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Lidocaine hydrochloride

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Active ingredient
Lidocaine Hydrochloride 4 g/100 mL
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
Dosage form
Liquid
Route
Auricular (otic)
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
February 6, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Lidocaine Hydrochloride 4 g/100 mL
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
Dosage form
Liquid
Route
Auricular (otic)
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
February 6, 2025
Manufacturer
Clarion Brands LLC
Registration number
M017
NDC root
69693-901
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

LipoFlavonoid is an ear pain relief drop that contains 4% lidocaine, designed to provide fast-acting relief from earaches. It works by soothing discomfort, reducing swelling and pressure, and helping to fight harmful bacteria. This product is particularly useful for alleviating earaches caused by swimming, colds, flu, and allergies.

Recommended by ENT doctors, LipoFlavonoid is safe and effective for children aged 2 years and older, although it's important to consult a doctor before using it on younger children. The drops can be applied directly into the affected ear to help relieve pain and discomfort.

Uses

You can use this medication for temporary relief of pain, especially if you're dealing with earaches. It works quickly to soothe discomfort, swelling, and pressure, making it a great option if you're experiencing ear pain from swimming, colds, flu, or allergies. Additionally, it helps fight harmful bacteria that can contribute to ear issues.

This medication is safe and effective for children aged 2 years and older, so you can feel confident using it for your little ones when they need relief.

Dosage and Administration

Lidocaine HCl 4% is a topical anesthetic, which means it is used to numb a specific area of your skin or mucous membranes to relieve pain or discomfort. When using this medication, it is important to apply it directly to the affected area as directed by your healthcare provider.

While the specific method and frequency of application are not detailed here, you should follow your doctor's instructions carefully to ensure safe and effective use. If you have any questions about how to apply it or how often to use it, don’t hesitate to ask your healthcare professional for guidance.

What to Avoid

It's important to use this medication safely. You should avoid allowing it to come into contact with your eyes and mucous membranes, as this can cause irritation or harm. Additionally, do not use this medication alongside other topical analgesics (pain-relieving medications applied to the skin), as this could lead to unwanted effects.

By following these guidelines, you can help ensure that you use the medication effectively and safely. If you have any questions or concerns, be sure to discuss them with your healthcare provider.

Side Effects

You should be aware that this product is for external use only and is flammable, so it's important to keep it away from fire, sparks, and heated surfaces. Avoid exposing it to temperatures above 130°F, as this could cause the container to burst. Store it at room temperature in a dry place.

Do not use this product in large amounts, especially on raw or blistered skin, and avoid using it for more than one week without consulting your doctor. If you notice a rash or irritation, or if your symptoms worsen or last longer than seven days, you should stop using it and speak with a healthcare professional. Additionally, do not use it if you have a hole in your eardrum or tubes in your ear.

Warnings and Precautions

This product is for external use only and is flammable, so be sure to keep it away from fire, sparks, and heated surfaces. Avoid exposing it to temperatures above 130°F, as this could cause the container to burst. Store it at room temperature in a dry place. Do not use this product in large amounts, especially on raw or blistered skin, and do not use it for more than one week without consulting your doctor. Additionally, do not use it if you have a hole in your eardrum or tubes in your ear.

If you accidentally swallow this product, seek emergency medical help or contact a Poison Control Center immediately. You should also stop using the product and call your doctor if you develop a rash or irritation, or if your symptoms worsen or last longer than seven days, or if they clear up and then return within a few days.

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 effects of an overdose for this medication, you should be aware of general signs that may indicate a problem. These can include unusual drowsiness, confusion, or difficulty breathing.

If you notice any of these symptoms or have concerns about a possible overdose, seek medical help right away. It's always better to err on the side of caution when it comes to your health. Remember, if you are ever in doubt, contacting a healthcare professional or poison control center can provide you with the guidance you need.

Pregnancy Use

The safety of Lipo Flavonoid Ear Pain Relief Drops, which contain 4% Lidocaine, during pregnancy has not been established. Because of potential risks to the fetus, it is not recommended for use in pregnant women. If you are pregnant or planning to become pregnant, it is important to consult your healthcare provider before using this product to discuss any potential risks and alternatives. Your health and the health of your baby should always come first.

Lactation Use

If you are breastfeeding, it's important to talk to your doctor before using this product. Currently, there is no specific information available about whether this product can pass into breast milk or what risks it may pose to your baby. Your healthcare provider can help you weigh the benefits and any potential concerns to ensure the safety of both you and your infant.

Pediatric Use

If your child is 2 years old or older, you can apply the medication to the affected area up to 3 to 4 times a day. It has been found to be safe and effective for children in this age group. However, if your child is under 2 years old, it's important to consult your doctor before using this medication. Always check with a healthcare professional to ensure it's appropriate for your little one.

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 any existing health conditions or medications, as this can help in making informed decisions about treatment options. Your safety and well-being are the top priority, so don’t hesitate to ask questions or express any concerns you may have.

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 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 differently due to your liver health.

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver function and how it relates to your treatment. They can help ensure that your medication is safe and effective for you.

