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Lidocaine Pain Relief Roll-on

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Active ingredient
Lidocaine Hydrochloride 4 g/100 mL
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
Dosage form
Liquid
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2019
Label revision date
December 18, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Lidocaine Hydrochloride 4 g/100 mL
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
Dosage form
Liquid
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 2019
Label revision date
December 18, 2024
Manufacturer
CVS Pharmacy
Registration number
M017
NDC root
69842-029
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 is a medication commonly used for the temporary relief of pain and itching. It works by numbing the area where it is applied, helping to alleviate discomfort. This makes it useful for various conditions that cause localized pain or irritation. If you're experiencing such symptoms, lidocaine may provide you with the relief you need.

Uses

You can use this medication for the temporary relief of pain and itching. It is designed to help alleviate discomfort, making it easier for you to manage your symptoms.

Additionally, there are no concerns regarding teratogenic effects (which means it does not cause birth defects) or nonteratogenic effects associated with this medication. This makes it a safer option for those who may be worried about potential risks.

Dosage and Administration

If you are an adult or a child aged 2 years and older, you can apply the medication to the affected area up to 3 to 4 times a day. Make sure to follow this guideline to ensure the best results.

For children under 2 years of age, it’s important to consult a doctor before using this medication. They can provide the best advice tailored to your child's needs. Always remember to use the medication as directed for safety and effectiveness.

What to Avoid

It's important to keep this medication out of reach of children to prevent accidental ingestion. If you or someone else swallows it, seek medical help or contact a Poison Control Center right away.

There are no specific contraindications, controlled substance classifications, or concerns about abuse, misuse, or dependence associated with this medication. However, always use it responsibly and follow any additional guidance from your healthcare provider.

Side Effects

When using this product, it's important to follow the directions carefully to avoid potential issues. This product is for external use only, so make sure not to apply it to wounds or damaged skin. Avoid using it in large amounts, especially on raw or blistered areas, and do not bandage tightly or use it with a heating pad. Additionally, keep it away from your eyes to prevent irritation.

By adhering to these guidelines, you can help ensure a safer experience with the product.

Warnings and Precautions

This product is for external use only, so be sure to follow the directions carefully. Avoid using it on wounds or damaged skin, and do not apply it in large amounts, especially on raw or blistered areas. It's important to keep the product away from your eyes and to avoid tightly bandaging the area after application or using it with a heating pad.

Make sure to keep this product out of reach of children. If a child accidentally swallows it, seek medical help or contact a Poison Control Center right away. If you experience any unusual reactions or have concerns while using this product, stop using it and consult your doctor for further advice.

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

When it comes to using Lidocaine Pain Relief Roll-On during pregnancy, there is currently no specific information available about its safety or effectiveness. This means that there are no known safety concerns, dosage changes, or special precautions outlined for pregnant individuals.

If you are pregnant or planning to become pregnant, it’s always best to consult with your healthcare provider before using any medication, including over-the-counter products like this one. They can help you weigh the potential benefits and risks based on your individual situation.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of this product while nursing. Additionally, there is no information available about whether this product is excreted in breast milk or any potential risks it may pose to your infant.

As always, if you have any concerns or questions about using this product while 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 to the affected area no more than 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

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 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 detailed guidelines available regarding how the medication may affect you or how your liver health might influence the medication's effectiveness or safety.

Before starting any new medication, it's crucial to discuss your liver condition with your healthcare provider. They can help determine the best approach for your treatment and ensure that you are monitored appropriately. Always keep your doctor informed about any changes in your health or liver function.

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 affect each other or any tests you may undergo. Your health and safety are the top priority, and discussing these details can help prevent any unforeseen issues.

Storage and Handling

To ensure the best quality and safety of your product, store it at room temperature and keep it away from direct light. It's important to keep the container tightly closed when not in use to prevent contamination. Once you open the container, please remember to discard it after use to maintain safety and effectiveness. Following these simple guidelines will help you use the product safely and effectively.

Additional Information

You should use this product only on the skin and as directed. For adults and children aged 2 years and older, apply it to the affected area no more than 3 to 4 times a day. If the user is under 2 years old, consult a doctor before use.

When using this product, avoid wrapping the area tightly or using a heating pad, and keep it away from your eyes. Do not apply it to wounds or damaged skin, and avoid using large amounts, especially on raw or blistered areas. Always keep it out of reach of children, and if swallowed, seek medical help or contact a Poison Control Center immediately.

FAQ

What is Lidocaine used for?

Lidocaine is used for the temporary relief of pain and itching.

How should I use Lidocaine?

Adults and children 2 years of age and older should apply it to the affected area no more than 3 to 4 times daily. For children under 2 years of age, consult a doctor.

Are there any contraindications for using Lidocaine?

No specific contraindications are listed for Lidocaine.

