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Derma Numb Pain Relief

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Active ingredient
Lidocaine Hydrochloride 40 mg/1 g
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
Dosage form
Gel
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2015
Label revision date
November 11, 2025
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
Gel
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 2015
Label revision date
November 11, 2025
Manufacturer
A. T. S. Laboratories, LLC
Registration number
M017
NDC root
70188-005
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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

This medication is designed to provide temporary relief from pain and itching caused by minor cuts or skin irritations. It can help soothe discomfort, allowing you to feel more comfortable while your skin heals. If you experience minor skin issues, this product may be a helpful option for you.

Uses

If you're dealing with minor cuts or skin irritations, this medication can provide temporary relief from pain and itching. It's designed to help soothe discomfort, allowing you to feel more comfortable as your skin heals. Remember, it's important to use it as directed for the best results.

Dosage and Administration

If you are an adult or a child aged two years or older, you can apply this medication to the affected area up to three to four times a day. Make sure to follow this guideline to ensure the best results.

If your child is under two years old, it's important to consult a physician (doctor) before using this medication. They can provide the best advice tailored to your child's needs. Always remember to use the medication as directed for safety and effectiveness.

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

It's important to use this product only on the skin and to avoid getting it in your eyes. If your condition worsens, if symptoms last longer than 7 days, or if they improve and then come back within a few days, you should stop using the product and consult your doctor.

Warnings and Precautions

This product is for external use only, so please avoid swallowing it. If you accidentally swallow it, seek medical help or contact a poison control center immediately. Be careful not to let it come into contact with your eyes, as this can cause irritation.

When using this product, do not apply it in large amounts, especially on raw or blistered skin. If your condition worsens, or if your symptoms last more than 7 days or improve and then return within a few days, stop using the product and consult your doctor. Your health and safety are important, so please follow these precautions closely.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's important to be aware of the general signs of an overdose, which can include symptoms like extreme drowsiness, confusion, or difficulty breathing. If you suspect an overdose, it is crucial to seek immediate medical help.

In case of an emergency, call your local emergency number or go to the nearest hospital. Always keep medications out of reach of children and follow the prescribed dosage to prevent any potential risks. If you have any concerns or questions about your medication, don’t hesitate to reach out to your healthcare provider for guidance.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to be cautious with any medications, including Derma Numb Pain Relief (lidocaine hcl gel). Currently, there is no specific information available about the safety of using this product during pregnancy, which means that potential risks or necessary dosage adjustments have not been clearly defined.

Before using Derma Numb or any other medication, you should consult with your healthcare provider to discuss your individual situation and any concerns you may have. They can help you weigh the benefits and risks, ensuring the best care for you and your baby.

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 to your infant. Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

Pediatric Use

When using this medication for children aged two years and older, you can apply it to the affected area no more than 3 to 4 times a day. However, if your child is under 2 years old, it's important to consult a physician (doctor) before use to ensure safety and proper care. Always follow these guidelines to help keep your child safe and healthy.

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. Since older adults may have different health needs and responses to medications, you should always consult with a healthcare provider before starting any new medication. They can help determine the right dosage and monitor for any potential side effects, ensuring that the treatment is safe and effective for you or your loved one.

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 information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to your condition. This means that there are no tailored recommendations for how the medication may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific situation. They can help determine the best approach based on your liver function and overall health.

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 supplements during your appointments. This way, you can receive the best possible care tailored to your needs.

Storage and Handling

To ensure the best performance of your product, it's important to store it in a cool, dry place, away from excessive heat and direct sunlight. This will help maintain its effectiveness and safety.

When handling the product, always do so with care to avoid any damage. Following these simple guidelines will help you use the product safely and effectively.

Additional Information

No further information is available.

FAQ

What is the purpose of this drug?

This drug is for temporary relief of pain and itching associated with minor cuts or minor skin irritations.

Who can use this drug?

Adults and children two years or older can use this drug. Children under 2 years of age should consult a physician.

How should I apply this drug?

You should apply it to the affected area not more than 3 to 4 times daily.

Are there any warnings I should be aware of?

Yes, this drug is for external use only, and you should avoid contact with eyes.

What should I do if my condition worsens?

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

What should I do if the product is swallowed?

If the product is swallowed, get medical help or contact a poison control center right away.

Can I use this drug in large quantities?

No, do not use in large quantities, particularly over raw surfaces or blistered areas.

Is there any information about using this drug during pregnancy?

