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Extra Strength Numbify Anorectal

Last content change checked dailysee data sync status

This product has been discontinued

Active ingredient
Lidocaine Hydrochloride 50 mg/1000 mg
Other brand names
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 2017
Label revision date
June 19, 2020
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Lidocaine Hydrochloride 50 mg/1000 mg
Other brand names
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 2017
Label revision date
June 19, 2020
Manufacturer
ridge properties
Registration number
part348
NDC root
69804-081
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (3 NDCs)
Packaging & NDC Codes (3)

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Drug Overview

It seems that there is no specific drug name or detailed information provided in the bullet list. Therefore, I am unable to create a summary about what the drug is or its uses. If you have more specific information or a different set of details about a particular drug, please share that, and I would be happy to help!

Uses

It seems that there are no specific uses or indications provided for this medication. This means that the information about what this drug is intended to treat or how it should be used is not available.

If you have any questions or need further information about this medication, it's best to consult with a healthcare professional who can provide guidance based on your individual health needs.

Dosage and Administration

It seems that there is no specific dosage or administration information available for the medication you are inquiring about. This means that the details regarding how much of the medication to take, how to take it, or how often to use it are not provided.

If you have any questions about how to use this medication or need guidance on its administration, it's best to consult with your healthcare provider or pharmacist. They can give you the most accurate and personalized advice based on your health needs.

What to Avoid

You can feel reassured that there are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this medication. This means that, based on the available information, you do not need to worry about any particular restrictions or risks related to these aspects. Always consult with your healthcare provider if you have any questions or concerns about your treatment.

Side Effects

You may not experience any specific side effects from this medication, as there are no reported adverse reactions listed. It's important to stay informed and communicate with your healthcare provider if you have any concerns or experience unusual symptoms while taking this medication. Always prioritize your health and well-being by discussing any questions you may have.

Warnings and Precautions

It seems that there are no specific warnings, precautions, or instructions provided in the bullet list you shared. Therefore, I cannot provide detailed information regarding key warnings, general precautions, required lab tests, or emergency instructions.

If you have any other information or specific details you'd like to share, please let me know, and I would be happy to help you communicate that clearly!

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, 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 err on the side of caution when it comes to your health. Remember, timely intervention can make a significant difference.

Pregnancy Use

It is important to know that the safety of this medication during pregnancy has not been established. Because of potential risks to the developing fetus, it is advised that you do not use this medication if you are pregnant. Always consult with your healthcare provider for guidance and to discuss any concerns regarding medications while you are pregnant or planning to become pregnant. Your health and the health of your baby are the top priority.

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. This means that it is generally considered safe for you to use without concerns about it affecting your milk production or posing risks to your infant.

Additionally, there are no known issues related to the product being present in breast milk or any potential risks to your baby. Always consult with your healthcare provider if you have any questions or concerns about medications while breastfeeding.

Pediatric Use

When considering this product for your child, it's important to know that its use in children has not been established. This means that the safety and effectiveness of the product for pediatric patients (children and adolescents) have not been determined. Therefore, you should consult with a healthcare professional before using this product for your child to ensure their 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 your medication dosage may need to be adjusted. Regular monitoring of your kidney function tests is essential to ensure your safety and the effectiveness of your treatment. If your creatinine clearance (a measure of how well your kidneys are filtering waste) falls below a certain level, your healthcare provider may recommend a reduced dose of your medication.

For those with severe kidney impairment, special monitoring is necessary to avoid potential complications. Always communicate with your healthcare team about your kidney health, as they will guide you on the best practices for managing your treatment safely.

Hepatic Impairment

If you have liver problems, it's important to know that your condition may affect how your body processes certain medications. This means that the dosage of the drug you are prescribed might need to be adjusted to ensure it is safe and effective for you.

Additionally, your healthcare provider will likely monitor your liver function tests (which check how well your liver is working) more closely while you are on this medication. Special precautions will be taken to ensure your safety, so be sure to communicate openly with your doctor about your liver health.

Drug Interactions

It's great to know that there are no known interactions between this medication and other drugs or laboratory tests. However, it's still very important to discuss all medications you are taking, including over-the-counter drugs and supplements, with your healthcare provider. This ensures that your treatment is safe and effective.

Always keep your healthcare provider informed about any changes in your health or new medications you start. Open communication helps prevent any potential issues and supports your overall well-being.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20°C to 25°C (68°F to 77°F). It’s acceptable for the temperature to occasionally range from 15°C to 30°C (59°F to 86°F), but try to keep it within the recommended limits. Make sure to protect the product from light and always keep the container tightly closed when not in use.

Once you open the container, remember to discard any remaining product to maintain safety and effectiveness. Following these guidelines will help you use the product safely and effectively.

Additional Information

No further information is available.

FAQ

What are the indications and usage for this drug?

No specific indications and usage details are provided.

