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Pain Relief

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This product has been discontinued

Active ingredient
Menthol 10.5 g/100 g
Other brand names
Dosage form
Spray
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2018
Label revision date
January 22, 2018
Active ingredient
Menthol 10.5 g/100 g
Other brand names
Dosage form
Spray
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2018
Label revision date
January 22, 2018
Manufacturer
Better Living Brands
Registration number
part348
NDC root
21130-333

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Drug Overview

This medication provides temporary relief from minor aches and pains in sore muscles and joints. It is commonly used for discomfort associated with conditions like arthritis, backaches, strains, and sprains. If you're experiencing these types of pain, this drug may help alleviate your symptoms and improve your comfort.

Uses

If you're dealing with minor aches and pains, this medication can provide temporary relief for sore muscles and joints. It's particularly effective for discomfort associated with conditions like arthritis, backaches, strains, and sprains.

You can rely on this treatment to help ease your discomfort and get you back to your daily activities. Remember, it's designed for short-term use to help manage those pesky aches.

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 physician (doctor) before using the medication. This will help ensure safety and proper care for younger children. Always follow your healthcare provider's advice regarding the use of any medication.

What to Avoid

It's important to keep this medication out of reach of children to prevent accidental ingestion. If you or someone else accidentally takes this medication, seek medical help or contact a Poison Control Center right away.

There are no specific contraindications, controlled substance classifications, or noted risks of abuse, misuse, or dependence associated with this medication. However, always use it responsibly and follow any additional guidance from your healthcare provider.

Side Effects

When using this product, it's important to be aware of some potential side effects and safety warnings. You should only use it externally and avoid contact with your eyes or any mucous membranes. It's also crucial not to apply it to wounds, damaged skin, or irritated areas, and you should refrain from bandaging the area after application. Remember to wash your hands with cool water after use.

If your condition worsens, symptoms persist for more than 7 days, or if they clear up and then return, you should stop using the product and consult a doctor. Additionally, keep in mind that this product is flammable, so avoid using it while smoking or near heat or flames.

Warnings and Precautions

This product is for external use only, so please avoid using it on broken or irritated skin, and do not apply it to wounds. It is also flammable, so make sure not to use it while smoking or near any heat sources or flames. When applying, keep it away from your eyes and mucous membranes, and do not bandage the area afterward. Remember to wash your hands with cool water after use, and avoid using it with heating pads or devices.

If you notice that 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. In case of accidental ingestion, seek medical help or contact a Poison Control Center right away.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While the specific signs of an overdose are not detailed, common 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 crucial to provide them with as much information as possible about the substance taken and the amount, if known. Remember, acting quickly can make a significant difference in your health and safety.

Pregnancy Use

When considering the use of PAIN RELIEF SIGNATURE CARE menthol 10.5% spray during pregnancy, it's important to note that the product insert does not provide specific warnings, precautions, or dosage modifications for pregnant individuals. Additionally, there is no information indicating whether the product is contraindicated (not recommended) during pregnancy or if there are any potential risks to the fetus.

Since the insert does not address safety concerns related to using this product while pregnant, it is advisable to consult with your healthcare provider before using it. They can help you weigh the benefits and any potential risks based on your individual circumstances.

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 are no known concerns about the product being passed into breast milk or any associated risks for your infant. This means you can use the product without worrying about its effects on your milk production or your baby's health.

Pediatric Use

If your child is under 2 years old, it's important to consult with a physician before using this medication. For children aged 2 years and older, you can apply the medication to the affected area, but be sure to do this no more than 3 to 4 times a day. Always follow these guidelines to ensure your child's safety and well-being.

Geriatric Use

While there is no specific information about how this medication should be used by 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 a good idea to discuss any medications with a healthcare provider. They can help ensure that the treatment is safe and appropriate, considering any unique health needs or conditions that may be present.

Since there are no dosage adjustments or special precautions mentioned for elderly patients, your healthcare provider will be the best resource for personalized advice. Always keep them informed about any other medications or health issues to ensure safe and effective care.

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 plan.

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 differently due to your liver health.

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver function and how it relates to your treatment. They can help ensure that your medication is safe and effective for you.

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 interactions with laboratory tests for the medication in question. However, every individual is different, and your healthcare provider can help ensure that your treatment is safe and effective based on your unique health needs. Always feel free to ask questions and share your complete list of medications and any tests you may be undergoing.

