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Topical Pain Relief

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This product has been discontinued

Active ingredient
Lidocaine Hydrochloride 4 g/100 mL
Other brand names
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 2018
Label revision date
July 7, 2018
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Lidocaine Hydrochloride 4 g/100 mL
Other brand names
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 2018
Label revision date
July 7, 2018
Manufacturer
LEON MEDICAL CENTERS, INC
Registration number
part348
NDC root
89076-1095
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

You may find that this medication is designed to temporarily relieve minor pains. It works by targeting the discomfort you may experience, helping to make daily activities more manageable. If you're dealing with minor aches, this drug could be a helpful option for you.

Uses

You can use this medication to temporarily relieve minor pains. It’s designed to help ease discomfort, making it a useful option when you’re dealing with everyday aches. Rest assured, there are no concerns about teratogenic effects (which means it doesn’t cause birth defects) or nonteratogenic effects (which refer to other types of harmful effects) associated with this medication.

Dosage and Administration

If you are an adult or a child over 12 years old, you can apply the medication generously to the affected area as needed. You should do this every 6 to 8 hours, but make sure not to exceed three applications in a 24-hour period.

Please note that this medication is not suitable for children under 12 years of age, so it should be kept out of their reach. Always follow these guidelines to ensure safe and effective use.

What to Avoid

It's important to keep this medication out of reach of children. If a child accidentally swallows it, seek medical help or contact a Poison Control Center immediately. There are no specific contraindications, controlled substance classifications, or concerns regarding abuse, misuse, or dependence associated with this medication. Always use it responsibly and as directed.

Side Effects

When using this product, it's important to be aware of potential side effects. You should stop using it and consult a doctor if your condition worsens, if symptoms last longer than seven days, or if they improve and then return shortly after.

Additionally, this product is for external use only and should not be applied to large areas of the body, on broken or irritated skin, or on puncture wounds. Avoid contact with your eyes, and do not use bandages or apply heat to the treated area. Always follow the directions on the label carefully.

Warnings and Precautions

This product is for external use only, so please avoid using it on large areas of your body or on any cut, irritated, or swollen skin. It should not be applied to puncture wounds, and you should not use it for more than one week without consulting your doctor. Always follow the directions on the label carefully, and make sure to keep it away from your eyes. Additionally, do not cover the treated area with bandages or apply heat, such as heating pads.

If your condition worsens, or if your symptoms last longer than seven days or return after clearing up, stop using the product and contact your doctor. In case of accidental swallowing, seek emergency medical help or contact a Poison Control Center immediately.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While the specific signs of an overdose are not detailed, common 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 crucial to provide them with as much information as possible about the substance taken and the amount, if known. Remember, acting quickly can make a significant difference in your health and safety.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult your doctor before using this medication. Your healthcare provider can help you understand any potential risks and ensure that you make the safest choice for you and your baby. Always prioritize open communication with your doctor regarding any medications you may be considering during this time.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult your doctor 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 healthcare provider regarding your breastfeeding journey.

Pediatric Use

This medication is not recommended for children under 12 years of age. If you have a child who is 12 years or older, you can apply it generously to the affected area as needed every 6 to 8 hours. However, be sure not to exceed three applications in a 24-hour period to ensure their safety. 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 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.

It's always best to consult with your healthcare provider about your specific situation, as they can offer personalized advice and ensure that any medications you take are safe and effective for you.

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. In this case, there are no specific drug interactions or laboratory test interactions noted, which means that the medication is generally considered safe to use with other drugs and tests. However, every individual is different, and your healthcare provider can help ensure that your treatment plan is safe and effective for you.

Always discuss any new medications or tests with your healthcare provider to avoid potential issues and to get the best care tailored to your needs.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20°C to 25°C (68°F to 77°F). It's important to protect it from light, so keep it in a dark area or use an opaque container. Always make sure the container is tightly closed to maintain its integrity.

Once you open the container, please remember to discard it after use to avoid any safety risks. Following these guidelines will help you handle the product safely and effectively.

Additional Information

You should apply the medication generously to the affected area as needed, but do not exceed three applications within a 24-hour period. If you are pregnant or breastfeeding, it's important to consult your doctor before using this product. Additionally, keep it out of reach of children; if swallowed, seek medical help or contact a Poison Control Center immediately.