What precautions should I take when using Lidocaine?

Use Lidocaine only as directed, avoid contact with eyes, and do not apply to wounds or damaged skin. Keep it out of reach of children.

What should I do if Lidocaine is swallowed?

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

Can I use Lidocaine during pregnancy?

There is no specific information regarding the use of Lidocaine during pregnancy.

Is it safe to use Lidocaine while nursing?

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

How should I store Lidocaine?

Store Lidocaine at room temperature, protect it from light, and keep the container tightly closed. Discard after opening.

Packaging Info

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

Packaging configurations for Lidocaine Pain Relief Roll-on.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The product is identified by the SPL Code 34089-3 and is associated with CVS Lidocaine in various forms, including LBL (Label), IFC (Information for Consumers), and Carton packaging. The product is represented visually by the image file CVGSLido.jpg. The active ingredient is lidocaine, a local anesthetic used for its numbing properties.

Uses and Indications

This drug is indicated for the temporary relief of pain and itching.

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

Dosage and Administration

For adults and children aged 2 years and older, the recommended application frequency is 3 to 4 times daily to the affected area. It is important to ensure that the application is limited to the specified frequency to avoid potential adverse effects.

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

Contraindications

Use is contraindicated in the following situations:

The product should be kept out of reach of children to prevent accidental ingestion. In the event of swallowing, immediate medical assistance or contact with a Poison Control Center is required.

Warnings and Precautions

For external use only, this product must be utilized strictly as directed. Healthcare professionals should advise patients against bandaging tightly or using heating pads in conjunction with this product. It is imperative to avoid contact with the eyes and to refrain from applying the product to wounds or damaged skin. Caution should be exercised to prevent the use of large quantities, especially over raw surfaces or blistered areas.

General precautions include ensuring that the product is 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 is recommended.

No specific laboratory tests or emergency medical instructions are provided in the insert. Therefore, healthcare professionals should remain vigilant and monitor patients for any adverse reactions or complications associated with the use of this product.

Side Effects

Patients should be aware that this product is for external use only. It is imperative to use the product strictly as directed to minimize the risk of adverse reactions. Users should avoid bandaging tightly or using the product in conjunction with a heating pad, as these practices may lead to increased irritation or other complications.

Contact with the eyes must be avoided, as this could result in significant discomfort or injury. Additionally, the product should not be applied to wounds or damaged skin, as this may exacerbate adverse effects. Caution is advised against using large quantities, particularly over raw surfaces or blistered areas, to prevent potential adverse reactions.

While specific adverse reactions have not been detailed in clinical trials or postmarketing experiences, adherence to these warnings is essential for ensuring patient safety and minimizing the risk of complications associated with improper use.

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 Roll-on (lidocaine 4%). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Lidocaine Pain Relief Roll-on.
Details

Pediatric Use

Pediatric patients aged 2 years and older may apply the medication to the affected area no more than 3 to 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 potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

There is currently no information available regarding the use of Lidocaine Pain Relief Roll-On during pregnancy. The prescribing information does not indicate any safety concerns, dosage modifications, or special precautions for pregnant patients. As such, healthcare professionals should exercise caution when considering the use of this product in pregnant individuals, given the absence of data on potential fetal impacts. It is advisable to weigh the benefits against any unknown risks when prescribing this medication to women of childbearing potential.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to 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 clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions 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 warranted based on clinical judgment.

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 substance involved, estimated dose, and time of exposure, is crucial for effective management and follow-up care.

Nonclinical Toxicology

No information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no data provided concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. It is crucial to inform patients that if the medication is swallowed, they should seek medical help or contact a Poison Control Center immediately. This guidance is essential to ensure the safety and well-being of patients and to mitigate any potential risks associated with accidental ingestion.

Storage and Handling

The product is supplied in a container that must be stored at room temperature. It is essential to protect the container from light exposure to maintain product integrity. The container should be kept tightly closed when not in use to prevent contamination. Additionally, the product should be discarded after opening to ensure safety and efficacy.

Additional Clinical Information

The product is administered topically, with a recommended application frequency of no more than 3 to 4 times daily for adults and children aged 2 years and older. For children under 2 years of age, consultation with a doctor is advised prior to use.

Clinicians should counsel patients on the following precautions: the product is for external use only and should be used strictly as directed. Patients should avoid bandaging tightly or using heating pads in conjunction with the product. Care should be taken to prevent contact with the eyes, and it should not be applied to wounds or damaged skin. Additionally, large quantities should be avoided, especially over raw surfaces or blistered areas. The product should be kept out of reach of children, and in the event of ingestion, medical assistance or contact with a Poison Control Center is necessary.

Drug Information (PDF)

This file contains official product information for Lidocaine Pain Relief Roll-on, 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 Roll-on, 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.