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Numb Master

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This product has been discontinued

Active ingredient
Lidocaine Hydrochloride 50 mg/1 g
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 2019
Label revision date
December 26, 2023
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Lidocaine Hydrochloride 50 mg/1 g
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 2019
Label revision date
December 26, 2023
Manufacturer
Clinical Resolution Laboratory, Inc.
Registration number
M015
NDC root
63742-031
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

This medication provides temporary relief from local and anorectal discomfort associated with anorectal disorders or inflammation. It is designed to help ease the symptoms you may experience in these areas, offering a supportive option for managing discomfort.

Uses

If you're experiencing discomfort in the anal or rectal area due to conditions like hemorrhoids or inflammation, this medication can provide temporary relief. It’s specifically designed to help ease the local discomfort associated with these anorectal disorders.

You can feel confident using this treatment, as there are no reported teratogenic effects (which means it doesn't cause birth defects) or nonteratogenic effects. Always consult with your healthcare provider if you have any questions or concerns about your symptoms or treatment options.

Dosage and Administration

To use this product effectively, start by cleaning the affected area with mild soap and warm water. Make sure to rinse it thoroughly and then gently dry the area by patting or blotting it with toilet tissue or a soft cloth. This preparation helps ensure the product works as intended.

You can apply the product up to six times a day, depending on your needs. If you are considering using it for a child under 12 years old, it’s important to consult a doctor first to ensure it’s safe and appropriate for them.

What to Avoid

You should avoid using this product if you are pregnant or breastfeeding unless you consult a healthcare professional first. In the event of an accidental overdose, it’s crucial to seek medical help or contact the Poison Control Center immediately. Additionally, do not use the product if the tamper-evident seal is broken or missing.

While using this product, make sure not to exceed the recommended daily dosage unless your doctor advises otherwise. Also, do not insert this product into the rectum using your finger or any medical device or applicator. Following these guidelines will help ensure your safety and the effective use of the product.

Side Effects

You should be aware that this product is for external use only. If you are pregnant or breastfeeding, it's important to consult a healthcare professional before using it. Be cautious of accidental overdose; if this occurs, seek medical help or contact the Poison Control Center right away.

While using this product, some individuals may experience allergic reactions to its ingredients. If the symptoms you are treating do not improve, or if you notice any redness, irritation, swelling, or pain, stop using the product and consult a doctor. Additionally, keep this product out of reach of children, and if ingested accidentally, seek medical attention immediately.

Warnings and Precautions

This product is for external use only, so please avoid applying it to any internal areas. If you are pregnant or breastfeeding, it's important to consult a healthcare professional before using this product. If you accidentally take too much, seek medical help or contact the Poison Control Center right away. Also, do not use the product if the seal is broken or missing, as this indicates it may have been tampered with.

You should stop using the product and contact your doctor if the symptoms you are treating do not improve, or if you experience any redness, irritation, swelling, pain, or other worsening symptoms. In the event that the product is ingested accidentally, seek emergency medical assistance immediately.

Overdose

If you suspect an accidental overdose, it’s crucial to seek medical help right away or contact the Poison Control Center. Signs of an overdose can vary, but they may include unusual symptoms that are not typical for you. If you or someone else has ingested too much of the medication, do not wait—get medical attention immediately.

Remember, acting quickly can make a significant difference in ensuring safety and health. Always keep emergency contact numbers handy and don’t hesitate to reach out for help if you have any concerns about an overdose.

Pregnancy Use

If you are pregnant or breastfeeding, it is important to avoid using this product. Always consult with a healthcare professional before using any medication during this time to ensure the safety of both you and your baby. Your health and the health of your child should always come first, so don't hesitate to seek guidance.

Lactation Use

If you are breastfeeding, it is important to avoid using this product. Always consult with a healthcare professional before using any medication while nursing. Your health and the well-being of your baby are paramount, so make sure to seek guidance to ensure safety for both of you.

Pediatric Use

If you have a child under 12 years old, it's important to consult a doctor before using this medication. This ensures that the treatment is safe and appropriate for their age and health needs. Always prioritize your child's well-being by seeking professional guidance when it comes to their health care.

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, it’s always a good idea to discuss any medications with a healthcare provider. They can help ensure that the treatment is safe and appropriate, considering any unique health needs or conditions.

Since there are no dosage adjustments or special precautions mentioned for elderly patients, your healthcare provider will be the best resource for personalized advice. Always keep them informed about any other medications or health issues to help manage your overall care effectively.

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 be adjusted 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 changes 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 you are taking. In this case, there are no specific drug interactions or laboratory test interactions noted, which means that the medication is generally considered safe to use with other drugs and tests. However, every individual is different, and your healthcare provider can help ensure that your treatment plan is safe and effective for you.

Always discuss any changes in your medications or health status with your healthcare provider to avoid any potential issues and to get the best care possible.

Storage and Handling

To ensure the best performance of your product, store it at room temperature, ideally between 59°F and 86°F (15°C and 30°C). It's important to keep the product away from direct sunlight and heat sources, as these can affect its quality and effectiveness.

When handling the product, always do so with clean hands and in a clean environment to maintain its integrity. If you have any specific disposal instructions, be sure to follow them carefully to ensure safety and compliance.

Additional Information

You should apply this medication topically, which means you will put it directly on your skin. You can use it up to six times a day as needed. There are no additional details available regarding laboratory tests, abuse potential, or patient counseling.

FAQ

What is the primary use of this product?

This product is used for the temporary relief of local and anorectal discomfort associated with anorectal disorders or inflammation.

How often can I apply this product?

You can apply this product up to 6 times a day.

What should I do before applying the product?

When practical, cleanse the affected area with mild soap and warm water, rinse thoroughly, and gently dry by patting or blotting with toilet tissue or a soft cloth.

