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Cold and Hot

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This product has been discontinued

Active ingredients
  • Menthol 7.6 g/100 g
  • Methyl Salicylate 29.0 g/100 g
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 2014
Label revision date
May 10, 2018
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Menthol 7.6 g/100 g
  • Methyl Salicylate 29.0 g/100 g
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 2014
Label revision date
May 10, 2018
Manufacturer
CVS
Registration number
part348
NDC root
59779-269
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

You can use this medication for the temporary relief of minor aches and pains in your muscles and joints. It is particularly helpful for conditions associated with arthritis, simple backaches, muscle strains, bruises, and sprains. This means that if you're experiencing discomfort from these common issues, this drug may provide you with some much-needed relief.

Uses

If you're dealing with minor aches and pains in your muscles and joints, this medication can help provide temporary relief. It's effective for discomfort associated with conditions like arthritis, simple backaches, muscle strains, bruises, and sprains.

You can rely on this treatment to ease your pain and help you get back to your daily activities. Remember, it's designed for short-term use to manage these specific types of discomfort.

Dosage and Administration

Before using the medication, make sure to shake the bottle well. If you are an adult or a child aged 2 years and older, you can spray the product directly onto the affected area. You should apply it no more than 3 to 4 times a day for the best results.

If your child is under 2 years old, it’s important to consult a doctor before using this product to ensure it’s safe and appropriate for their needs. Always follow these guidelines to help manage your condition effectively.

What to Avoid

It's important to be aware of certain precautions when using this medication. While there are no specific contraindications or concerns about abuse, misuse, or dependence (which means relying on a substance in a harmful way), you should take care to follow safety instructions.

If you accidentally swallow the medication, please seek help immediately or contact a Poison Control Center. Your safety is the top priority, so always use the medication as directed and reach out for assistance if needed.

Side Effects

When using this product, it's important to be aware of some potential side effects and safety warnings. You should avoid contact with your eyes and mucous membranes, and do not apply it to wounds or damaged skin. If your condition worsens, symptoms persist for more than a week, or if you need to use it for longer than a week, stop using the product and consult your doctor.

Additionally, if you are pregnant or breastfeeding, it's best to consult a healthcare professional before using this product. Remember, this product is for external use only and is flammable, so keep it away from fire, flames, and high temperatures. Always use it as directed and avoid tight bandaging.

Warnings and Precautions

This product is for external use only, so please avoid applying it to your eyes, mucous membranes, or any wounds and damaged skin. It’s important to use it as directed and not to bandage the area tightly. Remember, this product is flammable, so keep it away from fire, flames, and heat sources. Do not smoke while using it, and avoid storing it in temperatures above 104°F or puncturing the container, as it is under pressure.

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 consult your doctor. Additionally, if you are pregnant or breastfeeding, please speak with a healthcare professional before using this 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

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 or pharmacist regarding your breastfeeding status when considering treatment options.

Pediatric Use

If your child is 2 years old or older, you can use the spray product on the affected area up to 3 to 4 times a day. However, if your child is under 2 years of age, it's important to consult a doctor before using this product. Always ensure you follow these guidelines to keep your child safe and healthy.

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 responses to medications, you should always consult with a healthcare provider before starting any new medication. They can help determine the right dosage and monitor for any potential side effects, ensuring that the treatment is safe and effective for you or your loved one.

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 usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment plan.

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 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 your safety and the proper use of the product, it’s important to store it correctly. Keep it in a cool, dry place, avoiding temperatures above 104°F (40°C) and never exceeding 120°F (49°C). This helps maintain its effectiveness and safety.

When handling the product, remember that it is flammable, so keep it away from fire, flames, and heat sources. Avoid using it while smoking or near any open flames. Additionally, do not puncture or incinerate the container, as it is under pressure and could pose a risk. Following these guidelines will help you use the product safely and effectively.

Additional Information

You should apply this topical product by spraying it on the affected area, up to 3 to 4 times a day if you are an adult or a child aged 2 years and older. If the user is under 2 years old, it's important to consult a doctor first.

If you are pregnant or breastfeeding, make sure to ask a healthcare professional before using this product. Always keep it out of reach of children, and if the product is swallowed, seek help immediately or contact a Poison Control Center.

FAQ

What is the drug used for?

The drug is used for the temporary relief of minor aches and pains of muscles and joints associated with conditions like arthritis, simple backache, muscle strains, bruises, and sprains.

How should I use this product?

For adults and children 2 years of age and older, spray the product on the affected area no more than 3 to 4 times daily. For children under 2 years of age, consult a doctor.

Are there any warnings I should be aware of?

