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Myderm Numbing Roll-on

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This product has been discontinued

Active ingredient
Lidocaine Hydrochloride 5 g/100 mL
Other brand names
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 2023
Label revision date
January 31, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Lidocaine Hydrochloride 5 g/100 mL
Other brand names
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 2023
Label revision date
January 31, 2025
Manufacturer
Inspec Solutions LLC.
Registration number
M015
NDC root
72667-058
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

myDerm Numbing Roll-on is a topical formulation that contains 5% lidocaine, which is a medication commonly used to relieve pain and discomfort. This product is designed for application on the skin, making it suitable for adults and children aged 2 years and older. It can be applied to the affected area up to 3 to 4 times daily to help manage pain effectively.

Uses

You can use this medication for treating affected areas on your skin. It is suitable for both adults and children aged 2 years and older. You should apply it to the affected area no more than 3 to 4 times a day for the best results.

There are no specific concerns regarding teratogenic effects (which refer to substances that can cause birth defects) or nonteratogenic effects (which are effects that do not cause birth defects) mentioned for this medication, making it a safer option for use. Always follow the recommended application guidelines for optimal effectiveness.

Dosage and Administration

It seems that there is no specific dosage, route, method, or frequency information available for the medication. This means that you should consult your healthcare provider for personalized instructions on how to take or apply the medication. They will provide you with the necessary details tailored to your individual needs, ensuring you use the medication safely and effectively. Always follow their guidance for the best results.

What to Avoid

You should avoid using this medication if you are pregnant or breastfeeding, as it may pose risks to you and your baby. Additionally, be careful to keep the medication away from your eyes and mucous membranes, as contact can cause irritation or harm. Always prioritize your health and safety by following these guidelines.

Side Effects

For your safety, this product is intended for external use only. If you are pregnant or breastfeeding, it is important not to use this product.

You should stop using it and consult your doctor if your condition worsens, if symptoms last longer than 7 days, or if they improve and then come back within a few days.

Warnings and Precautions

This product is for external use only, so please avoid swallowing it. If you accidentally ingest it, seek emergency medical help or contact a Poison Control Center right away.

You should stop using this product and call your doctor if your condition worsens, if symptoms last longer than 7 days, or if your symptoms improve and then come back within a few days. Additionally, do not use this product if you are pregnant or breastfeeding.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there is no specific information available about the signs of overdose for this medication, general symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, or if you are unsure, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's always better to be safe and get checked by a healthcare professional if you have any concerns about your health.

Pregnancy Use

If you are pregnant or breastfeeding, it is important to avoid using this medication. The potential risks to your baby during pregnancy and while nursing are significant, and it is best to prioritize their safety. Always consult with your healthcare provider for guidance on safe treatment options during this time.

Lactation Use

If you are breastfeeding, it is important to avoid using this medication. There are potential risks associated with its use during breastfeeding, and it is not recommended for nursing mothers. Always consult with your healthcare provider for guidance on safe medication options while you are breastfeeding. Your health and the well-being of your baby are the top priorities.

Pediatric Use

If you are considering this medication for your child, it's important to know that it should not be used in children under 2 years of age. For children aged 2 years and older, you can apply it to the affected area, but make sure to do so no more than 3 to 4 times a day. Always follow these guidelines to ensure your child's safety and well-being.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. If you or a loved one is an older adult, be sure to discuss any potential risks or concerns with your healthcare provider. They can help determine the best approach, considering factors like overall health and any other medications being taken.

Always keep in mind that older adults may have different needs when it comes to medication, so regular check-ins with your doctor can ensure safety and effectiveness.

Renal Impairment

If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

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 you are taking, even if there are no specific drug interactions or laboratory test interactions noted for your treatment. This ensures that your healthcare team can provide the best care tailored to your needs.

Always feel free to ask questions about how different medications might work together or affect any tests you may need. Your health and safety are the top priority, and discussing your full medication list helps prevent any potential issues.

Storage and Handling

To ensure the best performance of your product, store it at room temperature and keep it away from direct light. It's important not to freeze the product, as this can affect its effectiveness. Once you open the product, be sure to discard it after use to maintain safety and quality. Following these simple guidelines will help you use the product safely and effectively.

Additional Information

You should apply this medication topically to the affected area, and it can be used by adults and children aged 2 years and older. It is recommended to apply it no more than 3 to 4 times a day for best results. There is no additional information available regarding laboratory tests, abuse potential, or patient counseling.

FAQ

What is myDerm Numbing Roll-on?

myDerm Numbing Roll-on is a topical formulation containing 5% Lidocaine.

How should I use myDerm Numbing Roll-on?

For adults and children 2 years of age and older, apply to the affected area no more than 3 to 4 times daily.

Can I use myDerm Numbing Roll-on if I am pregnant or breastfeeding?

No, you should not use myDerm Numbing Roll-on if you are pregnant or breastfeeding.

