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Pain Relief Roll-on

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This product has been discontinued

Active ingredient
Lidocaine Hydrochloride 4 g/100 mL
Other brand names
Dosage form
Gel
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
June 8, 2018
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Lidocaine Hydrochloride 4 g/100 mL
Other brand names
Dosage form
Gel
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
June 8, 2018
Manufacturer
Good Sense
Registration number
part348
NDC root
50804-774
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

This medication is designed to provide temporary relief from pain and itching. It can be helpful for various conditions that cause discomfort, allowing you to feel more at ease. While the specific details about how it works are not provided, its primary purpose is to alleviate these unpleasant sensations. If you're experiencing pain or itching, this medication may be a suitable option for you.

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.

Rest assured, there are no 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 concerned about potential risks.

Dosage and Administration

You can use this medication to help with your skin condition by applying it directly to the affected area. For adults and children who are 2 years old and older, you should apply it no more than 3 to 4 times a day. If your child is under 2 years of age, it’s important to consult a doctor before using this medication.

Make sure to follow these guidelines closely to ensure the best results. Remember, applying the medication too frequently may not provide additional benefits and could lead to irritation. Always wash your hands before and after applying the medication to keep the area clean and avoid spreading any infection.

What to Avoid

It's important to be aware of specific instructions regarding the use of this medication. If you accidentally swallow it, you should seek medical help or contact a Poison Control Center right away. This is crucial for your safety.

Currently, there are no listed contraindications, controlled substance classifications, or concerns about abuse, misuse, or dependence associated with this medication. However, always follow the guidance provided by your healthcare professional to ensure safe use.

Side Effects

When using this product, it's important to follow the directions carefully. It is meant for external use only, so avoid getting it in your eyes and do not apply it in large amounts, especially on raw or blistered skin. If your condition worsens, or if your symptoms last more than seven days or return after clearing up, you should stop using the product and consult a doctor.

Please remember to use this product responsibly to minimize any potential risks.

Warnings and Precautions

This product is for external use only, so please use it as directed. Be careful to avoid contact with your eyes, and do not apply it in large amounts, especially on raw or blistered skin. If your condition worsens, or if your symptoms last longer than 7 days or come back after improving, stop using the product and consult your doctor.

If you accidentally swallow this product, seek emergency medical help or contact a Poison Control Center right away. Your safety is important, so please follow these guidelines closely.

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 considering the use of Pain Relief Roll-On Good Sense (lidocaine hcl gel) during pregnancy, it's important to note that there is no specific information available about its safety, dosage adjustments, or any special precautions for pregnant individuals. This means that the effects of this product on you or your developing baby are not well understood.

If you are pregnant or planning to become pregnant, it is 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 risks and benefits 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 to your infant. This means that, based on current knowledge, you can use this product without concern for its effects on your milk production or your baby.

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 considering this medication, it’s important to consult with a healthcare provider. 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 information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to your condition. This means that there are no tailored recommendations for how the medication may affect you differently due to your liver health.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific situation. They can help determine the best approach based on your liver function and overall health.

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 changes in your medication or health status with your healthcare provider to avoid any potential issues and to get the best care possible.

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 to maintain its integrity and protect it from light exposure, which can affect its quality.

Once you open the container, please remember to discard it after use to ensure safety and effectiveness. Following these guidelines will help you handle the product safely and maintain its intended benefits.

Additional Information

You should apply this medication topically to the affected area, using it no more than 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, 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 the primary use of this drug?

This drug is used for temporary relief of pain and itching.

How should I apply this drug?

For adults and children 2 years of age and older, apply to the affected area not more than 3 to 4 times daily. For children under 2 years of age, consult a doctor.

Are there any warnings I should be aware of?

Yes, this product is for external use only. Avoid contact with eyes, use only as directed, and do not use in large quantities over raw surfaces or blistered areas.

What should I do if I swallow this drug?

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

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 clear up and occur again within a few days.

Is this drug safe to use during pregnancy or while nursing?

There is no specific information provided regarding the use of this product during pregnancy or lactation.

How should I store this drug?

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

Packaging Info

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

Packaging configurations for Pain Relief Roll-on.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No relevant information is available for SPL code 34089-3.

Uses and Indications

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

There are no teratogenic effects associated with this drug, nor are there any nonteratogenic effects mentioned.

Dosage and Administration

For adults and children aged 2 years and older, the recommended dosage is to apply the medication to the affected area no more than 3 to 4 times daily. 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

There are no specific contraindications listed for this product. However, it is imperative to seek medical assistance or contact a Poison Control Center immediately if the product is swallowed.

Warnings and Precautions

For external use only, this product must be utilized strictly as directed. Healthcare professionals should advise patients to avoid contact with the eyes and to refrain from applying the product in large quantities, especially over raw surfaces or blistered areas.

Patients are instructed to discontinue use and consult a physician if the condition worsens or if symptoms persist for more than 7 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.

It is imperative that patients are reminded to stop using the product and to reach out to their healthcare provider if they experience any worsening of their condition or if symptoms do not improve after the specified duration.

Side Effects

Patients should be aware that this product is for external use only. It is imperative to use the product strictly as directed and to avoid contact with the eyes. Additionally, patients should refrain from using the product in large quantities, especially over raw surfaces or blistered areas.

In the event that the condition worsens, or if symptoms persist for more than 7 days or resolve and then recur within a few days, patients are advised to discontinue use and consult a healthcare professional. These precautions are essential to ensure the safe and effective use of the product.

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

Packaging configurations for 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

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

There is no information available regarding the use of Pain Relief Roll-On Good Sense (lidocaine hcl gel) during pregnancy. As such, the safety of this medication in pregnant patients has not been established, and there are no known dosage modifications or special precautions recommended for use in this population. Healthcare professionals should consider the lack of data when prescribing this medication to women of childbearing potential and weigh the potential risks versus benefits.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there is no information provided about the potential for excretion in breast milk or any associated risks to breastfed infants during lactation.

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 of these patients.

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 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 compound in these areas.

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 important to emphasize that if the medication is swallowed, patients should seek medical help or contact a Poison Control Center immediately. This guidance is crucial to ensure the safety and well-being of patients, particularly in households with children.

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

The medication is administered topically, with the recommended application frequency for adults and children aged 2 years and older being 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. There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for 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 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

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.