Drug Interactions

It's important to be cautious when using certain medications together. Specifically, you should avoid using this medication alongside other topical analgesics (pain-relieving creams or ointments applied to the skin). Mixing these products can increase the risk of side effects or reduce their effectiveness.

Always discuss any medications you are taking, including over-the-counter products, with your healthcare provider. They can help ensure that your treatment is safe and effective, and they can provide guidance on how to use your medications properly.

Storage and Handling

To ensure the safety and effectiveness of your product, store it at room temperature in a dry place. It's important to keep it away from fire, sparks, and heated surfaces, as exposure to temperatures above 130°F can cause the container to burst. Always make sure the child-proof cap is tightly closed when not in use to prevent accidental access.

By following these simple storage and handling guidelines, you can help maintain the integrity of the product and ensure safe usage.

Additional Information

You should apply this medication to the affected ear using 2 to 3 drops, tilting your head to hold the position for one minute. For adults and children aged 2 years and older, you can use it no more than 3 to 4 times a day. If the patient is under 2 years old, consult a doctor before use.

Be cautious not to use this medication in large amounts, especially on raw or blistered skin, and avoid using it for more than a week without consulting a doctor. Keep it away from your eyes and mucous membranes, and do not combine it with other topical pain relievers. If you experience a rash, irritation, or if symptoms worsen or last longer than 7 days, stop using the medication and consult a doctor. If swallowed, seek medical help or contact a Poison Control Center immediately.

FAQ

What is LipoFlavonoid?

LipoFlavonoid is an ear pain relief drop that contains 4% Lidocaine, designed for fast-acting relief from earaches.

How does LipoFlavonoid work?

It soothes discomfort, swelling, and pressure, helps fight harmful bacteria, and provides relief from earaches due to swimming, cold & flu, and allergies.

Who can use LipoFlavonoid?

It is safe and effective for children 2 years old and up; consult your doctor before using it on children under 2 years old.

How should I use LipoFlavonoid?

Apply 2 to 3 drops into the affected ear, hold the position for 1 minute, and repeat no more than 4 times per day.

Are there any contraindications for using LipoFlavonoid?

Do not use LipoFlavonoid if you have a hole in your ear drum or tubes in your ear.

What should I do if I experience side effects?

Stop use and ask a doctor if rash or irritation develops, or if symptoms worsen or persist for more than 7 days.

Is LipoFlavonoid safe during pregnancy?

The safety of LipoFlavonoid during pregnancy has not been established, and it is not recommended for use in pregnant women.

What precautions should I take when using LipoFlavonoid?

Avoid contact with eyes and mucous membranes, do not use with other topical analgesics, and keep away from fire and heated surfaces.

What should I do if I swallow LipoFlavonoid?

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

Packaging Info

Below are the non-prescription pack sizes of Lipo Flavonoid Ear Pain Relief Drops with 4% Lidocaine. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Lipo Flavonoid Ear Pain Relief Drops with 4% Lidocaine.
Details

Drug Information (PDF)

This file contains official product information for Lipo Flavonoid Ear Pain Relief Drops with 4% Lidocaine, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

LipoFlavonoid® is an ear pain relief formulation presented as ear drops, containing 4% lidocaine. Each bottle contains 0.42 fluid ounces (12.4 mL) of the solution. This enhanced formula is designed for maximum strength pain relief and is indicated for use in children aged 2 years and older. The product aids in combating harmful bacteria and provides rapid relief from water-clogged ears. Additionally, it gently assists in flushing out ear wax and debris.

Uses and Indications

This drug is indicated for the temporary relief of pain, specifically for fast-acting earache pain relief. It is designed to soothe discomfort, swelling, and pressure associated with earaches. Additionally, this medication helps fight harmful bacteria and provides relief from earaches due to swimming, cold and flu, and allergies.

This drug is safe and effective for use in children aged 2 years and older. There are no teratogenic effects associated with this medication.

Dosage and Administration

Lidocaine HCl 4% is indicated for use as a topical anesthetic. The specific route of administration, method, and frequency have not been detailed in the provided information. Healthcare professionals are advised to follow standard practices for the application of topical anesthetics, ensuring that the area of application is clean and dry prior to use.

The dosage should be determined based on the individual patient's needs, the area to be treated, and the clinical context. It is essential to adhere to recommended guidelines for maximum dosage and to monitor the patient for any adverse reactions during and after administration.

Contraindications

Use of this product is contraindicated in the following situations:

Contact with the eyes and mucous membranes should be strictly avoided due to the potential for irritation or adverse reactions. Additionally, concurrent use with other topical analgesics is contraindicated to prevent possible interactions or compounded effects.

Warnings and Precautions

For external use only, this product is flammable and should be kept away from fire, sparks, and heated surfaces. Exposure to temperatures exceeding 130°F may result in bursting. It is essential to store the product at room temperature in a dry place to maintain its integrity.

