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Numbr-X

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Active ingredient
Lidocaine Hydrochloride 4 g/100 g
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
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 2024
Label revision date
July 10, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Lidocaine Hydrochloride 4 g/100 g
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
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 2024
Label revision date
July 10, 2025
Manufacturer
Prodigy Media Inc
Registration number
M017
NDC root
70171-0001
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

You can use this medication for the temporary relief of pain and itching caused by sunburns, minor cuts, insect bites, and various skin irritations. It is designed to help soothe discomfort and promote a sense of relief when you experience these common skin issues.

Uses

If you're dealing with discomfort from sunburns, minor cuts, insect bites, or skin irritations, this medication can help provide temporary relief from pain and itching. It's designed to soothe your skin and make you feel more comfortable during these minor irritations.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) associated with this medication, making it a safer option for those concerned about such risks.

Dosage and Administration

If you are an adult or a child aged 2 years and older, you can apply this medication to the affected area up to 3 to 4 times a day. Make sure to follow this guideline to ensure the best results.

However, if your child is under 2 years old, it’s important not to use this medication without first consulting a physician (doctor). Always prioritize safety and seek professional advice when it comes to younger children.

What to Avoid

It's important to be aware of specific instructions regarding the use of this product. If you accidentally swallow it, seek medical help or contact a Poison Control Center immediately. This is crucial for your safety.

Currently, there are no listed contraindications, controlled substance classifications, or concerns about abuse, misuse, or dependence (a condition where your body becomes reliant on a substance). However, always prioritize your health and follow the guidance provided.

Side Effects

When using this product, it's important to be aware of some potential side effects. You should stop using it and consult a doctor if your condition worsens or if symptoms persist for more than 7 days. If your symptoms improve and then return within a few days, it's also advisable to seek medical advice. Avoid using the product in large amounts, especially on raw or blistered skin, and do not exceed the recommended daily dosage unless directed by a healthcare professional.

Additionally, this product is for external use only, and you should avoid contact with your eyes. It is not recommended for use on wounds or damaged skin.

Warnings and Precautions

This product is for external use only, so please avoid contact with your eyes. It's important to stop using it and consult your doctor if your condition worsens or if symptoms last longer than 7 days. Additionally, if your symptoms improve and then return within a few days, you should also reach out to your healthcare provider. Be cautious not to use large amounts, especially on raw or blistered skin, and do not apply it to wounds or damaged areas.

If you accidentally swallow this product, seek emergency medical help or contact a Poison Control Center immediately. Always follow the recommended dosage and guidelines provided by your doctor to ensure your safety.

Overdose

Using this medication in large amounts, especially on raw or blistered skin, can lead to serious issues. It's important to stick to the recommended daily dosage unless your doctor advises otherwise.

If you suspect an overdose, look for signs such as unusual skin reactions or increased discomfort in the treated areas. In such cases, it's crucial to seek immediate medical help. Always prioritize your safety and consult a healthcare professional if you have any concerns about your dosage or experience any adverse effects.

Pregnancy Use

The safety of lidocaine HCL cream during pregnancy has not been established, which means that it’s unclear whether it could harm you or your developing baby. Because of this uncertainty, it is generally not recommended to use this cream while pregnant unless your healthcare provider believes that the benefits outweigh any potential risks to your fetus.

If you are pregnant or planning to become pregnant, it’s important to consult your physician before using lidocaine HCL cream. They can help you understand the potential risks and make an informed decision about your treatment options.

Lactation Use

If you are breastfeeding and considering the use of lidocaine HCl cream, you can feel reassured that there are no specific warnings or recommendations against its use for nursing mothers. Additionally, the information available does not indicate any risk of the cream being passed into breast milk or affecting your infant.

As always, it's a good idea to consult with your healthcare provider if you have any concerns or questions about using medications while breastfeeding.

Pediatric Use

When using this medication for children, it's important to follow specific guidelines. 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, you should not use this medication without first consulting a physician (a medical doctor). Always prioritize your child's safety and seek professional advice if you're unsure.

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 ensure that your healthcare provider is aware of your age and any existing health conditions, as they can provide personalized advice and monitor for any potential issues. Your safety and well-being are the top priority.

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 condition. They can help you understand how your kidney health may affect your medications and what steps to take for your well-being.

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, even if there are no known drug interactions or laboratory test interactions associated with them. This ensures that your treatment plan is safe and effective, tailored specifically to your health needs.

Always keep your healthcare team informed about all the medications and supplements you use, as well as any lab tests you may undergo. This way, they can provide the best care and monitor your health appropriately.

Storage and Handling

To ensure the best performance and safety of your product, store it at room temperature. It's important to check the packaging before use; do not use the product if the seal is broken, as this could compromise its safety and effectiveness. Always handle the product with care to maintain its integrity.

Additional Information

You should apply this medication topically to the affected area, using it no more than 3 to 4 times a day if you are an adult or a child aged 2 years and older. If the patient is under 2 years of age, it is important to consult a physician before use. There is no additional information available regarding laboratory tests, abuse potential, or patient counseling.

FAQ

What is the primary use of this drug?

This drug is used for the temporary relief of pain and itching associated with sunburns, minor cuts, insect bites, and skin irritations.

How should I apply this drug?

