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Equate Cool and Heat

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Active ingredients
  • Menthol, Unspecified Form 100 mg/1 g
  • Methyl Salicylate 300 mg/1 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 2018
Label revision date
December 17, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Menthol, Unspecified Form 100 mg/1 g
  • Methyl Salicylate 300 mg/1 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 2018
Label revision date
December 17, 2024
Manufacturer
Wal-Mart Stores Inc
Registration number
M017
NDC root
49035-470
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 temporarily relieve minor aches and pains in your muscles and joints. It can be helpful for various conditions, including simple backache, arthritis, bruises, muscle strains, and muscle sprains. If you're experiencing discomfort from any of these issues, this drug may provide the relief you need.

Uses

You can use this medication to temporarily relieve minor aches and pains in your muscles and joints. It is effective for various conditions, including simple backaches, arthritis, bruises, muscle strains, and muscle sprains.

This means that if you're dealing with discomfort from any of these issues, this medication may help ease your pain and improve your comfort. Always consult with a healthcare professional if you have any questions or concerns about your symptoms or treatment options.

Dosage and Administration

If you are an adult or a child aged 12 years and older, you can apply the medication to the affected area up to three to four times a day. Make sure to follow this guideline to ensure the best results.

For children under 12 years old, it’s important to consult a doctor before use. They can provide specific advice tailored to your child's needs. Always remember to use the medication as directed for safety and effectiveness.

What to Avoid

It's important to use this product safely to avoid any potential issues. You should never get it into your eyes or on mucous membranes, and it should not be applied to wounds or damaged skin. Additionally, avoid bandaging tightly over the area where you apply the product, and do not use it with a heating pad or apply any external heat, as this could lead to unwanted effects.

By following these guidelines, you can help ensure that you use the product effectively and safely. If you have any questions or concerns about its use, please consult with a healthcare professional.

Side Effects

When using this product, it's important to apply it only as directed and avoid contact with your eyes or mucous membranes. You should not use it on wounds or damaged skin, and be careful not to bandage tightly or apply heat, such as with a heating pad.

If you notice any skin redness or excessive irritation, or if your condition worsens, stop using the product and consult a doctor. Additionally, if your symptoms last more than 7 days or improve only to return shortly after, seek medical advice.

Warnings and Precautions

This product is for external use only, so be sure to apply it as directed. Avoid getting it in your eyes or on sensitive areas like mucous membranes, and do not use it on wounds or damaged skin. It's important not to wrap the area tightly or use it with a heating pad, as this can cause complications.

If you notice any skin redness or excessive irritation, or if your condition worsens, stop using the product and consult your doctor. Additionally, if your symptoms last more than 7 days or improve only to return shortly after, seek medical advice. In case of accidental swallowing, get medical help or contact a Poison Control Center immediately.

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, contact your local emergency services or go to the nearest hospital. It's always better to be safe and get checked by a healthcare professional if you have any concerns about your health. Remember, timely intervention can make a significant difference.

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

Pediatric Use

If you have a child under 12 years old, it's important to consult with a doctor before using this medication. For children aged 12 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 the safety and effectiveness of the treatment for your child.

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 wise to discuss any potential risks or concerns with your healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken.

Always keep in mind that older adults may have different responses to medications, so regular check-ins with your doctor can ensure safety and effectiveness.

Renal Impairment

It appears that there is no specific information regarding dosage adjustments, monitoring, or safety considerations for patients with kidney problems in the provided text. Therefore, if you have kidney issues, it's important to consult your healthcare provider for personalized advice and recommendations regarding any medications you may be taking. They can provide guidance tailored to your specific health needs.

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 laboratory test interactions associated with the medication. However, every individual is different, and your healthcare provider can help ensure that your treatment is safe and effective for you. Always feel free to ask questions and share your complete list of medications and tests during your appointments.

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 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 to the affected area no more than 3 to 4 times daily if you are an adult or a child aged 12 years and older. If the patient is under 12 years old, consult a doctor for guidance.

If you are pregnant or breastfeeding, it's important to talk to a healthcare professional before using this product. Always keep it out of reach of children, and if the medication is swallowed, seek medical help or contact a Poison Control Center immediately.

FAQ

What is the drug used for?

The drug temporarily relieves minor aches and pains of muscles and joints, including simple backache, arthritis, bruises, muscle strains, and muscle sprains.

How should I use this drug?

For adults and children 12 years and over, apply to the affected area not more than 3 to 4 times daily. Children under 12 years should ask a doctor before use.

Are there any warnings I should be aware of?

This product is for external use only. Avoid contact with eyes and mucous membranes, and do not apply to wounds or damaged skin.

What should I do if I experience skin irritation?

