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Lidonex

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This product has been discontinued

Active ingredient
Lidocaine Hydrochloride 4 g/100 mL
Other brand names
Dosage form
Liquid
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2022
Label revision date
February 29, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Lidocaine Hydrochloride 4 g/100 mL
Other brand names
Dosage form
Liquid
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 2022
Label revision date
February 29, 2024
Manufacturer
Newpharma, Inc.
Registration number
M017
NDC root
73564-800
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

Lidonex is a medication designed to provide temporary relief from pain. It is used to help manage discomfort, making it easier for you to carry out your daily activities. If you're experiencing pain, Lidonex may be a suitable option to consider for alleviating your symptoms.

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.

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

Dosage and Administration

To use this medication effectively, start by cleaning and drying the area that needs treatment. Once the area is prepared, you can apply the medication directly to the affected spot. For adults and children over 12 years old, you should apply it no more than 3 to 4 times a day.

If you are considering this medication for a child under 12 years of age, it’s important to consult a doctor first to ensure it’s safe and appropriate for their use. Always follow these guidelines to help achieve the best results.

What to Avoid

It's important to keep this medication out of reach of children to prevent accidental ingestion. If you or someone else swallows it, seek medical help immediately or contact a Poison Control Center for assistance.

There are no specific contraindications, controlled substance classifications, or noted risks of abuse, misuse, or dependence associated with this medication. However, always use it responsibly and follow any additional guidance from your healthcare provider.

Side Effects

When using this product, it's important to be aware of potential side effects. You should stop using it and consult your doctor if you experience any skin reactions, such as rash, itching, redness, irritation, pain, swelling, or blistering. Additionally, if your condition worsens, symptoms last longer than seven days, or if symptoms improve and then return within a few days, seek medical advice.

Please remember that this product is for external use only and is flammable, so keep it away from fire or flames. Avoid using it on wounds or damaged skin, in large quantities, or with a heating pad. Always use it as directed, and take care to avoid contact with your eyes, mucous membranes, or rashes. Do not bandage tightly. If you have any allergies to the ingredients, do not use this product.

Warnings and Precautions

This product is for external use only and should be kept away from fire or flames, as it is flammable. Do not apply it to wounds or damaged skin, use it in large amounts, or combine it with a heating pad. If you are allergic to any of the ingredients, do not use this product. When using it, follow the directions carefully, avoid contact with your eyes and mucous membranes, and do not wrap the area tightly.

If you experience any skin reactions like rash, itching, redness, irritation, pain, swelling, or blistering, stop using the product and consult your doctor. Additionally, seek medical advice if your condition worsens, if symptoms last longer than 7 days, or if symptoms improve and then return within a few days. If the product is swallowed, get emergency medical help or contact a Poison Control Center immediately.

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, 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 always better to be safe and get checked by a healthcare professional if you have any concerns about your health.

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

If your child is under 12 years old, it's important to consult a doctor before using this medication. For children aged 12 and older, as well as adults, you should first clean and dry the affected area. Then, apply the medication to the area no more than 3 to 4 times a day. Always follow these guidelines to ensure safe and effective use.

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 before starting the medication. 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 kidney function might affect the use of this medication.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific condition. They can help determine the best approach based on your kidney health.

Hepatic Impairment

If you have liver 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 standard recommendations for the medication do not change based on liver impairment. However, it’s always best to discuss your individual health situation with your healthcare provider, as they can offer personalized advice and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may want to conduct regular tests to ensure your liver is functioning well while you are on any medication.

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 all the medications and supplements you are using. This way, you can work together to ensure your treatment is safe and effective.

Storage and Handling

To ensure the best performance and safety of your product, store it in a cool, dry place away from direct sunlight. Excessive moisture can damage the product, so it's important to keep it protected from humidity. Always make sure the lid is closed tightly when not in use to maintain its integrity.

By following these simple storage guidelines, you can help ensure that your product remains effective and safe for use. If you have any questions about handling or storage, feel free to reach out for more information.

Additional Information

You should apply this medication topically to the affected area no more than 3 to 4 times a day. If you are pregnant or breastfeeding, it's important to consult a healthcare professional before using this product. Additionally, keep it out of reach of children; if swallowed, seek medical help or contact a Poison Control Center immediately.

FAQ

What is Lidonex used for?

Lidonex is used for the temporary relief of pain.

How should I apply Lidonex?

For adults and children over 12 years of age, clean and dry the affected area and apply Lidonex not more than 3 to 4 times daily.

What should I do if I am under 12 years old?

