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Numb520

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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
63742-030
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

You may find this medication helpful for the temporary relief of local and anorectal discomfort associated with anorectal disorders or inflammation. It is designed to ease the symptoms you might experience in these areas, providing comfort when you need it most.

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 is specifically designed to help ease the local discomfort associated with these anorectal disorders.

You can use this treatment to help manage your symptoms and improve your comfort. It's important to follow the recommended guidelines for use to ensure the best results.

Dosage and Administration

Before using this product, it's important to prepare the affected area properly. Start by gently cleaning the area with mild soap and warm water, then rinse it thoroughly. After rinsing, pat or blot the area dry using toilet tissue or a soft cloth. This step helps ensure that the product works effectively.

For adults, you can apply the product up to six times a day as needed. If you are considering using this product for a child under 12 years old, it's best 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, as this can lead to complications.

Side Effects

This product is for external use only. You should not use it if you are pregnant or breastfeeding unless you consult a healthcare professional first. If you accidentally use too much, seek medical help or contact the Poison Control Center right away. Make sure the seal is intact before using; do not use it if the seal is broken or missing.

While using this product, be aware that some people 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. 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. In the event of an accidental overdose, seek medical help or contact the Poison Control Center right away. Additionally, do not use the product if the seal is broken or missing, as this indicates tampering.

If you notice that the symptoms you are treating do not improve, or if you experience increased redness, irritation, swelling, pain, or any other concerning symptoms, stop using the product and contact your doctor. If the product is accidentally ingested, 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 drowsiness, confusion, or difficulty breathing.

Don’t wait for symptoms to worsen; getting prompt assistance can be vital. Always prioritize your safety and the safety of others by being aware of the proper steps to take in such situations.

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 professional guidance when it comes to your child's health.

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 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 you have renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your health situation. They can help monitor your kidney function 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 may affect you if you have hepatic impairment (liver issues).

Before starting any new medication, including this one, you should discuss your liver health with your healthcare provider. They can help determine the best approach for your treatment and ensure your safety.

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 monitor your health effectively and make informed decisions about your care.

Always feel free to ask questions and share all the medications and supplements you are using. This helps to avoid any potential issues and ensures that you receive the best possible treatment tailored to your needs.

Storage and Handling

To ensure the best performance of your product, store it at room temperature, ideally between 59-86°F (15-30°C). It's important to keep it 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. Following these simple storage and handling guidelines will help you use the product safely and effectively.

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 purpose of this product?

This product provides 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, then gently dry it by patting or blotting before application.

Can children use this product?

Children under 12 years of age should consult a doctor before use.

Are there any warnings I should be aware of?

This product is for external use only. Do not exceed the recommended dosage and avoid inserting it into the rectum using fingers or devices.

What should I do if I experience an allergic reaction?

If you develop redness, irritation, swelling, pain, or other symptoms, stop use and ask a doctor.

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

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

What should I do in case of accidental overdose?

Get medical help or contact the Poison Control Center immediately in case of accidental overdose.

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 I accidentally ingest this product?

Seek medical attention immediately if ingested.

Packaging Info

Below are the non-prescription pack sizes of Numb520 (lidocaine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Numb520.
Details

Drug Information (PDF)

This file contains official product information for Numb520, 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

For adults, it is recommended that the affected area be cleansed with mild soap and warm water, followed by 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.

For children under 12 years of age, consultation with a healthcare professional is advised before use.

Contraindications

Use of this product is contraindicated in the following situations:

Pregnancy and breastfeeding: The safety of this product during pregnancy and lactation has not been established. Consultation with a healthcare professional is advised prior to use.

Accidental overdose: In the event of an overdose, immediate medical assistance should be sought or the Poison Control Center contacted.

Tampering: The product should not be used if the tamper-evident seal is broken or missing, as this may indicate contamination or compromise of the product's integrity.

Recommended dosage: Exceeding the recommended daily dosage is contraindicated unless directed by a healthcare provider.

Rectal administration: This product should not be administered rectally using fingers, medical devices, or applicators, as this may lead to injury or improper dosing.

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 should be aware that this product is for external use only. It is contraindicated for use in individuals who are pregnant or breastfeeding; such individuals should consult a health professional prior to use. In the event of an accidental overdose, it is imperative to seek medical help or contact the Poison Control Center immediately.

During the use of this product, certain individuals may experience allergic reactions to one or more of the ingredients. Patients are advised to discontinue use and consult a doctor if the symptoms being treated do not improve, or if any new symptoms such as redness, irritation, swelling, or pain develop or worsen.

Additionally, this product should be kept out of reach of children. In the case of accidental ingestion, immediate medical attention is necessary. It is also important to note that the product should not be used if the tamper-evident seal is broken or missing.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions between the drug and 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 Numb520 (lidocaine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Numb520.
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

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

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 the safety of both the mother and the breastfed infant.

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 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 prescribing information.

Overdosage

In the event of an accidental overdose, it is imperative to seek medical assistance promptly. Healthcare professionals should advise patients or caregivers to contact the Poison Control Center immediately for guidance.

Symptoms of overdose may vary depending on the specific substance involved; therefore, a thorough assessment of the patient's condition is essential. Management of an overdose typically involves supportive care and symptomatic treatment, tailored to the individual’s clinical presentation.

Healthcare providers are encouraged to monitor the patient closely and implement appropriate interventions as necessary. Prompt recognition and management of overdose symptoms can significantly improve patient outcomes.

Nonclinical Toxicology

Do not use this product if pregnant or breastfeeding; consultation with a health professional is advised prior to use. Certain individuals may experience allergic reactions to the ingredients contained in this product.

No additional information is available regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has revealed that certain individuals may develop allergic reactions to ingredients in this product. These events have been reported voluntarily or identified through surveillance programs.

Patient Counseling

Healthcare providers should advise patients to seek medical attention immediately in the event of accidental ingestion of the 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 product's tamper-evident seal, advising patients to refrain from using the product if the seal is broken or missing.

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

Healthcare providers should also make patients aware that certain individuals may develop allergic reactions to the ingredients in the 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 upon request. 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.

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 Numb520, 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 Numb520, 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.