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X-Treme Freeze

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Active ingredient
Menthol 4 g/100 mL
Other brand names
Dosage form
Gel
Route
Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 2018
Label revision date
January 22, 2026
Active ingredient
Menthol 4 g/100 mL
Other brand names
Dosage form
Gel
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 2018
Label revision date
January 22, 2026
Manufacturer
Dynarex Corporation
Registration number
M017
NDC root
67777-144

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Drug Overview

You may find this medication helpful for temporary relief from minor aches and pains associated with sore muscles and joints, including those related to arthritis, backaches, strains, and sprains. It works by providing penetrating pain relief, helping you feel more comfortable during your daily activities. This medication has been effective since August 17, 2018, making it a trusted option for managing discomfort.

Uses

You can use this medication for temporary relief from minor aches and pains in sore muscles and joints. This includes discomfort associated with conditions like arthritis, backaches, strains, and sprains. It works by providing penetrating pain relief, helping you feel more comfortable during your daily activities.

Rest assured, there are no teratogenic effects (which means it doesn't cause birth defects) associated with this medication, making it a safer option for those concerned about such risks.

Dosage and Administration

If you are an adult or a child aged 2 years or older, you can apply this medication to the affected area up to 3 to 4 times a day. Make sure to follow this guideline to ensure the best results.

However, if your child is under 2 years old, it’s important not to use this medication without first consulting a doctor. Always prioritize safety and seek professional advice when it comes to younger children.

What to Avoid

It's important to use this medication safely to ensure your well-being. You should never apply it to wounds or damaged skin, as this can lead to complications. Additionally, avoid bandaging the area tightly after application, as this may interfere with the medication's effectiveness and could cause discomfort.

While there are no specific contraindications or concerns about abuse, misuse, or dependence associated with this medication, following these guidelines will help you use it properly and safely. Always consult with your healthcare provider if you have any questions or concerns about your treatment.

Side Effects

When using this product, it's important to avoid contact with your eyes and not to apply it to wounds or damaged skin. Additionally, do not bandage the area tightly. If your condition worsens, or if symptoms last more than seven days or return after clearing up, you should stop using the product and consult a doctor.

Keep this product out of reach of children. If swallowed, seek medical help immediately by contacting a physician or the Poison Control Center at 1-800-222-1222.

Warnings and Precautions

This product is for external use only, so please avoid applying it to your eyes, wounds, or any damaged skin. Additionally, do not wrap the area tightly after application.

If your condition worsens, or if your symptoms last more than seven days or improve and then return within a few days, stop using the product and consult your doctor.

In case of accidental ingestion, seek emergency medical help immediately by contacting a physician or the Poison Control Center at 1-800-222-1222.

Overdose

If you or someone else has swallowed too much of this medication, it’s important to seek medical help immediately. You should contact a physician or call the Poison Control Center at 1-800-222-1222 without delay.

Signs of an overdose can vary, but they may include unusual symptoms that are not typical for you. If you notice any concerning changes in your health after taking the medication, don’t hesitate to reach out for help. Remember, acting quickly can make a significant difference in ensuring safety and health.

Pregnancy Use

If you are pregnant or planning to become pregnant, it’s important to consult with a healthcare professional before using this medication. They can provide guidance tailored to your specific situation and help you understand any potential risks. Always prioritize your health and the health of your baby 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 receive personalized advice and understand any potential risks to you and your baby. Always prioritize your health and your baby's well-being by seeking guidance from a trusted medical expert.

Pediatric Use

If your child is under 2 years old, it's important not to use this medication without first consulting a doctor. For children aged 2 years and older, you can apply the medication 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

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 considering this medication, it’s important to consult with a healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken.

Always ensure that your healthcare provider is aware of your age and any existing health conditions, as they can provide personalized advice and monitor for any potential issues. Your safety and well-being are the top priority.

Renal Impairment

If you have kidney problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or safety considerations for your condition. This means that there are no tailored guidelines for how this medication may affect you if your kidneys are not functioning properly.

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your kidney health. They can help monitor your condition and make any necessary adjustments to 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 should be used if you have hepatic impairment (issues with liver function).

Before starting any new medication, including this one, you should discuss your liver health with your healthcare provider. They can help determine the best approach for your treatment and ensure your safety.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you. Always share your complete list of medications and any recent lab tests to avoid any potential issues. Your health and safety should always come first.

Storage and Handling

To ensure the safety and effectiveness of your product, store it in a cool, dry place. This helps maintain its quality and prevents any degradation. Always check the packaging for a tamper-evident seal before use; if the seal is damaged, do not use the product, as this could indicate contamination or that it has been compromised. Following these simple guidelines will help you use the product safely and effectively.

Additional Information

No further information is available.

FAQ

What is the primary use of this drug?