FAQ

What is the primary use of this drug?

This drug temporarily relieves minor pains.

Who can use this drug?

It is intended for adults and children over 12 years of age. It is not for use in children under 12.

How should I apply this drug?

Apply generously to the affected area as needed every 6-8 hours, not exceeding 3 applications in a 24-hour period.

Are there any warnings I should be aware of?

Yes, this product is for external use only. Do not use on large areas of the body, on cut or irritated skin, or for more than one week without consulting a doctor.

What should I do if I accidentally swallow this drug?

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

What should I do if my condition worsens or symptoms persist?

Stop use and ask a doctor if your condition worsens or if symptoms persist for more than 7 days or return after clearing up.

What precautions should I take if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, ask a doctor before use.

How should I store this drug?

Store at 20°C to 25°C (68°F to 77°F), protect from light, and keep the container tightly closed.

Packaging Info

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

Packaging configurations for Topical Pain Relief.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The drug is formulated as a Roll-On dosage form, providing a convenient method for application. The effective date of the insert is July 7, 2018. The labeling media is presented in an image format, specifically JPEG.

Uses and Indications

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

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

Dosage and Administration

For adults and children over 12 years of age, the recommended application is to apply the product generously to the affected area as needed. This should be done every 6 to 8 hours, with a maximum of 3 applications within a 24-hour period.

This product is not indicated for use in children under 12 years of age.

Contraindications

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

Warnings and Precautions

For external use only. This product should not be applied to large areas of the body, nor should it be used on cut, irritated, or swollen skin. It is contraindicated for application on puncture wounds. The product should not be used for more than one week without prior consultation with a healthcare professional.

When utilizing this product, it is imperative to adhere strictly to the provided instructions. Users must read and follow all directions and warnings indicated on the label. Care should be taken to avoid contact with the eyes. Additionally, the area of application should not be bandaged or subjected to local heat, such as heating pads.

Patients are advised to discontinue use and consult a physician if the condition worsens, if symptoms persist for more than seven days, or if symptoms resolve and then recur within a few days.

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

Side Effects

Patients using this product may experience a range of adverse reactions. It is important to note that this product is for external use only and should not be applied to large areas of the body, on cut, irritated, or swollen skin, or on puncture wounds. Additionally, it should not be used for more than one week without consulting a healthcare professional.

Common adverse reactions may include localized irritation or discomfort at the site of application. Patients are advised to use the product only as directed and to read and follow all directions and warnings on the label. Care should be taken to avoid contact with the eyes, as this may lead to further complications.

In the event that the condition worsens, or if symptoms persist for more than seven days or clear up and then recur within a few days, patients should discontinue use and consult a doctor. It is also recommended that patients refrain from bandaging or applying local heat, such as heating pads, to the area of use, as this may exacerbate adverse reactions.

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

Packaging configurations for Topical Pain Relief.
Details

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. For adolescents aged 12 years and older, the recommended application is to apply generously to the affected area as needed 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. It is important to assess the potential risks and benefits associated with the use of this drug during pregnancy and lactation. The safety of this medication in pregnant women has not been established, and caution is advised to ensure the well-being of both the mother and the fetus.

Lactation

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

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 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 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 initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

If the substance involved is known, specific antidotes or treatments may be indicated, and healthcare professionals should refer to established guidelines for the management of overdose related to that particular substance.

In all cases, contacting a poison control center or a medical toxicologist for guidance is recommended to ensure appropriate management and intervention.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

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. Instruct patients that if the medication is swallowed, they should seek medical help immediately or contact a Poison Control Center for assistance. It is important for patients to understand the potential risks associated with improper use and the necessary steps to take in case of an emergency.

Storage and Handling

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

Additional Clinical Information

Patients should apply the medication generously to the affected area as needed every 6-8 hours, ensuring that the total number of applications does not exceed three in a 24-hour period. Clinicians should advise patients who are pregnant or breastfeeding to consult a doctor prior to use. Additionally, it is important to keep the product out of reach of children; if ingested, medical assistance should be sought immediately or contact a Poison Control Center.

Drug Information (PDF)

This file contains official product information for Topical 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 Topical 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.