The product should not be used in large quantities, particularly over raw surfaces or blistered areas. Additionally, it is advised not to use this product for more than one week without consulting a healthcare professional. Caution is warranted for individuals with a perforated eardrum or those who have ear tubes, as the product is contraindicated in these cases.

In the event of accidental ingestion, immediate medical assistance should be sought, or contact a Poison Control Center without delay.

Patients should discontinue use and contact their healthcare provider if a rash or irritation develops. Furthermore, if symptoms worsen or persist beyond seven days, or if symptoms resolve and then recur within a few days, medical advice should be sought promptly.

Side Effects

Patients should be aware of the following adverse reactions associated with the use of this product.

Serious adverse reactions include the potential for rash or irritation. Patients are advised to discontinue use and consult a healthcare professional if such reactions develop. Additionally, if symptoms worsen or persist for more than seven days, or if they resolve and then recur within a few days, medical advice should be sought.

Common warnings associated with this product indicate that it is for external use only and is flammable. Patients should keep the product away from fire, sparks, and heated surfaces. Exposure to temperatures exceeding 130°F may lead to bursting of the container. It is recommended to store the product at room temperature in a dry place.

Patients should not use this product in large quantities, particularly over raw surfaces or blistered areas, and it should not be used for more than one week without consulting a doctor. Furthermore, individuals with a hole in their eardrum or tubes in their ear should avoid using this product.

Drug Interactions

The concomitant use of this medication with other topical analgesics is contraindicated. Co-administration may increase the risk of adverse effects without providing additional therapeutic benefit. It is advised to avoid using multiple topical analgesics simultaneously to ensure patient safety and optimal therapeutic outcomes. Monitoring for any signs of increased local irritation or systemic effects is recommended if such combinations are inadvertently used.

Packaging & NDC

Below are the non-prescription pack sizes of Lipo Flavonoid Ear Pain Relief Drops with 4% Lidocaine. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Lipo Flavonoid Ear Pain Relief Drops with 4% Lidocaine.
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. The product has been demonstrated to be safe and effective for this age group. For children under 2 years of age, it is advised to consult a doctor prior to use.

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 adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

The safety of Lipo Flavonoid Ear Pain Relief Drops containing 4% Lidocaine during pregnancy has not been established. Due to potential risks to the fetus, use of this product is not recommended in pregnant women. It is advised that pregnant patients or those planning to become pregnant consult a healthcare provider prior to use to discuss any potential risks and benefits associated with the treatment.

Lactation

Lactating mothers are advised to consult a doctor prior to using this product. Currently, there is no specific information available regarding the potential for excretion of this product 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

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 substance involved, estimated dose, and time of exposure, is crucial for effective management and follow-up care.

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 use of the compound in these contexts.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions: rash or irritation. In cases where symptoms worsen or persist for more than 7 days, or if symptoms clear up and then recur within a few days, it is advised to discontinue use and consult a healthcare professional.

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 essential for patients to use the product only as directed and to read and follow all instructions and warnings provided on the label.

Patients should be informed to avoid contact with the eyes and mucous membranes, as this may lead to irritation. Additionally, healthcare providers should counsel patients against using this product in conjunction with other topical analgesics to prevent potential adverse effects.

For adults and children aged 2 years and older, the product should be applied to the affected area no more than 3 to 4 times daily. For children under 2 years of age, patients should be instructed to consult a doctor before use.

Healthcare providers should emphasize that the packaging is child-resistant, promoting safe storage practices. Patients must be advised to discontinue use and consult a doctor if a rash or irritation develops. Furthermore, they should be informed to stop using the product and seek medical advice if symptoms worsen or persist for more than 7 days, or if symptoms clear up and then recur within a few days.

Storage and Handling

The product is supplied in a configuration that includes a child-proof cap to ensure safety during storage. It is essential to store the product at room temperature in a dry place, away from fire, sparks, and heated surfaces. Care should be taken to avoid exposure to temperatures exceeding 130°F, as this may lead to bursting of the container. To maintain the integrity of the product, the child-proof cap should be kept tightly closed when not in use.

Additional Clinical Information

Patients should be advised that the medication is administered auricularly (otic) and is intended for use in adults and children aged 2 years and older, with a recommended application of 2 to 3 drops into the affected ear up to 3 to 4 times daily. For children under 2 years of age, consultation with a doctor is necessary prior to use. It is important to maintain the head position for one minute after application.

Clinicians should counsel patients against using the medication in large quantities, especially on raw surfaces or blistered areas, and to avoid use for more than one week without medical advice. Patients should be instructed to prevent contact with the eyes and mucous membranes and to refrain from using other topical analgesics concurrently. They should discontinue use and seek medical advice if a rash or irritation occurs, if symptoms worsen or persist beyond 7 days, or if symptoms resolve and then recur shortly thereafter. In the event of accidental ingestion, patients should seek immediate medical assistance or contact a Poison Control Center.

Drug Information (PDF)

This file contains official product information for Lipo Flavonoid Ear Pain Relief Drops with 4% Lidocaine, 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 Lipo Flavonoid Ear Pain Relief Drops with 4% Lidocaine, 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.

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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.