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4rlf Topical Analgesic

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This product has been discontinued

Active ingredient
Menthol 0.1 g/1 mL
Other brand names
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2021
Label revision date
October 28, 2022
Active ingredient
Menthol 0.1 g/1 mL
Other brand names
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2021
Label revision date
October 28, 2022
Manufacturer
Rinati Skin, LLC
Registration number
part348
NDC root
76849-201

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Drug Overview

This medication is designed to provide temporary relief from pain associated with minor burns, sunburn, minor cuts, scrapes, and insect bites. It helps soothe discomfort and promotes a sense of comfort during the healing process. If you experience any of these minor skin irritations, this product may be a helpful option for you.

Uses

You can use this medication for the temporary relief of pain caused by minor burns, sunburn, minor cuts, scrapes, and insect bites. It’s designed to help soothe discomfort from these common skin irritations, allowing you to feel more comfortable while your skin heals.

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 concerned about such risks.

Dosage and Administration

To use this medication, you will apply it directly to the area of your skin that needs treatment. For adults and children aged 2 years and older, gently rub the medication into the skin. You can do this up to 3 to 4 times a day, but be sure not to exceed that amount.

If you have a child under the age of 2, it's important to consult a physician (doctor) before using this medication. Always follow these guidelines to ensure safe and effective use.

What to Avoid

It's important to be aware of specific instructions regarding the use of this medication. While there are no listed contraindications, controlled substance classifications, or risks of abuse or dependence, you should take care to follow the guidance provided.

If you accidentally swallow the medication, seek medical help immediately. Always prioritize your safety and well-being when using any medication.

Side Effects

It's important to use this product only on the skin and to avoid getting it in your eyes. If you accidentally do, make sure to rinse your eyes with water right away. If your condition worsens, or if your symptoms last longer than 7 days or come back after clearing up, stop using the product and talk to your doctor.

Please remember that these warnings are in place to help ensure your safety while using the product.

Warnings and Precautions

This product is for external use only, so be sure to avoid contact with your eyes. If you accidentally get it in your eyes, rinse them with water immediately. 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 right away. It's important to take these precautions seriously to ensure your safety and well-being.

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.

Pregnancy Use

When it comes to using this product during pregnancy, there is no specific information available about its safety or potential risks to you or your developing baby. The insert does not indicate whether the product is contraindicated (not recommended) for pregnant individuals, nor does it mention any necessary dosage adjustments or special precautions for use during pregnancy.

As always, it's important to consult with your healthcare provider before using any medication or product while pregnant to ensure the best care for you and your baby.

Lactation Use

If you are breastfeeding, it's important to note that there is no specific information available regarding the effects of this medication on nursing mothers or lactation (the process of producing breast milk). Since there are no guidelines or data provided, it may be wise to consult your healthcare provider for personalized advice. They can help you weigh the benefits and risks based on your individual situation and ensure the safety of both you and your baby.

Pediatric Use

If your child is 2 years of age or older, you can apply the medication to the affected area of their skin and gently rub it in. It’s important to limit this to no more than 3 to 4 times a day. However, if your child is under 2 years old, you should consult a physician (doctor) before using this medication to ensure it’s safe for them. Always prioritize your child's health and follow these guidelines carefully.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. If you or a loved one is an older adult, it’s always wise to discuss any medications with a healthcare provider, especially considering factors like overall health and any other medications being taken.

Since there are no dosage adjustments or special precautions mentioned for elderly patients, your healthcare provider can help determine the best approach tailored to individual needs. Always prioritize open communication with your doctor 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 and what steps to take for your safety.

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 established recommendations for how your liver health might affect the use of this medication.

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have about your liver health and medication use. They can help ensure that you receive the safest and most effective treatment tailored to your needs.

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 and safety of your product, store it in a cool, dark place where the temperature is below 100°F (37.8°C). It's important to keep it away from direct sunlight, as exposure can affect its quality.

When handling the product, always do so with clean hands and in a clean environment to maintain its integrity. Following these guidelines will help you use the product safely and effectively.

Additional Information

No further information is available.

