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Numb Gel Anesthetic

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This product has been discontinued

Active ingredient
Lidocaine Hydrochloride 1.12 g/28 g
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 2020
Label revision date
January 17, 2022
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Lidocaine Hydrochloride 1.12 g/28 g
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 2020
Label revision date
January 17, 2022
Manufacturer
RENU LABORATORIES, INC.
Registration number
part348
NDC root
76348-595
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

Numb is a medication designed to provide temporary relief from pain associated with minor skin procedures. It helps to ease discomfort during these procedures, making the experience more manageable for you. If you're facing a minor skin treatment, Numb may be a helpful option to consider for pain relief.

Uses

You can use this medication for the temporary relief of pain related to minor skin procedures. It is designed to help make these procedures more comfortable for you.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) associated with this medication, so it is considered safe in that regard.

Dosage and Administration

If you or your child is dealing with a specific skin issue, you can apply the medication directly to the affected area. For adults and children aged 2 years and older, it's recommended to use the medication up to 3 to 4 times a day. This means you can apply it several times throughout the day as needed to help manage the condition.

However, if your child is under 2 years old, it's important to consult with a doctor before using the medication. They can provide guidance on the best approach for younger children. Always follow these instructions to ensure safe and effective use of the medication.

What to Avoid

It's important to use this medication safely to avoid potential issues. You should never apply it in or near your eyes, and be cautious not to use it in large amounts, especially on raw or blistered skin. Additionally, avoid using it on puncture wounds. If you find that you need to use this medication for more than one week, please consult your doctor for guidance. Following these instructions will help ensure your safety and the effectiveness of the treatment.

Side Effects

If you experience an allergic reaction, such as rash or difficulty breathing, you should stop using the product and consult a doctor. Additionally, if your condition worsens or does not improve within 7 days, or if symptoms clear up and then return after a few days, it's important to seek medical advice. Be aware of any signs of redness, irritation, swelling, or increased pain, as these may indicate a need to stop use and contact a healthcare professional. Remember, this product is for external use only.

Warnings and Precautions

This product is for external use only, so please avoid ingesting it. Keep it out of reach of children, and if it is swallowed, seek medical help or contact a Poison Control Center immediately.

You should stop using this product and call your doctor if you experience an allergic reaction, if your condition worsens or does not improve within 7 days, if symptoms clear up and then return within a few days, or if you notice any redness, irritation, swelling, pain, or other symptoms that begin or increase. Your health and safety are important, so please take these precautions seriously.

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 be safe and get checked by a healthcare professional if you have any concerns about your health. Remember, timely intervention can make a significant difference.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this medication. They can provide guidance on whether it’s safe for you and your baby. Always prioritize your health and the health of your child by seeking expert advice.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication. This ensures that you understand any potential risks and can make informed decisions about your health and the health of your baby. Always prioritize open communication with your doctor regarding your breastfeeding journey.

Pediatric Use

When using this medication for children aged 2 years and older, you can apply it to the affected area up to 3 to 4 times a day. However, if your child is under 2 years old, it’s important to consult a doctor before use. Always follow these guidelines to ensure the safety and effectiveness of the treatment for your child.

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.

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 your treatment is safe and effective based on your individual health needs.

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 a temperature between 20 to 25 degrees Celsius (68 to 77 degrees Fahrenheit). This temperature range helps maintain the integrity and effectiveness of the device.

When handling the product, always do so with clean hands and in a clean environment to avoid contamination. If there are any specific components included with the product, make sure to follow any additional instructions provided for their use or safety. Proper storage and careful handling are key to ensuring your product works as intended.

Additional Information

No further information is available.

FAQ

What is Numb used for?

Numb is used for the temporary relief of pain associated with minor skin procedures.

How should I apply Numb?

For adults and children 2 years and older, apply to the affected area up to 3 to 4 times a day. For children under 2 years, consult a doctor.

Are there any contraindications for using Numb?

No specific contraindications are mentioned for Numb.

What should I avoid while using Numb?

Do not use Numb in or near the eyes, on puncture wounds, or in large quantities over raw surfaces or blistered areas.

What should I do if I experience an allergic reaction?

Stop using Numb and ask a doctor if an allergic reaction occurs or if the condition worsens or does not improve within 7 days.

Is Numb safe to use during pregnancy or breastfeeding?