Adults and children 2 years of age and older should apply it to the affected area not more than 3 to 4 times daily. Children under 2 years of age should not use it and should consult a physician.

Are there any contraindications for using this drug?

There are no specific contraindications listed, but do not use it on wounds or damaged skin.

What should I do if I swallow this product?

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

What precautions should I take while using this drug?

For external use only, avoid contact with eyes, and do not use in large quantities, particularly over raw surfaces or blistered areas.

What should I do if my condition worsens or symptoms persist?

Stop use and ask a doctor if your condition worsens or symptoms persist for more than 7 days, or if symptoms clear up and occur again within a few days.

Is this drug safe to use during pregnancy?

The safety of this drug during pregnancy has not been established, and it is not recommended unless the potential benefits justify the potential risks to the fetus.

Can nursing mothers use this drug?

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

How should I store this drug?

Store at room temperature and do not use if the seal is broken.

Packaging Info

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

Packaging configurations for Numbr-X.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The product is identified by the SPL code 34089-3. No additional specific description details are provided in the available information.

Uses and Indications

This drug is indicated for the temporary relief of pain and itching associated with sunburns, minor cuts, insect bites, and skin irritations.

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 application is to the affected area not more than 3 to 4 times daily. It is important to ensure that the application is limited to the specified frequency to avoid potential adverse effects.

For children under 2 years of age, the product should not be used without consulting a physician. Healthcare professionals are advised to assess the necessity and safety of treatment in this age group before proceeding with any application.

Contraindications

There are no specific contraindications listed for this product. However, it is imperative to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed.

Warnings and Precautions

For external use only. It is imperative to avoid contact with the eyes. In the event of accidental contact, immediate rinsing with water is recommended.

Healthcare professionals should advise patients to discontinue use and seek medical advice if any of the following occur: the condition worsens or symptoms persist for more than 7 days; or if symptoms resolve and then recur within a few days. It is crucial to avoid using this product in large quantities, especially on raw surfaces or blistered areas, and to adhere strictly to the recommended daily dosage unless otherwise directed by a physician. Additionally, this product should not be applied to wounds or damaged skin.

In cases where the product is ingested, immediate medical assistance should be sought, or the local Poison Control Center should be contacted without delay.

Patients should be instructed to stop using the product and consult their healthcare provider if the condition worsens or if symptoms persist beyond 7 days, as well as if symptoms resolve and then reappear shortly thereafter.

Side Effects

Patients should be aware that the product is intended for external use only and must be kept away from the eyes to prevent irritation.

In clinical practice, it is advised that patients stop using the product and consult a healthcare professional if their condition worsens or if symptoms persist for more than 7 days. Additionally, if symptoms resolve and then recur within a few days, medical advice should be sought.

It is crucial to avoid using the product in large quantities, especially on raw surfaces or blistered areas, and to adhere strictly to the recommended daily dosage unless otherwise directed by a healthcare provider. The product should not be applied to wounds or damaged skin to prevent potential adverse reactions.

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 Numbr-X (lidocaine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Numbr-X.
Details

Pediatric Use

Pediatric patients aged 2 years and older may apply the medication to the affected area no more than 3 to 4 times daily. For children under 2 years of age, the use of this medication is not recommended, and consultation with a physician is advised.

Geriatric Use

There is no specific information 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 they may have altered pharmacokinetics and pharmacodynamics. Close monitoring is recommended to ensure safety and efficacy in this population.

Pregnancy

The safety of lidocaine HCL cream during pregnancy has not been established. The use of this medication is not recommended during pregnancy unless the potential benefits justify the potential risks to the fetus. Pregnant patients or those planning to become pregnant should consult a physician prior to using this product to ensure appropriate evaluation and management of potential risks.

Lactation

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

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 clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions 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 warranted based on clinical judgment.

Overdosage

Overdosage of the medication can lead to significant adverse effects, particularly when used inappropriately. It is crucial to adhere to the recommended dosage guidelines to mitigate the risk of overdosage.

Recommended Dosage Guidelines Healthcare professionals should advise patients against using the medication in large quantities, especially over raw surfaces or blistered areas. The recommended daily dosage should not be exceeded unless specifically directed by a healthcare provider.

Potential Symptoms of Overdosage While specific symptoms of overdosage are not detailed, it is essential for healthcare professionals to monitor patients closely for any unusual reactions or exacerbation of side effects, particularly in cases where the medication has been applied excessively or improperly.

Management Procedures In the event of suspected overdosage, immediate consultation with a healthcare professional is advised. Appropriate management may include supportive care and symptomatic treatment, tailored to the individual patient's needs. It is imperative to follow established protocols for managing overdosage to ensure patient safety and effective intervention.

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 that if the product is swallowed, it is crucial to seek medical help immediately or contact a Poison Control Center. This information is essential for ensuring patient safety and prompt action in case of accidental ingestion.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers. It should be stored at room temperature to maintain its integrity and efficacy. Healthcare professionals are advised to ensure that the product is not used if the seal is broken, as this may compromise the safety and quality of the product. Proper handling and storage conditions are essential to ensure optimal performance.

Additional Clinical Information

The medication is administered topically, with the recommended application frequency for adults and children aged 2 years and older being 3 to 4 times daily to the affected area. For children under 2 years of age, use is not advised without consulting a physician.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Numbr-X, 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 Numbr-X, 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.