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K2 Cold Therapy

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This product has been discontinued

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
April 18, 2014
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
April 18, 2014
Manufacturer
The Podiatree Co
Registration number
part348
NDC root
54633-201

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Drug Overview

K2 Cold Therapy is a topical treatment designed to temporarily relieve minor pain associated with conditions such as arthritis, simple backache, muscle strains, and sprains. By applying this product to the affected area, you can experience soothing relief from discomfort, helping you to manage your pain more effectively.

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 about teratogenic effects (which means it won't cause birth defects) associated with this medication. This makes it a safer option for those who may be pregnant or planning to become pregnant.

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 applying it.

After each use, make sure to close the cap tightly to keep the medication effective and safe for future use. Always follow these guidelines to ensure the best results from your treatment.

What to Avoid

It's important to use this medication safely to avoid any potential issues. You should not bandage the area tightly or use a heating pad while using this product. Additionally, make sure not to apply it to any wounds or areas of skin that are damaged, broken, or irritated, as this could lead to complications.

By following these guidelines, you can help ensure that you use the medication effectively and safely. If you have any questions or concerns about its use, don't hesitate to reach out to your healthcare provider for more information.

Side Effects

When using this product, it's important to be aware of potential side effects. You should stop using it if your condition worsens, if you notice redness or irritation, or if your symptoms persist for more than 7 days or return shortly after improving.

Additionally, remember that this product is for external use only and is flammable, so keep it away from fire, sparks, and heated surfaces. Always prioritize your safety while using any topical treatment.

Warnings and Precautions

This product is for external use only, so please avoid applying it to any internal areas. It is also flammable, so keep it away from fire, sparks, and heated surfaces to prevent any accidents. Always store it out of reach of children, and if it is swallowed, seek 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 come back after clearing up. Your health and safety are important, so please take these precautions seriously.

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.

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. This ensures that the treatment is safe and appropriate for their age and health needs. Always prioritize professional guidance when it comes to the health of your little ones.

Geriatric Use

When considering K2 Cold Therapy (menthol liquid) for older adults, it's important to note that the drug insert does not provide specific information about its use in this age group. This means there are no established guidelines for dosage adjustments, safety concerns, or special precautions tailored for elderly patients.

As a caregiver or an older adult, you should approach the use of this product with caution, especially if there are underlying health conditions or other medications involved. Always consult with a healthcare professional before starting any new treatment to ensure it is safe and appropriate for your individual needs.

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.

It's always best to consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your situation. They can provide guidance tailored to your kidney health and any necessary monitoring.

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. 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.

By following these simple storage and handling guidelines, you can help maintain the quality and safety of the product. Always remember to keep it in a stable environment to ensure optimal use.

Additional Information

You should apply a thin layer of the medication to the affected area on your skin, not 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, it's important to consult a doctor before use.

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

FAQ

What is K2 Cold Therapy used for?

K2 Cold Therapy is used to temporarily relieve minor pain associated with arthritis, simple backache, muscle strains, and sprains.

How should I apply K2 Cold Therapy?

Apply a thin layer over the affected area not more than 3 to 4 times daily for adults and children 12 years of age and older. Consult a doctor for children 12 years of age or younger.

Are there any warnings I should be aware of?

Yes, K2 Cold Therapy is for external use only and is flammable; keep it away from fire, sparks, and heated surfaces.

What should I do if my condition worsens while using K2 Cold Therapy?

If your condition worsens, redness is present, irritation develops, or symptoms persist for more than 7 days, stop use and call your doctor.

Can I use K2 Cold Therapy if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, you should ask a health professional before using K2 Cold Therapy.

What should I do if I accidentally swallow K2 Cold Therapy?

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

Are there any contraindications for using K2 Cold Therapy?

No specific contraindications are mentioned for K2 Cold Therapy.

How should I store K2 Cold Therapy?

Store K2 Cold Therapy 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

K2 Cold Therapy is a therapeutic product designed for the management of pain and inflammation. It is formulated to provide localized cold therapy, which can aid in reducing swelling and discomfort associated with various musculoskeletal conditions. The product is typically utilized in clinical settings and may be indicated for post-operative care, sports injuries, and other acute pain scenarios. K2 Cold Therapy is characterized by its ease of application and effectiveness in delivering cold treatment to targeted areas.

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

For adults and children aged 12 years and older, a thin layer of the medication should be applied to the affected area no more than 3 to 4 times daily. It is important to ensure that the cap is closed tightly after each use to maintain the integrity of the product.

For children under 12 years of age, it is advised to consult a healthcare professional before use to determine the appropriate course of action.

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. This product is flammable; therefore, it must be kept away from fire, sparks, and heated surfaces to prevent any risk of ignition.

It is essential to keep this product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact a Poison Control Center without delay.

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

In cases of ingestion, it is critical to obtain emergency medical help or contact a Poison Control Center immediately.

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions. This product is intended for external use only and is flammable; therefore, it should be kept away from fire, sparks, and heated surfaces.

In the event of adverse reactions, patients are advised to discontinue use if any of the following occur: the condition worsens, redness is present, irritation develops, or if symptoms persist for more than 7 days or clear up and then reoccur within a few days. These reactions may indicate a need for further evaluation or alternative treatment options.

It is essential for patients to monitor their response to the product and seek medical advice if any concerning symptoms arise.

Drug Interactions

There are no specific drug interactions identified for this medication. Additionally, no laboratory test interactions have been reported. 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 or younger should consult a doctor prior to use. It is important for healthcare professionals to evaluate the appropriateness of treatment in this age group, considering potential differences in dosage and safety profiles compared to older populations.

Geriatric Use

There is no specific information regarding the use of K2 Cold Therapy (menthol liquid) in geriatric patients. The prescribing information does not provide guidance on dosage adjustments, safety concerns, or special precautions for elderly patients. Therefore, healthcare providers should exercise caution and consider individual patient factors when prescribing this medication to geriatric patients, as the absence of specific data necessitates careful monitoring and assessment of treatment efficacy and safety in this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing infant.

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 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 of these patients.

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 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 assessment of potential risks associated with the compound in these areas.

Postmarketing Experience

No postmarketing experience details are available in the provided data.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children. In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately.

Patients should be informed to monitor their condition closely. They should report to their healthcare provider if their condition worsens, if redness is present, or if any irritation develops. Additionally, patients should be instructed to seek medical advice if symptoms persist for more than 7 days or if symptoms clear up and then reoccur within a few days.

It is essential to emphasize that patients must use the medication only as directed. They should be cautioned against bandaging the area tightly or using a heating pad in conjunction with the treatment. Patients should also be advised to avoid contact with the eyes and mucous membranes, and to refrain from applying the medication to wounds or any damaged, broken, or irritated skin.

Storage and Handling

The product is supplied in a container 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 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 also important to instruct patients to keep the medication out of reach of children and to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed.

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.

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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.