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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
December 9, 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
December 9, 2025
Manufacturer
ALAINA HEALTHCARE PRIVATE LIMITED
Registration number
M017
NDC root
73492-272

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If you are a consumer or patient please visit this version.

Drug Overview

4% Lidocaine HCl Cream is a topical analgesic, which means it is a cream applied to the skin to help relieve pain and itching. This cream is designed to temporarily alleviate discomfort caused by various minor skin issues, including cuts, sunburn, scrapes, burns, insect bites, and other minor irritations.

When you apply this cream, it works by numbing the area, providing you with relief from pain and itching sensations. It's a convenient option for managing discomfort from everyday skin injuries and irritations.

Uses

You can use this medication to temporarily relieve pain and itching caused by various minor skin issues. It is effective for soothing discomfort from minor cuts, scrapes, burns, sunburn, insect bites, and other minor skin irritations.

This product is designed to help you feel more comfortable when dealing with these common skin problems, allowing you to go about your day with less discomfort.

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 each 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 for little ones.

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 intended for external use only. If you accidentally swallow it, seek medical help immediately or contact a Poison Control Center. It's important not to apply the product over large areas of your body.

You should stop using the product and consult 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 increase, please reach out to your healthcare provider.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's important to be aware of the general signs of an overdose, which can include symptoms like extreme drowsiness, confusion, or difficulty breathing. If you suspect that you or someone else may have taken too much of a medication, it’s crucial to seek immediate medical help.

In case of an overdose, you should contact your local emergency services or go to the nearest hospital right away. Always keep the medication packaging on hand, as it can provide important information to healthcare professionals. Remember, it's better to be safe and get checked out if you have any concerns about an overdose.

Pregnancy Use

When it comes to using Lidocaine HCl Cream during pregnancy, there is currently no specific information available about its safety, dosage adjustments, or any special precautions you should take. This means that if you are pregnant or planning to become pregnant, it’s important to consult with your healthcare provider before using this cream. They can help you weigh the potential risks and benefits based on your individual situation. Always prioritize open communication with your doctor regarding any medications you consider during this time.

Lactation Use

If you are breastfeeding, you can use Lidocaine HCl cream without specific warnings or recommendations against it. The information available does not indicate any particular concerns or precautions for nursing mothers regarding the use of this cream.

As always, if you have any questions or concerns about using medications while breastfeeding, it's a good idea to consult with your healthcare provider for personalized advice.

Pediatric Use

If your child is 2 years old or 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, it's important to consult a doctor before using this medication. Always ensure you follow these guidelines to keep your child safe and healthy.

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 wise to discuss any potential risks or benefits with your healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken.

Always keep in mind that older adults may have different responses to medications, so regular check-ins with your doctor can ensure safety and effectiveness.

Renal Impairment

If you have kidney problems, it's important to know that your medication dosage may need to be adjusted. This is because renal impairment can affect how your body processes certain drugs. Your healthcare provider will likely monitor your renal function tests regularly to ensure your kidneys are working properly.

If you have decreased creatinine clearance (a measure of kidney function), your doctor may recommend a reduced dose of your medication to avoid potential side effects. Always communicate openly with your healthcare team about your kidney health to ensure safe and effective treatment.

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 if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and how it may relate to your treatment. They can help ensure that you receive the safest and most effective care.

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 receive the best possible care tailored to your needs.

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 your product.

Additional Information

For adults and children aged 2 years and older, you should 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 4% Lidocaine HCl Cream used for?

4% Lidocaine HCl 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 apply 4% Lidocaine HCl Cream?

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

Are there any contraindications for using this cream?

There are no specified contraindications for 4% Lidocaine HCl Cream, but you should not apply it over large areas of the body or near the eyes.

What should I do if I experience an allergic reaction?

If an allergic reaction occurs, or if your condition worsens or does not improve within 7 days, stop using the cream and consult a doctor.

Is it safe to use 4% Lidocaine HCl Cream during pregnancy?

The insert does not provide specific information regarding the use of Lidocaine HCl Cream during pregnancy, including safety concerns or dosage modifications.

Can nursing mothers use this cream?

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

What should I do if I swallow the cream?

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

How should I store 4% Lidocaine HCl Cream?

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

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

No description information is available for the drug.

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 3 to 4 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 in the following situations:

Application over large areas of the body is not recommended due to the potential for systemic absorption and adverse effects. Use in or near the eyes is contraindicated to prevent irritation or injury. Additionally, the product should not be applied in large quantities, especially over raw surfaces or blistered areas, as this may increase the risk of local irritation or other complications.

Warnings and Precautions

For external use only. In the event of accidental ingestion, it is imperative to seek medical assistance or contact a Poison Control Center immediately.

The product should not be applied over large areas of the body to minimize the risk of adverse effects. Healthcare professionals should advise patients to discontinue use and consult a physician 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 emergence or exacerbation of redness, irritation, swelling, pain, or other concerning symptoms. Monitoring for these signs is essential to ensure patient safety and effective management of the condition.

Side Effects

For external use only. Patients should discontinue use and consult a healthcare professional if an allergic reaction occurs. Additionally, if the condition worsens or does not improve within 7 days, or if symptoms clear up and then return within a few days, medical advice should be sought. Patients are also advised to stop use and contact a doctor if they experience any increase in redness, irritation, swelling, pain, or other symptoms.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

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

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 Lidocaine HCl Cream during pregnancy has not been established, as the prescribing information does not provide specific data regarding its use in pregnant patients. There are no known safety concerns, dosage modifications, or special precautions outlined for this population. Healthcare professionals should weigh the potential benefits against any unknown risks when considering the use of this medication in women of childbearing potential. It is advisable to exercise caution and to discuss the potential implications with patients who are pregnant or planning to become pregnant.

Lactation

There are no specific warnings or recommendations regarding the use of 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 may require dosage adjustments to ensure safety and efficacy. It is essential to monitor renal function tests in individuals with kidney problems to assess their renal status. Additionally, a reduced dose should be considered for patients with decreased creatinine clearance to mitigate the risk of adverse effects associated with impaired renal function.

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

There is currently no specific information available regarding overdosage for this medication. Healthcare professionals are advised to monitor patients closely for any unusual symptoms or adverse effects that may arise. In the event of suspected overdosage, it is recommended to initiate supportive care and symptomatic treatment as necessary.

Healthcare providers should consider contacting a poison control center or a medical toxicologist for guidance on management strategies tailored to the specific situation. Continuous assessment of the patient's clinical status is essential to ensure appropriate interventions are implemented promptly.

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 compound in these areas.

Postmarketing Experience

No postmarketing experience details are provided in the insert.

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 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, or if symptoms resolve and then return within a few days. Additionally, they should be made aware that they need to stop using the product if they notice any redness, irritation, swelling, pain, or if other symptoms begin or increase.

When discussing the application of this product, healthcare providers should emphasize that it should not be used in or near the eyes. Patients should also 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 upon request. 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.