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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)
Marketed in the U.S.
Since 2018
Label revision date
February 14, 2018
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
Marketed in the U.S.
Since 2018
Label revision date
February 14, 2018
Manufacturer
Topicare Management, LLC
Registration number
part348
NDC root
70112-155

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Drug Overview

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

By applying LevigoSP to the affected area, you can experience relief from pain while also benefiting from its antiseptic properties, which help to clean the skin. This combination makes it a practical option for managing minor injuries or irritations.

Uses

If you have a skin issue, this product can help you clean and treat the affected area. For adults and children over 2 years old, you should clean the area first and then apply a small amount of the product 1 to 3 times a day. If the area is bandaged, make sure to let it dry before applying the product.

If your child is under 2 years old, it's important to consult a doctor before using this product. Additionally, if you are pregnant or breastfeeding, you should also ask a doctor for advice before using it to ensure it's safe for you and your baby.

Dosage and Administration

It seems that there is no specific dosage or administration information available for the medication you are inquiring about. This means that details such as how much to take, how often to take it, or how to apply it are not provided.

If you have any questions about how to use this medication or need guidance on its administration, it's best to consult with your healthcare provider or pharmacist. They can give you the most accurate and personalized information based on your health needs.

What to Avoid

It's important to use this medication safely to avoid any potential issues. You should never apply it in or near your eyes, as this can cause irritation or damage. Additionally, avoid using it over large areas of your body or on raw surfaces and blistered areas, as this can lead to unwanted side effects.

By following these guidelines, you can help ensure that you use the medication effectively and safely. If you have any questions or concerns about its use, please consult your healthcare provider for more information.

Side Effects

For your safety, this product is intended for external use only. 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.

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 call your doctor if your condition worsens, if your symptoms last more than 7 days, or if your 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 need it.

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 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, it's important to follow specific guidelines. For children over 2 years old, you can clean the affected 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. However, if your child is under 2 years old, you should consult a doctor before using it.

Always keep this medication out of reach of children. If it is swallowed, seek medical help or contact a Poison Control Center immediately. Your child's safety is the top priority, so following these instructions carefully is essential.

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. If you or a loved one is an older adult, it’s always a good idea to discuss any medications with a healthcare provider. They can help ensure that the treatment is safe and appropriate, considering any unique health needs or conditions that may be present.

Since there are no dosage adjustments or special precautions mentioned for elderly patients, your healthcare provider will be the best resource for personalized advice. Always keep them informed about any other medications being taken or health changes that occur.

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 and what steps to take for your safety.

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 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 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 provide the best care tailored to your needs.

Always feel free to ask questions and share all the medications and supplements you are using. This helps your provider monitor your health effectively and make informed decisions about your treatment.

Storage and Handling

To ensure the safety and effectiveness of your product, it's important to store it in a cool, dry place, away from excessive heat. This will help maintain its quality and performance. When handling the product, be sure to follow any specific instructions provided to avoid any potential issues.

If you have any components that come with the product, make sure to keep them in their designated storage conditions as well. Proper disposal of any used materials should also be done according to local regulations to ensure safety and environmental protection.

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 pregnant, breastfeeding, or if the patient is under 2 years old, consult a doctor before use.

FAQ

What is LevigoSP?

LevigoSP is a topical anesthetic and antiseptic 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 precautions for pregnant or breastfeeding women?

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

What should I do if I experience worsening symptoms?

Stop using LevigoSP and consult a doctor if your condition worsens or if symptoms persist for more than 7 days.

Can I use LevigoSP near my eyes?

No, do not use LevigoSP in or near the eyes.

What should I do if LevigoSP is swallowed?

If swallowed, seek medical help or contact a Poison Control Center immediately.

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 storage instructions for LevigoSP?

Protect LevigoSP from excessive heat and keep it out of reach of children.

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 and antiseptic 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 application to the skin, providing localized anesthetic effects while also serving as an antiseptic agent.

Uses and Indications

This drug is indicated for the topical treatment of affected areas in adults and children over 2 years of age. It is recommended to clean the affected area and apply a small amount of the drug 1 to 3 times daily. If the area is bandaged, it should be allowed to dry before application.

For children under 2 years of age, consultation with a healthcare professional is advised prior to use. Additionally, pregnant or breastfeeding individuals should seek medical advice before using this drug due to potential teratogenic effects. No nonteratogenic effects have been mentioned.

Dosage and Administration

No dosage or administration information is available for this product. Healthcare professionals are advised to consult the prescribing information or relevant clinical guidelines for specific dosing recommendations and administration techniques.

Contraindications

Use is contraindicated in the following situations:

  • Application in or near the eyes is prohibited due to the potential for irritation or damage to ocular tissues.

  • Application over large areas of the body is not recommended, as it may lead to systemic absorption and increased risk of adverse effects.

  • Application over raw surfaces or blistered areas is contraindicated to prevent exacerbation of irritation and to ensure proper healing of the affected skin.

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 promptly or to contact a Poison Control Center for guidance.

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 no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no recommendations for dosage adjustments or monitoring are necessary at this time.

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 aged 2 years and older may use the product by cleaning the affected area and applying a small amount 1 to 3 times daily. 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 product 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 adverse effects or changes in therapeutic response, 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 considered, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to discuss their pregnancy status and any plans for pregnancy with their healthcare provider to ensure appropriate management and care.

Lactation

Lactating mothers are advised to consult a healthcare professional regarding the use of this medication while breastfeeding. There is limited information available on the excretion of this drug in human breast milk and 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

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.

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 initiate supportive care, 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 treatment options.

Documentation of the incident, including the substance involved, the amount taken, and the time of ingestion, 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 question.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this 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 informed to stop using the product 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.

When using this product, patients must be reminded 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 encourage patients to ask a doctor before using the product 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 medication 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

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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.