Yes, the product is for external use only and is flammable. Keep it away from fire or flame, and avoid contact with eyes and mucous membranes.

What should I do if I swallow the product?

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

What should I do if my condition worsens?

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

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

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

Are there any contraindications for this drug?

No contraindications are listed in the provided information.

What should I avoid while using this product?

Avoid using the product while smoking or near heat or flame, and do not apply it to wounds or damaged skin.

Packaging Info

Below are the non-prescription pack sizes of Cold and Hot (menthol 7.6% mehyl salicylate 29.0%). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Cold and Hot.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The product is identified by the SPL code 34089-3. No additional relevant details are available regarding its chemical composition, structural formula, inactive ingredients, or other characteristics.

Uses and Indications

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

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

Dosage and Administration

The product should be shaken well prior to use. For adults and children aged 2 years and older, the recommended administration involves spraying the product onto the affected area, with a maximum frequency of 3 to 4 times daily. For children under 2 years of age, it is advised to consult a healthcare professional before use.

Contraindications

There are no specific contraindications listed for this product. However, it is imperative to seek immediate assistance or contact a Poison Control Center if the product is swallowed.

Warnings and Precautions

This product is intended for external use only. It is important to note that the formulation is flammable; therefore, it must be kept away from fire or flame. Users should refrain from using the product while smoking or in proximity to heat sources. Long-term storage should not exceed temperatures of 104˚F, and the product should never be punctured or incinerated, as it is under pressure. Additionally, storage at temperatures above 120˚F is prohibited.

When applying this product, care should be taken to avoid contact with the eyes and mucous membranes. It is contraindicated for use on wounds or damaged skin, and users should not apply a tight bandage over the area. The product should only be used as directed to ensure safety and efficacy.

Patients are advised to discontinue use and consult a healthcare professional if any of the following occur: the condition worsens, symptoms persist for more than 7 days, symptoms resolve and then recur within a few days, or if the product is needed for longer than one week.

For individuals who are pregnant or breastfeeding, it is essential to seek advice from a healthcare professional prior to using this product to ensure safety for both the mother and child.

Side Effects

Patients should be aware that this product is for external use only and is flammable. It is essential to keep the product away from fire or flame, refrain from using it while smoking or near heat sources, and avoid long-term storage above 104°F. The contents are under pressure; therefore, puncturing or incinerating the container is prohibited, and storage should not exceed temperatures of 120°F.

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

Patients are advised to stop using the product and consult a healthcare professional if the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Additionally, if the product is needed for longer than 1 week, medical advice should be sought. Pregnant or breastfeeding individuals should consult a health professional before use.

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 Cold and Hot (menthol 7.6% mehyl salicylate 29.0%). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Cold and Hot.
Details

Pediatric Use

Pediatric patients aged 2 years and older may use the spray product on the affected area, with a maximum application frequency of 3 to 4 times daily. For children under 2 years of age, it is advised to consult a doctor prior to use.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in efficacy, given the lack of targeted data for 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 considered, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to discuss their individual circumstances with a healthcare provider 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 specific data available regarding the excretion of this medication in 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 data 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 lack of information necessitates careful clinical judgment and monitoring.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to 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 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 implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective treatment and follow-up care.

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 the potential toxicological profile in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the provided data.

Patient Counseling

Healthcare providers should advise patients that in the event of accidental ingestion, it is crucial to seek immediate assistance. Patients should be instructed to contact a Poison Control Center or seek help without delay. This information is vital for ensuring patient safety and prompt intervention in case of an emergency.

Storage and Handling

This product is supplied in a pressurized container and must be handled with care due to its flammable nature. It is essential to keep the product away from fire, flame, and heat sources. Users are advised not to use the product while smoking or in proximity to any heat or flame.

For optimal storage, it is crucial to avoid long-term exposure to temperatures exceeding 104°F. Additionally, the product should not be stored at temperatures above 120°F. Puncturing or incinerating the container is strictly prohibited, as it is under pressure and may pose safety risks. Proper handling and storage conditions are vital to ensure the safety and efficacy of the product.

Additional Clinical Information

The product is administered topically, with a recommended application of the spray on the affected area for adults and children aged 2 years and older, not exceeding 3 to 4 times daily. For children under 2 years of age, consultation with a healthcare provider is advised prior to use.

Clinicians should counsel patients to seek advice from a health professional if they are pregnant or breastfeeding. It is important to keep the product out of reach of children, and in the event of accidental ingestion, immediate assistance should be sought by contacting a Poison Control Center.

Drug Information (PDF)

This file contains official product information for Cold and Hot, 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 Cold and Hot, 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.