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Cool N Heat

Last content change checked dailysee data sync status

This product has been discontinued

Active ingredient
Menthol 160 mg/1 mL
Other brand names
Dosage form
Spray
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2013
Label revision date
February 8, 2018
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Menthol 160 mg/1 mL
Other brand names
Dosage form
Spray
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 2013
Label revision date
February 8, 2018
Manufacturer
Walgreens
Registration number
part348
NDC root
0363-3207
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 medication is designed to provide temporary relief from pain and itching associated with various conditions, including arthritis, simple backache, muscle strains, bruises, cramps, and muscle sprains. It works by targeting the discomfort you may experience from these issues, helping to ease your symptoms and improve your comfort.

Uses

You can use this medication for the temporary relief of pain and itching caused by various conditions. It is effective for managing discomfort associated with arthritis, simple backaches, muscle strains, bruises, cramps, and muscle sprains.

This means that if you're dealing with any of these issues, this medication may help alleviate your symptoms and improve your comfort. Always consult with a healthcare professional for personalized advice and treatment options.

Dosage and Administration

Before using this medication, make sure to shake the bottle well. If you are an adult or a child aged 12 years and older, you can spray it on the affected area up to 3 to 4 times a day. However, if the person using it is under 12 years old, it’s important to consult a doctor first to ensure it’s safe and appropriate for them.

What to Avoid

It's important to use this medication 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 interfere with the medication's effectiveness and could cause discomfort. Always follow these guidelines to ensure your safety and the best possible outcome from your treatment.

Side Effects

When using this product, it's important to be aware of some potential side effects and safety precautions. You should avoid contact with your eyes and mucous membranes, and do not apply it to wounds or damaged skin. If your condition worsens, lasts more than seven days, or returns shortly after improvement, stop using the product and consult a doctor. Additionally, if you are pregnant or breastfeeding, it's best to consult a healthcare professional before use.

Keep this product out of reach of children, as swallowing it can be harmful. If ingestion occurs, seek medical help or contact a Poison Control Center immediately. Remember, this product is for external use only, and you should avoid using it near heat or flames, as it is flammable. Always store it properly and use it as directed.

Warnings and Precautions

This product is for external use only and is flammable, so please avoid using it while smoking or near any heat sources or flames. Store it in a cool place, not exceeding 104°F, and never puncture or incinerate the container, as it is under pressure. Additionally, do not store it at temperatures above 120°F.

When using this product, be careful to avoid contact with your eyes and mucous membranes, and do not apply it to wounds or damaged skin. It's important not to bandage the area tightly and to use the product only as directed. If your condition worsens, if symptoms last more than 7 days, or if they clear up and then return within a few days, stop using the product and call your doctor. If you need to use it for longer than one week, consult your healthcare provider.

In case of accidental swallowing, seek emergency medical help or contact a Poison Control Center immediately. If you are pregnant or breastfeeding, please consult a health professional before using this product.

Overdose

If you or someone else has swallowed too much of a medication, it’s important to seek medical help immediately. You can do this by contacting a Poison Control Center or going to the nearest emergency room. Acting quickly can make a significant difference in the outcome.

Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, don’t hesitate to get help right away. Remember, it’s always better to be safe and seek assistance if you suspect an overdose.

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 benefits for both you and your baby. Always prioritize your health and your child's well-being by seeking expert advice.

Pediatric Use

If your child is under 12 years old, it's important to consult a doctor before using this medication. For those aged 12 and older, you can apply the spray to the affected area, but be sure not to use it more than 3 to 4 times a day. Always follow these guidelines to ensure safe and effective use for your child.

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 the standard dosing guidelines apply, but it’s always important for you or your caregiver to discuss any potential risks or considerations with your healthcare provider.

If you are an older adult or caring for one, make sure to monitor for any unusual side effects or changes in health, and communicate openly with your doctor about any concerns. Your healthcare provider can help ensure that the medication is safe and effective for your individual needs.

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).

Before starting any new medication, including this one, you should discuss your liver health with your healthcare provider. They can help determine the best approach for your treatment and ensure your safety.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking, even if there are no specific drug interactions or laboratory test interactions noted for your treatment. This ensures that your healthcare team can monitor your health effectively and make informed decisions about your care.

Always feel free to ask questions and share all the medications and supplements you are using. This helps to avoid any potential issues and ensures that you receive the best possible treatment tailored to your needs.

Storage and Handling

To ensure the safety and effectiveness of your product, it's important to store it properly. Keep it in a cool, dry place, avoiding long-term storage at temperatures above 104°F (40°C) and never exceeding 120°F (49°C). High temperatures can compromise the product's integrity.

When handling the product, please remember that it is under pressure, so do not puncture or incinerate it. This will help prevent any accidents and ensure your safety while using the device. Always follow these guidelines to maintain the product's quality and your well-being.

Additional Information

You should apply this medication topically, spraying it on the affected area no more than 3 to 4 times a day if you are an adult or a child aged 12 years and older. If the user is under 12 years old, it's important to consult a doctor before use.

If you are pregnant or breastfeeding, make sure to ask a health professional for advice before using this product.

FAQ

What conditions can this drug temporarily relieve?

