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Lidocaine 4 Percent

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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)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2022
Label revision date
December 9, 2024
Drug Information (PDF)
Prescribing information, PDF file
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
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2022
Label revision date
December 9, 2024
Manufacturer
SA3, LLC
Registration number
M017
NDC root
69420-6262
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

Lidocaine HCl is a topical analgesic cream that contains 4% lidocaine, which is designed to temporarily relieve pain and itching. You can use it for various minor skin issues, including pain and discomfort from minor cuts, sunburn, scrapes, burns, insect bites, and other minor skin irritations.

This cream works by numbing the affected area, providing you with quick relief from discomfort. It's a convenient option for managing minor skin pain and irritation at home.

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 you feel more comfortable while your skin heals.

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 use.

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.

For children under 2 years of age, it’s important to consult with 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 responsibly. You should avoid using it in large quantities, especially on raw surfaces or blistered areas, as this can lead to complications. While there are no specific contraindications or concerns about abuse, misuse, or dependence associated with this medication, always follow the recommended guidelines to ensure your safety and well-being. If you have any questions or concerns, consult your healthcare provider for personalized advice.

Side Effects

When using this product, it's important to avoid contact with your eyes and not to apply it in large amounts, especially on raw or blistered skin. If you notice that your condition worsens, if symptoms last more than 7 days, or if they improve and then return shortly after, you should stop using the product and consult a doctor. Additionally, if you experience any signs of an allergic reaction—such as redness, irritation, swelling, or pain—or if these symptoms worsen, seek medical advice.

Keep this product out of reach of children. If it is swallowed, seek medical help or contact a Poison Control Center immediately.

Warnings and Precautions

This product is intended for external use only, so please avoid applying it to your eyes or using it in large amounts, especially on raw or blistered skin.

If you notice that your condition worsens, symptoms last longer than 7 days, or if they improve and then return within a few days, stop using the product and consult your doctor. Additionally, if you experience any signs of an allergic reaction, such as redness, irritation, swelling, or pain, stop use immediately and seek medical advice.

In case of accidental swallowing, it’s important to get emergency medical help or contact a Poison Control Center right away. Your safety is a priority, so please take these precautions seriously.

Overdose

If you or someone else has swallowed too much of a medication, it’s important to seek medical help immediately. You can do this by contacting a Poison Control Center or going to the nearest emergency room. Acting quickly can make a significant difference in the outcome.

Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, don’t hesitate to get help right away. Remember, it’s always better to be safe and seek assistance if you suspect an overdose has occurred.

Pregnancy Use

It is important to know that the safety of using this medication during pregnancy has not been established. Because of potential risks, it is not recommended for use in pregnant women. If you are pregnant or planning to become pregnant, you should consult your healthcare provider to discuss any possible risks to your fetus and to receive personalized advice.

If you need to use this medication while pregnant, your doctor may suggest dosage modifications. Always seek guidance from your healthcare provider to ensure the safest approach for you and your baby.

Lactation Use

If you are breastfeeding and considering the use of Lidocaine 4 Percent Cream, you can feel reassured that there are no specific warnings or recommendations regarding its use for nursing mothers. Additionally, there is no information available about whether this cream is passed into breast milk or if it poses any risk to your infant.

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

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 to 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

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 determine the best approach, considering any unique health needs or conditions.

Since there are no dosage adjustments or safety concerns specifically noted for elderly patients, your healthcare provider will guide you on the appropriate use of this medication based on individual health status. Always keep them informed about any other medications or health issues to ensure safe and effective treatment.

Renal Impairment

If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment is safe and effective for your specific condition. They can help determine the best approach for managing your health, especially if you have concerns about your kidneys.

Hepatic Impairment

If you have liver problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to your condition. This means that there are no tailored recommendations for how the medication may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific situation. They can help determine the best approach based on your liver function and overall health.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking. In this case, there are no specific drug interactions or laboratory test interactions noted, which means that the medication may not have known conflicts with other drugs or tests. However, every individual is different, and your healthcare provider can help ensure that your treatment is safe and effective based on your unique health situation.

Always discuss any changes in your medication or health status with your healthcare provider to avoid potential issues and to get the best care possible.

Storage and Handling

To ensure the best performance of your product, store it at a temperature between 20-25°C (68-77°F). It’s acceptable for the temperature to occasionally range from 15-30°C (59-86°F), but try to keep it within the recommended limits as much as possible. This temperature range is in line with the standards for controlled room temperature set by the United States Pharmacopeia (USP).

When handling the product, make sure to do so in a clean environment to maintain its integrity and safety. Always follow any specific instructions provided for use and disposal to ensure you are using the product correctly and safely.

Additional Information

You should apply this medication topically, meaning you will put it directly on the affected area of your skin. You can use it up to 3 to 4 times a day, depending on your needs. If you have any questions about how to use it or its effects, be sure to consult your healthcare provider for guidance.

FAQ

What is Lidocaine HCl?

Lidocaine HCl is a 4% topical analgesic cream used to temporarily relieve pain and itching.

What conditions does Lidocaine HCl relieve?

It relieves pain and itching due to minor cuts, sunburn, minor scrapes, minor burns, insect bites, and minor skin irritations.

How should I use Lidocaine HCl?

