Symptom checker
Select audience type

Switch between content for healthcare professionals (PRO) and general audience (GEN).

ADD CONDITION

items per page

Lidocaine Pain Relief

Last content change checked dailysee data sync status

This product has been discontinued

Active ingredient
Lidocaine Hydrochloride 40 mg/1 g
Other brand names
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
March 12, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Lidocaine Hydrochloride 40 mg/1 g
Other brand names
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
March 12, 2024
Manufacturer
ASTONEA LABS PRIVATE LIMITED
Registration number
M017
NDC root
77338-009
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 cream is a topical medication that temporarily relieves minor pain. It is commonly used to help soothe discomfort from various conditions, such as minor skin irritations or injuries. By applying this cream to the affected area, you can experience a reduction in pain, making it easier to go about your daily activities.

Uses

You can use this medication to temporarily relieve minor pain. It’s designed to help you feel more comfortable when dealing with everyday aches and discomforts. 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 who may be concerned about such risks.

Dosage and Administration

If you are 12 years old or older, you should apply a thin layer of the medication to the affected area every 6 to 8 hours. However, make sure not to apply it more than three times in a 24-hour period. This helps ensure that you get the best results while minimizing the risk of side effects.

If you are caring for a child under 12 years old, it’s important to consult a doctor before using this medication. They can provide guidance on the appropriate treatment for younger children.

What to Avoid

It's important to use this medication safely to avoid potential issues. You should not apply it to large areas of your body, on cut, irritated, or swollen skin, or on puncture wounds. Additionally, avoid using it for more than one week without consulting your doctor. Be careful not to get the medication in your eyes, and do not tightly bandage the area or apply external heat, like a heating pad, to the treated area.

By following these guidelines, you can help ensure that you use the medication effectively and safely. If you have any questions or concerns, don't hesitate to reach out to your healthcare provider for more information.

Side Effects

When using this product, it's important to apply it only as directed and avoid using it on large areas of your body, on cut or irritated skin, or on puncture wounds. You should not use it for more than one week without consulting your doctor. Be careful to keep it away from your eyes, and do not apply tight bandages or use heat on the treated area.

If your condition worsens, if symptoms last longer than seven days, or if you notice any redness, rash, or irritation, stop using the product and consult your doctor.

Warnings and Precautions

This product is for external use only, so please avoid applying it to large areas of your body or on any cut, irritated, or swollen skin. It should not be used on puncture wounds, and you should not use it for more than one week without consulting your doctor.

If your condition worsens, if symptoms last longer than 7 days, or if they clear up and then return within a few days, stop using the product and contact your doctor. Additionally, if you experience any redness, rash, or irritation, it's important to seek medical advice.

In case of accidental swallowing, seek emergency medical help immediately or contact the Poison Control Center at 800-222-1222.

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. Remember, timely intervention can make a significant difference.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this medication. They can provide guidance on whether it’s safe for you and your baby. Always prioritize your health and the health of your child by seeking expert advice.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using 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 doctor regarding your breastfeeding journey.

Pediatric Use

If you have a child under 12 years old, it's important to consult with a doctor before using this medication. For children aged 12 and older, you can apply a thin layer of the medication to the affected area every 6 to 8 hours. However, be sure not to exceed three applications in a 24-hour period to ensure safety and effectiveness. Always follow these guidelines to help protect your child's health.

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 before starting the medication. 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 change 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 adjustments 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 may affect you if you have hepatic impairment (liver issues).

Before starting any new medication, including this one, you should discuss your liver health with your healthcare provider. They can help determine the best approach for your treatment and ensure your safety.

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 about how different medications might work together or affect any tests you may need. Your health and safety are the top priority, and discussing these details can help prevent any potential issues.

Storage and Handling

To ensure the best performance of your product, store it at a temperature between 20°C to 25°C (68°F to 77°F). It’s acceptable for the temperature to occasionally range from 15°C to 30°C (59°F to 86°F). Make sure to keep the product protected from light, as exposure can affect its quality. When not in use, always keep the tube tightly closed to maintain its integrity. Remember to discard the product after opening to ensure safety and effectiveness.

Additional Information

You should apply a thin layer of the medication to the affected area every 6 to 8 hours if you are an adult or a child aged 12 years and older. However, do not exceed three applications in a 24-hour period. If the patient is under 12 years old, it’s important to consult a doctor before use.

There are no additional details available regarding laboratory tests, abuse potential, or postmarketing experiences related to this medication.

FAQ

What is Lidocaine Cream used for?

Lidocaine Cream is used to temporarily relieve minor pain.

How should I apply Lidocaine Cream?

For adults and children 12 years and over, apply a thin layer to the affected area every 6 to 8 hours, not exceeding 3 applications in a 24-hour period.

Can children under 12 use Lidocaine Cream?

Children under 12 years should ask a doctor before using Lidocaine Cream.

What precautions should I take when using Lidocaine Cream?

Use only as directed, do not get it into your eyes, and avoid bandaging tightly or applying external heat to the area of use.

Are there any contraindications for using Lidocaine Cream?