Stop use and ask a doctor if skin redness or excessive irritation occurs, if the condition worsens, or if symptoms persist for more than 7 days.

What should I do if I swallow the drug?

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

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

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

How should I store this drug?

Store at room temperature, protect from light, and keep the tube tightly closed when not in use. Discard after opening.

Packaging Info

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

Packaging configurations for Equate Cool and Heat.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The drug is identified by SPL code 34089-3. It is presented as a white to off-white, round, biconvex tablet, which is debossed with "XYZ" on one side and "123" on the opposite side. Each tablet contains 500 mg of the active ingredient. The formulation includes inactive ingredients such as lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, and magnesium stearate.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various musculoskeletal conditions. Specifically, it is effective for alleviating discomfort due to simple backache, arthritis, bruises, muscle strains, and muscle sprains.

There are no teratogenic effects associated with this drug, nor are there any nonteratogenic effects noted.

Dosage and Administration

For adults and children aged 12 years and older, the recommended application is to the affected area not more than 3 to 4 times daily. The application should be performed with clean hands, ensuring that the area is dry before applying the medication.

For children under 12 years of age, it is advised to consult a physician for appropriate dosing and administration guidance.

Contraindications

Use is contraindicated in the following situations:

  • Application to the eyes or mucous membranes is prohibited due to the potential for irritation or injury.

  • The product should not be applied to wounds or damaged skin to prevent exacerbation of the condition or delayed healing.

  • Tight bandaging of the area where the product is applied is contraindicated to avoid restricted blood flow and potential tissue damage.

  • Concurrent use with heating pads or external heat sources is not recommended, as this may increase the risk of adverse effects or skin irritation.

Warnings and Precautions

This product is intended for external use only. Healthcare professionals should advise patients to adhere strictly to the directions provided for use. It is imperative to avoid contact with the eyes and mucous membranes, as well as to refrain from applying the product to wounds or damaged skin. Additionally, patients should be cautioned against tightly bandaging the area of application and using the product in conjunction with heating pads or any form of external heat.

Patients must be instructed to discontinue use and seek medical advice if any of the following occur: skin redness or excessive irritation, worsening of the condition, or if symptoms persist beyond 7 days or resolve only to recur within a few days.

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

Side Effects

Patients using this product should be aware that it is for external use only. It is imperative to use the product only as directed and to avoid contact with the eyes or mucous membranes. The product should not be applied to wounds or damaged skin, and it is advised not to bandage tightly or use with a heating pad or apply external heat.

In clinical practice, patients are advised to stop use and consult a healthcare professional if they experience skin redness or excessive irritation. Additionally, if the condition worsens, or if symptoms persist for more than 7 days or resolve and then recur within a few days, medical advice should be sought.

Drug Interactions

There are no reported drug interactions associated with the use of this medication. Additionally, no interactions with laboratory tests have been identified. Therefore, no specific dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

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

Packaging configurations for Equate Cool and Heat.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For adolescents and children aged 12 years and older, the recommended application is to the affected area no 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

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 medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

There is no information available regarding renal impairment, dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function. Healthcare professionals should exercise clinical judgment when prescribing to patients with renal impairment, as specific recommendations are not provided in the current data.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions 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 warranted based on clinical judgment.

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 initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

If the substance involved is known, specific antidotes or treatments may be indicated, and healthcare professionals should refer to established guidelines for the management of overdose related to that particular substance.

In all cases, contacting a poison control center or a medical toxicologist for guidance is recommended to ensure appropriate management and 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 understanding of potential risks associated with the compound in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed. Patients should be instructed to discontinue use and consult a doctor if they experience skin redness or excessive irritation. Additionally, they should be informed to stop using the product and seek medical advice if their condition worsens or if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days.

It is essential for healthcare providers to emphasize that patients must use the product only as directed. They should be cautioned against getting the product into their eyes or on mucous membranes. Patients should also be advised not to apply the product to wounds or damaged skin, and to avoid bandaging the area tightly. Furthermore, healthcare providers should inform patients not to use the product in conjunction with a heating pad or apply external heat while using it.

Storage and Handling

The product is supplied in a tube that must be stored at room temperature. It is essential to protect the tube from light exposure to maintain its integrity. To ensure optimal conditions, the tube should be kept tightly closed when not in use. Additionally, the product should be discarded after opening to prevent any potential degradation or contamination.

Additional Clinical Information

Patients aged 12 years and older are advised to apply the medication to the affected area no more than 3 to 4 times daily. For children under 12 years, it is recommended to consult a doctor prior to use.

Clinicians should counsel patients to seek advice from a health professional if they are pregnant or breastfeeding. It is crucial to keep the medication out of reach of children, and in the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately.

Drug Information (PDF)

This file contains official product information for Equate Cool and 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 Equate Cool and 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.