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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 15, 2023
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 15, 2023
Manufacturer
Humco Holding Group, Inc.
Registration number
M017
NDC root
0395-9130
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

CVS Lidocaine is a medication designed to provide temporary relief from pain and itching. It works by numbing the affected area, helping to alleviate discomfort. This can be particularly useful for conditions that cause localized pain or irritation, allowing you to feel more comfortable in your daily activities.

Uses

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

Rest assured, there are no known teratogenic effects (which means it doesn’t cause birth defects) or nonteratogenic effects associated with this medication. This makes it a safer option for those concerned 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 the medication. This will help ensure safety and proper care for younger children. Always follow your healthcare provider's advice regarding the use of any medication.

What to Avoid

It's important to keep this medication out of reach of children to ensure their safety. If a child accidentally swallows it, seek medical help or contact a Poison Control Center right away.

There are no specific contraindications, controlled substance classifications, or noted risks of abuse, misuse, or dependence associated with this medication. However, always use it responsibly and follow any additional guidance provided by your healthcare professional.

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 you should not apply it to your eyes, wounds, or damaged skin. Additionally, avoid using it in large amounts, especially on raw or blistered areas. Be cautious not to bandage tightly or use it with a heating pad, as this can lead to complications. Always prioritize your safety by adhering to these guidelines.

Warnings and Precautions

This product is for external use only, so please use it as directed. Avoid wrapping the area tightly or using a heating pad while applying it. Be careful to keep it away from your eyes, and do not apply it to wounds or damaged skin. It's important not to use large amounts, especially on raw surfaces or blistered areas.

If you accidentally swallow this product, seek emergency medical help or contact a Poison Control Center right away. Always prioritize your safety and well-being when using any medication.

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 feel unwell after taking the medication, seek medical help right away.

In case of an overdose, contact your healthcare provider or local emergency services immediately. It's always better to be safe and get professional assistance if you have any concerns about your health.

Pregnancy Use

The safety of lidocaine during pregnancy has not been established, which means that its effects on you and your developing baby are not fully known. There may be potential risks to the fetus, so it’s important to consult your healthcare provider before using this medication.

If you are pregnant, your doctor may recommend dosage adjustments to ensure safety. Always discuss your specific situation with a healthcare professional and use lidocaine only if it is clearly needed. Your health and the health of your baby should always come first.

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 to your infant. Always consult with your healthcare provider if you have any concerns or questions about 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 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

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 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 there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations for the medication do not change based on liver impairment. However, it’s always a good idea to discuss your liver health with your healthcare provider, as they can offer personalized advice and monitor your condition effectively.

Make sure to keep them informed about any liver issues you may have, as they can help ensure that your treatment is safe and appropriate for you.

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 potential issues.

Storage and Handling

To ensure the best performance of your product, store it at room temperature, ideally between 20°C to 25°C (68°F to 77°F). It's important to keep the container tightly closed and protect it from light to maintain its effectiveness. Once you open the container, please remember to discard it after use to ensure safety and prevent contamination. Following these guidelines will help you use the product safely and effectively.

Additional Information

You should apply this product to the affected area no more than 3 to 4 times daily if you are an adult or a child aged 2 years and older. If the user is under 2 years old, it's important to consult a doctor first.

Remember, this product is for external use only. Use it as directed, and avoid bandaging tightly or using it with a heating pad. Keep it away from your eyes, and do not apply it to wounds or damaged skin. Avoid using large amounts, especially on raw surfaces 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 CVS Lidocaine used for?

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

How should I apply CVS 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 CVS Lidocaine?

No contraindications are listed for CVS Lidocaine.

What precautions should I take when using CVS Lidocaine?

Use CVS Lidocaine only as directed, avoid contact with eyes, and do not apply to wounds or damaged skin. It is for external use only.

What should I do if CVS Lidocaine is swallowed?

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

Is CVS Lidocaine safe to use during pregnancy?

The safety of CVS Lidocaine during pregnancy has not been established, and there may be potential risks to the fetus. Consult a healthcare provider before use.

What should nursing mothers know about CVS Lidocaine?

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

How should I store CVS Lidocaine?

Store CVS Lidocaine at room temperature, between 20°C to 25°C (68°F to 77°F), protect it from light, and keep the container tightly closed.

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 presented in a carton labeled as CVS Lidocaine. The associated image file is named CVGSLido.jpg. The active ingredient in this formulation is lidocaine.

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 children due to the risk of accidental ingestion. In the event of accidental swallowing, immediate medical assistance or contact with a Poison Control Center is advised.

Warnings and Precautions

For external use only, this product must be utilized strictly as directed to ensure safety and efficacy. Healthcare professionals should advise patients to avoid bandaging tightly or using heating pads in conjunction with this product, as these practices may exacerbate adverse effects. It is imperative to prevent contact with the eyes, as this could lead to significant irritation or injury. Additionally, the product should not be applied to wounds or damaged skin, and caution should be exercised to avoid large quantities, particularly over raw surfaces or blistered areas.

In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Patients are advised to discontinue use and consult their healthcare provider if they experience any concerning symptoms, although specific instructions for cessation were not provided in the available information. Regular monitoring and assessment of the patient's condition are recommended to ensure safe use of the 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.

When using this product, patients should avoid bandaging tightly or using it in conjunction with a heating pad, as these practices may lead to increased irritation or other adverse effects. Additionally, contact with the eyes must be avoided to prevent potential ocular complications.

The product should not be applied to wounds or damaged skin, as this may exacerbate irritation or lead to further complications. Caution is advised against using the product in large quantities, particularly over raw surfaces or blistered areas, as this may increase the likelihood of adverse reactions.

These precautions are essential to ensure the safe and effective use of the product, and patients are encouraged to adhere to these guidelines to mitigate risks.

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no recommendations for dosage adjustments or monitoring 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 recommended 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 therapeutic response, given the lack of targeted data for this population.

Pregnancy

The safety of lidocaine during pregnancy has not been established. There may be potential risks to the fetus; therefore, it is essential for pregnant patients to consult a healthcare provider before use. Dosage adjustments may be necessary for pregnant individuals, and medical advice should be sought to determine the appropriate course of action. Lidocaine should be used only if clearly needed and after thorough discussion with a healthcare professional regarding the potential risks and benefits.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there is no information available concerning 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 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 the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions indicated 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 outlined in the available 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, as the lack of detailed overdosage data necessitates a vigilant approach. Symptoms may vary 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 standard supportive measures, which may include maintaining airway patency, providing supplemental oxygen, and ensuring adequate circulation.

Additionally, it is recommended to consult local poison control centers or toxicology experts for guidance on specific management strategies tailored to the situation. Continuous assessment and supportive care are critical in managing any adverse effects that may occur as a result of an overdose.

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 keep the 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 patient safety and to mitigate any potential risks associated with accidental ingestion.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain its integrity. It should be stored at room temperature, specifically within the range of 20°C to 25°C (68°F to 77°F). It is essential to protect the product from light exposure to prevent degradation. Once opened, the product should be discarded to ensure safety and efficacy.

Additional Clinical Information

Patients aged 2 years and older are advised to apply the product to the affected area no more than 3 to 4 times daily, while those under 2 years should consult a doctor prior to use. Clinicians should emphasize that the product is for external use only and must be applied as directed. Patients should avoid bandaging tightly, using with a heating pad, or applying it to wounds or damaged skin. Contact with eyes should be avoided, and the product should not be used in large quantities, especially over raw surfaces or blistered areas.

Additionally, it is crucial to keep the product out of reach of children. In the event of ingestion, patients should seek medical assistance or contact a Poison Control Center immediately.

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.