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Lidozall Plus

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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 2025
Label revision date
November 12, 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 2025
Label revision date
November 12, 2025
Manufacturer
V2 Pharma LLC
Registration number
M017
NDC root
72835-114
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 designed to provide temporary relief from pain and itching caused by minor skin irritations. It can be helpful if you're dealing with discomfort from conditions like insect bites, minor cuts, or rashes. While the specific details about how it works are not provided, its primary purpose is to soothe your skin and alleviate discomfort.

Uses

You can use this medication for the temporary relief of pain and itching caused by minor skin irritations. Whether it's a small rash, insect bite, or other minor skin issues, this treatment can help soothe your discomfort.

It's important to note that there are no reported teratogenic effects (which means it doesn't cause birth defects) associated with this medication, making it a safer option for those who may be concerned about such risks.

Dosage and Administration

You can use this medication if you are an adult or a child who is at least two years old. To relieve pain, apply one packet, which contains 2 grams of the medication, directly to the area that is hurting. You can do this up to four times a day, but make sure not to exceed a total of four packets, or 8 grams, in one day. This way, you can manage your pain effectively while staying within the recommended limits.

What to Avoid

It's important to use this medication responsibly. You should avoid using it in large quantities, especially on raw surfaces or blistered areas, as this can lead to complications. While there are no specific contraindications or concerns about abuse, misuse, or dependence associated with this medication, always follow the recommended guidelines to ensure your safety and well-being. If you have any questions or concerns, don't hesitate to reach out to your healthcare provider for more information.

Side Effects

It's important to be aware of some key warnings and recommendations when using this product. It is for external use only, so make sure to avoid contact with your eyes. If your condition worsens, or if symptoms last more than 7 days or improve and then return within a few days, you should stop using the product and consult a doctor.

Taking these precautions can help ensure your safety and the effectiveness of the treatment.

Warnings and Precautions

This product is for external use only, so please avoid using it on large areas of your skin, especially over raw or blistered surfaces. Be careful not to let it come into contact with your eyes.

Keep this product out of reach of children. If it is swallowed, seek medical help immediately or contact a Poison Control Center. If your condition worsens, or if symptoms last more than 7 days or return after clearing up, stop using the product and consult your doctor.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it’s always important to be aware of the signs of an overdose, which can include unusual drowsiness, confusion, or difficulty breathing. If you suspect that you or someone else may have taken too much of a medication, it’s crucial to seek immediate medical help.

In case of an overdose, contact your local emergency services or go to the nearest hospital. Having the medication packaging or information on hand can help medical professionals provide the best care. Always remember that when it comes to medications, it’s better to be safe and get help if you have any concerns.

Pregnancy Use

There are no specific guidelines or warnings about using Lidozall Plus during pregnancy in the available information. This means that the insert does not highlight any safety concerns, contraindications (situations where the drug should not be used), or special precautions for pregnant individuals.

If you are pregnant or planning to become pregnant, it's always best to consult with your healthcare provider before using any medication, including Lidozall Plus, to ensure it is safe for you and your baby.

Lactation Use

If you are breastfeeding, you can use Lidozall Plus without specific warnings or recommendations against it. Currently, there is no information available about whether this medication passes into breast milk or if it poses any risk to your nursing infant.

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

Pediatric Use

When using this product for children aged two years and older, you should apply one packet (2 grams) to the affected area up to four times a day as needed for pain relief. It's important not to exceed four packets (8 grams) in a single day. Always keep the product out of reach of children, and if it is accidentally swallowed, seek medical help or contact a Poison Control Center immediately.

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. As you age, your body may process medications differently, and factors like kidney function (renal impairment) and changes in cognition can affect how well a drug works or how it may impact you.

If you are an older adult or a caregiver, it’s wise to discuss any concerns with your healthcare provider. They can help determine the best approach for your individual health needs, ensuring that any medication you take is safe and effective for you. Always keep your doctor informed about all medications you are taking, as this can help prevent potential interactions or side effects.

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 you understand how to manage your health while considering your liver condition.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you.

Always feel free to ask questions and share your complete list of medications and any lab tests you may be undergoing. This way, you can receive the best possible care tailored to your needs.

Storage and Handling

To ensure the best performance of your product, it's important to store it in a cool, dry place, away from excessive heat and direct sunlight. This will help maintain its effectiveness and safety.

When handling the product, always do so with care to avoid any damage. Following these simple guidelines will help you use the product safely and effectively.

Additional Information

No further information is available.

FAQ

What is the primary use of this drug?

This drug is used for temporary relief of pain and itching due to minor skin irritations.

Who can use this drug?

It is intended for adults and children two years or older.

How should I apply this drug?

