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Levigosp

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This product has been discontinued

Active ingredients
  • Lidocaine Hydrochloride 2.5 mg/1 mL
  • Benzalkonium Chloride 0.13 mg/1 mL
Other brand names
Dosage form
Spray
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2018
Label revision date
August 9, 2018
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Lidocaine Hydrochloride 2.5 mg/1 mL
  • Benzalkonium Chloride 0.13 mg/1 mL
Other brand names
Dosage form
Spray
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 2018
Label revision date
August 9, 2018
Manufacturer
Topicare Management, LLC
Registration number
part348
NDC root
70112-155
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

LevigoSP is a topical anesthetic spray that combines Lidocaine HCL (a medication that numbs the skin) at a concentration of 2.5% and Benzalkonium Chloride (a compound that helps prevent infection) at 0.13%. It is designed to temporarily relieve minor pain, making it useful for various minor skin irritations or discomforts.

When applied to the affected area, LevigoSP works by numbing the skin, which can help you feel more comfortable during activities that may cause pain or irritation.

Uses

You can use this medication to help clean and treat affected areas on your skin. For adults and children over 2 years old, simply clean the area and apply a small amount of the medication 1 to 3 times a day. If the area is bandaged, make sure to let it dry first before applying the medication.

If you have a child under 2 years old or if you are pregnant or breastfeeding, it's important to consult with a doctor before using this product.

Dosage and Administration

It seems that there are no specific dosage or administration instructions available for this medication. This means that you should consult your healthcare provider for personalized guidance on how to take or use this medication. They will provide you with the necessary information regarding the appropriate dosage, how to administer it, and how often you should do so. Always follow their recommendations to ensure safe and effective use.

What to Avoid

You should avoid using this product in or near your eyes, as it can cause irritation or harm. Additionally, do not apply it over large areas of your body or on raw surfaces and blistered areas, as this can lead to unwanted effects. Following these guidelines will help ensure your safety while using the product.

Side Effects

For your safety, this product is intended for external use only. If your condition worsens, or if symptoms last longer than 7 days or return after clearing up, you should stop using the product and consult a doctor.

It's also important to talk to your doctor before using this product if you have deep or puncture wounds, animal bites, or serious burns.

Warnings and Precautions

This product is for external use only, so please avoid ingesting it. Keep it out of reach of children to prevent accidental swallowing. If it is swallowed, seek medical help immediately or contact a Poison Control Center.

You should stop using this product and consult your doctor if your condition worsens, if symptoms last longer than 7 days, or if symptoms improve and then return within a few days. Your health and safety are important, so don’t hesitate to reach out for help if you have any concerns.

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 feel unwell after taking the medication, 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. Remember, your safety is the top priority.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult with your doctor before taking any medication. Your healthcare provider can help you understand the potential risks and benefits, ensuring the safety of both you and your baby. Always prioritize open communication with your doctor regarding your health during this time.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with your doctor before taking 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 healthcare provider regarding your breastfeeding status.

Pediatric Use

When using this medication for children over 2 years old, you should clean the affected area and apply a small amount of the product 1 to 3 times daily. If the area is bandaged, make sure to let it dry first. For children under 2 years old, it’s important to consult a doctor before use.

Always keep this medication out of reach of children. If a child accidentally swallows it, seek medical help or contact a Poison Control Center immediately. Your vigilance is key to ensuring their safety.

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 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 (issues with liver function).

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 determine the best course of action based on your individual situation.

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 avoid any potential issues and receive the best care possible.

Storage and Handling

To ensure the safety and effectiveness of your product, it's important to store it properly. Keep it in a cool, dry place and protect it from excessive heat, as high temperatures can damage the product.

When handling the product, always do so with care to maintain its integrity. If there are any specific components included, make sure to follow any additional instructions provided for their use or safety. Proper storage and handling will help you get the best results from your product.

Additional Information

You should apply this medication topically, which means you will put it directly on the skin. For adults and children over 2 years old, clean the affected area first, then apply a small amount of the medication 1 to 3 times a day. If the area is bandaged, allow it to dry before covering. If you are treating a child under 2 years old or if you are pregnant or breastfeeding, be sure to consult a doctor before use.

FAQ

What is LevigoSP?

LevigoSP is a topical anesthetic spray that contains Lidocaine HCL 2.5% and Benzalkonium Chloride 0.13%, indicated for the temporary relief of minor pain.

How should I use LevigoSP?

For adults and children over 2 years, clean the affected area and apply a small amount 1 to 3 times daily. If bandaged, let it dry first. For children under 2 years, consult a doctor.

Are there any warnings for using LevigoSP?

Yes, use LevigoSP only as directed, avoid using it in or near the eyes, and do not apply it over large areas of the body or on raw surfaces or blistered areas.

What should I do if my condition worsens while using LevigoSP?

