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Point Relief Cold Spot Pain Relieving

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Active ingredient
Menthol 120 mg/1 g
Other brand names
Dosage form
Gel
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2019
Label revision date
November 5, 2023
Active ingredient
Menthol 120 mg/1 g
Other brand names
Dosage form
Gel
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2019
Label revision date
November 5, 2023
Manufacturer
Fabrication Enterprises
Registration number
M017
NDC root
51452-036

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Drug Overview

This medication is designed to provide temporary relief from minor aches and pains in your muscles and joints. It can be particularly helpful for conditions such as simple backaches, arthritis, bruises, strains, and sprains. If you're experiencing discomfort from these common issues, this drug may be a suitable option to help ease your pain.

Uses

You can use this medication for the temporary relief of minor aches and pains in your muscles and joints. It is effective for conditions such as simple backache, arthritis, bruises, strains, and sprains.

Rest assured, there are no teratogenic effects (which means it does not cause birth defects) or nonteratogenic effects noted with this medication. This makes it a safer option for managing your discomfort.

Dosage and Administration

To use this medication, you should apply it directly to the area that is affected. It's important to remember that you should not apply it more than four times a day. Following these guidelines will help ensure that you use the medication safely and effectively.

What to Avoid

It's important to use this product safely. You should not apply it to open wounds or damaged skin, as this can lead to complications. If your symptoms last longer than seven days, please stop using the product and consult your physician for further guidance.

By following these instructions, you can help ensure a safe and effective experience with the product. Always prioritize your health and well-being.

Side Effects

It's important to use this product only on the skin and avoid contact with your eyes. Do not apply it to open wounds or damaged skin. If your symptoms last longer than seven days, you should stop using the product and talk to your doctor.

Keep this product out of reach of children. If it is swallowed, seek medical advice immediately. Additionally, avoid wrapping the area tightly after application.

Warnings and Precautions

This product is for external use only, so please avoid applying it to your eyes or on open wounds and damaged skin. It's important to keep it out of reach of children. If you accidentally swallow any of the product, consult your physician right away.

If your symptoms last longer than seven days, stop using the product and reach out to your doctor for further advice. Additionally, when applying the product, do not bandage the area tightly, as this could cause issues. Always prioritize your safety and well-being while using this product.

Overdose

If you or someone else has swallowed too much of this medication, it’s important to consult a physician right away. Overdosing can lead to serious health issues, so don’t hesitate to seek professional help.

Signs of an overdose may include unusual symptoms, and it’s crucial to be aware of these changes. If you suspect an overdose, contact a healthcare provider immediately for guidance on what to do next. Your health and safety are the top priority, so always err on the side of caution.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that there is no information available about the use of this medication during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions related to pregnancy have not been addressed.

Before taking this medication, you should discuss it with your healthcare provider to understand any potential risks and to ensure the best care for you and your baby. Always prioritize open communication with your doctor regarding any medications you may be considering during pregnancy.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to be aware 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’s advisable to consult your healthcare provider for personalized advice and to discuss any potential risks or concerns related to your situation. Your healthcare provider can help you make informed decisions that prioritize both your health and your baby's well-being.

Pediatric Use

It's important to keep this medication out of reach of children to prevent accidental ingestion. If your child accidentally swallows it, you should consult a physician immediately for guidance. Always prioritize safety and ensure that medications are stored securely.

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 a good idea to discuss any medications with a healthcare provider. They can help determine the best approach, considering any unique health needs or conditions.

Since there are no dosage adjustments or special precautions mentioned for elderly patients, your healthcare provider will guide you on the appropriate use of this medication based on individual health status. Always keep an open line of communication with your doctor about any concerns or side effects you may experience.

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 is safe and effective for your specific condition. They can help you understand any necessary precautions or adjustments based on your kidney 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 determine the best course of action based on your individual situation.

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 keep your healthcare team informed about all the medications and supplements you use, as well as any lab tests you may undergo. This way, they can provide the best care tailored to you.

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. Once you open the product, remember to discard it after use to maintain safety and quality.

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 directly to the affected area, making sure not to use it more than four times a day. There are no additional details available regarding laboratory tests, abuse potential, or patient counseling information.

FAQ

What is the drug used for?

The drug is used for temporary relief of minor aches and pains of the muscles and joints associated with simple backache, arthritis, bruises, strains, and/or sprains.

How should I apply the drug?

You should apply it directly to the affected area and not use it more than four times per day.

Are there any contraindications for this drug?

There are no contraindications listed for this drug.

What precautions should I take when using this drug?

