer to each affected area, allowing it to air dry. The application may be repeated, but it should not exceed 3 to 4 times daily.

For children under 2 years of age, the product is not recommended, and consultation with a healthcare professional is advised prior to use.

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

There is no information available regarding the use of Theraworx Pain Relief Roll-On Lidocaine during pregnancy. As such, the safety of this product in pregnant patients has not been established, and there are no known dosage modifications or special precautions recommended for use in this population. Healthcare professionals should consider the lack of data when advising women of childbearing potential and weigh the potential risks and benefits before prescribing this medication during pregnancy.

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 the use of this medication. Consequently, there is no information available regarding dosage adjustments, special monitoring requirements, or precautions 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.

Overdosage

In the event of an overdose, immediate medical assistance is crucial. Healthcare professionals are advised to instruct patients or caregivers to seek medical help or contact a Poison Control Center without delay if the substance is ingested.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved; therefore, a thorough assessment and appropriate management strategies should be implemented based on clinical presentation and available guidelines.

It is imperative that healthcare providers remain vigilant and prepared to initiate supportive care and symptomatic treatment as necessary.

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 in these areas limits the understanding of the compound's safety profile in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

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 inform patients not to use the product in large quantities, especially on raw surfaces or blistered areas, to prevent potential complications.

Patients should be instructed to discontinue use 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. Additionally, healthcare providers should emphasize the importance of avoiding contact with the eyes while using this product to prevent irritation or injury.

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 within a temperature range of 32°F to 120°F to maintain its integrity and efficacy. Proper storage conditions must be adhered to, ensuring that the product is kept in a suitable container that protects it from environmental factors. Special handling requirements should be observed to prevent any compromise to the product's quality.

Additional Clinical Information

The medication is administered topically. For adults and children aged 2 years and older, a thin layer should be rolled onto each affected area, allowing it to air dry. The application should not exceed 3 to 4 times daily.

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 Theraworx Pain Relief Roll- on- 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 Theraworx Pain Relief Roll- on- 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.