FAQ

What is the drug used for?

The drug is used for the temporary relief of pain from minor burns, sunburn, minor cuts, scrapes, and insect bites.

How should I apply the drug?

For adults and children 2 years of age or older, apply to the desired area and gently rub into the skin, not more than 3 to 4 times daily.

What should I do if I have a child under 2 years old?

If your child is under the age of 2, you should consult a physician before use.

Are there any contraindications for this drug?

No contraindications are listed for this drug.

What should I do if I accidentally swallow the drug?

If swallowed, you should get medical help immediately.

What precautions should I take while using this drug?

This product is for external use only. Avoid contact with eyes, and if contact occurs, flush eyes with water.

What should I do if my condition worsens or does not improve?

If your condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use and consult a physician.

How should I store this drug?

Store the drug in a cool, dark place, and avoid storage directly in sunlight.

Packaging Info

Below are the non-prescription pack sizes of 4rlf Topical Analgesic (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for 4rlf Topical Analgesic.
Details

Drug Information (PDF)

This file contains official product information for 4rlf Topical Analgesic, 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. No specific description details are provided in the text.

Uses and Indications

This drug is indicated for the temporary relief of pain associated with minor burns, sunburn, minor cuts, scrapes, and insect bites.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

For adults and children aged 2 years and older, the recommended dosage is to apply the product to the desired area and gently rub it into the skin. This application should not exceed 3 to 4 times daily.

For children under the age of 2, it is advised to consult a physician prior to use.

The product is intended for topical application, and the method of administration involves gently rubbing it into the skin as specified.

Contraindications

There are no specific contraindications listed for this product. However, it is advised that if the product is swallowed, medical assistance should be sought immediately.

Warnings and Precautions

The product is intended for external use only. Healthcare professionals should advise patients to avoid contact with the eyes. In the event of accidental eye contact, it is imperative to flush the eyes thoroughly with water.

Patients should be instructed to discontinue use and seek medical advice if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days.

In cases of ingestion, immediate medical assistance should be sought. It is crucial for healthcare providers to emphasize the importance of monitoring the patient's condition and to encourage them to report any adverse changes promptly.

Side Effects

Patients using this product should be aware that it is intended for external use only. Care should be taken to avoid contact with the eyes; in the event of eye contact, it is recommended to flush the eyes with water immediately.

In clinical practice, if the condition being treated worsens, or if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, patients are advised to discontinue use of the product and consult a physician. These precautions are essential to ensure patient safety and to prevent potential complications associated with prolonged use or misuse of the product.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions between the drug and laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

Packaging & NDC

Below are the non-prescription pack sizes of 4rlf Topical Analgesic (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for 4rlf Topical Analgesic.
Details

Pediatric Use

Pediatric patients aged 2 years and older may apply the medication to the desired area and gently rub it into the skin, not exceeding 3 to 4 applications daily. For children under the age of 2, it is advised to consult a physician 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

The available prescribing information does not provide specific data regarding the use of this product during pregnancy. There are no contraindications noted for use in pregnant patients, nor are there any associated risks to the fetus identified in the available literature. Additionally, no dosage modifications or special precautions for use during pregnancy have been specified. Healthcare professionals should consider the lack of data when prescribing this product to women of childbearing potential and weigh the potential benefits against any unknown risks.

Lactation

There is no specific information available regarding the use of this medication in nursing mothers or lactation considerations. Healthcare professionals should exercise caution and consider the potential risks and benefits when prescribing this medication to lactating mothers. The effects on breastfed infants have not been established, and further research may be necessary to determine any implications for breastfeeding.

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 is no information available 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.

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 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. It is important to inform patients that if the medication is swallowed, they should seek medical help immediately. This guidance is crucial for ensuring the safety and well-being of patients and their families.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product in a cool, dark place, ensuring that the temperature does not exceed 100°F. Direct exposure to sunlight should be avoided to maintain the integrity of the product. Proper storage conditions are crucial for preserving the efficacy and safety of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for 4rlf Topical Analgesic, 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 4rlf Topical Analgesic, 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.