This drug provides temporary relief from minor aches and pains of sore muscles and joints associated with arthritis, backache, strains, and sprains.

How often can I apply this drug?

Adults and children 2 years of age or older can apply it to the affected area not more than 3 to 4 times daily.

Are there any contraindications for this drug?

No specific contraindications are mentioned for this drug.

What should I do if I experience worsening symptoms?

You should stop using the product and ask a doctor if your condition worsens or if symptoms last more than 7 days.

Is this drug safe for children under 2 years of age?

No, do not use this drug for children under 2 years of age without consulting a doctor.

What precautions should I take when using this drug?

Avoid contact with eyes, do not apply to wounds or damaged skin, and do not bandage tightly.

What should I do if the drug is swallowed?

If swallowed, get medical help immediately by contacting a physician or Poison Control Center at 1-800-222-1222.

Is there any information about use during pregnancy or breastfeeding?

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

How should I store this drug?

Store the drug in a cool, dry place and do not use it if the seal is damaged.

Packaging Info

Below are the non-prescription pack sizes of X-Treme Freeze (cold therapy gel). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for X-Treme Freeze.
Details

Drug Information (PDF)

This file contains official product information for X-Treme Freeze, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with sore muscles and joints, including those related to arthritis, backache, strains, and sprains. It provides penetrating pain relief to alleviate discomfort in these conditions.

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

Dosage and Administration

For adults and children aged 2 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 2 years of age, the product should not be used without consulting a healthcare professional. It is essential to seek medical advice before administering this treatment to this age group.

Contraindications

The product should not be applied to wounds or damaged skin due to the potential for irritation or adverse reactions. Additionally, it is contraindicated to bandage tightly, as this may impede circulation and lead to further complications.

Warnings and Precautions

For external use only. It is imperative to avoid contact with the eyes. The product should not be applied to wounds or damaged skin, and tight bandaging is contraindicated.

Healthcare professionals should advise patients to discontinue use and seek medical advice if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days.

In the event of accidental ingestion, immediate medical assistance is required. Patients should be instructed to contact a physician or the Poison Control Center at 1-800-222-1222 without delay.

Side Effects

Patients using this product should be aware that it is intended for external use only. It is crucial to avoid contact with the eyes and to refrain from applying the product to wounds or damaged skin. Additionally, patients should not bandage the area tightly after application.

In clinical practice, patients are advised to discontinue use and consult a healthcare professional if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days.

Furthermore, this product should be kept out of reach of children. In the event of accidental ingestion, it is imperative to seek medical assistance immediately by contacting a physician or the Poison Control Center at 1-800-222-1222.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

Below are the non-prescription pack sizes of X-Treme Freeze (cold therapy gel). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for X-Treme Freeze.
Details

Pediatric Use

Pediatric patients under 2 years of age should not use this medication without consulting a doctor. For children aged 2 years and older, the recommended application is to the affected area no more than 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 adverse effects or changes in therapeutic response, given the potential for altered pharmacokinetics and pharmacodynamics in this population.

Pregnancy

Pregnant patients should consult a healthcare professional prior to using this medication. The safety of this drug during pregnancy has not been established, and potential risks to fetal outcomes are not fully understood. It is essential for women of childbearing potential to discuss their individual circumstances with their healthcare provider to weigh the benefits and risks associated with the use of this medication during pregnancy.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is 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 drug insert 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 there is no available data to guide dosing or monitoring in this population.

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 prescribing information.

Overdosage

In the event of an overdosage, immediate medical assistance is crucial. If the substance is ingested, it is imperative to seek medical help without delay. Healthcare professionals should advise patients or caregivers to contact a physician or the Poison Control Center at 1-800-222-1222 for guidance.

Prompt intervention is essential to manage potential complications associated with overdosage. The healthcare provider should assess the patient's condition and determine the appropriate course of action based on the severity of the symptoms and the amount ingested. Monitoring and supportive care may be necessary, depending on the clinical presentation.

Nonclinical Toxicology

There is currently no available information regarding teratogenic effects, non-teratogenic effects, or any specific findings in the nonclinical toxicology section. Additionally, there are no details provided concerning animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are provided in the insert.

Patient Counseling

Patients should be advised to seek immediate medical assistance if the product is swallowed, including contacting a physician or the Poison Control Center at 1-800-222-1222.

Healthcare providers should instruct patients to discontinue use and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days.

While using this product, patients must be cautioned to avoid contact with the eyes. They should also be informed not to apply the product to wounds or damaged skin and to refrain from tightly bandaging the area where the product is applied.

Storage and Handling

The product is supplied in a tamper-evident container. It is essential to inspect the seal before use; do not use the product if the seal is damaged.

For optimal storage, the product should be kept in a cool, dry place to maintain its integrity and effectiveness.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for X-Treme Freeze, 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 X-Treme Freeze, 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.