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Lidocoll

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This product has been discontinued

Active ingredient
Lidocaine Hydrochloride 4.6 g/115 g
Other brand names
Dosage form
Spray
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2011
Label revision date
December 29, 2011
Active ingredient
Lidocaine Hydrochloride 4.6 g/115 g
Other brand names
Dosage form
Spray
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2011
Label revision date
December 29, 2011
Manufacturer
Innocoll Pharmaceuticals
Registration number
part348
NDC root
51715-001

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Drug Overview

This medication is designed to provide temporary relief from pain and itching caused by minor burns, sunburn, minor cuts, scrapes, insect bites, and other minor skin irritations. It works by soothing the affected area, helping you feel more comfortable while your skin heals.

If you're dealing with any of these minor skin issues, this product can be a helpful option to alleviate discomfort and promote healing. Always remember to follow the instructions for use to ensure the best results.

Uses

You can use this medication for the temporary relief of pain and itching caused by various minor skin issues. This includes discomfort from minor burns, sunburn, cuts, scrapes, insect bites, and other minor skin irritations. It’s designed to help soothe your skin and provide quick relief from these common problems.

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 use Lidocoll spray to help manage pain. You should apply the spray no more than 3 to 4 times a day. Additionally, if you need to remove a dressing, you can moisten it with the spray beforehand to help reduce any discomfort.

For children under 2 years of age, it’s important to consult a doctor before using this spray. Always follow your healthcare provider's advice to ensure safe and effective use.

What to Avoid

You can feel confident using this medication, as there are no specific contraindications (conditions that would prevent you from taking it) or concerns regarding abuse, misuse, or dependence (a condition where your body becomes reliant on a substance). Additionally, there are no particular instructions indicating that you should avoid taking or using this medication under any circumstances. Always remember to follow your healthcare provider's guidance for the best results.

Side Effects

It’s important to be aware of some warnings associated with this medication. You should avoid contact with your eyes, as this can lead to irritation. If your condition worsens, or if symptoms persist for more than 7 days, or if they clear up and then return within a few days, you should stop using the product and consult a doctor. Additionally, make sure to keep this medication out of reach of children to ensure their safety.

Warnings and Precautions

It's important to avoid getting this product in your eyes, as it can cause irritation. If your condition worsens, or if your symptoms last longer than 7 days, or if they improve and then come back within a few days, you should stop using the product and consult your doctor for further advice.

Make sure to keep this product out of reach of children to prevent accidental ingestion or misuse. Always prioritize safety and seek medical help if you have any concerns about your health while using this product.

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, 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 err on the side of caution when it comes to your health. Remember, timely intervention can make a significant difference.

Pregnancy Use

When considering the use of Lidocoll (lidocaine hcl spray) during pregnancy, it's important to note that there is no specific information available regarding its safety, dosage adjustments, or any special precautions for pregnant individuals. This means that the potential risks and benefits of using this medication while pregnant have not been clearly established.

If you are pregnant or planning to become pregnant, it is crucial to discuss any medications you are considering with your healthcare provider. They can help you understand the potential risks and make informed decisions about your treatment options. Always prioritize your health and the health of your baby when it comes to medication use during pregnancy.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding nursing mothers or lactation in the information provided. This means that, based on the available data, there are no known risks associated with breastfeeding while using this medication. However, it's always a good idea to consult with your healthcare provider if you have any concerns or questions about your specific situation.

Pediatric Use

When using Lidocoll spray for children, it's important to follow specific guidelines. For children aged 2 years and older, you can apply the spray no more than 3 to 4 times a day. If you're removing a dressing, moistening it with the spray can help reduce pain during the process.

However, if your child is under 2 years old, you should consult a doctor before using this product. Always prioritize your child's safety and comfort by following these recommendations.

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. Since older adults may have different health needs and may be taking multiple medications, it’s always a good idea to consult with a healthcare provider before starting any new medication. They can help ensure that the treatment is safe and appropriate for your individual health situation.

If you or a loved one is an older adult, be sure to discuss any concerns about potential side effects or interactions with other medications you may be taking. Your healthcare provider can provide guidance tailored to your specific needs.

Renal Impairment

If you have kidney 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 usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment plan.

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 should be used if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver health. They can help monitor your condition and make any necessary adjustments to your treatment plan.

Drug Interactions

It's great to know that there are no known interactions between this medication and other drugs or laboratory tests. However, it's still very important to discuss all medications you are taking, including over-the-counter drugs and supplements, with your healthcare provider. This ensures that your treatment is safe and effective.