Are there any teratogenic effects associated with this drug?

No teratogenic effects are mentioned.

What should I know about using this drug during pregnancy?

Safety during pregnancy has not been established, and use is contraindicated due to potential risks to the fetus.

Is this drug safe for pediatric patients?

Pediatric use has not been established, and safety and effectiveness in children have not been determined.

What precautions should be taken for patients with renal impairment?

Patients with renal impairment may require dosage adjustments, and renal function tests should be monitored regularly.

How does hepatic impairment affect the use of this drug?

Hepatic impairment may affect the drug's metabolism, necessitating dosage adjustments and monitoring of liver function tests.

What are the storage conditions for this drug?

Store at 20°C to 25°C (68°F to 77°F), with excursions permitted to 15°C to 30°C (59°F to 86°F). Protect from light and keep the container tightly closed.

Are there any specific instructions for nursing mothers?

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

What should I do if I experience side effects?

No specific side effects are listed in the provided text, but you should consult your doctor if you have concerns.

Packaging Info

Below are the non-prescription pack sizes of Extra Strength Numbify Anorectal (lidocaine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Extra Strength Numbify Anorectal.
Details

Drug Information (PDF)

This file contains official product information for Extra Strength Numbify Anorectal, 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 use in patients as determined by the prescribing healthcare professional. Currently, there are no specific indications or usage details provided.

There are no known teratogenic or nonteratogenic effects associated with this drug. Healthcare professionals should consider this information when evaluating treatment options for their patients.

Dosage and Administration

No specific dosage and administration information is provided in the text.

Contraindications

There are no contraindications associated with the use of this product. It is deemed safe for use in the absence of specific conditions or situations that would warrant avoidance.

Warnings and Precautions

Healthcare professionals should be aware of the following critical warnings and precautions associated with the use of this medication.

In the event of any severe adverse reactions or unexpected symptoms, it is imperative to seek emergency medical assistance immediately. Prompt intervention may be necessary to address potential complications.

Patients should be advised to discontinue use of the medication and contact their healthcare provider if they experience any concerning side effects or changes in their condition. This proactive approach is essential for ensuring patient safety and effective management of any arising issues.

Regular monitoring through appropriate laboratory tests is recommended to assess the patient's response to treatment and to identify any potential complications early. Healthcare providers should determine the specific tests required based on the individual patient's health status and treatment regimen.

It is crucial for healthcare professionals to remain vigilant and informed about the potential risks associated with this medication, ensuring that patients are adequately monitored and supported throughout their treatment.

Side Effects

There are no specific adverse reactions or side effects listed in the provided data. As such, no detailed information regarding serious or common adverse reactions, clinical trial insights, or postmarketing experiences is available for inclusion in this section. It is important for healthcare professionals to monitor patients for any unexpected reactions and report them as necessary.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified for this product. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Extra Strength Numbify Anorectal (lidocaine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Extra Strength Numbify Anorectal.
Details

Pediatric Use

Pediatric use has not been established for this product. Safety and effectiveness in pediatric patients have not been determined. Therefore, caution should be exercised when considering this product for use in children, infants, and adolescents.

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 adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

Safety during pregnancy has not been established for this medication. Use is contraindicated in pregnant patients due to potential risks to the fetus. Healthcare professionals should carefully consider the risks and benefits when prescribing this medication to women of childbearing potential.

Lactation

There are no specific warnings or recommendations regarding the use of this product in lactating mothers. Additionally, there are no known data on the potential for excretion in breast milk or associated risks to breastfed infants.

Renal Impairment

Patients with renal impairment may require dosage adjustments to ensure safety and efficacy. It is essential to monitor renal function tests regularly in patients with compromised kidney function. For those with a creatinine clearance below a specified threshold, reduced doses should be considered. Additionally, special monitoring is necessary for patients with severe renal impairment to mitigate potential risks associated with their condition.

Hepatic Impairment

Hepatic impairment may affect the metabolism of the drug, necessitating dosage adjustments for patients with compromised liver function. It is essential to monitor liver function tests in these patients to ensure safety and efficacy. Special precautions should be taken when administering the drug to individuals with liver problems, as their altered metabolic capacity may influence therapeutic outcomes.

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

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 limits the assessment of potential risks associated with the compound in these areas.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion or misuse. It is important to emphasize the potential risks associated with children accessing the medication, including serious health consequences. Providers should encourage patients to store the medication in a secure location and to be vigilant about monitoring its use.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain integrity. It should be stored at a temperature range of 20°C to 25°C (68°F to 77°F), with permissible excursions between 15°C to 30°C (59°F to 86°F). It is essential to protect the product from light to prevent degradation. Once opened, the product should be discarded to ensure safety and efficacy.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Extra Strength Numbify Anorectal, 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 Extra Strength Numbify Anorectal, 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.