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Lidocaine hydrochloride

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This product has been discontinued

Active ingredient
Lidocaine Hydrochloride 40 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 2017
Label revision date
July 31, 2017
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Lidocaine Hydrochloride 40 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 2017
Label revision date
July 31, 2017
Manufacturer
SIGAN INDUSTRIES GROUP
Registration number
part348
NDC root
65365-284
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

NEW MAX STRENGTH LIDOCAINE 4% is a topical cream designed to provide temporary relief from pain. It contains lidocaine hydrochloride (HCl) at a concentration of 4%, which works by blocking pain receptors in the affected area, helping to numb discomfort effectively.

This cream is odor-free and formulated to minimize irritation and burning sensations, making it a gentle option for those seeking pain relief. With a net weight of 2.7 ounces (76.5 grams), it is easy to apply as needed for various types of pain.

Uses

You can use this medication for the temporary relief of pain. It is designed to help alleviate discomfort, making it easier for you to go about your daily activities. If you're experiencing pain, this medication may provide the relief you need.

Dosage and Administration

You should apply the medication directly to the affected area of your skin. If you are an adult or a child aged 12 years and older, you can use it up to 3 to 4 times a day. However, if the person needing treatment is under 12 years old, it’s important to consult a doctor before use to ensure safety and proper guidance.

Remember to follow these instructions carefully to get the best results from your treatment. Always apply the medication as directed, and do not exceed the recommended frequency.

What to Avoid

It's important to use this medication safely to avoid potential issues. You should not apply it to large areas of your body, on raw or blistered skin, or on any wounds or damaged skin. Additionally, avoid using large quantities and ensure that it does not come into contact with your eyes.

When using this medication, refrain from applying tight bandages or heating pads to the treated skin, as these can cause complications. Following these guidelines will help ensure your safety and the effectiveness of the treatment.

Side Effects

This product is intended for external use only. If you notice that your condition worsens or if your symptoms last longer than 7 days, it’s important to stop using the product and consult a doctor. Additionally, if your symptoms improve but then return within a few days, you should also seek medical advice.

Warnings and Precautions

This product is for external use only, so please avoid applying it to large areas of your body or on any raw, blistered, or damaged skin. It’s important to keep it away from wounds to prevent any complications.

If you accidentally swallow this product, seek medical help or contact a poison control center right away. Additionally, if your condition worsens or if your symptoms last more than seven days, you should stop using the product and call your doctor. If your symptoms improve but then come back within a few days, it’s also important to reach out to your healthcare provider.

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 extreme 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 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

If you are pregnant or planning to become pregnant, it’s important to consult with a healthcare professional before using this medication. They can provide guidance tailored to your specific situation and help you understand any potential risks. Always prioritize your health and the health of your baby 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

If your child is under 12 years old, it's important to consult a doctor before using this medication. For those aged 12 and older, you can apply it to the affected area up to 3 to 4 times a day. Always keep the medication out of reach of children to prevent accidental ingestion. If your child accidentally swallows it, seek medical help or contact a poison control center right away.

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, it’s important to consult with a healthcare provider for personalized advice. 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 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 change 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 situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

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 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. This helps maintain its effectiveness and safety. After each use, make sure to close the cap tightly to prevent contamination and preserve the integrity of the contents. Following these simple steps will help you use the product safely and effectively.

Additional Information

No further information is available.

FAQ

What is NEW MAX STRENGTH LIDOCAINE 4% used for?

NEW MAX STRENGTH LIDOCAINE 4% is used for the temporary relief of pain.

How should I apply NEW MAX STRENGTH LIDOCAINE 4%?

For adults and children 12 years and older, apply to the affected area not more than 3 to 4 times daily. Children under 12 years of age should ask a doctor.

Are there any contraindications for using this cream?

No specific contraindications are mentioned for NEW MAX STRENGTH LIDOCAINE 4%.

What precautions should I take when using this cream?

Do not use on large areas of the body, raw or blistered skin, or wounds. Avoid contact with eyes and do not apply tight bandages or heating pads to treated skin.

What should I do if I accidentally swallow the cream?

If swallowed, get medical help or contact a poison control center immediately.

What should I do if my symptoms persist?

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

Is there any information about using this cream during pregnancy or breastfeeding?

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

How should I store NEW MAX STRENGTH LIDOCAINE 4%?

Store at room temperature and close the cap tightly after use.

