Symptom checker
Select audience type

Switch between content for healthcare professionals (PRO) and general audience (GEN).

ADD CONDITION

items per page

The Solution Numbing

Last content change checked dailysee data sync status

Active ingredient
Lidocaine Hydrochloride 5 g/100 mL
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 2024
Label revision date
May 25, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Lidocaine Hydrochloride 5 g/100 mL
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 2024
Label revision date
May 25, 2024
Manufacturer
SCALP TECH INC
Registration number
M017
NDC root
82617-105
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 is used for the temporary relief of discomfort and itching in the perianal area, particularly associated with conditions like hemorrhoids and other anorectal disorders. It can help alleviate symptoms such as pain, soreness, and burning in inflamed hemorrhoidal tissues. If you're experiencing these uncomfortable symptoms, this medication may provide the relief you need.

Uses

If you're experiencing discomfort or itching in the perianal area due to hemorrhoids or other anorectal disorders, this medication can provide temporary relief. It is effective for alleviating pain, soreness, and burning sensations associated with inflamed hemorrhoidal tissues and anorectal inflammation.

You can use this treatment to help manage the symptoms of hemorrhoids, commonly referred to as piles, and improve your comfort during daily activities. Remember, it's important to follow the guidance of your healthcare provider when using any medication.

Dosage and Administration

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

Once the area is clean and dry, you can apply the product externally to the affected area. You should do this up to six times a day, but be careful not to use it more often than directed. When applying, gently pat the product onto the area and then discard the pad you used. If you are considering this product for a child under 12 years of age, it’s important to consult a physician first.

What to Avoid

There are no specific contraindications, controlled substance classifications, or risks of abuse, misuse, or dependence associated with this medication. This means that, based on the available information, there are no particular situations or conditions under which you should avoid using it. Always consult with your healthcare provider for personalized advice and to ensure that this medication is appropriate for your individual health needs.

Side Effects

You may experience allergic reactions to some ingredients in this product. If you notice any symptoms such as redness, irritation, swelling, or pain that do not improve, it's important to stop using the product and consult your doctor. Always pay attention to how your body responds, and seek medical advice if you have concerns.

Warnings and Precautions

If you are using this product, please be aware of some important warnings. Stop using it and consult your doctor if your condition worsens or does not improve within 7 days. It's crucial not to exceed the recommended daily dosage unless directed by your physician. If you experience any bleeding, seek medical attention immediately. Avoid inserting this product into the rectum using fingers or any devices, as this can cause harm. Be cautious, as some individuals may have allergic reactions to the ingredients. If you notice any redness, irritation, swelling, pain, or if your symptoms do not improve, discontinue use and contact your doctor.

In case of accidental swallowing, seek emergency medical help right away by calling a poison control center. Always prioritize your health and safety by following these guidelines closely.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While the specific signs of an overdose are not detailed, common 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 crucial to provide them with as much information as possible about the substance taken and the amount, if known. Remember, acting quickly can make a significant difference in your health and safety.

Pregnancy Use

The safety of lidocaine hydrochloride gel during pregnancy has not been established, which means that it may not be safe for you or your developing baby. Because of potential risks to the fetus, it is advised that you do not use this product while pregnant.

If you are pregnant or planning to become pregnant, it is important to consult your physician before using this gel. They can provide guidance and discuss any potential risks associated with its use during this critical time.

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

If your child is under 12 years old, it's important to consult a physician (doctor) before using this medication. For children who are 12 and older, you can apply the medication externally to the affected area up to six times a day. However, make sure not to use it more often than directed, as following the recommended dosage is crucial for safety and effectiveness. Always keep an eye on how your child responds to the treatment and reach out to a healthcare professional if you have any concerns.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult considering this medication, it’s important to consult with a healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken.

Always prioritize open communication with your healthcare team to ensure safe and effective treatment, especially as age can affect how medications work in the body.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect 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 (issues with liver function).

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver health and medication use. They can help ensure that you receive the safest and most effective treatment based on your individual needs.

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 any other medications or supplements you may be using. This helps to create a comprehensive picture of your health and ensures your safety while receiving treatment.

Storage and Handling

To ensure the best performance of your product, store it at room temperature, ideally between 15° and 30°C (59° to 86°F). This temperature range helps maintain the product's effectiveness and safety.

When handling the product, make sure to do so in a clean environment to avoid contamination. Always follow any specific instructions provided for use and disposal to ensure safety and effectiveness.

Additional Information

You should apply this medication topically, meaning you will put it directly on the affected area of your skin. You can use it up to six times a day, depending on your needs. There are no additional details available regarding laboratory tests, abuse potential, or patient counseling.

FAQ

What is this product used for?