Storage and Handling

To ensure the best performance of your product, store it at room temperature and keep it away from direct light. It's important not to freeze the product, as this can affect its effectiveness. Always make sure the container is tightly closed when not in use to maintain its integrity. Once opened, please remember to discard the product after use to ensure safety and prevent contamination.

Additional Information

For adults and children aged 2 years and older, you should apply the medication to the affected area no more than 3 to 4 times a day. If the patient 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 the primary use of this drug?

This drug provides temporary relief from minor aches and pains of sore muscles and joints associated with arthritis, backache, strains, and sprains.

How should I apply this drug?

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

Are there any contraindications for this drug?

No contraindications are listed for this drug.

What precautions should I take when using this drug?

This product is for external use only and is flammable. Avoid contact with eyes, do not apply to wounds or damaged skin, and wash hands after use.

What should I do if I accidentally ingest this drug?

If accidentally ingested, seek medical help or contact a Poison Control Center immediately.

Can I use this drug during pregnancy?

There are no specific warnings or contraindications regarding the use of this product during pregnancy.

Is this drug safe for nursing mothers?

There are no specific warnings or recommendations regarding the use of this product by nursing mothers.

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

Stop using the product and consult a doctor if your condition worsens, if symptoms persist for more than 7 days, or if they clear up and reoccur.

How should I store this drug?

Store at room temperature, protect from light, do not freeze, and keep the container tightly closed. Discard after opening.

Packaging Info

Below are the non-prescription pack sizes of Pain Relief (menthol 10.5%). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Pain Relief.
Details

Drug Information (PDF)

This file contains official product information for Pain Relief, 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 minor aches and pains associated with sore muscles and joints, including those related to arthritis, backache, strains, and sprains.

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 application is to the affected area not 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 physician prior to use to determine the appropriate course of action and ensure safety.

Contraindications

Use is contraindicated in children due to the risk of accidental ingestion. In the event of accidental ingestion, it is imperative to seek medical assistance or contact a Poison Control Center immediately.

Warnings and Precautions

For external use only. This product is flammable; therefore, it should not be used while smoking or in proximity to heat or flame. When applying this product, it is essential to avoid contact with the eyes and mucous membranes. It should not be applied to wounds, damaged skin, or irritated skin. Additionally, the product should not be bandaged, and hands must be washed thoroughly with cool water after use. The use of heating pads or devices in conjunction with this product is contraindicated.

Healthcare professionals should advise patients to discontinue use and consult a physician if the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then reoccur.

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

Side Effects

Patients should be aware that the product is for external use only and is flammable; therefore, it should not be used while smoking or near heat or flame. When using this product, it is important to avoid contact with the eyes or mucous membranes. The product should not be applied to wounds, damaged skin, or irritated skin, and it should not be bandaged. Patients are advised to wash their hands with cool water after use and to refrain from using the product in conjunction with a heating pad or device.

In the event that the condition worsens, or if symptoms persist for more than 7 days, or if symptoms clear up and then reoccur, patients should stop use and consult a doctor.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified in the available data. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Pain Relief (menthol 10.5%). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Pain Relief.
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 not more than 3 to 4 times daily.

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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

There are no specific warnings, precautions, or dosage modifications regarding the use of PAIN RELIEF SIGNATURE CARE menthol 10.5% spray in pregnant patients. The prescribing information does not indicate whether the product is contraindicated during pregnancy or if there are any associated risks to the fetus. Additionally, no safety concerns related to the use of this product during pregnancy have been provided. Healthcare professionals should consider the lack of data when advising women of childbearing potential regarding the use of this product during pregnancy.

Lactation

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

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 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 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 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 the medication out of reach of children to prevent accidental ingestion. It is important for patients to understand the potential risks associated with accidental ingestion. In the event that the medication is ingested, patients should be instructed to seek medical help or contact a Poison Control Center immediately. This information is crucial for ensuring patient safety and promoting appropriate responses in emergency situations.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at room temperature, ensuring that it is protected from light exposure. Freezing the product is strictly prohibited, as it may compromise its integrity. The container must be kept tightly closed to maintain the product's quality, and it is advised to discard any remaining product after opening to ensure safety and efficacy.

Additional Clinical Information

For patients aged 2 years and older, the medication should be applied 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 physician prior to use. No further information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Pain Relief, 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, 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.