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Lidoguard

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Active ingredient
Lidocaine Hydrochloride 4 g/100 g
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2025
Label revision date
June 4, 2025
Active ingredient
Lidocaine Hydrochloride 4 g/100 g
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2025
Label revision date
June 4, 2025
Manufacturer
ViolaCare, Inc.
Registration number
M017
NDC root
85231-200

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

LidoGuard Cream is a topical analgesic, which means it is a pain-relieving cream that you apply directly to your skin. This cream is designed to temporarily relieve pain and itching caused by various minor skin issues, including cuts, sunburn, scrapes, burns, insect bites, and other minor skin irritations.

By using LidoGuard Cream, you can find relief from discomfort associated with these everyday skin problems, helping you feel more comfortable in your daily activities.

Uses

You can use this medication to temporarily relieve pain and itching caused by various minor skin issues. This includes discomfort from minor cuts, scrapes, burns, sunburn, insect bites, and other minor skin irritations. It’s designed to help soothe your skin and make you feel more comfortable.

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 or your child is 2 years old or older, you can apply the medication directly to the affected area of the skin. You should do this up to 3 to 4 times a day, depending on your needs. Make sure to follow the instructions carefully to ensure the best results.

If your child is under 2 years old, it's important to consult a doctor before using this medication. They can provide guidance on the appropriate treatment for younger children. Always prioritize safety and follow professional advice when it comes to medication.

What to Avoid

It's important to use this medication safely to avoid potential issues. You should not apply it over large areas of your body or use it near your eyes. Additionally, avoid using large quantities, especially on raw surfaces or blistered areas, as this can lead to complications.

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

This product is intended for external use only. You should stop using it and consult a doctor if you experience an allergic reaction, if your condition worsens or does not improve within 7 days, or if your symptoms clear up and then return within a few days. Additionally, if you notice any redness, irritation, swelling, pain, or other symptoms that begin or increase, it's important to seek medical advice.

Warnings and Precautions

This product is for external use only, so please avoid swallowing it. If you accidentally ingest it, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

You should stop using this product and call your doctor if you experience any allergic reactions, if your condition worsens or does not improve within 7 days, or if your symptoms clear up and then return within a few days. Additionally, if you notice any redness, irritation, swelling, pain, or other symptoms that begin or worsen, it’s important to reach out to your healthcare provider.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. This means that there are no defined signs, symptoms, or recommended actions if an overdose occurs.

If you ever suspect that you or someone else may have taken too much of a medication, it’s important to seek help immediately. You can contact your healthcare provider or call your local poison control center for guidance. Always err on the side of caution when it comes to medication safety.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of Lidocaine HCl during pregnancy has not been established. This medication is generally not recommended for use while pregnant due to potential risks to your developing baby. If you are considering using Lidocaine HCl, you should consult your healthcare provider to discuss any possible risks and to determine if it is necessary for your situation.

Additionally, if your healthcare provider does recommend its use, be aware that dosage adjustments may be needed. Always prioritize open communication with your healthcare provider to ensure the best care for you and your baby.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of LidoGuard (lidocaine hcl cream) while nursing. The information available does not indicate any particular considerations or precautions you need to take when using this cream during lactation.

As always, if you have any concerns about medications and their effects on breastfeeding, it's a good idea to consult with your healthcare provider for personalized advice.

Pediatric Use

When using this medication for children, it's important to follow specific guidelines. For children aged 2 years and older, you can apply the medication externally to the affected area up to 3-4 times a day. However, if your child is under 2 years old, you should consult a doctor before using it. This ensures that the treatment is safe and appropriate for their age. Always prioritize your child's health by seeking professional advice when needed.

Geriatric Use

When considering the use of LidoGuard (lidocaine hcl cream) for older adults, it's important to note that the drug insert does not provide specific information about dosage adjustments, safety concerns, or special precautions for elderly patients. This means that while the cream may be used, there are no established guidelines tailored for older adults.

If you are caring for an older adult who may need this treatment, it’s advisable to consult with a healthcare professional. They can help determine the best approach and ensure that any potential risks are managed appropriately. Always prioritize safety and open communication with healthcare providers when it comes to medication use in older individuals.

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 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 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 best performance of your product, store it in a cool, dry place at a temperature between 20° to 25° C (68° to 77° F). It’s acceptable for the temperature to occasionally range from 15° to 30° C (59° to 86° F), but try to keep it within the recommended limits for optimal safety and effectiveness.

When handling the product, make sure to maintain a clean environment to avoid contamination. Always follow any specific instructions provided for use and disposal to ensure safety. Proper storage and handling are key to maintaining the quality and effectiveness of the product.

Additional Information

For adults and children aged 2 years and older, you can apply the medication externally to the affected area up to 3-4 times a day. If the patient is under 2 years old, it's important to consult a doctor before use. There are no additional details available regarding laboratory tests, abuse potential, or patient counseling.

FAQ

What is LidoGuard Cream used for?

LidoGuard Cream is a topical analgesic that temporarily relieves pain and itching due to minor cuts, sunburn, minor scrapes, minor burns, insect bites, and minor skin irritations.

How should I use LidoGuard Cream?

For adults and children 2 years and older, apply the cream externally to the affected area up to 3-4 times daily. Consult a doctor for children under 2 years.

Are there any contraindications for using LidoGuard Cream?

LidoGuard Cream is contraindicated in pregnancy due to potential risks to the fetus. There are no other specific contraindications mentioned.

What should I do if I experience an allergic reaction?

If an allergic reaction occurs, stop using the cream and consult a doctor immediately.

What precautions should I take when using LidoGuard Cream?

Do not apply the cream over large areas of the body, in or near the eyes, or in large quantities over raw surfaces or blistered areas. It is for external use only.

