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Pain Relieving Gel

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Active ingredient
Menthol, Unspecified Form 40 mg/1 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 2023
Label revision date
January 30, 2026
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Menthol, Unspecified Form 40 mg/1 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 2023
Label revision date
January 30, 2026
Manufacturer
Rite Aid Corporation
Registration number
M017
NDC root
11822-8940
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 roll-on product is designed to provide temporary relief from minor aches and pains in your muscles and joints. It contains 4% menthol, which has a soothing effect that can help alleviate discomfort associated with conditions like simple backache, arthritis, strains, bruises, and sprains. The formula is paraben-free and comes in a convenient 2.5 FL OZ (73 mL) size, making it easy to apply directly to the affected area for quick relief.

Uses

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

You can rely on it to help ease discomfort associated with these common issues, allowing you to get back to your daily activities with less pain.

Dosage and Administration

If you are an adult or a child aged 2 years and older, you can apply the medication to the affected area up to 3 to 4 times a day. Make sure to follow this guideline to ensure the best results.

For children under 2 years of age, it’s important to consult a doctor before using this medication. This will help ensure that it is safe and appropriate for their specific needs. Always follow your healthcare provider's advice for the best care.

What to Avoid

It's important to use this product safely. You should not apply it to wounds or any damaged skin, as this can lead to complications. Additionally, avoid bandaging the area tightly after application, as this may cause irritation or other issues.

While there are no specific contraindications or concerns about abuse, misuse, or dependence associated with this product, following these guidelines will help ensure your safety and the effectiveness of the treatment.

Side Effects

It's important to use this product only on the skin and to keep it away from fire or flames, as it is flammable. If your condition worsens, or if your symptoms last more than 7 days or improve and then return within a few days, you should stop using the product and consult a doctor.

Warnings and Precautions

This product is intended for external use only, so please avoid applying it to any areas that may come into contact with your mouth or be ingested. It is also flammable, so keep it away from fire or flames to prevent any accidents.

If you accidentally swallow this product, seek medical help immediately or contact a Poison Control Center. You should stop using the product and consult your doctor if your condition worsens, if symptoms last longer than 7 days, or if they improve and then return within a few days. Your health and safety are important, so don’t hesitate to reach out for help if needed.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's always important to be aware of the potential risks associated with taking more than the recommended dose. If you suspect an overdose, look out for any unusual symptoms or changes in your health.

In the event of an overdose, it is crucial to seek immediate medical attention. You can contact your local emergency services or go to the nearest hospital. Always keep the medication packaging on hand to provide healthcare professionals with important information. Remember, it's better to be safe and get checked if you have any concerns about your health.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of this product during pregnancy has not been established. There are no adequate studies in pregnant women, so potential risks to your fetus cannot be ruled out. Before using this product, you should consult your healthcare provider to discuss your specific situation and any potential risks and benefits.

If your healthcare provider determines that you need to use this product, be aware that there are no specific dosage modifications for pregnant individuals. It is recommended to use this product only if it is clearly needed, emphasizing the importance of professional guidance in making this decision.

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 it may pose to your infant. Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

Pediatric Use

When using this medication for children aged 2 years and older, you can apply it to the affected area no more than 3 to 4 times a day. However, if your child is under 2 years old, it's important to consult a doctor before use.

Always keep this medication out of reach of children. If your child accidentally swallows it, seek medical help or contact a Poison Control Center immediately. Your child's safety is a priority, so following these guidelines is essential.

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. Since older adults may have different health needs and may be taking multiple medications, it’s always a good idea to consult with a healthcare provider before starting any new medication. They can help ensure that the treatment is safe and appropriate for your individual health situation.

If you or a loved one is an older adult, be sure to discuss any concerns about potential side effects or interactions with other medications you may be taking. Your healthcare provider can provide guidance tailored to your specific needs.

Renal Impairment

If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

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 or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you.

Always feel free to ask questions and share your complete list of medications and any lab tests you may be undergoing. This way, you can avoid any potential issues and receive the best care possible.

Storage and Handling

To ensure the best performance and safety of your product, store it in a cool, dry place with the lid closed tightly. This helps protect it from moisture and temperature fluctuations that could affect its effectiveness.