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.

Can I use LevigoSP if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, you should ask a doctor before using LevigoSP.

What should I do if LevigoSP is swallowed?

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

Is LevigoSP safe for children?

LevigoSP can be used for children over 2 years, but you should consult a doctor for children under 2 years.

What are the key ingredients in LevigoSP?

LevigoSP contains Lidocaine HCL 2.5% and Benzalkonium Chloride 0.13%.

Packaging Info

Below are the non-prescription pack sizes of Levigosp (lidocaine/benzalkoium chloride spray). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Levigosp.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

LevigoSP is a topical anesthetic spray containing Lidocaine HCl at a concentration of 2.5% and Benzalkonium Chloride at 0.13%. It is indicated for the temporary relief of minor pain. The formulation is designed for local application, providing targeted anesthetic effects.

Uses and Indications

This drug is indicated for the topical treatment of affected areas in adults and children over 2 years of age. The recommended application involves cleaning the affected area and applying a small amount of the drug 1 to 3 times daily. If the area is bandaged, it is advised to allow the drug to dry before covering.

For children under 2 years of age, consultation with a healthcare professional is recommended prior to use. Additionally, pregnant or breastfeeding individuals should seek advice from a healthcare provider before using this drug.

No teratogenic or nonteratogenic effects have been reported.

Dosage and Administration

There are currently no specific dosage or administration instructions available for this medication. Additionally, no details regarding the route, method, or frequency of administration have been provided. Healthcare professionals are advised to refer to the prescribing information or clinical guidelines for further guidance on appropriate dosing and administration practices.

Contraindications

Use is contraindicated in the following situations:

Application near the eyes is prohibited due to the potential for irritation or injury. The product should not be applied over large areas of the body, as this may increase the risk of systemic absorption and adverse effects. Additionally, application over raw surfaces or blistered areas is contraindicated to prevent further irritation and complications.

Warnings and Precautions

For external use only. It is imperative to keep this product out of reach of children to prevent accidental ingestion. In the event of swallowing, immediate medical assistance should be sought, or contact a Poison Control Center without delay.

Healthcare professionals should advise patients to discontinue use and consult a physician if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. These actions are crucial to ensure patient safety and effective management of their condition.

In cases of accidental ingestion, it is essential to seek emergency medical help or contact a Poison Control Center immediately to mitigate potential health risks.

Side Effects

For external use only. Patients are advised to stop use and consult a doctor if the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then occur again within a few days. Additionally, it is recommended that patients ask a doctor before use if they have deep or puncture wounds, animal bites, or serious burns.

Drug Interactions

There are currently no specific drug interactions identified for the medication. Additionally, no interactions with laboratory tests have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary at this time. It is advisable for healthcare professionals to remain vigilant and consult updated resources as new data may emerge.

Packaging & NDC

Below are the non-prescription pack sizes of Levigosp (lidocaine/benzalkoium chloride spray). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Levigosp.
Details

Pediatric Use

Pediatric patients over 2 years of age may apply a small amount of the medication to the affected area 1 to 3 times daily after cleaning the area. If the area is bandaged, it should be allowed to dry before application. For children under 2 years of age, it is advised to consult a physician prior to use.

It is important to keep the medication out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

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 or those who are breastfeeding should consult a healthcare professional before using this medication. The potential risks and benefits must be carefully evaluated in these populations to ensure the safety of both the mother and the fetus or infant.

Lactation

Lactating mothers are advised to consult a healthcare professional regarding the use of this medication while breastfeeding. There is no specific data available on the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, careful consideration and professional guidance are recommended to ensure the safety of both the mother and the nursing infant.

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 advisable in 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 excessive dosing. Symptoms of overdosage 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 monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

If available, consultation with a poison control center or a medical toxicologist is recommended to guide further management and intervention strategies.

Documentation of the incident, including the amount ingested and the time of exposure, is crucial for effective treatment 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

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the product out of reach of children. In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately.

Patients should be instructed to discontinue use and consult a doctor if their condition worsens, if symptoms persist for more than seven days, or if symptoms resolve and then recur within a few days.

When using this product, it is essential for patients to use it only as directed. They should be cautioned against using the product in or near the eyes, applying it over large areas of the body, or using it on raw surfaces or blistered areas.

Additionally, healthcare providers should recommend that patients consult a doctor prior to use if they have deep or puncture wounds, animal bites, or serious burns.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product in a manner that protects it from excessive heat to maintain its integrity and efficacy. Proper storage conditions should be observed to ensure optimal performance.

Additional Clinical Information

The medication is administered topically. For adults and children over 2 years of age, the affected area should be cleaned before applying a small amount of the product 1 to 3 times daily. If the area is bandaged, it should be allowed to dry first. For children under 2 years, consultation with a doctor is advised, as well as for pregnant or breastfeeding patients.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

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