Always keep your healthcare provider informed about any changes in your health or new medications you start. Open communication helps prevent any potential issues and supports your overall well-being.

Storage and Handling

To ensure the best performance of your product, store it at room temperature and keep it away from direct light. It's important to keep the container tightly closed when not in use to maintain its integrity. Once you open the container, please remember to discard it after use to ensure safety and effectiveness. Following these simple guidelines will help you use the product safely and effectively.

Additional Information

No further information is available.

FAQ

What is the drug used for?

The drug is used for the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, or minor skin irritations.

How often can I apply the drug?

Adults and children 2 years of age and older can apply the drug not more than 3 to 4 times per day.

What should I do if symptoms persist?

If the condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use and consult a doctor.

Is it safe to use the drug during pregnancy?

There is no specific information regarding the use of this drug during pregnancy in the provided text.

Can children under 2 years use this drug?

Children under 2 years of age should consult a doctor before use.

What precautions should I take while using the drug?

Avoid contact with eyes and keep the drug out of reach of children.

How should I store the drug?

Store the drug at room temperature, protect it from light, and keep the container tightly closed. Discard after opening.

Packaging Info

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

Packaging configurations for Lidocoll.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The drug associated with SPL code 34089-3 does not have specific details available regarding its chemical name, physical characteristics, or inactive ingredients. Further information may be required to provide a comprehensive description of the drug's properties and formulation.

Uses and Indications

This drug is indicated for the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, and minor 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, Lidocoll spray should be applied no more than 3 to 4 times per day. Additionally, to alleviate pain during dressing removal, the dressing may be moistened with the spray prior to removal.

In the case of children under 2 years of age, it is advised to consult a healthcare professional before use.

Contraindications

There are no contraindications associated with the use of this product. It is not classified as a controlled substance, and there are no identified risks of abuse, misuse, or dependence. Additionally, there are no specific instructions indicating that the product should not be taken or used in any particular situation.

Warnings and Precautions

Healthcare professionals should be aware of the following warnings and precautions associated with the use of this product.

It is imperative to avoid contact with the eyes. In the event of accidental contact, the affected area should be rinsed thoroughly with water.

Should the condition worsen, or if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days, it is advised to discontinue use and consult a healthcare provider for further evaluation and management.

Additionally, this product should be kept out of reach of children to prevent accidental ingestion or misuse. Proper storage and handling are essential to ensure safety.

Side Effects

Patients should be advised to avoid contact with the eyes while using this product. In the event that the condition worsens, or if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, it is recommended to discontinue use and consult a healthcare professional. Additionally, this product should be kept out of reach of children to prevent accidental ingestion or misuse.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified for this product. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

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

Packaging configurations for Lidocoll.
Details

Pediatric Use

Pediatric patients aged 2 years and older may use Lidocoll spray, with a recommended application frequency of no more than 3 to 4 times per day. For the management of pain during dressing removal, it is advised to moisten the dressing prior to removal.

For children under 2 years of age, consultation with a healthcare professional is necessary before 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

There is no specific information regarding the use of Lidocoll (lidocaine hcl spray) during pregnancy. The prescribing information does not provide safety concerns, dosage modifications, or special precautions for pregnant patients. Therefore, healthcare professionals should exercise caution when considering the use of this medication in women who are pregnant or may become pregnant. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes. Further studies may be necessary to establish the safety profile of Lidocoll in this population.

Lactation

There are no specific warnings or recommendations regarding the use of this medication in nursing mothers. Additionally, there are no specific warnings or recommendations related to lactation. Healthcare professionals should consider the absence of data when advising lactating mothers on the use of this medication.

Renal Impairment

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be warranted in these patients to ensure safety and efficacy.

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 when administering the medication. It is essential to monitor patients closely for any signs of adverse effects or symptoms that may arise from excessive dosing.

In the event of suspected overdosage, immediate medical attention should be sought. Healthcare providers should implement supportive measures as necessary, which may include symptomatic treatment and monitoring of vital signs.

Due to the lack of detailed overdosage information, it is recommended that healthcare professionals refer to established clinical guidelines and protocols for managing overdose situations relevant to the specific medication in question. Additionally, contacting a poison control center may provide further guidance on appropriate management strategies.

Continued vigilance and patient assessment are crucial in mitigating potential risks associated with overdosage.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion or misuse. It is important to emphasize the necessity of proper storage to ensure the safety of young children.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain its integrity. It should be stored at room temperature, away from direct light exposure to protect its quality. Once opened, the product should be discarded to ensure safety and efficacy.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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