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K2 Cold Therapy

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Active ingredient
Menthol 10 g/100 mL
Other brand names
Dosage form
Liquid
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2014
Label revision date
January 9, 2018
Active ingredient
Menthol 10 g/100 mL
Other brand names
Dosage form
Liquid
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2014
Label revision date
January 9, 2018
Manufacturer
The Podiatree Co
Registration number
part348
NDC root
54633-414

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Drug Overview

This medication is designed to temporarily relieve minor pain associated with various conditions, including arthritis, simple backache, muscle strains, and sprains. It works by targeting the sources of pain to help you feel more comfortable and manage your symptoms effectively.

If you're dealing with any of these types of pain, this medication may provide the relief you need to go about your daily activities with less discomfort. Always consult with a healthcare professional for personalized advice and to ensure it's the right option for you.

Uses

If you're dealing with minor pain from conditions like arthritis, simple backaches, muscle strains, or sprains, this medication can provide temporary relief. It's designed to help ease discomfort so you can go about your daily activities with less pain.

Rest assured, there are no concerns regarding teratogenic effects (which means it doesn't cause birth defects) or nonteratogenic effects (which refers to other types of harmful effects during pregnancy) associated with this medication. This makes it a safer option for those who may be concerned about these issues.

Dosage and Administration

When using this medication, you should apply a thin layer to the affected area. For adults and children aged 12 years and older, you can do this up to 3 to 4 times a day. If the person using the medication is 12 years old or younger, it’s important to consult a doctor before use to ensure safety and proper guidance.

After each application, make sure to close the cap tightly to keep the medication effective and prevent contamination. Following these steps will help you use the medication safely and effectively.

What to Avoid

It's important to use this product safely to avoid any potential issues. You should not bandage tightly or use it with a heating pad, as this can lead to complications. Additionally, avoid applying the product to wounds or any damaged, broken, or irritated skin to ensure your safety and the effectiveness of the treatment. By following these guidelines, you can help protect your health while using this product.

Side Effects

This product is intended for external use only. You should stop using it and consult a doctor if your condition worsens, if you notice any redness or irritation, or if your symptoms persist for more than seven days. Additionally, if your symptoms improve and then come back within a few days, it's important to seek medical advice.

Warnings and Precautions

This product is for external use only, so please avoid swallowing it. If you accidentally ingest it, seek emergency medical help or contact a Poison Control Center immediately.

You should stop using this product and call your doctor if your condition worsens, if you notice any redness or irritation, or if your symptoms last more than 7 days or improve only to come back within a few days. It's important to monitor your response to the treatment and take these precautions seriously to ensure your safety and well-being.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While the specific signs of an overdose are not detailed, common 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 crucial to provide them with as much information as possible about the substance taken and the amount, if known. 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 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 12 years old or younger, it's important to consult a doctor before using this medication. For adults and children aged 12 and older, you can apply a thin layer of the medication to the affected area, but be sure not to do this more than 3 to 4 times a day. Always follow these guidelines to ensure safe and effective use.

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 if you or a loved one is an older adult, it’s important to consult with a healthcare provider before starting the medication. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

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 determine the best approach based on your liver function and overall health.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking. In this case, there are no specific drug interactions or laboratory test interactions noted, which means that this medication is generally considered safe to use alongside other treatments and tests. However, every individual is different, and your healthcare provider can help ensure that your overall treatment plan is safe and effective for you. Always feel free to ask questions or express any concerns you may have regarding your medications or tests.

Storage and Handling

To ensure the best performance of your product, store it at a controlled room temperature. This means keeping it in a place that is neither too hot nor too cold, typically around 20-25°C (68-77°F). It's important to handle the bottle carefully; avoid shaking it when the cap is removed, as this can affect the product's effectiveness.

Always remember to keep the product in a safe, dry place away from direct sunlight and extreme temperatures. Following these simple storage and handling guidelines will help maintain the quality and safety of your product.

Additional Information

You should apply a thin layer of the medication to the affected area on your skin, using it no more than 3 to 4 times a day if you are an adult or a child aged 12 years and older. If the patient is younger than 12 years, 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 is the general use of this drug?

This drug temporarily relieves minor pain associated with conditions such as arthritis, simple backache, muscle strains, and sprains.

