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Cooln Heat Muscle Rub

Last content change checked dailysee data sync status

This product has been discontinued

Active ingredient
Menthol 2.5 g/100 mL
Other brand names
Dosage form
Gel
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2016
Label revision date
February 20, 2018
Active ingredient
Menthol 2.5 g/100 mL
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 2016
Label revision date
February 20, 2018
Manufacturer
Walgreens
Registration number
part348
NDC root
0363-7002

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Drug Overview

This drug is designed to provide temporary relief from minor pain associated with various conditions, including arthritis, simple backaches, strains, and bruises. It works by targeting the discomfort you may experience from these common ailments, helping you feel more comfortable in your daily activities.

Uses

If you're dealing with minor pain from conditions like arthritis, simple backaches, strains, or bruises, this medication can help provide temporary relief. It's designed to ease discomfort so you can go about your daily activities with less pain.

Rest assured, there are no concerns about teratogenic effects (which means it won't cause birth defects) associated with this medication. This makes it a safer option for those who may be pregnant or planning to become pregnant.

Dosage and Administration

To use the pain-relieving gel, start by squeezing the amount you need directly onto the area where you feel pain. Make sure to rub it in until it is completely absorbed into your skin. You can apply the gel as needed, but be careful not to use it more than four times in one day.

If you are using this gel for a child who is 12 years old or younger, it’s important to consult a doctor before applying it. This ensures that the treatment is safe and appropriate for their age and condition.

What to Avoid

You can feel reassured that there are no specific contraindications, controlled substance classifications, or risks of abuse or misuse associated with this medication. Additionally, there are no concerns regarding dependence (a condition where your body becomes reliant on a substance) or any particular instructions advising against its use. Always consult with your healthcare provider if you have any questions or concerns about your treatment.

Side Effects

When using this product, it's important to follow the instructions carefully to avoid potential issues. This product is for external use only, so make sure not to apply it to wounds or any damaged, broken, or irritated skin. Additionally, avoid contact with your eyes or mucous membranes, and do not bandage the area tightly or use it with a heating pad.

By adhering to these guidelines, you can help ensure a safer experience while using the product.

Warnings and Precautions

This product is for external use only, so please make sure to follow the directions carefully. Avoid wrapping the area tightly or using a heating pad while applying it. It's important to keep the product away from your eyes and any mucous membranes, and do not apply it to wounds or any skin that is damaged, broken, or irritated.

If you experience any unusual reactions or have concerns while using this product, stop using it immediately and contact your doctor for further advice. Always prioritize your safety and well-being when using any medical product.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there is no specific information available about the signs of overdose for this medication, general 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, contacting your healthcare provider or local poison control center is crucial. They can provide guidance on what steps to take next. Always err on the side of caution—if you feel something is wrong, don’t hesitate to get help.

Pregnancy Use

When it comes to using this product during pregnancy, there is no specific information available in the drug insert. This means that there are no clear guidelines about whether the product is safe or poses any risks to you or your developing baby. Additionally, there are no recommendations for adjusting the dosage or taking special precautions if you are pregnant.

If you are pregnant or planning to become pregnant, it’s always best to consult with your healthcare provider before using any medication. They can help you weigh the potential benefits and risks based on your individual situation.

Lactation Use

Currently, there is no specific information available about the use of COOLN HEAT MUSCLE RUB for nursing mothers or during lactation (the period of breastfeeding). This means that the effects of this product on breast milk or nursing infants have not been studied or documented.

If you are breastfeeding and considering using this product, it’s a good idea to consult with your healthcare provider to discuss any potential risks or concerns. They can help you make an informed decision that prioritizes your health and the well-being of your baby.

Pediatric Use

If you are considering this medication for a child who is 12 years old or younger, it’s important to consult with a doctor first. This ensures that the treatment is safe and appropriate for your child's specific needs. Always prioritize professional guidance when it comes to the health of your little ones.

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 considering this medication, it’s important to consult with a healthcare provider. 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 there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations for the medication do not include special monitoring or safety considerations tailored for patients with 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 provide guidance based on your individual needs and kidney function.

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 discuss any concerns you may have about taking this medication with your liver condition. They can help ensure that your treatment is safe and effective for you.

Drug Interactions

It's great to know that there are no reported drug interactions or laboratory test interactions with this medication. However, it's still very important to discuss all medications you are taking, including over-the-counter drugs and supplements, with your healthcare provider. This ensures that your treatment is safe and effective, and helps avoid any potential issues.

Always keep your healthcare provider informed about any changes in your health or new medications you may start. Open communication is key to managing your health effectively.

Storage and Handling

To ensure the best performance of your product, store it at room temperature, away from excessive heat. It's important to avoid freezing, as this can damage the product. Once you open the package, please remember to discard any unused portions to maintain safety and effectiveness. Following these guidelines will help you use the product safely and effectively.

Additional Information

You can use this pain-relieving gel by applying it directly to the painful area of your skin. For adults and children over 12 years old, squeeze the desired amount of gel and rub it in until it is fully absorbed. You can repeat this process as needed, but do not apply it more than four times a day. If you are considering using it for a child under 12 years old, be sure to consult a doctor first.

FAQ

What minor pains does this drug relieve?

This drug provides temporary relief of minor pain associated with arthritis, simple backache, strains, and bruises.