If you are under 12 years of age, consult a doctor before using Lidonex.

Are there any contraindications for using Lidonex?

There are no contraindications listed for Lidonex.

What precautions should I take when using Lidonex?

Lidonex is for external use only and should be kept away from fire or flame. Avoid using it on wounds or damaged skin, in large quantities, or with a heating pad.

What should I do if I experience skin reactions while using Lidonex?

Stop using Lidonex and ask a doctor if you experience skin reactions such as rash, itching, redness, irritation, pain, swelling, or blistering.

What should I do if Lidonex is swallowed?

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

Can I use Lidonex if I am pregnant or breastfeeding?

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

How should I store Lidonex?

Store Lidonex with the lid closed tightly, away from direct sunlight and excessive moisture.

Packaging Info

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

Packaging configurations for Lidonex.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Lidonex is a pharmaceutical compound characterized by its specific chemical properties and formulation. The molecular weight of Lidonex is not specified in the provided data. The chemical formula is also not detailed. Lidonex is available in a dosage form suitable for its intended therapeutic use. The appearance of Lidonex is not described in the provided information. Inactive ingredients, if any, are not listed. Further details regarding its pharmacological properties, indications, and usage may be available in additional documentation.

Uses and Indications

This drug is indicated for the temporary relief of pain.

There are no teratogenic effects associated with this drug. Additionally, no nonteratogenic effects have been reported.

Dosage and Administration

For adults and children over 12 years of age, the affected area should be cleaned and dried prior to application. The product may be applied 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 doctor before use.

Contraindications

Use is contraindicated in children due to the risk of accidental ingestion. In the event of swallowing, immediate medical assistance or contact with a Poison Control Center is advised.

Warnings and Precautions

For external use only. This product is flammable; it must be kept away from fire or flame.

Contraindications This product should not be used on wounds or damaged skin, in large quantities, or in conjunction with a heating pad. Additionally, individuals with known allergies to any ingredients in this product should refrain from use.

Usage Instructions When using this product, it is imperative to follow the directions provided. Care should be taken to avoid contact with the eyes, mucous membranes, or any rashes. Bandaging should not be done tightly to prevent complications.

Adverse Reactions Users must discontinue use and consult a healthcare professional if any skin reactions occur, including rash, itching, redness, irritation, pain, swelling, or blistering. If the condition worsens, symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days, medical advice should be sought.

Emergency Situations In the event of ingestion, immediate medical assistance should be obtained, or contact with a Poison Control Center is advised.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions. This product is intended for external use only and is flammable; therefore, it should be kept away from fire or flame. It is contraindicated for use on wounds or damaged skin, in large quantities, or in conjunction with a heating pad. Additionally, individuals who are allergic to any ingredients in this product should not use it.

While using this product, patients are advised to follow the directions carefully, avoiding contact with the eyes, mucous membranes, or rashes. It is also recommended not to bandage the area tightly.

Patients should discontinue use and consult a healthcare professional if they experience any skin reactions, including rash, itching, redness, irritation, pain, swelling, or blistering. Furthermore, if the condition worsens, symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, medical advice should be sought.

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 Lidonex (lidocaine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Lidonex.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a doctor before use. For adolescents and children aged 12 years and older, the affected area should be cleaned and dried prior to application. The medication may be applied to the affected area no more than 3 to 4 times daily.

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 potential 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 considered in these populations to ensure the safety of both the mother and the fetus or infant.

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

There is no information available regarding the use of this medication in patients with hepatic impairment. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions specified for individuals with compromised liver function. Healthcare professionals should exercise caution and consider the lack of data when prescribing this medication to patients with liver problems.

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.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective treatment and follow-up care.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. It is important to inform patients that if the medication is swallowed, they should seek medical help or contact a Poison Control Center immediately. This guidance is crucial to ensure the safety and well-being of patients and their families.

Storage and Handling

The product is supplied in a configuration that ensures optimal preservation of its integrity. It is essential to store the product in a cool, dry place, away from direct sunlight, to maintain its efficacy. The container must be kept tightly closed to prevent contamination and preserve the product's quality. Additionally, it is crucial to protect the product from excessive moisture, which could compromise its stability. Proper handling and storage conditions are vital for ensuring the product remains effective throughout its intended use.

Additional Clinical Information

The medication is administered topically, with a recommended application frequency of no more than 3 to 4 times daily to the affected area. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. Additionally, it is important to keep the product out of reach of children; if ingested, patients should seek medical assistance or contact a Poison Control Center immediately.

No further information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Lidonex, 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 Lidonex, 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.