Are there any precautions for children?

For children under 12 years of age, you should consult a doctor before use.

What should I do if I accidentally overdose?

In case of accidental overdose, get medical help or contact the Poison Control Center immediately.

Can I use this product if I am pregnant or breastfeeding?

You should not use this product if you are pregnant or breastfeeding without consulting a health professional.

What should I do if I experience side effects?

Stop use and ask a doctor if the symptom being treated does not subside, or if you experience redness, irritation, swelling, pain, or other symptoms that develop or increase.

How should I store this product?

Store the product at room temperature (59-86°F/15-30°C) and keep it away from direct sunlight or heat.

What should I do if the seal is broken or missing?

Do not use this product if the seal is broken or missing, as it may not be safe.

Is this product for external use only?

Yes, this product is for external use only.

Packaging Info

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

Packaging configurations for Numb Master.
Details

Drug Information (PDF)

This file contains official product information for Numb Master, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

No relevant information is available for SPL code 34089-3.

Uses and Indications

This drug is indicated for the temporary relief of local and anorectal discomfort associated with anorectal disorders or inflammation.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

When administering this product, it is recommended that adults first cleanse the affected area with mild soap and warm water, ensuring thorough rinsing. The area should then be gently dried by patting or blotting with toilet tissue or a soft cloth prior to the application of the product.

The product may be applied up to six times a day, as needed. For children under 12 years of age, it is advised to consult a doctor before use to determine appropriate treatment options.

Contraindications

Use of this product is contraindicated in the following situations:

Pregnant or breastfeeding individuals should consult a healthcare professional prior to use. Accidental overdose requires immediate medical attention or contact with the Poison Control Center. The product should not be used if the tamper-evident seal is broken or missing, as this indicates potential contamination.

Additionally, the recommended daily dosage should not be exceeded unless directed by a physician. Insertion of this product into the rectum using fingers, medical devices, or applicators is contraindicated.

Warnings and Precautions

For external use only. This product is contraindicated in individuals who are pregnant or breastfeeding; consultation with a healthcare professional is advised prior to use in these populations.

In the event of an accidental overdose, it is imperative to seek medical assistance or contact the Poison Control Center without delay. The integrity of the product must be maintained; therefore, it should not be used if the tamper-evident seal is broken or missing.

Healthcare professionals should advise patients to discontinue use and consult a physician if the symptoms being treated do not improve, or if any adverse reactions such as redness, irritation, swelling, pain, or other symptoms develop or worsen.

In cases of accidental ingestion, immediate medical attention is required. Prompt intervention is crucial to ensure patient safety and mitigate potential complications.

Side Effects

Patients using this product may experience adverse reactions, which can vary in seriousness. It is important to note that this product is for external use only.

Certain individuals may develop allergic reactions to the ingredients contained in this formulation. In the event of an allergic reaction or if symptoms such as redness, irritation, swelling, or pain develop or worsen, patients should discontinue use and consult a healthcare professional.

Patients are advised not to use this product if they are pregnant or breastfeeding without first consulting a health professional. Additionally, in the case of accidental overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted.

The product should not be used if the tamper-evident seal is broken or missing, as this indicates potential contamination. It is also crucial to keep this product out of reach of children; in the event of accidental ingestion, medical attention should be sought 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 Numb Master (lidocaine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Numb Master.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional prior to use. It is important to assess the appropriateness of treatment and dosage for this age group, as specific recommendations may vary based on individual health needs and conditions.

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 potential 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 product. It is essential for women of childbearing potential to consult a healthcare professional prior to use to discuss potential risks and benefits. The safety of this product during pregnancy and lactation has not been established, and therefore, caution is advised.

Lactation

Lactating mothers are advised against the use of this product while breastfeeding. It is important for lactating mothers to consult a healthcare professional prior to use to ensure safety for both the mother and the breastfed infant.

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 event of an accidental overdose, it is imperative to seek medical assistance or contact the Poison Control Center without delay. Prompt action is crucial to mitigate potential risks associated with overdosage.

Should accidental ingestion occur, immediate medical attention is also required. Healthcare professionals should be prepared to assess the situation and provide appropriate interventions based on the severity of the overdose and the specific substance involved.

Monitoring for symptoms related to overdosage is essential, as they may vary depending on the substance and the amount ingested. Timely management can significantly influence patient outcomes, underscoring the importance of swift and decisive action in these scenarios.

Nonclinical Toxicology

The use of this product is contraindicated in pregnant or breastfeeding individuals. It is advised to consult a health professional prior to use in these populations. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to seek medical attention immediately in the event of accidental ingestion of this product. It is important for patients who are pregnant or breastfeeding to consult a health professional before using this product.

In cases of accidental overdose, patients should be instructed to obtain medical help or contact the Poison Control Center without delay. Providers should emphasize the importance of the tamper-evident seal, advising patients not to use the product if the seal is broken or missing.

Patients should be informed to stop using the product and consult a doctor if the symptoms being treated do not subside, or if they experience any redness, irritation, swelling, pain, or other symptoms that develop or increase. It is crucial to communicate that patients should not exceed the recommended daily dosage unless directed by a healthcare professional.

Providers should also make patients aware that certain individuals may develop allergic reactions to the ingredients in this product. Additionally, patients must be cautioned against inserting the product into the rectum using fingers, medical devices, or applicators.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at room temperature, within the range of 59-86°F (15-30°C). Care should be taken to keep the product away from direct sunlight and heat to maintain its integrity and efficacy. Proper storage conditions are essential to ensure the product remains effective throughout its shelf life.

Additional Clinical Information

The medication is administered topically and may be applied up to six times a day. 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 Numb Master, 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 Numb Master, 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.