How should adults and children 12 years of age and older use this drug?

Apply a thin layer over the affected area not more than 3 to 4 times daily.

What should children 12 years of age and younger do before using this drug?

Consult a doctor before use.

Are there any teratogenic effects associated with this drug?

No teratogenic effects are mentioned.

What precautions should I take when using this drug?

Use only as directed, avoid contact with eyes and mucous membranes, and do not apply to wounds or damaged skin.

What should I do if my condition worsens or irritation develops?

Stop use and ask a doctor if your condition worsens, redness is present, irritation develops, or symptoms persist for more than 7 days.

Is this drug safe for use during pregnancy or breastfeeding?

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

What should I do if I accidentally swallow this drug?

Get medical help or contact a Poison Control Center right away if swallowed.

How should I store this drug?

Store at controlled room temperature and do not shake the bottle with the cap removed.

Packaging Info

Below are the non-prescription pack sizes of K2 Cold Therapy (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for K2 Cold Therapy.
Details

Drug Information (PDF)

This file contains official product information for K2 Cold Therapy, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

The drug is presented with a principal display panel as indicated in the package label. The effective date of the insert is April 1, 2014. Additionally, the insert contains a reference to an image of the label, which is formatted in JPEG.

Uses and Indications

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

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

Dosage and Administration

Adults and children 12 years of age and older should apply a thin layer of the medication over the affected area, not exceeding 3 to 4 applications per day. For children under 12 years of age, it is recommended to consult a doctor prior to use.

After each application, ensure that the cap is closed tightly to maintain the integrity of the product.

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 exacerbate 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. It is imperative that healthcare professionals advise patients to adhere strictly to this guideline to prevent potential adverse effects associated with inappropriate use.

In the event of accidental ingestion, immediate medical assistance should be sought. Patients or caregivers are advised to contact a Poison Control Center or seek emergency medical help without delay.

Healthcare professionals should instruct patients to discontinue use and consult their physician if any of the following occur: worsening of the condition, the presence of redness, development of irritation, or if symptoms persist for more than 7 days. Additionally, if symptoms resolve and then reoccur within a few days, patients should also seek medical advice. Monitoring for these signs is crucial to ensure patient safety and effective management of their condition.

Side Effects

For external use only. Patients should discontinue use and consult a healthcare professional if any of the following occur: the condition worsens, redness is present, irritation develops, or symptoms persist for more than 7 days or clear up and then reoccur within a few days.

Drug Interactions

No specific drug interactions have been identified for the product. 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 K2 Cold Therapy (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for K2 Cold Therapy.
Details

Pediatric Use

Pediatric patients 12 years of age and younger should consult a doctor before use. For those aged 12 years and older, the recommended application is a thin layer over the affected area, not to exceed 3 to 4 times daily.

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 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 mothers.

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

Additionally, it is recommended to contact a poison control center or consult relevant clinical guidelines for further management strategies tailored to the specific circumstances of the overdose.

Documentation of the incident, including the substance involved, the amount ingested, and the time of ingestion, 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 assessment of potential risks associated with the compound in these areas.

Postmarketing Experience

No postmarketing experience details are available for SPL code 90375-7.

Patient Counseling

Patients should be advised to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed.

Healthcare providers should instruct patients to discontinue use and consult a doctor if any of the following occur: the condition worsens, redness appears, irritation develops, or symptoms persist for more than 7 days, or if symptoms clear up and then reoccur within a few days.

When using this product, patients must be reminded to use it only as directed. They should be cautioned against bandaging tightly or using the product in conjunction with a heating pad. It is important to avoid contact with the eyes and mucous membranes, and patients should not apply the product to wounds or to damaged, broken, or irritated skin.

Storage and Handling

The product is supplied in a bottle that must be stored at controlled room temperature. It is essential to avoid shaking the bottle when the cap is removed to maintain the integrity of the product.

Additional Clinical Information

The medication is administered topically, with a recommended application of a thin layer over the affected area for adults and children aged 12 years and older, not exceeding 3 to 4 times daily. For children under 12 years of age, consultation with a doctor is advised prior to use. There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for K2 Cold Therapy, 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 K2 Cold Therapy, 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.