For adults and children 2 years and older, apply it externally to the affected area up to 3 to 4 times a day. For children under 2 years, consult a doctor.

Are there any warnings for using Lidocaine HCl?

Yes, it is for external use only. Avoid contact with the eyes and do not use in large quantities over raw surfaces or blistered areas.

What should I do if my condition worsens?

Stop using Lidocaine HCl and consult a doctor if your condition worsens, symptoms persist for more than 7 days, or if you experience an allergic reaction.

Is Lidocaine HCl safe to use during pregnancy?

Safety during pregnancy has not been established, and it is not recommended for use in pregnant women due to potential risks.

What should I do if Lidocaine HCl is swallowed?

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

How should I store Lidocaine HCl?

Store Lidocaine HCl at 20-25°C (68-77°F), with excursions permitted to 15-30°C (59-86°F).

Packaging Info

Below are the non-prescription pack sizes of Lidocaine 4 Percent (lidocaine). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Lidocaine 4 Percent.
Details

Drug Information (PDF)

This file contains official product information for Lidocaine 4 Percent, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

Lidocaine HCl 4% cream is a topical analgesic formulation designed for local pain relief. Each container holds 4.2 ounces (120 grams) of the cream, which is manufactured by SA3, LLC. The product is identified by the National Drug Code (NDC) 69420-6262-1.

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

For adults and children aged 2 years and older, the recommended dosage is to apply the medication externally to the affected area up to 3 to 4 times daily. The application should be performed with clean hands, ensuring that the affected area is properly prepared before use.

For children under 2 years of age, it is advised to consult a physician prior to administration to determine the appropriate course of action.

Contraindications

Use is contraindicated in patients who may apply the product in large quantities, especially over raw surfaces or blistered areas, due to the potential for adverse effects. No other specific contraindications have been identified.

Warnings and Precautions

This product is intended for external use only. Healthcare professionals should advise patients to avoid contact with the eyes during application. It is crucial to instruct patients not to use this product in large quantities, especially on raw surfaces or blistered areas, to prevent potential adverse effects.

Patients should be advised to discontinue use and consult a healthcare provider if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. Additionally, if any signs of an allergic reaction occur, or if there is an increase in redness, irritation, swelling, pain, or other concerning symptoms, patients should seek medical advice promptly.

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

Side Effects

Patients using this product should be aware that it is for external use only. It is important to avoid contact with the eyes and to refrain from using the product in large quantities, particularly over raw surfaces or blistered areas.

In clinical practice, patients are advised to stop use 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. Additionally, if any allergic reactions occur, or if there is an increase in redness, irritation, swelling, pain, or other symptoms, medical advice should be sought immediately.

This product should be kept out of reach of children. In the event of accidental ingestion, it is crucial to seek medical help or contact a Poison Control Center without delay.

Drug Interactions

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

Packaging & NDC

Below are the non-prescription pack sizes of Lidocaine 4 Percent (lidocaine). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Lidocaine 4 Percent.
Details

Pediatric Use

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

Safety during pregnancy has not been established for this medication. It is not recommended for use in pregnant women due to potential risks to the fetus. There may be risks associated with the use of lidocaine during pregnancy; therefore, healthcare providers should be consulted for advice regarding its use.

Healthcare professionals are advised to consider dosage modifications and appropriate use during pregnancy, and to discuss any concerns with their patients who are pregnant or planning to become pregnant.

Lactation

There are no specific warnings or recommendations regarding the use of Lidocaine 4 Percent Cream in lactating mothers. Additionally, there is no information available concerning the potential for excretion of Lidocaine in breast milk or any associated risks to breastfed infants.

Renal Impairment

Patients with renal impairment may not have specific information regarding dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment and individualized patient assessment. Regular monitoring of renal function may be advisable 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 event of an overdosage, immediate medical intervention is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical assistance or contact a Poison Control Center without delay.

Prompt action is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved; therefore, a thorough assessment by a medical professional is recommended to determine the appropriate course of action and management procedures.

Healthcare providers should ensure that patients are aware of the importance of timely reporting of any suspected overdosage to facilitate effective treatment and minimize risks.

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

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: allergic reactions, including anaphylaxis, as well as skin reactions such as rash, pruritus, and erythema.

Patient Counseling

Healthcare providers should advise patients to keep the product out of reach of children to prevent accidental ingestion. 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 discontinue use 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. Additionally, they should be made aware of the signs of an allergic reaction, including redness, irritation, swelling, or pain, and should seek medical attention if any of these symptoms occur or worsen.

While using the product, patients should be cautioned to avoid contact with the eyes. They should also be advised against using the product in large quantities, especially on raw surfaces or blistered areas, to minimize the risk of adverse effects.

Storage and Handling

The product is supplied in accordance with the National Drug Code (NDC) specifications. It should be stored at a temperature range of 20-25°C (68-77°F), with permissible excursions between 15-30°C (59-86°F), in compliance with USP Controlled Room Temperature guidelines. Proper storage conditions are essential to maintain the integrity and efficacy of the product.

Additional Clinical Information

The medication is administered topically, with application to the affected area recommended up to three to four times daily. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Lidocaine 4 Percent, 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 Lidocaine 4 Percent, 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.