This product is used for the temporary relief of discomfort and itching in the perianal area due to hemorrhoids, anorectal disorders, and inflamed hemorrhoidal tissues.

How should I apply this product?

You should apply it externally to the affected area up to 6 times daily, gently patting the area after cleansing.

Are there any warnings I should be aware of?

Yes, you should stop use and consult a physician if your condition worsens, does not improve within 7 days, or if you experience bleeding.

Can I use this product if I am pregnant?

Consult a physician before using this product if you are pregnant or planning to become pregnant, as its safety during pregnancy has not been established.

Is this product safe for children?

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

What should I do if I experience an allergic reaction?

If you develop an allergic reaction or if symptoms like redness, irritation, or swelling increase, discontinue use and consult a physician.

What should I do if I accidentally swallow this product?

If swallowed, call a poison control center or get medical help right away.

How should I store this product?

Store the product at room temperature, between 15° - 30°C.

Packaging Info

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

Packaging configurations for The Solution Numbing.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The drug is a sterile, clear, colorless to slightly yellow solution containing the active ingredient, insert active ingredient name here. Inactive ingredients include insert inactive ingredients here. The pH of the solution is insert pH value here, and the osmolarity is insert osmolarity value here. The solution is packaged in insert packaging details here.

Uses and Indications

This drug is indicated for the temporary relief of discomfort and itching associated with perianal area conditions, including hemorrhoids, anorectal disorders, inflamed hemorrhoidal tissues, and anorectal inflammation. It is also indicated for the alleviation of pain, soreness, and burning in these areas.

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

Dosage and Administration

The affected area should be cleansed with mild soap and warm water, followed by thorough rinsing. This can be accomplished by patting or blotting the area with an appropriate cleansing pad. After cleansing, the area must be gently dried by patting or blotting with toilet tissue or a soft cloth prior to the application of the product.

For adults, the product should be applied externally to the affected area up to six times daily. It is imperative that the product is not used more frequently than directed. The application should be performed gently by patting the product onto the affected area, after which the application pad should be discarded.

For children under 12 years of age, it is recommended to consult a physician before use.

Contraindications

There are no contraindications associated with the use of this product. It is not classified as a controlled substance, and there are no known risks of abuse, misuse, or dependence.

Warnings and Precautions

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

Patients are advised to discontinue use and consult a physician if their condition worsens or does not improve within 7 days. It is imperative that the recommended daily dosage is not exceeded unless directed by a physician. In the event of bleeding, prompt consultation with a physician is necessary.

The product should not be administered rectally using fingers, mechanical devices, or applicators. There is a potential for certain individuals to develop allergic reactions to the ingredients contained in this product. If the symptoms being treated do not subside, or if any redness, irritation, swelling, pain, or other symptoms develop or worsen, patients should discontinue use and seek medical advice.

In cases of accidental ingestion, immediate action is required. Patients should call a poison control center or seek emergency medical assistance without delay.

Healthcare professionals are encouraged to monitor patients for these adverse effects and to provide guidance on the appropriate use of the product to ensure safety and efficacy.

Side Effects

Patients may experience allergic reactions to ingredients in this product. It is important for individuals to monitor for any signs of such reactions. In the event that the symptom being treated does not subside, or if symptoms such as redness, irritation, swelling, or pain develop or worsen, patients should discontinue use immediately and consult a physician for further evaluation and guidance.

Drug Interactions

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

Packaging & NDC

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

Packaging configurations for The Solution Numbing.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a physician prior to use. The medication is intended for external application to the affected area, with a maximum frequency of up to 6 times daily. It is important to adhere to the directed usage and not exceed the recommended application frequency.

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

The safety of lidocaine hydrochloride gel during pregnancy has not been established. Use of this product is contraindicated in pregnancy due to potential risks to the fetus. Pregnant patients or those planning to become pregnant should consult a physician before using this product to discuss potential risks and alternative options.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there is no information available concerning the potential for excretion in breast milk or any associated risks to breastfed infants.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

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 from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

If available, consultation with a poison control center or a medical toxicologist is recommended to guide the management of the overdose effectively.

Documentation of the incident, including the substance involved, the amount taken, and the time of ingestion, is crucial for appropriate treatment and follow-up care.

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 use of the compound in these contexts.

Postmarketing Experience

No postmarketing experience details are provided in the insert.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. In the event that the medication is swallowed, patients should be instructed to call a poison control center or seek medical assistance immediately. It is essential for patients to understand the importance of these precautions to ensure their safety and the safety of others.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at room temperature, maintaining a range of 15° to 30°C. Proper storage conditions are crucial to ensure the integrity and efficacy of the product.

Additional Clinical Information

The medication is administered topically, with application to the affected area permitted up to six times daily. 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 The Solution Numbing, 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 The Solution Numbing, 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.