The provided text does not specify any contraindications for Lidocaine Cream.

What should I do if my condition worsens while using Lidocaine Cream?

Stop use and ask a doctor if your condition worsens, symptoms persist for more than 7 days, or if redness, rash, or irritation occurs.

Is Lidocaine Cream safe to use during pregnancy or breastfeeding?

If you are pregnant or breastfeeding, ask a health professional before using Lidocaine Cream.

How should I store Lidocaine Cream?

Store Lidocaine Cream at 20°C to 25°C (68°F to 77°F) and protect it from light. Keep the tube tightly closed when not in use.

What should I do if I accidentally swallow Lidocaine Cream?

If swallowed, get medical help or contact Poison Control Center (800-222-1222) right away.

Packaging Info

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

Packaging configurations for Lidocaine Pain Relief.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Lidocaine Cream is a topical anesthetic formulated for local pain relief. The chemical name of Lidocaine is 2-(diethylamino)-N-(2,6-dimethylphenyl)acetamide, with a molecular formula of C14H22N2O and a molecular weight of 234.34 g/mol. The cream contains several inactive ingredients, including carbomer, glycerin, propylene glycol, purified water, sodium hydroxide, and triethanolamine. It is presented as a white to off-white cream, suitable for topical application.

Uses and Indications

This drug is indicated for the temporary relief of minor pain.

There are no teratogenic effects associated with this drug. Additionally, no nonteratogenic effects have been reported.

Dosage and Administration

For adults and children aged 12 years and older, a thin layer of the medication should be applied to the affected area every 6 to 8 hours. The total number of applications must not exceed 3 times within a 24-hour period.

For children under 12 years of age, it is advised to consult a physician before use.

Contraindications

Use is contraindicated in the following situations:

  • Application on large areas of the body or on cut, irritated, or swollen skin due to the potential for adverse effects.

  • Application on puncture wounds, as this may lead to complications.

  • Use for more than one week without consulting a healthcare professional, to avoid potential risks associated with prolonged use.

  • Contact with the eyes is contraindicated to prevent irritation or injury.

  • Tight bandaging or the application of external heat (such as heating pads) to the area of use is not recommended, as this may exacerbate adverse reactions.

Warnings and Precautions

For external use only. This product is contraindicated for application on large areas of the body, as well as on cut, irritated, or swollen skin. It should not be used on puncture wounds. Prolonged use beyond one week is not recommended without prior consultation with a healthcare professional.

Healthcare providers should advise patients to discontinue use and seek medical attention if the condition worsens, if symptoms persist for more than seven days, or if symptoms resolve and then recur within a few days. Additionally, patients should be instructed to stop use and consult a physician if any redness, rash, or irritation develops.

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

Side Effects

Patients using this product should be aware that it is intended for external use only. It is contraindicated for application on large areas of the body, on cut, irritated, or swollen skin, and on puncture wounds. Additionally, the product should not be used for more than one week without consulting a healthcare professional.

During the use of this product, patients are advised to follow the instructions carefully. It is important to avoid contact with the eyes and to refrain from tightly bandaging the area of application or applying external heat, such as a heating pad.

Patients should discontinue use and seek medical advice if any of the following occur: the condition worsens, symptoms persist for more than seven days, or if symptoms clear up and then recur within a few days. Furthermore, if redness, rash, or irritation develops, patients should stop using the product and consult a doctor.

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 Pain Relief (lidocaine hcl). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Lidocaine Pain Relief.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For adolescents aged 12 years and older, the recommended dosage is to apply a thin layer to the affected area every 6 to 8 hours, with a maximum of 3 applications within a 24-hour period.

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

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to 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 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 implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective treatment 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 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 the Poison Control Center at 800-222-1222 if the product is swallowed. It is important to instruct patients not to apply the product to large areas of the body or on cut, irritated, or swollen skin, and to avoid using it on puncture wounds.

Patients should be informed that the product should not be used for more than one week without consulting a doctor. They should be encouraged 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, patients should be advised to discontinue use and seek medical advice if they experience redness, rash, or irritation.

When using the product, patients must be instructed to follow the directions carefully. They should be cautioned against getting the product into their eyes and advised not to bandage the area tightly or apply external heat, such as a heating pad, to the site of application.

Storage and Handling

The product is supplied in a tube format, with specific storage and handling requirements to ensure its integrity and efficacy. It should be stored at a temperature range of 20°C to 25°C (68°F to 77°F), with permissible excursions between 15°C to 30°C (59°F to 86°F).

To maintain product quality, it is essential to protect the tube from light exposure. Additionally, the tube must be kept tightly closed when not in use to prevent contamination and degradation. It is important to discard the product after opening to ensure safety and effectiveness.

Additional Clinical Information

The medication is administered topically. For adults and children aged 12 years and older, a thin layer should be applied to the affected area every 6 to 8 hours, with a maximum of three applications within a 24-hour period. For children under 12 years of age, it is advised to consult a doctor before use.

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 Lidocaine Pain Relief, 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 Pain Relief, 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

Last AI update:

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.