This drug is for external use only. Avoid contact with eyes and do not apply to open wounds or damaged skin.

What should I do if symptoms persist?

If symptoms persist for more than seven days, you should discontinue use and consult a physician.

How should I store the drug?

Store the drug at room temperature, protect it from light, and do not freeze. Discard it after opening.

What should I do if the drug is swallowed?

If swallowed, consult a physician immediately.

Is there any information regarding use during pregnancy or nursing?

No specific information is provided regarding use during pregnancy or nursing mothers.

Are there any specific drug interactions?

No specific drug interactions are mentioned for this drug.

Packaging Info

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

Packaging configurations for Point Relief Cold Spot Pain Relieving.
Details

Drug Information (PDF)

This file contains official product information for Point Relief Cold Spot Pain Relieving, 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 additional specific description details are provided in the available text.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains of the muscles and joints associated with conditions such as simple backache, arthritis, bruises, strains, and sprains.

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

Dosage and Administration

The medication should be applied directly to the affected area. Healthcare professionals are advised to limit the application to a maximum of four times per day. Care should be taken to ensure that the dosage does not exceed this frequency to avoid potential adverse effects.

Contraindications

Use is contraindicated in patients with open wounds or damaged skin due to the potential for irritation or adverse reactions. Additionally, if symptoms persist for more than seven days, discontinuation of use is advised, and a consultation with a physician is recommended.

Warnings and Precautions

For external use only. It is imperative to avoid contact with the eyes to prevent irritation or injury. The product should not be applied to open wounds or damaged skin, as this may exacerbate the condition or lead to adverse effects.

In cases where symptoms persist for more than seven days, it is recommended to discontinue use and consult a physician for further evaluation and management. To ensure safety, the product must be kept out of reach of children. In the event of accidental ingestion, immediate consultation with a physician is advised.

Additionally, care should be taken not to bandage the area tightly, as this may impede circulation and lead to complications.

Side Effects

Patients should be aware that the product is intended for external use only and should avoid contact with the eyes. It is contraindicated for application on open wounds or damaged skin. In clinical practice, if symptoms persist for more than seven days, patients are advised to discontinue use and consult a physician.

Additionally, it is crucial to keep the product out of reach of children. In the event of accidental ingestion, patients should seek medical advice promptly. Furthermore, patients should not bandage the area tightly after application to prevent any potential complications.

Drug Interactions

No specific drug interactions have been identified for this medication. Additionally, there are no reported interactions with laboratory tests. 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 Point Relief Cold Spot Pain Relieving (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Point Relief Cold Spot Pain Relieving.
Details

Pediatric Use

Pediatric patients should be advised to keep this medication out of reach of children. In the event of accidental ingestion, it is important to consult a physician immediately.

Geriatric Use

There is no specific information available 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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

Pregnancy

There is no information available regarding the use of this medication during pregnancy, including safety concerns, dosage modifications, or any special precautions that should be taken. Healthcare professionals are advised to consider the lack of data when prescribing this medication to pregnant patients and to weigh the potential risks and benefits. Women of childbearing potential should be counseled accordingly.

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 may not have specific dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment and monitoring of these patients.

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 event of an overdosage, it is imperative that healthcare professionals take immediate action. If the product is ingested, the first step is to consult a physician for further evaluation and management.

Potential symptoms of overdosage may vary depending on the specific circumstances and the individual’s health status. Therefore, a thorough assessment by a healthcare provider is essential to determine the appropriate course of action.

Management of overdosage should be guided by clinical judgment and may include supportive care and symptomatic treatment as necessary. Continuous monitoring of the patient’s condition is recommended to address any emerging symptoms promptly.

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 consult a physician immediately if the product is swallowed. It is important to instruct patients not to bandage the area tightly after application, as this may lead to complications. Additionally, patients should be informed that the product should not be applied to open wounds or damaged skin to prevent adverse effects.

Patients should also be made aware that if their symptoms persist for more than seven days, they should discontinue use of the product and seek medical advice. This guidance is essential to ensure patient safety and effective management of their condition.

Storage and Handling

The product is supplied in packaging that includes specific NDC numbers. It should be stored at room temperature, ensuring that it is protected from light exposure. Freezing the product is not permitted, as it may compromise its integrity. Additionally, it is important to discard the product after opening to maintain safety and efficacy.

Additional Clinical Information

Patients should apply the medication directly to the affected area, ensuring that it is not used more than four times per day. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Point Relief Cold Spot Pain Relieving, 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 Point Relief Cold Spot Pain Relieving, 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.