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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
Product Quest Mfg, LLC
Registration number
part348
NDC root
64048-3334
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 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 them. Always follow these guidelines to help manage your condition effectively.

What to Avoid

It's important to be aware of specific instructions regarding the use of this medication. If you accidentally swallow it, seek help immediately or contact a Poison Control Center. This is crucial for your safety.

Currently, there are no listed contraindications, controlled substance classifications, or concerns about abuse, misuse, or dependence (a condition where your body becomes reliant on a substance). Always prioritize your health and safety by following these guidelines.

Side Effects

When using this product, it's important to be aware of some potential side effects and safety warnings. You should only use it externally and avoid contact with your eyes and mucous membranes. If you notice that your condition worsens, symptoms last more than seven days, or if they improve and then return shortly after, stop using the product and consult your doctor. Additionally, if you are pregnant or breastfeeding, it's best to speak with a healthcare professional before using it.

Please remember that this product is flammable, so keep it away from fire, flames, and heat sources. Avoid storing it in places that exceed 104°F and do not puncture or incinerate the container, as it is under pressure. Always use the product as directed and do not apply it to wounds or damaged skin.

Warnings and Precautions

This product is for external use only, so please avoid using it on your eyes, mucous membranes, or any wounds and damaged skin. It is also flammable, so keep it away from fire, flames, and heat sources. Do not store it in temperatures above 120°F, and avoid long-term storage above 104°F. Always use the product as directed and do not apply tight bandages over it.

If you notice that 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 contact your doctor. If you are pregnant or breastfeeding, consult a healthcare professional before use. In case of accidental swallowing, seek emergency 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 effects of an overdose for this medication, you should be aware of general signs that may indicate a problem. These can include unusual drowsiness, confusion, or difficulty breathing.

If you notice any of these symptoms or have concerns about a possible overdose, seek medical help right away. It's always better to err on the side of caution when it comes to your health. Remember, if you are ever in doubt, contacting a healthcare professional is the best course of action.

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 your child is under 2 years old, it's important to consult a doctor before using this product. For children aged 2 years and older, you can apply the spray 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 your child's safety and well-being.

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 benefits with a healthcare provider. They can help determine if this medication is appropriate and whether any adjustments are needed based on individual health conditions.

Always keep in mind that older adults may have different health needs, and medications can affect them differently. Regular check-ins with your healthcare provider can ensure that any treatment remains safe and effective.

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 safety considerations and monitoring practices for patients with renal impairment (kidney issues) are not detailed.

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 provide guidance tailored to your specific 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 medication use. They can help ensure that you receive the safest and most effective treatment based on your individual needs.

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 away from fire, flames, and heat sources, as it is flammable. Avoid storing it in places where temperatures exceed 104°F (40°C) for long periods, and never store it above 120°F (49°C).

When handling the product, do not puncture or incinerate it, as the contents are under pressure and can be dangerous. Additionally, refrain from using it while smoking or near any heat sources to prevent accidents. 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 it 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 drug?

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. Consult a doctor for children under 2 years of age.

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, if symptoms persist for more than 7 days, or if symptoms clear up and occur again within a few days.

Can I use this drug 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 for this drug.

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

No relevant information is available for SPL code 34089-3.

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 doctor before use.

Contraindications

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

Warnings and Precautions

For external use only. This product is flammable; therefore, it is imperative to keep it away from fire or flame. Users should refrain from using the product while smoking or near heat sources. 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 discouraged. It is essential to use the product only as directed to ensure safety and efficacy.

Users are advised to discontinue use 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. If the product is needed for longer than one week, medical advice should be sought. Pregnant or breastfeeding individuals should consult a health professional before using this product.

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

Side Effects

Patients should be aware of several important warnings associated with the use of this product. It is intended for external use only and is flammable; therefore, it should be kept away from fire or flame. Patients are advised not to use the product while smoking or near heat sources and to avoid long-term storage above 104°F. Additionally, the product should not be punctured or incinerated, as it contains contents under pressure, and should not be stored at temperatures exceeding 120°F.

When using this product, patients should avoid contact with the eyes and mucous membranes. It is also important not to apply the product to wounds or damaged skin and to refrain from bandaging tightly. The product should be used only as directed.

Patients are instructed to stop use 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. Furthermore, if the product is needed for longer than 1 week, patients should seek medical advice. Pregnant or breastfeeding individuals are encouraged to consult a health professional before using this product.

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 under 2 years of age should consult a doctor prior to use. For children aged 2 years and older, the recommended dosage involves applying the spray product 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. It is essential to evaluate the potential risks and benefits associated with the use of this drug during pregnancy and lactation. Healthcare providers should consider the available data and individual patient circumstances when advising on the use of this medication in these populations.

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

There is no specific information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

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 an overdosage, there is currently no specific information available regarding the effects or management of such an occurrence. Healthcare professionals are advised to monitor the patient closely and provide supportive care as needed. It is essential to assess the patient's clinical status and implement standard emergency protocols for overdose situations.

In the absence of detailed guidance, practitioners should consider consulting local poison control centers or relevant medical literature for additional support and recommendations on managing potential overdosage scenarios.

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 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 classified as flammable and must be kept away from fire or flame. It is imperative that the product is not used while smoking or in proximity to heat sources or open flames.

For optimal storage, it is essential to avoid long-term exposure to temperatures exceeding 104°F. Additionally, the product should not be stored at temperatures above 120°F. Care should be taken to ensure that the container is not punctured or incinerated, as the contents are under pressure.

Healthcare professionals are advised to adhere strictly to these storage and handling guidelines to ensure safety and product integrity.

Additional Clinical Information

The product is administered topically, with a recommended application frequency of 3 to 4 times daily for adults and children aged 2 years and older. For children under 2 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. It is important to keep the product out of reach of children, and in the event of 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.