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Proplex Greaseless Muscle Rub

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This product has been discontinued

Active ingredients
  • Menthol, Unspecified Form 10 mg/1 g
  • Methyl Salicylate 15 mg/1 g
Other brand names
Dosage form
Cream
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
January 12, 2021
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Menthol, Unspecified Form 10 mg/1 g
  • Methyl Salicylate 15 mg/1 g
Other brand names
Dosage form
Cream
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
January 12, 2021
Manufacturer
Natureplex LLC
Registration number
part348
NDC root
67234-043
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

PRO PLEX is a greaseless muscle rub designed to provide temporary relief from minor aches and pains in muscles and joints. It contains menthol (a compound that creates a cooling sensation) at 10% and methyl salicylate (a compound that helps reduce pain and inflammation) at 15%.

You can use PRO PLEX for discomfort associated with conditions such as simple backache, arthritis, muscle strains, and bruises. This product is formulated to help soothe your pain without leaving a greasy residue on your skin.

Uses

If you're dealing with minor aches and pains in your muscles and joints, this medication can help provide temporary relief. It's effective for various conditions, including simple backaches, arthritis, muscle strains, and bruises.

You can rely on it to ease discomfort and get you back to your daily activities. Remember, this medication is designed for short-term use to help manage these common issues.

Dosage and Administration

If you are an adult or a child aged 2 years and older, you should apply the medication to the affected area three to four times a day. This regular application helps ensure that the treatment is effective in managing your condition.

For children under 2 years of age, it’s important to consult a physician (doctor) before using this medication. They can provide guidance on the appropriate treatment for younger children. Always follow your healthcare provider's instructions for the best results.

What to Avoid

It's important to follow specific guidelines when using this medication to ensure your safety and effectiveness. You should not use it in any way other than as directed by your healthcare provider. Avoid applying it to wounds or damaged skin, as this can lead to complications. Additionally, be cautious not to wrap the area with a bandage too tightly, as this could cause further issues.

While there are no specific contraindications or concerns about abuse, misuse, or dependence associated with this medication, adhering to these instructions is crucial for your well-being. Always consult your healthcare provider if you have any questions or concerns about its use.

Side Effects

You should be aware that this product is for external use only and should not come into contact with your eyes or mucous membranes. Avoid using it on wounds or damaged skin, and do not apply a tight bandage over the area. If you experience a rash or excessive irritation, or if your condition worsens or does not improve after 7 days, stop using the product and consult a physician. Additionally, if your symptoms clear up and then return within a few days, seek medical advice.

If you are pregnant or breastfeeding, it's important to consult a healthcare professional before using this product. Always keep it out of reach of children, and if swallowed, seek medical help immediately or contact a Poison Control Center at 800-222-1222.

Warnings and Precautions

This product is intended for external use only, so please avoid applying it to your eyes or any mucous membranes. It’s important not to use it for an extended period and to follow the directions provided. Do not apply it to wounds or damaged skin, and avoid wrapping it tightly with a bandage.

If you notice a rash or excessive irritation, or if your condition worsens or does not improve after 7 days, stop using the product and consult your doctor. Additionally, if your symptoms clear up and then return within a few days, reach out to your healthcare provider. Always keep this product out of reach of children, and if it is swallowed, seek medical help immediately or contact a Poison Control Center at 800-222-1222.

Overdose

If you or someone else has swallowed too much of this medication, it’s important to seek medical help immediately. You can contact a Poison Control Center at 800-222-1222 for guidance.

Signs of an overdose may include unusual symptoms, which can vary depending on the medication. If you notice any concerning changes in behavior or health, don’t hesitate to get help. Remember, acting quickly can make a significant difference in ensuring safety and health.

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

If your child is under 2 years old, it's important to consult a physician (doctor) before using this medication. For children aged 2 years and older, you can apply the medication to the affected area 3 to 4 times a day. Always follow these guidelines to ensure your child's safety and well-being.

Geriatric Use

When considering the use of Proplex Greaseless Muscle Rub for older adults, it's important to note that the drug insert does not provide specific information about dosage adjustments, safety concerns, or special precautions for elderly patients. This means that while the product may be used, there are no tailored guidelines or warnings specifically addressing the needs of older adults.

As always, if you or a caregiver are considering this product, it's wise to consult with a healthcare professional. They can provide personalized advice based on individual health conditions and any other medications being taken.

Renal Impairment

If you have kidney problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or safety considerations for your condition. This means that there are no tailored guidelines for how this medication should be used if you have renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your health situation. They can help determine the best course of action based on your kidney function and overall health.

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 you understand how to manage your treatment effectively.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking, even if there are no known drug interactions or laboratory test interactions associated with them. This ensures that your treatment plan is safe and effective for your individual health needs.

Always feel free to ask questions and share your complete list of medications and any tests you may undergo. Your healthcare provider can help you understand how different treatments may work together and monitor your health effectively.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 15 to 30°C (59 to 86°F). After each use, make sure to close the cap tightly to maintain its integrity. It's important to check the seal on the tube before use; do not use the product if the seal is punctured or missing, as this could compromise safety and effectiveness.

By following these simple storage and handling guidelines, you can help ensure that the product remains safe and effective for your needs.

Additional Information

You should apply the medication to the affected area 3 to 4 times daily if you are an adult or a child aged 2 years and older. If your child is under 2 years old, it's important to consult a physician before use. There are no additional details available regarding laboratory tests, abuse potential, or patient counseling.

FAQ

What is PRO PLEX?

PRO PLEX is a greaseless muscle rub designed to temporarily relieve minor aches and pains of muscles and joints.