You should apply 1 packet (2 grams) topically to the affected area(s) up to 4 times daily as needed for pain, but do not exceed 4 packets (8 grams) per day.

Are there any contraindications for this drug?

No contraindications are listed for this drug.

What precautions should I take when using this drug?

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

What should I do if my condition worsens?

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

What should I do if the product is swallowed?

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Is this drug safe to use during pregnancy?

There are no specific statements regarding the use of this drug during pregnancy.

Can nursing mothers use this drug?

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

What should I do if I experience side effects?

If you experience any side effects, discontinue use and consult a healthcare professional.

Packaging Info

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

Packaging configurations for Lidozall Plus.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No description information is available for the drug.

Uses and Indications

This drug is indicated for the temporary relief of pain and itching associated with minor skin irritations.

There are no teratogenic or nonteratogenic effects reported for this drug.

Dosage and Administration

For adults and children aged two years and older, the recommended dosage is to apply one packet (2 grams) topically to the affected area(s) up to four times daily as needed for pain relief. It is important to note that the total daily dosage should not exceed four packets (8 grams).

Healthcare professionals should instruct patients to ensure the affected area is clean and dry prior to application. The product should be gently massaged into the skin until fully absorbed. Care should be taken to avoid contact with eyes and mucous membranes.

Contraindications

Use is contraindicated in patients who may apply the product in large quantities, particularly over raw surfaces or blistered areas, due to the potential for adverse effects. No other contraindications are listed.

Warnings and Precautions

For external use only. It is imperative to avoid contact with the eyes to prevent irritation or injury.

Caution is advised regarding the quantity of product used. It should not be applied in large amounts, especially on raw surfaces or blistered areas, as this may exacerbate irritation or lead to adverse effects.

In the event of accidental ingestion, immediate medical assistance is required. The product should be kept out of reach of children, and if swallowed, healthcare professionals should be contacted or a Poison Control Center should be reached without delay.

Healthcare professionals should instruct patients to discontinue use and seek medical advice if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. In such cases, it is essential to stop using the product and consult a physician for further evaluation and management.

Side Effects

Patients should be aware that the product is intended for external use only and must avoid contact with the eyes. In the event of worsening conditions or if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, patients are advised to discontinue use and consult a healthcare professional.

These precautions are essential to ensure the safe and effective use of the product, minimizing the risk of adverse reactions.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

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

Packaging configurations for Lidozall Plus.
Details

Pediatric Use

Pediatric patients aged two years and older may use this product topically for pain relief. The recommended dosage is 1 packet (2 grams) applied to the affected area(s) up to 4 times daily, with a maximum of 4 packets (8 grams) per day.

Caution is advised to keep the product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact a Poison Control Center.

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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

There are no specific statements regarding the use of Lidozall Plus during pregnancy. The available prescribing information does not indicate any safety concerns, contraindications, or special precautions associated with the use of Lidozall Plus in pregnant patients. As such, healthcare professionals should consider the absence of data when advising women of childbearing potential and weigh the potential benefits against any unknown risks when prescribing this medication during pregnancy.

Lactation

There are no specific warnings or recommendations regarding the use of Lidozall Plus in lactating mothers. Additionally, there is no information available about 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 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 overdosage information, it is essential for healthcare professionals to remain vigilant regarding the potential for overdose with this medication. In cases where an overdose is suspected, immediate medical attention should be sought.

Healthcare providers are advised to monitor patients closely for any signs or symptoms that may indicate an overdose. These may include, but are not limited to, increased severity of known side effects, unusual behavioral changes, or any other atypical clinical manifestations.

Management of an overdose should be guided by the clinical presentation of the patient. Supportive care is paramount, and symptomatic treatment should be initiated as necessary. It is recommended that healthcare professionals consult local poison control centers or relevant toxicology resources for specific guidance on the management of overdose cases.

In summary, while specific overdosage data is not available, healthcare professionals should exercise caution, remain observant for potential overdose symptoms, and implement appropriate management strategies as needed.

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

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: allergic reactions, which include rash, itching, and hives; as well as local skin reactions characterized by redness and irritation at the application site.

Patient Counseling

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

Patients should be cautioned against using the product in large quantities, especially on raw surfaces or blistered areas, as this may lead to adverse effects.

Additionally, healthcare providers should inform patients to discontinue use and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. It is important for patients to be aware of these guidelines to ensure safe and effective use of the product.

Storage and Handling

This product is supplied in various package configurations, with specific NDC numbers available upon request. It is essential to protect the product from excessive heat and direct sunlight to maintain its integrity and efficacy. Proper storage conditions should be ensured to prevent any degradation of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Lidozall Plus, 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 Lidozall Plus, 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.