The insert does not provide specific information regarding the use of this drug during pregnancy.

What about nursing mothers?

There are no specific warnings or recommendations regarding the use of this product in nursing mothers.

How should I store this product?

Protect this product from excessive heat and direct sun.

Packaging Info

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

Packaging configurations for Derma Numb Pain Relief.
Details

Drug Information (PDF)

This file contains official product information for Derma Numb 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 specified drug.

Uses and Indications

This drug is indicated for the temporary relief of pain and itching associated with minor cuts and minor skin irritations. It is intended for use in patients experiencing these specific conditions to alleviate discomfort and promote healing.

Dosage and Administration

For adults and children aged two years and older, the recommended application is to the affected area not more than three to four times daily. It is important to ensure that the application is limited to the specified frequency to avoid potential adverse effects.

For children under two years of age, it is advised to consult a physician prior to use to determine the appropriate course of action and ensure safety.

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 in these conditions. No other specific contraindications have been identified.

Warnings and Precautions

For external use only. It is imperative to avoid contact with the eyes to prevent irritation or injury.

Caution is advised regarding the quantity of product applied. Users should refrain from using large amounts, especially on raw surfaces or blistered areas, as this may exacerbate irritation or lead to adverse effects.

In the event of accidental ingestion, immediate medical assistance should be sought. Contact a poison control center or seek emergency medical help without delay.

Healthcare professionals should instruct patients to discontinue use and consult a physician if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. In such cases, it is essential to cease application of the product.

Side Effects

Patients should be aware that the product is for external use only and should avoid contact with the eyes. In the event of contact with the eyes, immediate rinsing with water is recommended.

In clinical practice, patients are advised to stop using the product 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. Discontinuation of use is recommended under these circumstances to ensure patient safety and effective management of their condition.

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 Derma Numb Pain Relief (lidocaine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Derma Numb Pain Relief.
Details

Pediatric Use

Pediatric patients aged two years and older may apply the medication to the affected area no more than 3 to 4 times daily. For children under two years of age, it is recommended to consult a physician prior to use.

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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

The safety of Derma Numb Pain Relief (lidocaine hcl gel) during pregnancy has not been established, as the prescribing information does not provide specific data regarding its use in pregnant patients. There are no documented safety concerns, dosage modifications, or special precautions outlined for this population. Healthcare professionals should exercise caution when considering the use of this product in women of childbearing potential and weigh the potential benefits against any unknown risks to fetal outcomes. It is advisable to consult with a healthcare provider for individualized assessment and recommendations.

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

Patients with renal impairment may not have specific dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment and individualized patient assessment. Regular monitoring of renal function is advisable to ensure patient safety and therapeutic efficacy.

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 overdosage information, it is essential for healthcare professionals to remain vigilant and prepared for potential scenarios involving overdose.

Healthcare providers should be aware that the clinical presentation of an overdose may vary depending on the substance involved and the individual patient’s characteristics. Symptoms of overdose can range from mild to severe and may include alterations in consciousness, respiratory distress, cardiovascular instability, and other systemic effects.

In the event of a suspected overdose, immediate medical evaluation is recommended. Healthcare professionals should assess the patient's vital signs and clinical status, and initiate supportive care as necessary. It is crucial to gather a detailed history of the substance involved, including the amount and route of administration, to guide further management.

Management procedures may include the administration of activated charcoal if the patient presents within a suitable timeframe and is not at risk of aspiration. In cases of severe toxicity, specific antidotes may be indicated, and consultation with a poison control center or a medical toxicologist is advised.

Continuous monitoring of the patient’s condition is essential, and supportive measures should be tailored to the symptoms presented. Prompt recognition and intervention can significantly improve outcomes in cases of overdose.

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 text.

Patient Counseling

Healthcare providers should advise patients to keep the product out of reach of children to prevent accidental ingestion. In the event that the product is swallowed, patients should seek medical help or contact a poison control center immediately.

Patients should be cautioned against using the product in large quantities, especially on raw surfaces or blistered areas, as this may lead to adverse effects.

Additionally, healthcare providers should instruct patients to 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. It is important for patients to discontinue use under these circumstances to ensure their safety and well-being.

Storage and Handling

This product should be protected from excessive heat and direct sunlight to maintain its integrity and efficacy. It is essential to store the product in a cool, dry place, away from sources of heat and light. Proper handling and storage conditions are crucial to ensure the product remains effective throughout its shelf life.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Derma Numb 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 Derma Numb 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.