What are the active ingredients in PRO PLEX?

PRO PLEX contains 10% menthol and 15% methyl salicylate.

What conditions does PRO PLEX help relieve?

It temporarily relieves minor aches and pains associated with simple backache, arthritis, muscle strains, and bruises.

How should I use PRO PLEX?

Adults and children 2 years of age and older should apply it to the affected area 3 to 4 times daily. For children under 2 years, consult a physician.

Are there any contraindications for using PRO PLEX?

There are no specific contraindications listed for PRO PLEX.

What should I avoid while using PRO PLEX?

Do not use PRO PLEX on wounds or damaged skin, do not apply a bandage tightly, and avoid contact with eyes and mucous membranes.

What should I do if I experience a rash or irritation?

Stop using PRO PLEX and ask a physician if a rash or excessive irritation develops, or if the condition worsens or persists for more than 7 days.

Is PRO PLEX safe to use during pregnancy or breastfeeding?

If you are pregnant or breastfeeding, consult a health professional before using PRO PLEX.

What should I do if PRO PLEX is swallowed?

If swallowed, seek medical help or contact a Poison Control Center immediately at 800-222-1222.

How should I store PRO PLEX?

Store PRO PLEX at 15 to 30°C (59 to 86°F) and ensure the cap is tightly closed after use.

Packaging Info

Below are the non-prescription pack sizes of Proplex Greaseless Muscle Rub (menthol, unspecified form and methyl salicylate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Proplex Greaseless Muscle Rub.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

This product is identified by NDC # 67234-043-01 and is formulated as a greaseless muscle rub. It contains 10% menthol and 15% methyl salicylate as active ingredients. The net weight of the product is 3 oz (85 g). The brand name associated with this formulation is PRO PLEX.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with muscles and joints. Specifically, it is effective for alleviating discomfort related to simple backache, arthritis, muscle strains, and bruises.

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 medication to the affected area 3 to 4 times daily. It is important to ensure that the application is made to clean, dry skin for optimal absorption and effectiveness.

For children under 2 years of age, it is advised to consult a physician prior to use to determine the appropriate course of action and dosage.

Contraindications

The product should not be used in the following situations:

Use is contraindicated if the product is not used as directed. Application on wounds or damaged skin is prohibited due to the potential for adverse effects. Additionally, the product should not be applied with a tightly secured bandage, as this may lead to complications.

Warnings and Precautions

This product is intended for external use only. Healthcare professionals should advise patients to avoid contact with the eyes and mucous membranes to prevent irritation. Prolonged use of this product is not recommended, and it should only be used as directed.

The product should not be applied to wounds or damaged skin, nor should it be covered with a tightly fitting bandage. If a rash or excessive irritation of the skin develops, or if the condition worsens or symptoms persist for more than 7 days, patients are instructed to discontinue use and consult a physician. Additionally, if the condition clears up and then recurs within a few days, medical advice should be sought.

It is essential to keep this product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be obtained by contacting a Poison Control Center at 800-222-1222.

Side Effects

Patients using this product may experience various adverse reactions. It is important to note that this product is for external use only and should not come into contact with the eyes or mucous membranes. Prolonged use is not recommended.

Patients should avoid using this product on wounds or damaged skin and should not apply a bandage tightly over the treated area. If a rash or excessive irritation of the skin develops, or if the condition worsens or symptoms persist for more than 7 days, patients are advised to stop use and consult a physician. Additionally, if the condition clears up and then recurs within a few days, medical advice should be sought.

For pregnant or breastfeeding individuals, it is recommended to consult a health professional before use. This product should be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center should be made at 800-222-1222.

Drug Interactions

There are no specific drug interactions identified for this medication. Additionally, no laboratory test interactions have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Proplex Greaseless Muscle Rub (menthol, unspecified form and methyl salicylate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Proplex Greaseless Muscle Rub.
Details

Pediatric Use

Pediatric patients under 2 years of age should consult a physician prior to use. For children aged 2 years and older, the recommended application is to the affected area 3 to 4 times daily.

Geriatric Use

There is no specific information regarding the use of Proplex Greaseless Muscle Rub in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when administering this product to elderly patients, as the absence of data necessitates careful monitoring for any potential adverse effects or reactions. It is advisable to consider the overall health status and individual needs of geriatric patients when recommending this product.

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 weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure the safety of both the mother and the developing fetus.

Lactation

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

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to 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 prescribing information.

Overdosage

In the event of an overdosage, immediate medical assistance is crucial. Healthcare professionals are advised to instruct patients or caregivers to seek medical help or contact a Poison Control Center without delay if the substance is ingested. The national Poison Control Center can be reached at 800-222-1222.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are recommended to ensure patient safety and effective resolution of any complications arising from the overdosage.

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 question. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

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 crucial to inform patients that if the medication is swallowed, they should seek medical help immediately or contact a Poison Control Center at 800-222-1222 for assistance. This information is essential for ensuring patient safety and prompt action in case of an emergency.

Storage and Handling

The product is supplied in a tube format, with specific handling and storage requirements to ensure its integrity and efficacy. It should be stored at a temperature range of 15 to 30°C (59 to 86°F).

To maintain the quality of the product, it is essential to close the cap tightly after each use. Additionally, the product must not be used if the seal on the tube is punctured or missing, as this may compromise its safety and effectiveness.

Additional Clinical Information

For patients aged 2 years and older, the medication should be applied to the affected area 3 to 4 times daily. For children under 2 years of age, it is advised to consult a physician prior to use. No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Proplex Greaseless Muscle Rub, 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 Proplex Greaseless Muscle Rub, 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.