This drug can temporarily relieve pain and itching associated with arthritis, simple backache, muscle strains, bruises, cramps, and muscle sprains.

How should I use this drug?

Shake well before use. Spray on the affected area, not more than 3 to 4 times daily for adults and children 12 years and older. Consult a doctor for children under 12.

Are there any warnings I should be aware of?

This product is for external use only and is flammable. Avoid using it while smoking or near heat, and do not store it above 120°F.

What should I do if I experience worsening symptoms?

Stop use and ask a doctor if your condition worsens, symptoms last more than 7 days, or if symptoms clear up and occur again within a few days.

Is it safe to use this drug if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, ask a health professional before use.

What should I do if this product is swallowed?

If swallowed, get medical help or contact a Poison Control Center right away.

Are there any contraindications for this drug?

No specific contraindications are listed for this drug.

Can I apply this drug to wounds or damaged skin?

No, do not apply this drug to wounds or damaged skin.

Packaging Info

Below are the non-prescription pack sizes of Cool N Heat (menthol 16%). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Cool N Heat.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The product associated with SPL code 34089-3 does not have specific details regarding its chemical name, physical characteristics, or inactive ingredients available in the provided information. Further data may be required to furnish a comprehensive description.

Uses and Indications

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

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

Dosage and Administration

Healthcare professionals are advised to instruct patients to shake the product well before use. For adults and children aged 12 years and older, the recommended administration is to spray the product on the affected area, not exceeding 3 to 4 times daily. For children under 12 years of age, it is essential to consult a doctor prior to use to determine appropriate dosing and administration.

Contraindications

The product is contraindicated for application to wounds or damaged skin due to the potential for irritation and adverse effects. Additionally, it should not be used with tight bandaging, as this may compromise circulation and lead to further complications.

Warnings and Precautions

For external use only. This product is flammable; therefore, it should not be used while smoking or near heat or flame. Long-term storage above 104°F should be avoided, and the product must not be punctured or incinerated, as it contains contents under pressure. Additionally, storage at temperatures exceeding 120°F is prohibited.

When utilizing this product, it is crucial to avoid contact with the eyes and mucous membranes. The product should not be applied to wounds or damaged skin, and tight bandaging is not recommended. It is imperative to use the product only as directed to ensure safety and efficacy.

Healthcare professionals should advise patients to discontinue use and seek medical attention if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. Furthermore, if the product is needed for longer than one week, medical consultation is advised.

In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

For individuals who are pregnant or breastfeeding, it is essential to consult a healthcare professional prior to use to ensure safety for both the mother and child.

Side Effects

Patients should be aware that this product is for external use only. It is flammable; therefore, it should not be used while smoking or near heat or flame. Long-term storage above 104°F should be avoided, and the product should not be punctured or incinerated, as it contains contents under pressure. Additionally, storage at temperatures above 120°F is not recommended.

When using this product, patients should avoid contact with eyes and mucous membranes. It should not be applied to wounds or damaged skin, and tight bandaging should be avoided. The product should be used only as directed.

Patients are advised to stop use and consult a doctor if the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. If the product is needed for longer than 1 week, medical advice should be sought.

This product should be kept out of reach of children. In the event of ingestion, immediate medical help should be sought or contact with a Poison Control Center should be made.

For pregnant or breastfeeding individuals, it is recommended to consult a health professional before use.

Drug Interactions

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

Packaging & NDC

Below are the non-prescription pack sizes of Cool N Heat (menthol 16%). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Cool N Heat.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a doctor before use. For adolescents and children aged 12 years and older, the recommended application is to spray on the affected area, not exceeding 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

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 safe use during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this drug in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

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.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this drug. Consequently, there are no 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. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical help or contact a Poison Control Center without delay.

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 these contexts.

Postmarketing Experience

No postmarketing experience details are available in the provided data.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. Instruct patients that if the product is swallowed, they should seek medical help or contact a Poison Control Center immediately.

Patients should be informed to discontinue use and consult a doctor if their condition worsens or if symptoms persist for more than 7 days. Additionally, they should be cautioned to stop using the product and seek medical advice if symptoms clear up and then recur within a few days. It is important to remind patients not to use the product for longer than one week without consulting a healthcare professional.

While using this product, patients should be advised to avoid contact with their eyes and mucous membranes. They should also be instructed not to apply the product to wounds or damaged skin and to refrain from bandaging the area tightly. Emphasize the importance of using the product only as directed to ensure safety and efficacy.

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 in a controlled environment, avoiding long-term storage at temperatures exceeding 104°F. Additionally, the product must not be stored at temperatures above 120°F to maintain its integrity and efficacy.

Care should be taken to avoid puncturing or incinerating the container, as the contents are under pressure. Proper handling and storage conditions are crucial to ensure the safety and effectiveness of the product.

Additional Clinical Information

The product is administered topically, with a recommended application of 3 to 4 times daily for adults and children aged 12 years and older. For children under 12 years of age, consultation with a healthcare professional is advised prior to use. Clinicians should counsel patients to seek advice from a health professional if they are pregnant or breastfeeding before using the product.

No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Cool N Heat, 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 Cool N Heat, 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.