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Cool Heat

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This product has been discontinued

Active ingredients
  • Menthol 10 g/100 g
  • Methyl Salicylate 30 g/100 g
Other brand names
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2016
Label revision date
July 1, 2016
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Menthol 10 g/100 g
  • Methyl Salicylate 30 g/100 g
Other brand names
Dosage form
Cream
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 2016
Label revision date
July 1, 2016
Manufacturer
Dolgencorp Inc
Registration number
part348
NDC root
55910-405
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

COOL HEAT PAIN RELIEVING CREAM is an extra strength topical cream designed to temporarily relieve minor pain. It can be used for various types of discomfort, including pain associated with arthritis, simple backaches, muscle strains, sprains, bruises, and cramps.

This cream works by providing a soothing sensation that helps alleviate pain, making it a convenient option for those seeking relief from everyday aches and pains.

Uses

If you're dealing with minor pain, this medication can help provide temporary relief. It's effective for various types of discomfort, including pain from arthritis, simple backaches, muscle strains, sprains, bruises, and cramps. Whether you're recovering from an injury or just experiencing everyday aches, this medication can support your comfort.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) associated with this medication, making it a safer option for those concerned about such risks.

Dosage and Administration

When using this medication, if you are an adult or a child over 12 years old, you should apply a generous amount to the area that is causing you pain. Make sure to massage it into your skin until it is fully absorbed. You can repeat this process as needed, but do not apply it more than four times in a single day.

If you are caring for a child who is 12 years old or younger, it’s important to consult a doctor before using this medication. They can provide guidance on the appropriate use for younger children.

What to Avoid

It's important to use this medication safely to avoid any potential issues. You should not bandage the area tightly or use a heating pad while using this product. Additionally, avoid applying it to wounds or any damaged, broken, or irritated skin, as this can lead to complications.

By following these guidelines, you can help ensure that you use the medication effectively and safely. If you have any questions or concerns about its use, please consult your healthcare provider for more information.

Side Effects

It's important to be aware of some key warnings associated with this product. It is for external use only, meaning it should not be ingested. If you have a history of allergic reactions to aspirin or salicylates (a group of chemicals related to aspirin), you should consult your doctor before using this product to ensure it is safe for you.

Always prioritize your health and safety by being informed about potential reactions. If you experience any unusual symptoms after using the product, seek medical advice promptly.

Warnings and Precautions

This product is for external use only. If you have a history of allergic reactions to aspirin or salicylates, please consult your doctor before using it. If you are pregnant or breastfeeding, it's important to talk to a healthcare professional before use. Always keep this product out of reach of children.

In the event of accidental ingestion, seek medical help immediately or contact a Poison Control Center. Your safety is a priority, so please take these precautions seriously.

Overdose

If you accidentally take 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.

Signs of an overdose can vary, but they may include unusual symptoms that are not typical for you. If you notice anything concerning, don’t hesitate to reach out for help. Remember, acting quickly can make a significant difference in your safety and health.

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 professional 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 can make informed decisions about your health and the health of your baby. Always prioritize open communication with your healthcare provider regarding your breastfeeding journey.

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 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, make sure to communicate openly with your doctor about your overall health and any other medications you may be taking. This will help ensure that you receive the safest and most effective treatment tailored to your 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 monitor your liver function and make any necessary adjustments to your care.

Drug Interactions

If you have a history of allergic reactions to aspirin or salicylates, it's important to talk to your doctor before using this medication. Allergies can lead to serious health issues, and your healthcare provider can help determine the best course of action for you.

Additionally, there are no specific interactions with other drugs or laboratory tests noted, but it's always a good practice to discuss all medications and tests with your healthcare provider. This ensures that you receive safe and effective care tailored to your needs.

Storage and Handling

To ensure the best performance of your product, store it at room temperature and protect it from excessive heat. It's important to keep the tube tightly closed when not in use to maintain its integrity. Once you open the tube, please remember to discard it after use to ensure safety and effectiveness. Following these simple guidelines will help you handle the product safely and effectively.

Additional Information

You should apply this medication topically to the affected area, gently massaging it into the skin until fully absorbed. For adults and children over 12 years, you can repeat this process as needed, but do not exceed four applications in a day. If the user is a child under 12 years old, consult a doctor before use.

It's important to be aware of a few safety precautions. If you have a history of allergic reactions to aspirin or salicylates, talk to your doctor before using this product. Additionally, if you are pregnant or breastfeeding, consult a healthcare professional first. Always keep the medication out of reach of children, and in case of accidental ingestion, seek medical help or contact a Poison Control Center immediately.

FAQ

What is COOL HEAT PAIN RELIEVING CREAM used for?

COOL HEAT PAIN RELIEVING CREAM is used to temporarily relieve minor pain associated with conditions like arthritis, simple backache, muscle strains, sprains, bruises, and cramps.

How should I apply COOL HEAT PAIN RELIEVING CREAM?

For adults and children over 12 years, apply generously to the affected area and massage until thoroughly absorbed. You can repeat this up to 4 times daily.