What should I do if my condition worsens or does not improve?

If your condition worsens or does not improve within 7 days, or if symptoms return after clearing up, stop using the cream and consult a doctor.

What are the storage conditions for LidoGuard Cream?

Store LidoGuard Cream at 20° to 25° C (68° to 77° F), with excursions permitted between 15° to 30° C (59° to 86° F).

Is LidoGuard Cream safe to use during pregnancy?

The safety of LidoGuard Cream during pregnancy has not been established, and it should only be used if clearly needed and after consulting a healthcare provider.

Can I use LidoGuard Cream while breastfeeding?

There are no specific warnings or recommendations regarding the use of LidoGuard Cream in nursing mothers mentioned in the insert.

Packaging Info

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

Packaging configurations for Lidoguard.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

LidoGuard™ Cream is a topical analgesic formulated for pain relief. Each container contains 1.05 oz (30 g) of the cream. It is manufactured for ViolaCare, Inc., located in Parsippany, New Jersey, 07054. The product is identified by the National Drug Code (NDC) 85231-200-30.

Uses and Indications

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

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Adults and children aged 2 years and older are instructed to apply the medication externally to the affected area up to three to four times daily. For children under 2 years of age, it is recommended to consult a healthcare professional prior to use.

Contraindications

The product is contraindicated for application over large areas of the body due to the potential for systemic absorption and adverse effects. It should not be used in or near the eyes to prevent irritation or injury. Additionally, the use of large quantities, particularly over raw surfaces or blistered areas, is contraindicated to avoid exacerbating skin irritation or compromising the integrity of the skin barrier.

Warnings and Precautions

For external use only. It is imperative that healthcare professionals advise patients to adhere strictly to this guideline to prevent unintended ingestion or exposure.

In the event of accidental ingestion, immediate medical assistance should be sought. Patients should be instructed to contact a Poison Control Center at 1-800-222-1222 without delay.

Healthcare providers should counsel patients to discontinue use and seek medical attention under the following circumstances: if an allergic reaction occurs; if the condition being treated worsens or fails to improve within 7 days; if symptoms initially resolve but then recur within a few days; or if there is an increase in redness, irritation, swelling, pain, or any other concerning symptoms. Monitoring for these signs is essential to ensure patient safety and effective management of their condition.

Side Effects

For external use only. Patients should discontinue use and consult a healthcare professional if any of the following occur: an allergic reaction, worsening of the condition, lack of improvement within 7 days, recurrence of symptoms after initial resolution, or the onset or increase of redness, irritation, swelling, pain, or other symptoms.

Drug Interactions

There are no specific drug interactions identified in the available data. Additionally, no laboratory test interactions have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

Packaging & NDC

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

Packaging configurations for Lidoguard.
Details

Pediatric Use

Pediatric patients aged 2 years and older may apply the medication externally to the affected area up to 3-4 times daily. For children under 2 years of age, it is advised to consult a doctor prior to use.

Geriatric Use

There is no specific information regarding the use of LidoGuard (lidocaine hcl cream) in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as the absence of data necessitates careful consideration of individual patient factors and potential risks. Monitoring for efficacy and adverse effects is recommended in this population, given the lack of established guidelines for geriatric use.

Pregnancy

The safety of Lidocaine HCl during pregnancy has not been established. Due to potential risks to the fetus, Lidocaine HCl is contraindicated in pregnancy. There may be risks associated with the use of lidocaine during this period; therefore, it is essential for pregnant patients to consult a healthcare provider for advice.

Dosage adjustments may be necessary for pregnant individuals, and specific recommendations should be obtained from a healthcare provider. Pregnant women should use this product only if clearly needed and after thorough discussion with their healthcare provider regarding the potential risks and benefits.

Lactation

There are no specific warnings or recommendations regarding the use of LidoGuard (lidocaine hcl cream) in lactating mothers. Additionally, the insert does not provide any specific considerations or precautions related to lactation or breastfeeding. Therefore, healthcare professionals may consider the use of this medication in nursing mothers without specific concerns related to its effects on breastfed infants.

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 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, it is important for healthcare professionals to remain vigilant and consider the potential implications of excessive dosing of the medication.

Healthcare providers should be aware that the lack of documented overdosage data does not preclude the possibility of adverse effects resulting from excessive intake. In the event of suspected overdosage, it is recommended that healthcare professionals assess the patient for any unusual symptoms or reactions that may arise.

Management of overdosage should include supportive care and symptomatic treatment as necessary. Monitoring of vital signs and laboratory parameters may be warranted to ensure patient safety. If available, consultation with a poison control center or a medical toxicologist is advised for guidance on specific management strategies.

In summary, while no specific overdosage information is provided, healthcare professionals should exercise caution and implement appropriate management protocols in the event of suspected 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 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 seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 if the product is swallowed. It is important to instruct patients not to apply the product over large areas of the body to avoid potential adverse effects.

Patients should be informed to discontinue use and consult a doctor if they experience any allergic reactions, if their condition worsens or does not improve within 7 days, if symptoms resolve and then return within a few days, or if they notice any increase in redness, irritation, swelling, pain, or other symptoms.

When using this product, healthcare providers should emphasize that it should not be applied in or near the eyes. Additionally, patients should be cautioned against using large quantities of the product, especially on raw surfaces or blistered areas, to minimize the risk of complications.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at a temperature range of 20° to 25° C (68° to 77° F). Temporary excursions are permissible between 15° to 30° C (59° to 86° F). Proper storage conditions are essential to maintain the integrity and efficacy of the product.

Additional Clinical Information

Patients aged 2 years and older are advised to apply the medication externally to the affected area up to 3-4 times daily. For children under 2 years, it is recommended to consult a doctor prior to use. There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

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