How should adults and children over 12 use this drug?

Squeeze the desired amount of pain relieving gel into the painful area until thoroughly absorbed. You can repeat this as necessary, but not more than 4 times daily.

What should children 12 years or younger do?

Children 12 years or younger should ask a doctor before using this product.

Are there any warnings for using this drug?

Yes, this product is for external use only. Avoid contact with eyes or mucous membranes, do not apply to wounds or damaged skin, and do not bandage tightly or use with a heating pad.

Is there any information about the drug's use during pregnancy?

No specific information regarding use during pregnancy is provided, and there are no contraindications mentioned.

How should this drug be stored?

Store at room temperature, protect from excessive heat, and do not freeze. Discard after opening.

Are there any contraindications for this drug?

No contraindications are listed for this drug.

What is the effective date for the information provided?

The effective time for the information provided is February 20, 2018.

Packaging Info

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

Packaging configurations for Cooln Heat Muscle Rub.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No specific details regarding the Description section for SPL code 34089-3 are provided in the text.

Uses and Indications

This drug is indicated for the temporary relief of minor pain associated with various conditions, including arthritis, simple backache, strains, and bruises.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

For adults and children over 12 years of age, the recommended application involves squeezing the desired amount of pain-relieving gel directly onto the affected area. The gel should be massaged into the skin until it is thoroughly absorbed. This application may be repeated as necessary, but should not exceed four times within a 24-hour period.

For children aged 12 years or younger, it is advised to consult a physician prior to use to determine appropriate dosing and administration.

Contraindications

There are no contraindications associated with the use of this product. It is deemed safe for use in the absence of specific conditions or situations that would warrant avoidance.

Warnings and Precautions

This product is intended for external use only. Healthcare professionals should advise patients to use the product strictly as directed. It is imperative to avoid bandaging the area tightly or using it in conjunction with a heating pad, as these practices may lead to adverse effects.

Contact with the eyes or mucous membranes must be avoided to prevent irritation or injury. Additionally, the product should not be applied to wounds or any areas of damaged, broken, or irritated skin, as this could exacerbate the condition or lead to complications.

Healthcare providers should ensure that patients are aware of these warnings to promote safe and effective use of the product.

Side Effects

Patients should be aware that this product is for external use only. It is imperative to use the product strictly as directed to minimize the risk of adverse reactions. Patients are advised against bandaging tightly or using the product in conjunction with a heating pad, as these practices may lead to increased adverse effects.

Additionally, care should be taken to avoid contact with the eyes or mucous membranes, as this may result in irritation or other complications. The product should not be applied to wounds or any damaged, broken, or irritated skin, as this could exacerbate adverse reactions or lead to further complications.

These precautions are essential to ensure the safe and effective use of the product, and adherence to these guidelines is strongly recommended to prevent potential adverse effects.

Drug Interactions

There are no known drug interactions associated with the use of this medication. Additionally, there are no reported interactions between this drug and laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

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

Packaging configurations for Cooln Heat Muscle Rub.
Details

Pediatric Use

Pediatric patients 12 years of age or younger should consult a healthcare professional before use. It is important to assess the appropriateness of treatment and dosage for this age group, as specific recommendations may vary based on individual health needs and conditions.

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

Pregnancy

There is no specific information regarding the use of this product in pregnant patients. The prescribing information does not indicate whether the product is contraindicated during pregnancy or outline any associated risks to the fetus. Additionally, there are no dosage modifications or special precautions recommended for use in pregnant individuals. Healthcare professionals should consider the lack of data when prescribing this product to women of childbearing potential and weigh the potential benefits against any unknown risks.

Lactation

There is no specific information available regarding the use of COOLN HEAT MUSCLE RUB in lactating mothers or its effects on breastfed infants. Healthcare professionals should exercise caution and consider the lack of data when advising lactating mothers on the use of this product.

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 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 and consider the overall clinical context when prescribing this medication to patients with hepatic impairment.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution when administering the medication. It is essential to monitor patients closely for any signs of adverse effects or symptoms that may arise from excessive dosing.

In the event of suspected overdosage, immediate medical attention should be sought. Healthcare providers should implement supportive measures as necessary, which may include symptomatic treatment and monitoring of vital signs.

Due to the lack of detailed overdosage information, it is recommended that healthcare professionals refer to established clinical guidelines and protocols for managing overdose situations relevant to the specific medication in question. Additionally, contacting a poison control center may provide further guidance on appropriate management strategies.

Continued vigilance and patient assessment are crucial in mitigating potential risks associated with 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 the medication out of reach of children to prevent accidental ingestion or misuse. It is important to emphasize the necessity of proper storage to ensure the safety of young children.

Storage and Handling

The product is supplied in configurations that include specific NDC numbers. It should be stored at room temperature, ensuring that it is protected from excessive heat. Freezing is not permitted, as it may compromise the integrity of the product. Once opened, the product must be discarded to ensure safety and efficacy.

Additional Clinical Information

The product is administered topically. For adults and children over 12 years, the recommended application involves squeezing the desired amount of pain-relieving gel onto the painful area until it is thoroughly absorbed, with a maximum frequency of four times daily as needed. For children aged 12 years or younger, it is advised to consult a doctor before use.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Cooln Heat 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 Cooln Heat 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

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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.