What should I do if my condition worsens or does not improve?

Stop use and ask your doctor if your condition worsens, if symptoms persist for more than 7 days, or if they clear up and reoccur within a few days.

Is myDerm Numbing Roll-on safe for children under 2 years of age?

No, do not use myDerm Numbing Roll-on on children under 2 years of age.

What should I do if I accidentally swallow myDerm Numbing Roll-on?

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

How should I store myDerm Numbing Roll-on?

Store at room temperature, protect from light, and do not freeze. Discard after opening.

Are there any specific warnings for using myDerm Numbing Roll-on?

Yes, it is for external use only and you should avoid contact with the eyes or mucous membranes.

Packaging Info

Below are the non-prescription pack sizes of Myderm Numbing Roll-on (inspec solutions llc). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Myderm Numbing Roll-on.
Details

Drug Information (PDF)

This file contains official product information for Myderm Numbing Roll-on, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

myDerm Numbing Roll-on contains 5% lidocaine as its active ingredient. Lidocaine is a local anesthetic that provides temporary relief from pain and discomfort. The formulation is designed for topical application, allowing for targeted delivery to the affected area. The product is presented in a roll-on dosage form, facilitating ease of use and precise application.

Uses and Indications

This drug is indicated for the topical treatment of affected areas in adults and children aged 2 years and older. It should be applied to the affected area no more than 3 to 4 times daily.

Limitations of Use: There are no specific teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

There is currently no specific dosage information available for the medication. Additionally, no details regarding the route, method, or frequency of administration have been provided. Healthcare professionals are advised to refer to the prescribing information or clinical guidelines for further instructions on dosage and administration.

Contraindications

Use is contraindicated in patients who are pregnant or breastfeeding. Due to the potential risks to the fetus or nursing infant, administration in these populations should be avoided. Additionally, contact with the eyes or mucous membranes should be strictly avoided to prevent irritation or adverse effects.

Warnings and Precautions

For external use only. Healthcare professionals should advise patients to seek emergency medical assistance immediately if the product is ingested. In such cases, contacting a Poison Control Center is essential.

Patients should be instructed to discontinue use and consult their healthcare provider if their condition worsens, if symptoms persist for more than seven days, or if symptoms resolve and then reoccur within a few days. Additionally, this product is contraindicated for use during pregnancy or while breastfeeding.

Side Effects

For external use only. Patients are advised to discontinue use and consult a healthcare professional if the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then reoccur within a few days. Additionally, the product should not be used by individuals who are pregnant or breastfeeding.

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Myderm Numbing Roll-on (inspec solutions llc). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Myderm Numbing Roll-on.
Details

Pediatric Use

Pediatric patients under 2 years of age should not use this medication. 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

There is no specific information available 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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

Pregnant patients and those who are breastfeeding should not use this medication. The potential risks associated with the use of this drug during pregnancy and lactation have not been established, and its safety profile in these populations remains unclear. Healthcare professionals are advised to consider alternative treatments for women who are pregnant or nursing to avoid any potential adverse effects on fetal outcomes or infant health.

Lactation

Lactating mothers are advised against the use of this medication while breastfeeding. There is no available data on the excretion of this drug in human breast milk or its effects on breastfed infants. Therefore, the potential risks to nursing infants must be considered, and alternative treatments should be explored for lactating mothers.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of 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 available information.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise, as the clinical presentation can vary depending on the substance involved and the individual patient's response. Common symptoms of overdose may include, but are not limited to, altered mental status, cardiovascular instability, and respiratory distress.

In the event of an overdose, immediate medical intervention is recommended. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs. The use of activated charcoal may be considered if the patient presents within a suitable timeframe and if the ingestion was recent.

Furthermore, it is crucial to consult local poison control centers or toxicology experts for guidance on specific management protocols and antidotes, if applicable. Continuous assessment and supportive measures should be prioritized to ensure patient safety and mitigate potential complications associated with overdose.

Nonclinical Toxicology

The use of this product is contraindicated in pregnant or breastfeeding individuals due to potential teratogenic and non-teratogenic effects. No additional information regarding nonclinical toxicology or animal pharmacology and toxicology is available.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the 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.

Patients should be informed 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 reoccur within a few days. It is important to emphasize that the product should not be used if the patient is pregnant or breastfeeding.

Additionally, healthcare providers should remind patients to avoid contact with the eyes or mucous membranes while using this product.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at room temperature, ensuring that it is protected from light exposure to maintain its integrity. Freezing the product is strictly prohibited, as it may compromise its effectiveness. Additionally, once opened, the product must be discarded to ensure safety and efficacy.

Additional Clinical Information

The medication is administered topically, with a recommended application frequency of no more than 3 to 4 times daily for adults and children aged 2 years and older. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Myderm Numbing Roll-on, 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 Myderm Numbing Roll-on, 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.