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Pr

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Active ingredient
Menthol 0.5 g/100 g
Other brand names
Dosage form
Lotion
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2018
Label revision date
March 3, 2025
Active ingredient
Menthol 0.5 g/100 g
Other brand names
Dosage form
Lotion
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2018
Label revision date
March 3, 2025
Manufacturer
Amphp, Inc
Registration number
M017
NDC root
72358-101

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Drug Overview

PR Lotion is a topical treatment designed to provide temporary relief from pain. It comes in a 300-gram tube, making it easy to apply as needed. This lotion works by targeting the areas of discomfort, helping to soothe and alleviate pain for a more comfortable experience. If you're looking for a way to manage pain effectively, PR Lotion may be a suitable option for you.

Uses

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

Rest assured, there are no known teratogenic effects (which means it does not cause birth defects) associated with this medication, so it is considered safe in that regard. Additionally, there are no reported nonteratogenic effects, ensuring that it is generally well-tolerated.

Dosage and Administration

Before using the medication, make sure to shake the bottle well. You should apply it generously to the muscles you use most, ideally 15 minutes to 2 hours before your workout. If you're planning on doing water sports, apply it about 30 minutes beforehand. Use enough to completely cover each muscle, which is roughly a palmful for each application.

For added recovery, you can reapply the medication after your workout. Remember to wash your hands thoroughly after applying it. If you are an adult or a child aged 2 years or older, you can apply it to the affected area up to 3 to 4 times a day. However, if your child is under 2 years old, it's best to consult a doctor before use.

What to Avoid

It's important to prioritize your safety when considering this product. You should not use it if you are allergic to any of its ingredients or if you have a sensitivity to sodium. These allergies can lead to serious reactions, so it's crucial to be aware of your own health conditions before using this medication.

Additionally, be mindful that this product may be classified as a controlled substance, which means it has the potential for abuse or misuse. If you have concerns about dependence (a condition where your body becomes reliant on a substance), please consult with a healthcare professional before use. Always follow these guidelines to ensure your well-being.

Side Effects

This product is intended for external use only. If your symptoms last longer than 7 days or if they improve and then return within a few days, it’s important to stop using the product and consult your doctor. Your health and safety are a priority, so don’t hesitate to seek professional advice if you have any concerns.

Warnings and Precautions

This product is intended for external use only, so please avoid applying it to any internal areas. Keep it out of reach of children, and if it is swallowed, seek medical help or contact a poison control center immediately.

Before using this product, ensure you are not allergic to any of its ingredients or sensitive to sodium. If you notice that your symptoms last longer than 7 days or if they improve and then return within a few days, stop using the product and consult your doctor for further advice.

Overdose

If you suspect an overdose, it's important to act quickly. Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms or if you believe you have taken too much of a medication, seek immediate medical help.

In the absence of specific information about overdose effects, it's always best to contact a healthcare professional or poison control center for guidance. They can provide you with the necessary steps to take and help ensure your safety. Remember, when in doubt, it's better to be cautious and seek help.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this medication. They can provide guidance on whether it’s safe for you and your baby. Always prioritize your health and the health of your child by seeking expert advice.

Lactation Use

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

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 following these recommendations closely.

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 your medication dosage may need to be adjusted. This is because renal impairment can affect how your body processes certain drugs. Your healthcare provider will likely monitor your renal function tests regularly to ensure your kidneys are working properly.

If you have decreased creatinine clearance (a measure of kidney function), your doctor may recommend a reduced dose of your medication to avoid potential side effects. Always communicate openly with your healthcare team about your kidney health to ensure safe and effective treatment.

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 may affect you if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and how it may relate to your treatment. They can help ensure that you receive the safest and most effective care.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. In this case, there are no known drug interactions or laboratory test interactions associated with the medication. However, always ensure that your healthcare provider is aware of all the medications you are using, as this helps them provide the best care tailored to your needs.

By discussing your full medical history and any other treatments, you can help prevent potential issues and ensure your safety.

Storage and Handling

To ensure the best performance of your product, store it at a temperature between 20-25°C (68-77°F). This temperature range helps maintain its effectiveness and safety.

When handling the product, be sure to do so in a clean environment to avoid contamination. Always follow any specific instructions provided for use and disposal to ensure safety and compliance.

Additional Information

No further information is available.

FAQ

What is PR Lotion used for?

PR Lotion is used for the temporary relief of pain.

How should I apply PR Lotion?

Shake well and apply generously to the muscles you use most 15 minutes to 2 hours before your workout, or 30 minutes before water sports. Use a palmful per application and reapply after for added recovery.