When handling the product, always make sure to keep the storage area clean and organized to avoid contamination. Following these simple guidelines will help you maintain the quality and safety of the product for its intended use.

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 patient counseling.

FAQ

What is the general description of this product?

This product is a roll-on, cooling pain relief formulation containing 4% menthol and is paraben-free, available in a 2.5 FL OZ (73 mL) size.

What conditions does this product help relieve?

It provides temporary relief from minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains.

How should I use this product?

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

Are there any contraindications for using this product?

Do not apply to wounds or damaged skin, and do not bandage tightly. For external use only.

What should I do if I experience worsening symptoms?

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 product safe to use during pregnancy?

The safety of this product during pregnancy has not been established. Consult a healthcare provider before use if pregnant or planning to become pregnant.

What precautions should I take when using this product?

Keep it out of reach of children, and if swallowed, get medical help or contact a Poison Control Center right away. It is flammable, so keep it away from fire or flame.

How should I store this product?

Store in a cool, dry place with the lid closed tightly.

Packaging Info

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

Packaging configurations for Pain Relieving Gel.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No description information is available for the drug.

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 conditions such as simple backache, arthritis, strains, bruises, and sprains.

Limitations of Use: There are no reported teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

For adults and children aged 2 years and older, the recommended application is to the affected area not more than 3 to 4 times daily. It is important to ensure that the application is performed with clean hands and that the affected area is properly prepared prior to administration.

For children under 2 years of age, it is advised to consult a healthcare professional before use to determine the appropriate course of action.

Contraindications

The product should not be applied to wounds or damaged skin due to the potential for irritation or adverse reactions. Additionally, it is contraindicated to bandage tightly, as this may impede circulation and lead to further complications.

Warnings and Precautions

This product is intended for external use only. It is important to note that the formulation is flammable; therefore, it should be kept away from fire or flame to prevent any risk of ignition.

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

Healthcare professionals should advise patients 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. Monitoring for these signs is essential to ensure patient safety and effective management of the condition being treated.

Side Effects

Patients should be aware that the product is for external use only and is flammable; it should be kept away from fire or flame.

In clinical practice, patients are advised to discontinue use and consult a healthcare professional if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. These precautions are essential to ensure patient safety and effective management of their condition.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

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

Packaging configurations for Pain Relieving Gel.
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.

It is important to keep the medication out of reach of children. In the event of accidental ingestion, medical assistance should be sought immediately, or contact a Poison Control Center.

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

The safety of this product during pregnancy has not been established. Pregnant patients or those planning to become pregnant should consult a healthcare provider before use. There are no adequate and well-controlled studies in pregnant women, and potential risks to the fetus cannot be ruled out. No specific dosage modifications are provided for pregnant individuals. This product should be used only if clearly needed, and the risks and benefits must be discussed with a healthcare professional.

Lactation

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

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no available information 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. Regular monitoring of liver function may be warranted in these patients to ensure safety and therapeutic effectiveness.

Overdosage

There is currently no specific 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 excessive dosing.

In the event of suspected overdosage, it is recommended that healthcare providers initiate supportive care and symptomatic treatment as necessary. Patients should be evaluated for potential complications, and appropriate interventions should be implemented based on clinical judgment.

For further guidance, healthcare professionals may refer to established protocols for managing drug overdosage or consult a poison control center.

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 these contexts.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed. It is important for patients to understand that they should discontinue use and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days.

When using this product, healthcare providers should instruct patients to avoid contact with the eyes and to refrain from applying the product to wounds or damaged skin. Additionally, patients should be cautioned against tightly bandaging the area where the product is applied.

Storage and Handling

The product is supplied in a configuration that ensures optimal preservation of its integrity. It is essential to store the product in a cool, dry place, ensuring that the lid is closed tightly to prevent contamination and maintain efficacy. Proper storage conditions are critical for the product's stability and longevity.

Additional Clinical Information

The medication is administered topically, with a recommended application frequency of 3 to 4 times daily for adults and children aged 2 years and older. 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 Relieving Gel, 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 Relieving Gel, 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.