If you are pregnant or breastfeeding, ask a health professional before using Numb.

What should I do if Numb is swallowed?

If swallowed, get medical help or contact a Poison Control Center right away.

What are the storage conditions for Numb?

Store Numb at 20 - 25°C (68 - 77°F).

Packaging Info

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

Packaging configurations for Numb Gel Anesthetic.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The product is presented with specific labeling and packaging, including a jar label and box art designated as "Numb." The visual elements are designed to ensure clear identification and branding of the product.

Uses and Indications

This drug is indicated for the temporary relief of pain associated with minor skin procedures.

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

Dosage and Administration

For adults and children aged 2 years and older, the recommended dosage is to apply the medication to the affected area up to 3 to 4 times daily. For children under 2 years of age, it is advised to consult a physician prior to use.

The application should be performed directly on the affected area, ensuring that the area is clean and dry before administration. Care should be taken to avoid contact with eyes and mucous membranes.

Contraindications

Use is contraindicated in the following situations:

  • Application in or near the eyes is prohibited due to the potential for irritation or injury.

  • The product should not be applied in large quantities, especially over raw surfaces or blistered areas, as this may exacerbate irritation or lead to adverse effects.

  • Application on puncture wounds is contraindicated to prevent complications associated with improper use.

  • Prolonged use beyond one week without medical consultation is not recommended, as it may lead to unforeseen complications or adverse reactions.

Warnings and Precautions

For external use only. It is imperative that this product is kept out of reach of children to prevent accidental ingestion. In the event of swallowing the product, immediate medical assistance should be sought, or contact a Poison Control Center without delay.

Healthcare professionals should advise patients to discontinue use and consult a physician if any of the following occur: an allergic reaction, worsening of the condition, lack of improvement within 7 days, recurrence of symptoms after initial resolution, or the emergence or escalation of redness, irritation, swelling, pain, or other concerning symptoms.

In cases of ingestion, it is crucial to obtain emergency medical help or contact a Poison Control Center immediately.

Side Effects

Patients using this product should be aware that it is intended for external use only. In the event of an allergic reaction, patients are advised to stop use and consult a healthcare professional. Additionally, if the condition being treated worsens or does not improve within 7 days, or if symptoms initially clear up and then return within a few days, medical advice should be sought.

Patients should also monitor for any signs of redness, irritation, swelling, pain, or other symptoms that may begin or increase during the course of treatment. These reactions warrant immediate consultation with a healthcare provider to ensure appropriate management and care.

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 Numb Gel Anesthetic (lidocaine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Numb Gel Anesthetic.
Details

Pediatric Use

Pediatric patients aged 2 years and older may apply the medication to the affected area up to 3 to 4 times a day. For infants and children under 2 years of age, it is advised to consult a healthcare professional before 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. 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

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

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 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 maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

If available, specific antidotes or treatments should be administered as indicated based on the clinical scenario and the substance involved. Continuous assessment and supportive care are critical in managing the patient's condition effectively.

Healthcare professionals are encouraged to consult local poison control centers or toxicology experts for guidance on the management of overdose cases, ensuring that appropriate interventions are undertaken promptly.

Nonclinical Toxicology

If pregnant or breast-feeding, it is advised to consult a health professional prior to use. No non-teratogenic effects have been provided in the insert. Additionally, there is no information available regarding nonclinical toxicology or animal pharmacology and toxicology in the insert.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. Instruct patients that if the product is swallowed, they should seek medical help or contact a Poison Control Center immediately.

Patients should be informed to stop using the product and consult a doctor if they experience any allergic reactions, if their condition worsens or does not improve within 7 days, if symptoms resolve and then return within a few days, or if they notice any increase in redness, irritation, swelling, pain, or other symptoms.

It is important to remind patients not to use the product in or near the eyes, and to avoid applying it in large quantities, especially over raw surfaces or blistered areas. Additionally, patients should be cautioned against using the product on puncture wounds. They should also be advised not to use the product for more than one week without first consulting a doctor.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at a temperature range of 20 to 25 degrees Celsius (68 to 77 degrees Fahrenheit) to ensure optimal stability and efficacy. Proper container requirements must be adhered to, and special handling needs should be observed to maintain the integrity of the product during storage.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Numb Gel Anesthetic, 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 Gel Anesthetic, 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.