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Lidocaine Hcl 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 2024
Label revision date
April 30, 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 2024
Label revision date
April 30, 2024
Manufacturer
ARI BRANDS, LLC
Registration number
M017
NDC root
71436-0026
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, designed to provide temporary relief from pain and itching. You can use it for various minor skin issues, including cuts, sunburn, scrapes, burns, insect bites, and other minor skin irritations.

This cream works by numbing the affected area, helping to alleviate discomfort and promote a sense of relief. 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.

If your child is under 2 years old, 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 guidance provided by your healthcare professional to ensure safe and effective use.

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 seven days, or if they improve and then return shortly after, you should stop using the product and consult a doctor.

Additionally, watch for signs of an allergic reaction, such as increased redness, irritation, swelling, or pain. If any of these symptoms occur or worsen, seek medical advice. Keep this product out of reach of children, and if it is swallowed, contact a medical professional or Poison Control Center immediately.

Warnings and Precautions

This product is for external use only, so please avoid applying it to your eyes or using it in large amounts, especially on raw or blistered skin. It's important to keep this product out of reach of children. If a child accidentally swallows it, seek medical help or contact a Poison Control Center immediately.

If you notice that your condition worsens, or if symptoms last more than 7 days, or if they improve and then come back within a few days, stop using the product and consult your doctor. Additionally, if you experience any signs of an allergic reaction, such as increased redness, irritation, swelling, or pain, stop using it and reach out to your healthcare provider.

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.

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, acting quickly can make a significant difference in the outcome.

Pregnancy Use

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

Additionally, if you do use this medication while pregnant, your healthcare provider may need to adjust the dosage. Always prioritize open communication with your healthcare team to ensure the best care for you and your baby.

Lactation Use

If you are breastfeeding and considering the use of Lidocaine HCl 4% 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 this product while breastfeeding.

Pediatric Use

If your child is 2 years old or 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, it’s important to consult a doctor before using this medication. Always follow these guidelines to ensure your child's safety and well-being.

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 for personalized advice. 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 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 be adjusted based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary changes to your medications.

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 monitor your health effectively and make informed decisions about your care.

Always feel free to ask questions and share all the medications and supplements you are using. This helps to avoid any potential issues and ensures that you receive the best possible treatment tailored to your needs.

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 as close to the recommended range as possible. This helps maintain the product's effectiveness and safety.

When handling the product, make sure to do so in a clean environment to avoid contamination. Always follow any specific instructions provided for use to ensure safety and effectiveness. If you have any questions about disposal or further handling, please refer to the guidelines provided with your product.

Additional Information

You should apply this medication externally to the affected area up to 3 to 4 times a day if you are an adult or a child aged 2 years and older. If the patient is under 2 years old, consult a doctor for guidance.

It's important to avoid contact with your eyes and not to use the medication in large amounts, especially on raw or blistered skin. If your condition worsens, symptoms persist for more than 7 days, or if they clear up and return within a few days, stop using the medication and consult a doctor. Additionally, seek medical help immediately if you experience an allergic reaction or if redness, irritation, swelling, or pain increases. Keep this medication out of reach of children, and if swallowed, contact a Poison Control Center or seek medical assistance right away.

FAQ

What is Lidocaine HCl?

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

What conditions can Lidocaine HCl help relieve?

It can relieve 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 while using Lidocaine HCl?

Stop use and ask a doctor if your condition worsens, if 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 without consulting a healthcare provider.

What should I do if Lidocaine HCl is swallowed?

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

How should I store Lidocaine HCl?

Store it 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 Hcl 4 Percent (lidocaine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Lidocaine Hcl 4 Percent.
Details

Drug Information (PDF)

This file contains official product information for Lidocaine Hcl 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 provided in a 4.2 oz (120 g) container. The product is manufactured by AriBrands, LLC and is identified by the National Drug Code (NDC) 71436-0026-1. This cream is designed for local anesthetic use, delivering a 4% concentration of lidocaine hydrochloride.

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 prior to administration.

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

Contraindications

Use is contraindicated in patients who may apply the product in large quantities, particularly over raw surfaces or blistered areas, due to the potential for adverse effects in these conditions. 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 refrain from using this product in large quantities, especially on raw surfaces or blistered areas, to prevent potential adverse effects.

Patients should be instructed to discontinue use and seek medical advice 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, medical consultation is recommended.

To ensure safety, this product should be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center should be made without delay.

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 using the product and consult a healthcare professional 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 promptly.

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 immediately.

Drug Interactions

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

Packaging & NDC

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

Packaging configurations for Lidocaine Hcl 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 potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

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

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

Lactation

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

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment. 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 prescribing information.

Overdosage

In the event of an overdosage, immediate medical assistance is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical help or contact a Poison Control Center without delay.

Prompt intervention 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.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are advised to ensure patient safety and effective resolution of any complications arising from the 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 compound in these areas.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

Healthcare providers should advise patients to keep this 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 cautioned to stop use and seek medical advice if they experience any allergic reactions or if symptoms such as redness, irritation, swelling, or pain begin or worsen.

It is important to remind patients to avoid contact with the eyes while using this product. Furthermore, they should be advised against using large quantities, especially on raw surfaces or blistered areas, to prevent potential 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

Patients aged 2 years and older are advised to apply the medication externally to the affected area up to 3 to 4 times a day. For children under 2 years, consultation with a doctor is recommended prior to use.

Clinicians should counsel patients to avoid contact with the eyes and to refrain from using the product in large quantities, especially over raw surfaces or blistered areas. Patients should discontinue use and seek medical advice if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. Additionally, patients should be informed to stop use and consult a doctor if any allergic reactions or symptoms such as redness, irritation, swelling, or pain occur or worsen. It is crucial to keep the product out of reach of children, and in the event of ingestion, medical assistance or contact with a Poison Control Center should be sought immediately.

Drug Information (PDF)

This file contains official product information for Lidocaine Hcl 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 Hcl 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.

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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.