Are there any precautions for using this cream?

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

What should I do if I accidentally ingest the cream?

If accidental ingestion occurs, seek medical help or contact a Poison Control Center immediately.

Can I use this cream if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, consult a healthcare professional before using COOL HEAT PAIN RELIEVING CREAM.

Is there an allergy alert for this product?

Yes, if you are prone to allergic reactions from aspirin or salicylates, consult a doctor before use.

What is the storage requirement for this cream?

Store COOL HEAT PAIN RELIEVING CREAM at room temperature, protect it from excessive heat, and keep the tube tightly closed when not in use.

Is this cream safe for children under 12?

For children 12 years or younger, you should ask a doctor before use.

Packaging Info

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

Packaging configurations for Cool Heat.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

EXTRA STRENGTH COOL HEAT PAIN RELIEVING CREAM is a topical formulation designed for pain relief. The product has a net weight of 1.25 ounces (35 grams).

Uses and Indications

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

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 dosage is to apply the product generously to the affected area. The application should be followed by a gentle massage into the painful area until the product is thoroughly absorbed into the skin. This process may be repeated as necessary, but should not exceed four applications within a 24-hour period.

For children 12 years of age or younger, it is advised to consult a physician before use.

Contraindications

Use of this product is contraindicated in the following situations:

Tight bandaging or the application of a heating pad is not recommended, as this may lead to adverse effects. Additionally, the product should not be applied to wounds or areas of damaged, broken, or irritated skin to prevent further irritation or complications.

Warnings and Precautions

For external use only. Individuals with a known allergy to aspirin or salicylates should consult a healthcare professional prior to use to mitigate the risk of an allergic reaction.

Pregnant or breastfeeding individuals are advised to seek guidance from a healthcare professional before using this product. It is essential to keep this product out of the reach of children to prevent accidental ingestion. In the event of accidental ingestion, immediate medical assistance should be sought, or contact a Poison Control Center without delay.

No specific laboratory tests are recommended for monitoring in conjunction with the use of this product. However, vigilance regarding the aforementioned precautions is critical to ensure safe usage.

Side Effects

Patients should be aware that the product is intended for external use only. There is an allergy alert for individuals who are prone to allergic reactions from aspirin or salicylates; such patients are advised to consult a doctor prior to use.

No additional serious or common adverse reactions have been reported in clinical trials or postmarketing experiences. It is essential for patients to monitor for any unexpected reactions and to seek medical advice if they experience any adverse effects.

Drug Interactions

Patients with a known allergy to aspirin or salicylates should consult a healthcare professional prior to use, as there is a potential risk of allergic reactions.

No specific drug or laboratory test interactions have been identified in the available data. Therefore, routine monitoring or dosage adjustments related to drug interactions are not necessary.

Packaging & NDC

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

Packaging configurations for Cool Heat.
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

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 healthcare 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 not been specifically addressed in the prescribing information 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 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 accidental ingestion, it is imperative to seek immediate medical assistance or contact a Poison Control Center. Prompt action is crucial to ensure the safety and well-being of the patient.

Healthcare professionals should be aware that symptoms of overdosage may vary depending on the substance involved. Therefore, a thorough assessment of the patient's condition is essential.

Management of overdosage should include supportive care and symptomatic treatment as necessary. Continuous monitoring of the patient's vital signs and clinical status is recommended to address any complications that may arise.

In all cases of suspected overdosage, it is vital to gather as much information as possible regarding the substance, the amount ingested, and the time of ingestion to facilitate appropriate medical intervention.

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 text.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. In the event of accidental ingestion, patients should seek medical help or contact a Poison Control Center immediately.

When using this product, it is essential for patients to use it only as directed. They should be informed not to bandage tightly or use the product in conjunction with a heating pad, as this may lead to adverse effects. Patients should also be cautioned to avoid contact with the eyes or mucous membranes, as this could cause irritation. Furthermore, it is important to instruct patients not to apply the product to wounds or to damaged, broken, or irritated skin to ensure safe and effective use.

Storage and Handling

The product is supplied in a tube format, with specific handling and storage requirements to ensure its integrity and efficacy. It should be stored at room temperature, away from excessive heat. To maintain the quality of the product, the tube must be kept tightly closed when not in use. Additionally, it is important to discard the product after opening to prevent any potential degradation or contamination.

Additional Clinical Information

The product is administered topically, with specific instructions for different age groups. Adults and children over 12 years should apply the product generously to the affected area, massaging it into the skin until fully absorbed, with a maximum frequency of four times daily. For children aged 12 years or younger, it is advised to consult a doctor before use.

Clinicians should counsel patients on important safety information. Individuals with a history of allergic reactions to aspirin or salicylates should seek medical advice prior to use. Pregnant or breastfeeding patients are also encouraged to consult a healthcare professional. Additionally, the product should be kept out of reach of children, and in the event of accidental ingestion, immediate medical assistance or contact with a Poison Control Center is necessary.

Drug Information (PDF)

This file contains official product information for Cool 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 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.