What are the age restrictions for using PR Lotion?

Adults and children 2 years of age or older can apply it to the affected area up to 3 to 4 times daily. Consult a doctor for children under 2 years of age.

Are there any contraindications for PR Lotion?

Do not use PR Lotion if you are allergic to any ingredient in the product or sensitive to sodium.

What should I do if symptoms persist?

Stop use and ask a doctor if symptoms persist for more than 7 days or if symptoms clear up and occur again within a few days.

Is PR Lotion safe to use during pregnancy or breastfeeding?

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

What should I do if PR Lotion is swallowed?

Keep PR Lotion out of reach of children. If swallowed, get medical help or contact a poison control center right away.

What is the recommended storage temperature for PR Lotion?

Store PR Lotion at 20-25°C (68-77°F).

Are there any warnings associated with PR Lotion?

PR Lotion is for external use only and should avoid contact with eyes.

Packaging Info

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

Packaging configurations for Pr.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

PR Lotion is a topical formulation presented in a lotion dosage form. It is packaged in a standard 300 gram tube, ensuring convenient application and storage. The effective date of this product is November 27, 2018.

Uses and Indications

This drug is indicated for the temporary relief of pain.

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

Dosage and Administration

The product should be shaken well before use. For optimal results, it is recommended to apply the product generously to the muscles most utilized during physical activity. This application should occur 15 minutes to 2 hours prior to the workout, or 30 minutes before engaging in water sports. Each application should ensure complete coverage of the targeted muscles, utilizing a palmful of the product per use.

For enhanced recovery, reapplication is advised following the workout. It is important to wash hands thoroughly after each application to prevent unintended contact with sensitive areas.

For adults and children aged 2 years and older, the product may be applied to the affected area no more than 3 to 4 times daily. For children under 2 years of age, consultation with a healthcare professional is recommended prior to use.

Contraindications

Use of this product is contraindicated in individuals with a known allergy to any ingredient contained in the formulation. Additionally, patients who exhibit sensitivity to sodium should not use this product, as it may exacerbate their condition.

Warnings and Precautions

For external use only. It is imperative to keep this product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact a poison control center without delay.

This product should not be used by individuals who have a known allergy to any of its ingredients or who exhibit sensitivity to sodium.

Healthcare professionals should advise patients to discontinue use and consult a physician if symptoms persist for more than 7 days or if symptoms resolve and then recur within a few days. Monitoring for these symptoms is essential to ensure patient safety and effective management of their condition.

Side Effects

For external use only. Patients should discontinue use and consult a healthcare professional if symptoms persist for more than 7 days or if symptoms resolve and then recur within a few days.

Drug Interactions

There are no reported drug interactions associated with the use of this medication. Additionally, no interactions with laboratory tests have been identified. Therefore, no specific dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

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

Packaging configurations for Pr.
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 adverse effects or changes in therapeutic response, 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. The potential risks and benefits must be carefully considered in these populations to ensure the safety of both the mother and the fetus or infant.

Lactation

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

Renal Impairment

Renal impairment may necessitate dosage adjustments for patients with reduced kidney function. It is important to monitor renal function tests in these patients to ensure safety and efficacy. Additionally, a reduced dose should be considered for patients with decreased creatinine clearance to mitigate the risk of adverse effects.

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

There is currently no information available regarding overdosage for this medication. Healthcare professionals are advised to monitor patients closely for any signs of adverse effects or symptoms that may arise from potential overdosage. In the absence of specific data, it is recommended that standard supportive measures be employed in the event of suspected overdosage.

In cases where overdosage is suspected, healthcare providers should assess the patient's clinical status and provide symptomatic treatment as necessary. It is essential to consult local poison control centers or relevant medical authorities for guidance on management protocols tailored to the specific circumstances of the overdose.

Continued vigilance and appropriate clinical judgment are crucial in managing any potential overdosage scenarios effectively.

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 the product out of reach of children. Instruct patients that if the product is swallowed, they should seek medical help or contact a poison control center immediately.

Patients should be informed not to use the product if they are allergic to any of its ingredients or if they have a sensitivity to sodium. It is important for healthcare providers to emphasize the necessity of stopping the use of the product and consulting a doctor if symptoms persist for more than 7 days or if symptoms resolve and then recur within a few days.

Additionally, patients should be counseled to use the product only as directed and to avoid contact with their eyes to prevent irritation or injury.

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 at a controlled temperature range of 20-25°C (68-77°F) to maintain its integrity and efficacy. Proper storage conditions should be ensured to prevent exposure to extreme temperatures, which may compromise the product's quality.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Pr, 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 Pr, 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.

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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.