Symptom checker
Select audience type

Switch between content for healthcare professionals (PRO) and general audience (GEN).

ADD CONDITION

items per page

Theraworx Pain Relief Roll-on with Lidocaine for Diabetics

Last content change checked dailysee data sync status

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
January 8, 2024
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
January 8, 2024
Manufacturer
AVADIM HOLDINGS, INC.
Registration number
M017
NDC root
61594-030
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. There are no known teratogenic effects (which means it does not cause birth defects) or nonteratogenic effects associated with this medication. Always consult with your healthcare provider if you have any questions or concerns about its use.

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 as necessary, but remember not to use it more than 3 to 4 times a day. After applying the product, wash your hands to avoid any unwanted contact with other areas of your body.

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

What to Avoid

It's important to use this product safely to avoid any potential issues. You should not use it in large quantities, especially on raw surfaces or blistered areas, as this could lead to irritation or other complications. Additionally, be careful to avoid contact with your eyes while using this product, as it may cause discomfort or harm.

Currently, there are no specific contraindications, controlled substance classifications, or noted risks of abuse, misuse, or dependence associated with this product. Always follow these guidelines to ensure your safety and well-being.

Side Effects

This product is intended for external use only, so be sure to avoid applying it in large amounts, especially on raw or blistered skin. While using it, take care to keep it away from your eyes. If your condition worsens, or if symptoms last more than seven days or return shortly after improvement, stop using the product and consult a doctor.

If you are pregnant or breastfeeding, it's important to speak with a healthcare professional before using this product. Additionally, keep it out of reach of children, and 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. If you are pregnant or breastfeeding, it's important to speak with a healthcare professional before using this product. Always keep it out of reach of children, and if it is swallowed, seek medical help or contact a Poison Control Center immediately.

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 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

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.

For children under 2 years of age, it is important not to use this product without first consulting a doctor. Always prioritize safety and seek professional advice when it comes to younger children.

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 should be used if you have hepatic impairment (issues with liver function).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver health. They can help determine the best course of action based on your individual situation.

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 your complete list of medications and any lab tests you may undergo. Your healthcare provider can help you understand how these factors may affect your health and treatment.

Storage and Handling

To ensure the best performance 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 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 further handling, please refer to the guidelines provided with your product.

Additional Information

You should apply this medication topically, which means you will be putting it directly on your skin. For both adults and children aged 2 years and older, you need to 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 drug?

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

How should I apply this drug?

Shake the bottle well, roll a thin layer to each affected area, and allow it to air dry. Wash your hands after applying.

How often can I use this drug?

You should not use this drug more than 3 to 4 times daily.

Are there any warnings I should be aware of?

This product is for external use only. Avoid contact with the eyes and do not use in large quantities, especially over raw surfaces or blistered areas.

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 or return after a few days.

Is it safe to use this drug if I am pregnant or breastfeeding?

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

What should I do if this drug is swallowed?

Keep this drug out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

What are the storage conditions for this drug?

Store this drug between 32°F and 120°F.

Packaging Info

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

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

Drug Information (PDF)

This file contains official product information for Theraworx Pain Relief Roll-on with Lidocaine for Diabetics, 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. It 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. The formulation includes inactive ingredients such as lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, and magnesium stearate.

Uses and Indications

This drug is indicated for the temporary relief of pain. There are no teratogenic or nonteratogenic effects mentioned in the available data.

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 before 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 limit the use to no more than 3 to 4 times daily. After application, hands should be washed thoroughly to prevent unintentional contact with other areas of the body or surfaces.

For children under 2 years of age, the product is not recommended. Consultation with a healthcare professional is advised prior to 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 irritation or adverse effects. Additionally, contact with the eyes must be avoided to prevent ocular irritation or injury.

Warnings and Precautions

This product is intended for external use only. It is imperative to avoid applying it 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.

Healthcare professionals should advise patients to discontinue use and seek medical advice if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days.

For individuals who are pregnant or breastfeeding, consultation with a healthcare professional is recommended prior to use to ensure safety for both the mother and child.

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 contact with a Poison Control Center should be made without delay.

Side Effects

Patients should be aware that this product is for external use only. It is advised not to use the product in large quantities, particularly over raw surfaces or blistered areas, as this may lead to adverse effects. During use, it is important to avoid contact with the eyes to prevent irritation or injury.

In the event that the condition worsens, or if symptoms persist for more than 7 days or clear up and then recur within a few days, patients should stop use and consult a doctor. Additionally, pregnant or breastfeeding individuals are encouraged to seek advice from a health professional prior to using this product.

This product should be kept out of reach of children. If swallowed, it is crucial to seek medical help or contact a Poison Control Center immediately.

Drug Interactions

There are no specific drug interactions identified for this medication. Additionally, no laboratory test interactions have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

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

Packaging configurations for Theraworx Pain Relief Roll-on with Lidocaine for Diabetics.
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 doctor is advised prior to use.

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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in 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, as well as any available data regarding fetal outcomes and breastfeeding safety. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the health and safety of both the patient and the fetus or infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this medication in human 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 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 intervention is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical assistance or contact a Poison Control Center without delay.

Prompt action is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved; therefore, a thorough assessment by a medical professional is recommended to determine the appropriate course of action and management strategies.

Healthcare providers should ensure that patients are aware of the importance of timely reporting of any suspected overdosage to facilitate effective treatment and minimize risks.

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 potential effects in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert.

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 resolve 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 further information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Theraworx Pain Relief Roll-on with Lidocaine for Diabetics, 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 with Lidocaine for Diabetics, 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.