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Cvs Health Cold and Hot Pain Relieving

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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 2016
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 2016
Label revision date
December 17, 2024
Manufacturer
CVS Pharmacy
Registration number
M017
NDC root
59779-791
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, muscle strains, bruises, 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 conditions such as simple backache, arthritis, muscle strains, bruises, 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 mobility. Always consult with a healthcare professional if you have any questions or concerns about your symptoms or treatment options.

Dosage and Administration

When using this medication, you should apply it to the affected area of your skin no more than 3 to 4 times a day if you are an adult or a child aged 12 years and older. This helps ensure that you get the best results while minimizing the risk of side effects.

If the person needing treatment is a child under 12 years old, it’s important to consult a doctor before use. They can provide guidance on the appropriate dosage and whether this medication is suitable for your child. Always follow these instructions carefully to ensure safe and effective use.

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, as this can cause irritation. Additionally, avoid applying it to wounds or any irritated or damaged skin, and refrain from bandaging tightly over the area where it's applied. Using a heating pad or applying external heat while using this product is also not recommended, as it can lead to unwanted effects.

By following these guidelines, you can help ensure a safe and effective experience with the product. If you have any questions or concerns, 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 any irritated or damaged skin, and avoid tight bandaging or using it 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 persist for more than 7 days or return shortly after clearing up, seek medical advice.

Warnings and Precautions

This product is for external use only, so please avoid applying it to your eyes or any mucous membranes. Make sure to use it exactly as directed, and do not apply it to wounds or any irritated or damaged skin. It's important not to bandage the area tightly or use it with a heating pad or any external heat source.

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 persist for more than 7 days or improve and then return within a few days, reach out to your healthcare provider for advice.

In case of accidental swallowing, seek emergency medical help or contact a Poison Control Center immediately. Your safety is important, so please follow these precautions carefully.

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 are considering using this medication for your child, it's important to know that you should consult a doctor if your child is under 12 years old. For children aged 12 and older, you can apply the medication to the affected area up to 3 to 4 times a day.

Always keep this medication out of reach of children. If your child accidentally swallows it, seek medical help or contact a Poison Control Center immediately. Your child's safety is the top priority, so make sure to follow these guidelines closely.

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. Since older adults may have different health needs and may be taking multiple medications, it’s always a good idea to consult with a healthcare provider before starting any new medication. They can help ensure that the treatment is safe and appropriate for your individual health situation.

If you or a loved one is an older adult, be sure to discuss any concerns about potential side effects or interactions with other medications you may be taking. Your healthcare provider can provide guidance tailored to your specific 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 is safe and effective, especially if you have any concerns about your kidney health. They can provide the necessary guidance based on your individual situation.

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 if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and how it may relate to your treatment. They can help ensure that you receive the safest and most effective care.

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 protect it from excessive heat. It's important to keep the tube tightly closed when not in use to maintain its integrity. If you open the tube and do not use it within a specified time frame, be sure to discard it to ensure safety and effectiveness. Following these guidelines will help you handle the product safely and effectively.

Additional Information

You should apply this medication topically to the affected area, using it 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, it's important to consult a doctor before use. There are no additional details available regarding laboratory tests, abuse potential, or postmarketing experiences related to this medication.

FAQ

What conditions does this drug temporarily relieve?

This drug temporarily relieves minor aches and pains of muscles and joints associated with simple backache, arthritis, muscle strains, bruises, 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. For children under 12 years, ask a doctor.

Are there any warnings I should be aware of?

Yes, this product is for external use only. Avoid contact with eyes and mucous membranes, and do not apply to wounds or irritated 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 accidentally swallow this 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 pregnant or breastfeeding, ask a health professional before use.

How should I store this drug?

Store at room temperature, protect from excessive heat, and keep the tube tightly closed when not in use.

Packaging Info

Below are the non-prescription pack sizes of Cvs Health Cold and Hot Pain Relieving (menthol, methyl salicylate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Cvs Health Cold and Hot Pain Relieving.
Details

Drug Information (PDF)

This file contains official product information for Cvs Health Cold and Hot Pain Relieving, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

This product is presented in a carton and is identified by the code 51945-4, as per the code system 2.16.840.1.113883.6.1. The effective date of this labeling is June 17, 2022. The principal display panel includes a multimedia rendering, which is referenced as image-01.jpg.

Uses and Indications

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

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

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. It is important to ensure that the application is limited to the specified frequency to avoid potential adverse effects.

For children under 12 years of age, it is advised to consult a physician before use to determine the appropriate dosage and administration guidelines tailored to the child's specific needs.

Contraindications

Use is contraindicated in the following situations:

  • Application to the eyes or mucous membranes is prohibited due to the potential for irritation and adverse effects.

  • The product should not be applied to wounds or areas of irritated or damaged skin, as this may exacerbate the condition or lead to further complications.

  • Tight bandaging of the area post-application is contraindicated to prevent restricted blood flow and potential tissue damage.

  • The use of external heat sources, such as heating pads, in conjunction with this product is not recommended, as it may increase the risk of adverse reactions.

Warnings and Precautions

For external use only. It is imperative that the product is utilized strictly as directed to ensure safety and efficacy. Care should be taken to avoid contact with the eyes and mucous membranes, as exposure may lead to irritation. The product should not be applied to wounds or areas of irritated or damaged skin, as this may exacerbate the condition. Additionally, it is advised not to bandage the area tightly or use the product in conjunction with a heating pad or any form of external heat, as these practices may increase the risk of adverse effects.

Healthcare professionals should instruct patients 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 for more than 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 local Poison Control Center should be contacted without delay.

Side Effects

Patients should be aware that this product is for external use only and must be used strictly as directed. It is important to avoid contact with the eyes and mucous membranes, and the product should not be applied to wounds or areas of irritated or damaged skin. Additionally, patients should refrain from bandaging the area tightly and should not use the product in conjunction with a heating pad or apply external heat.

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

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 Cvs Health Cold and Hot Pain Relieving (menthol, methyl salicylate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Cvs Health Cold and Hot Pain Relieving.
Details

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For adolescents and adults aged 12 years and older, the recommended application is to the affected area no more than 3 to 4 times daily.

It is important to keep this product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is advised.

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 potential adverse effects or changes in efficacy.

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

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 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 absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and consider the potential risks associated with excessive administration of the medication.

It is essential to monitor patients closely for any signs or symptoms that may arise from overdosage. Symptoms may vary depending on the individual and the extent of the overdose.

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

For further guidance, consultation with a poison control center or a medical toxicologist is recommended to ensure appropriate management of the situation.

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 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. Patients should be cautioned against getting the product into their eyes or on mucous membranes. They should also be advised not to apply the product to wounds or to irritated or damaged skin. Furthermore, patients should be informed not to bandage the area tightly and to avoid using the product in conjunction with a heating pad or applying external heat.

Storage and Handling

The product is supplied in a tube format, with specific handling and storage requirements to ensure its integrity and effectiveness. It should be stored at room temperature, away from excessive heat to maintain its quality.

To prevent contamination and preserve the product, the tube must be kept tightly closed when not in use. Additionally, it is important to discard the product after opening if it is not used within the specified time frame, which is not detailed in the provided information.

Additional Clinical Information

The medication is administered topically, with a recommended application frequency of no more than 3 to 4 times daily for adults and children aged 12 years and older. For children under 12 years, it is advised to consult a doctor regarding the appropriate use. There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Cvs Health Cold and Hot 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 Cvs Health Cold and Hot 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.

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.