Packaging Info

Below are the non-prescription pack sizes of Pomoda Dragon Pain Numbing. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Pomoda Dragon Pain Numbing.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

New Max Strength Lidocaine 4% is a topical anesthetic cream formulated to provide effective pain relief. The active ingredient, Lidocaine HCl, is present at a concentration of 4%. This cream is designed to block pain receptors, thereby alleviating discomfort. It is odor-free and formulated to minimize irritation and burning sensations upon application. The product is packaged in a net weight of 2.7 ounces (76.5 grams).

Uses and Indications

This drug is indicated for the temporary relief of pain. There are no teratogenic or nonteratogenic effects associated with its use.

Dosage and Administration

Adults and children 12 years of age and older are instructed to apply the medication to the affected area no more than 3 to 4 times daily. For children under 12 years of age, it is recommended to consult a physician prior to use.

The medication should be applied directly to the affected area, adhering to the specified frequency of administration. It is essential to ensure that the application does not exceed the maximum recommended frequency for optimal safety and efficacy.

Contraindications

Use of this product is contraindicated in the following situations:

Application on large areas of the body or on raw or blistered skin is prohibited due to the potential for increased absorption and adverse effects. The product should not be applied to wounds or damaged skin, as this may exacerbate irritation or delay healing. Additionally, use in large quantities is contraindicated to prevent systemic effects.

Contact with the eyes must be avoided to prevent irritation or injury. The application of tight bandages over treated areas is not recommended, as this may lead to increased local pressure and potential skin reactions. Furthermore, the use of heating pads on treated skin is contraindicated, as it may enhance absorption and increase the risk of adverse effects.

Warnings and Precautions

FOR EXTERNAL USE ONLY. This product is intended solely for topical application and should not be ingested.

General precautions must be observed to ensure safe use. The product should not be applied to large areas of the body, nor should it be used on raw or blistered skin. Additionally, it is contraindicated for application on wounds or damaged skin, as this may exacerbate irritation or lead to adverse effects.

In the event of accidental ingestion, it is imperative to seek emergency medical assistance or contact a poison control center immediately. Prompt action is crucial to mitigate potential health risks associated with ingestion.

Patients should discontinue use and consult a healthcare professional if any of the following occur: conditions worsen, symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. These actions are essential to ensure appropriate management and to prevent complications.

Side Effects

Patients should be aware that the product is intended for external use only.

In clinical practice, it is advised that patients discontinue use and consult a healthcare professional if their conditions worsen or if symptoms persist for more than 7 days. Additionally, if symptoms resolve and then recur within a few days, patients should seek medical advice. These precautions are essential to ensure the safety and well-being of individuals using the product.

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 Pomoda Dragon Pain Numbing. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Pomoda Dragon Pain Numbing.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For adolescents and adults aged 12 years and older, the recommended application is to the affected area no more than 3 to 4 times daily. It is essential to keep the product out of reach of children to prevent accidental ingestion. In the event of swallowing, immediate medical assistance or contact with a poison control center 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 individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

Pregnancy

Pregnant patients are advised to consult a healthcare professional prior to using this medication. The safety of this drug during pregnancy has not been established, and potential risks to fetal outcomes are not fully characterized. Therefore, it is essential for women of childbearing potential to discuss their individual circumstances and any potential risks with their healthcare provider before initiating treatment.

Lactation

Lactating mothers are advised to consult a healthcare professional prior to using this medication. There is limited information available regarding the excretion of this drug in human breast milk and 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 initiate supportive care, which may include maintaining airway patency, ensuring adequate ventilation, and monitoring vital signs.

If available, the use of antidotes or specific treatments should be considered based on the substance involved and the clinical presentation. Consultation with a poison control center or a medical toxicologist may provide additional guidance on the management of overdose cases.

Documentation of the incident, including the substance, amount ingested, and time of ingestion, is crucial for effective management and treatment planning.

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 seek immediate medical assistance or contact a poison control center if the product is swallowed. It is important to instruct patients not to use the product on large areas of the body, raw skin, blistered skin, wounds, or damaged skin to prevent adverse effects.

Patients should be informed to stop using the product and consult a doctor if their condition worsens or if symptoms persist for more than seven days. Additionally, they should be cautioned to discontinue use and seek medical advice if symptoms improve and then recur within a few days.

When discussing the product's application, healthcare providers should emphasize the importance of using it only as directed and avoiding large quantities. Patients should also be reminded to avoid contact with their eyes and not to apply tight bandages or heating pads to the treated skin, as these actions may lead to complications.

Storage and Handling

The product is supplied in a configuration that allows for easy handling and storage. It should be stored at room temperature to maintain its integrity and effectiveness. After each use, it is essential to close the cap tightly to prevent contamination and ensure the product remains in optimal condition.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Pomoda Dragon Pain 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 Pomoda Dragon Pain 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.